Clinical trial NCT02630719
Conditions: Migraine
Keywords: headache
Sponsor: University of Missouri, Kansas City
Start date: 2016-01-01; Completion date: 2017-08-01
Enrollment: 10 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The goal of this study is to determine whether timolol eye drops are effective in alleviating acute migraine headaches. Subjects will be randomized to receive either timolol eye drops or placebo (tears) to use as a migraine abortive medication.

Detailed description:

Arms: arm 1: All subjects received timolol eye drops or placebo (artificial tears) for two months then crossed over to the opposite medication for the final two months of the study. arm 2: All subjects received timolol eye drops or placebo (artificial tears) for two months then crossed over to the opposite medication for the final two months of the study.
Interventions: intervention 1: Timolol eye drops intervention 2: Artificial tears
Intervention descriptions: intervention 1: eye drops intervention 2: Placebo drop

Protocol documents:
ICF_000.pdf: 
UMKC IRB # 15-152 
Page 1 of 5  
Version Date: 8/12/2014 
UMKC IRB 
Approved 
From: 08/04/2016 to: 05/30/2017 
CONSENT FORM FOR PARTICIPATION IN A RESEARCH STUDY 
Introduction 
You are being asked to participate in a research study. This study is being conducted at Truman 
Medical Center (TMC) and Sabates Eye Centers. 
The researchers in charge of this study are Dr. Sean Gratton, Dr. Ashley Abraham and Dr. 
Matthew Cossack. The study team is asking you to take part in this research study because you 
have a diagnosis of migraine headaches.  Research studies only include people who choose to 
take part.  Please read this consent form carefully and take your time making your decision. The 
study doctors will go over this consent form with you. Ask him/her to explain anything that you 
do not understand.  Think about it and talk it over with your family and friends before you decide 
if you want to take part in this research study. This consent form explains what to expect: the 
risks, discomforts, and benefits, if any, if you consent to be in the study. 
Background 
According to the American Migraine Prevalence and Prevention study, migraine affects 29.5 
million Americans. Of those affected by migraine headache, 51% reported reduced work or 
school productivity; and, as the third leading cause of emergency room visits, migraine headache 
represents a significant burden for patients and healthcare systems. Treatments for migraines do 
not always work well. This research study will look at a treatment that may work well and is 
fast-acting. 
Purpose 
The purpose of this study is to look at how well of the use of eye drops are in the treatment of 
migraine headaches. This eye drop, Timolol, is FDA approved and has been safely used for 
decades for the treatment of other medical conditions.  
You will be one of about 50 subjects in the study at Truman Medical Center and Sabates Eye 
Centers.   
Study Procedures and Treatments 
If you chose to participate in this study, the study doctor will ask you to complete a personal 
health questionnaire. A thorough medical history will be obtained prior to you being enrolled in 
this study to make sure you are qualified to participate .You will be asked to have a complete eye 
and neurological (looking at your nervous system) exam. We will check your blood pressure and 
heart rate. If you are female and of child-bearing age, you will be given a urine pregnancy test to 
make sure you are not pregnant.  If you are pregnant or breast feeding you cannot be in this 
study.  


UMKC IRB # 15-152 
 
 
 
Page 2 of 5  
Version Date: 8/12/2014 
 
 
UMKC IRB 
Approved 
From: 08/04/2016 to: 05/30/2017 
 
You will be randomly placed (like the flip of a coin) into one of two groups. One group will 
initially receive Timolol for migraine headaches. The other group will initially receive a placebo 
(eye drops that do not have any drug). You will be given the eye drops to use when you have a 
headache. You are to follow the instructions for eye drop use. You will also be given a migraine 
diary to track your symptoms and treatment. 
 
You will be asked to come back to the clinic for 4 follow up visits to discuss how you are doing 
and to monitor your health. At each visit you will have a neurologic exam as well as 
measurements of intraocular pressure (the pressure inside your eye), blood pressure, and heart 
rate. You will be asked to bring your migraine diary and your unused eye drops. We will provide 
additional drops as needed. 
 
After two months, on your third visit, we will provide you with the alternative set of drops. 
Patients who started with timolol will receive placebo and those that started with placebo will 
receive timolol. We will ask you to not use any drops for three days and then to continue with 
drop usage and journaling with the new set of drops. At the fifth and final visit, we will collect 
unused drops and your journal. 
 
All identifying information such as your name, medical record number, date of birth, etc. will be 
kept confidential.   
 
Possible Risks or Side Effects of Taking Part in this Study  
 
Side effects from Timolol eye drops are mild and rare, but may be serious in some individuals. 
Adverse reactions include eye irritation, cardiovascular (heart) and pulmonary (lungs) side 
effects. There may be additional risks of participating in this study that we do not know about.  
 
Possible Benefits for Taking Part in this Study 
 
By taking part in this study you may see improvement in your migraine symptom relief. 
Information we collect in this study may help researchers better understand migraine headaches 
and may lead to better treatment of this condition. Your symptoms may or may not get better 
from being in this study. 
 
Costs and Compensations for Taking Part in this Study  
 
There are no costs to you for being in this research study. You will not receive any payment or 
compensation for your participation.   
 
 
 
 


UMKC IRB # 15-152 
 
 
 
Page 3 of 5  
Version Date: 8/12/2014 
 
 
UMKC IRB 
Approved 
From: 08/04/2016 to: 05/30/2017 
Alternatives to Study Participation  
 
If you decide not to participate in this study, no changes will be made to your normal care.  You 
will continue to receive treatment for migraine headaches whether or not you participate in this 
study.    
 
Confidentiality and Access to your Records  
 
The Bar Code at the top of this consent form will be used to link this consent form and your 
participation in this research study to your TMC permanent medical record.  If you do not want 
this consent form or your participation in this study to be a part of your permanent medical 
record you cannot participate in this research study.    
The results of this research may be published or presented for scientific purposes. You will not 
be named in any reports of the results.  Your study or applicable medical records that have your 
identity in them may be shown to the Institutional Review Board (IRB) (a committee that 
reviews and approves research studies), the Food and Drug Administration, or other governing 
agencies. This is to prove which study procedures you completed and to check the data reported 
about you. They may also review your medical records for any treatment you received before 
you agreed to take part in this study.  This is to confirm your medical history and that you meet 
the requirements to be in this study. Information about the research study will also be available 
online at ClinicalTrials.gov. The study team will keep all information about you confidential as 
provided by law, but complete confidentiality cannot be guaranteed. 
 
If you leave the study or are removed from the study, the study data collected before you left 
may still be used along with other data collected as part of the study.  For purposes of follow-up 
studies and if any unexpected events happen, subject identification will be filed at TMC under 
appropriate security and with access limited to medical research personnel only. 
 
If you sign this consent form, you are allowing the study team and these other agencies to see 
your medical records.  
 
In Case of Injury  
 
Truman Medical Center (TMC) will provide medical attention to you in the event of any medical 
emergency while present at TMC from participation in this research, whatever the cause at the 
usual charge and you will have the benefit of the coverage of any existing health insurance you 
own.  
 
Participation in this research study does not take the place of routine physical examinations or 
clinic visits to your personal physician.  If you believe you have been injured as a result of 
participating in this study you are encouraged to contact the study investigators, Dr. Sean Gratton 
or Dr. Matthew Cossack, at (816) 404-3900. 
 


UMKC IRB # 15-152 
 
 
 
Page 4 of 5  
Version Date: 8/12/2014 
 
 
UMKC IRB 
Approved 
From: 08/04/2016 to: 05/30/2017 
The University of Missouri-Kansas City appreciates people who help it gain knowledge by being 
in research studies. It is not the University’s policy to pay for or provide medical treatment for 
persons who participate in studies.  
 
Contacts for Questions about the Study  
 
You should contact the IRB Administrator of UMKC’s Institutional Review Board at 816-235-
5927 if you have any questions, concerns or complaints about your rights as a research subject. 
You may call the researcher Dr. Matthew Cossack at (816) 404-3900 if you have any questions 
about this study. You may also call him if any problems come up.  
 


UMKC IRB # 15-152 
 
 
 
Page 5 of 5  
Version Date: 8/12/2014 
 
 
UMKC IRB 
Approved 
From: 08/04/2016 to: 05/30/2017 
 
Voluntary Participation  
 
Taking part in this research study is voluntary. If you choose to be in the study, you are free to 
stop participating at any time and for any reason. If you choose not to be in the study or decide to 
stop participating, your decision will not affect any care or benefits you are entitled to. The 
researchers, may stop the study or take you out of the study at any time 
 If they decide that it is in your best interest to do so,  
 If you experience a study-related injury,  
 If you need additional or different medication/treatment, 
 If you no longer meet the study criteria, or  
 If you do not comply with the study plan.  
 
They may also remove you from the study for other administrative or medical reasons. You will 
be told of any important findings developed during the course of this research.  
 
You have read this Consent Form or it has been read to you. You have been told why this 
research is being done and what will happen if you take part in the study, including the risks and 
benefits. You have had the chance to ask questions, and you may ask questions at any time in the 
future by calling Dr. Matthew Cossack at (816) 404-3900.  By signing this consent form, you 
volunteer and consent to take part in this research study. You will be given a copy of this consent 
form.  
 
 
 
_________________________________________  
____________________________________ 
Signature (Volunteer Subject)  
Date  
Printed Name (Volunteer Subject) 
 
 
 
_________________________________________  
____________________________________ 
Signature (Authorized Consenting Party) 
Date  
Printed Name (Authorized Consenting Party) 
 
 
 
________________________________________  
 
Relationship of Authorized Consenting 
 
 
 
Party to Subject 
 
 
_________________________________________  
____________________________________ 
Signature of Person Obtaining Consent 
Date  
Printed Name of Person Obtaining Consent 
 

SAP_002.pdf: 
Timolol Eye Drops in the Treatment of Acute Migraine Headache 
NCT 02630719 
4/22/19 
 
 
Statistical Analysis 
 
The main outcome measure was percent of migraine attacks at 0 or 1 after treatment with timolol or 
artificial tears.  A total of 198 migraine attacks were studied among 10 participants.  The groups were 
compared using a Wilcoxon match paired test to account for repeated measurements and the difference 
between the two groups was found not to be significant.  A 2-tailed chi-squared statistic suggested that 
172 randomized participants would be needed to power a study with alpha </= 0.05 and beta </= 0.2. 

Prot_001.pdf: 
Page 1 of 30
1
PROTOCOL
Expedited/Full Board Application
UMKC
Protocol # 15-152
 Date Printed: 03/26/2015
Protocol Title:
Timolol Eye Drops in the Treatment of Acute Migraine Headache
Protocol Type:
Expedited/Full Board Application
Date Submitted:
03/18/2015
Approval Period:
Draft
Important Note:
This Print View may not reflect all comments and contingencies for approval.
Please check the comments section of the online protocol.
Questions that appear to not have been answered may not have been required
for this submission. Please see the system application for more details.
-------------------------------------------------------------------------------------
* * * Personnel Information * * *
Principal Investigator
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---------------------------------------------------------------------------------------------
* * * Subject Checklist * * *
Subject Checklist


Page 2 of 30
 
2
PROTOCOL
Expedited/Full Board Application
UMKC
Protocol # 15-152
 Date Printed: 03/26/2015
Protocol Title:
Timolol Eye Drops in the Treatment of Acute Migraine Headache
Protocol Type:
Expedited/Full Board Application
Date Submitted:
03/18/2015
Approval Period:
Draft
Important Note:
This Print View may not reflect all comments and contingencies for approval.
Please check the comments section of the online protocol.
Questions that appear to not have been answered may not have been required
for this submission. Please see the system application for more details.
-------------------------------------------------------------------------------------
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* * * Study Location * * *
 
 
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Page 3 of 30
 
3
PROTOCOL
Expedited/Full Board Application
UMKC
Protocol # 15-152
 Date Printed: 03/26/2015
Protocol Title:
Timolol Eye Drops in the Treatment of Acute Migraine Headache
Protocol Type:
Expedited/Full Board Application
Date Submitted:
03/18/2015
Approval Period:
Draft
Important Note:
This Print View may not reflect all comments and contingencies for approval.
Please check the comments section of the online protocol.
Questions that appear to not have been answered may not have been required
for this submission. Please see the system application for more details.
-------------------------------------------------------------------------------------
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* * * General Checklist * * *
 
 
General Checklist
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Page 4 of 30
 
4
PROTOCOL
Expedited/Full Board Application
UMKC
Protocol # 15-152
 Date Printed: 03/26/2015
Protocol Title:
Timolol Eye Drops in the Treatment of Acute Migraine Headache
Protocol Type:
Expedited/Full Board Application
Date Submitted:
03/18/2015
Approval Period:
Draft
Important Note:
This Print View may not reflect all comments and contingencies for approval.
Please check the comments section of the online protocol.
Questions that appear to not have been answered may not have been required
for this submission. Please see the system application for more details.
-------------------------------------------------------------------------------------
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* * * Funding * * *
 
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Page 5 of 30
 
5
PROTOCOL
Expedited/Full Board Application
UMKC
Protocol # 15-152
 Date Printed: 03/26/2015
Protocol Title:
Timolol Eye Drops in the Treatment of Acute Migraine Headache
Protocol Type:
Expedited/Full Board Application
Date Submitted:
03/18/2015
Approval Period:
Draft
Important Note:
This Print View may not reflect all comments and contingencies for approval.
Please check the comments section of the online protocol.
Questions that appear to not have been answered may not have been required
for this submission. Please see the system application for more details.
-------------------------------------------------------------------------------------
 
UM Research Board
Federal Government
 
Other Gov. (i.e., State, local)
 
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Page 6 of 30
 
6
PROTOCOL
Expedited/Full Board Application
UMKC
Protocol # 15-152
 Date Printed: 03/26/2015
Protocol Title:
Timolol Eye Drops in the Treatment of Acute Migraine Headache
Protocol Type:
Expedited/Full Board Application
Date Submitted:
03/18/2015
Approval Period:
Draft
Important Note:
This Print View may not reflect all comments and contingencies for approval.
Please check the comments section of the online protocol.
Questions that appear to not have been answered may not have been required
for this submission. Please see the system application for more details.
-------------------------------------------------------------------------------------
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Page 7 of 30
 
7
PROTOCOL
Expedited/Full Board Application
UMKC
Protocol # 15-152
 Date Printed: 03/26/2015
Protocol Title:
Timolol Eye Drops in the Treatment of Acute Migraine Headache
Protocol Type:
Expedited/Full Board Application
Date Submitted:
03/18/2015
Approval Period:
Draft
Important Note:
This Print View may not reflect all comments and contingencies for approval.
Please check the comments section of the online protocol.
Questions that appear to not have been answered may not have been required
for this submission. Please see the system application for more details.
-------------------------------------------------------------------------------------
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Page 8 of 30
8
PROTOCOL
Expedited/Full Board Application
UMKC
Protocol # 15-152
 Date Printed: 03/26/2015
Protocol Title:
Timolol Eye Drops in the Treatment of Acute Migraine Headache
Protocol Type:
Expedited/Full Board Application
Date Submitted:
03/18/2015
Approval Period:
Draft
Important Note:
This Print View may not reflect all comments and contingencies for approval.
Please check the comments section of the online protocol.
Questions that appear to not have been answered may not have been required
for this submission. Please see the system application for more details.
-------------------------------------------------------------------------------------

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* * * Summary,Purpose,Background,Study Procedures * * *
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Page 9 of 30
9
PROTOCOL
Expedited/Full Board Application
UMKC
Protocol # 15-152
 Date Printed: 03/26/2015
Protocol Title:
Timolol Eye Drops in the Treatment of Acute Migraine Headache
Protocol Type:
Expedited/Full Board Application
Date Submitted:
03/18/2015
Approval Period:
Draft
Important Note:
This Print View may not reflect all comments and contingencies for approval.
Please check the comments section of the online protocol.
Questions that appear to not have been answered may not have been required
for this submission. Please see the system application for more details.
-------------------------------------------------------------------------------------
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Page 10 of 30
10
PROTOCOL
Expedited/Full Board Application
UMKC
Protocol # 15-152
 Date Printed: 03/26/2015
Protocol Title:
Timolol Eye Drops in the Treatment of Acute Migraine Headache
Protocol Type:
Expedited/Full Board Application
Date Submitted:
03/18/2015
Approval Period:
Draft
Important Note:
This Print View may not reflect all comments and contingencies for approval.
Please check the comments section of the online protocol.
Questions that appear to not have been answered may not have been required
for this submission. Please see the system application for more details.
-------------------------------------------------------------------------------------
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Page 11 of 30
11
PROTOCOL
Expedited/Full Board Application
UMKC
Protocol # 15-152
 Date Printed: 03/26/2015
Protocol Title:
Timolol Eye Drops in the Treatment of Acute Migraine Headache
Protocol Type:
Expedited/Full Board Application
Date Submitted:
03/18/2015
Approval Period:
Draft
Important Note:
This Print View may not reflect all comments and contingencies for approval.
Please check the comments section of the online protocol.
Questions that appear to not have been answered may not have been required
for this submission. Please see the system application for more details.
-------------------------------------------------------------------------------------
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Page 12 of 30
12
PROTOCOL
Expedited/Full Board Application
UMKC
Protocol # 15-152
 Date Printed: 03/26/2015
Protocol Title:
Timolol Eye Drops in the Treatment of Acute Migraine Headache
Protocol Type:
Expedited/Full Board Application
Date Submitted:
03/18/2015
Approval Period:
Draft
Important Note:
This Print View may not reflect all comments and contingencies for approval.
Please check the comments section of the online protocol.
Questions that appear to not have been answered may not have been required
for this submission. Please see the system application for more details.
-------------------------------------------------------------------------------------
 
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* * * Drugs and Devices * * *
 
 
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Drugs
Name
IND Number
Type of Research
timolol ophthalmic solution 0.5%
Treatment
Saline ophthalmic solution
Treatment
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Page 13 of 30
13
PROTOCOL
Expedited/Full Board Application
UMKC
Protocol # 15-152
 Date Printed: 03/26/2015
Protocol Title:
Timolol Eye Drops in the Treatment of Acute Migraine Headache
Protocol Type:
Expedited/Full Board Application
Date Submitted:
03/18/2015
Approval Period:
Draft
Important Note:
This Print View may not reflect all comments and contingencies for approval.
Please check the comments section of the online protocol.
Questions that appear to not have been answered may not have been required
for this submission. Please see the system application for more details.
-------------------------------------------------------------------------------------
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Page 14 of 30
14
PROTOCOL
Expedited/Full Board Application
UMKC
Protocol # 15-152
 Date Printed: 03/26/2015
Protocol Title:
Timolol Eye Drops in the Treatment of Acute Migraine Headache
Protocol Type:
Expedited/Full Board Application
Date Submitted:
03/18/2015
Approval Period:
Draft
Important Note:
This Print View may not reflect all comments and contingencies for approval.
Please check the comments section of the online protocol.
Questions that appear to not have been answered may not have been required
for this submission. Please see the system application for more details.
-------------------------------------------------------------------------------------
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Page 15 of 30
15
PROTOCOL
Expedited/Full Board Application
UMKC
Protocol # 15-152
 Date Printed: 03/26/2015
Protocol Title:
Timolol Eye Drops in the Treatment of Acute Migraine Headache
Protocol Type:
Expedited/Full Board Application
Date Submitted:
03/18/2015
Approval Period:
Draft
Important Note:
This Print View may not reflect all comments and contingencies for approval.
Please check the comments section of the online protocol.
Questions that appear to not have been answered may not have been required
for this submission. Please see the system application for more details.
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Page 16 of 30
16
PROTOCOL
Expedited/Full Board Application
UMKC
Protocol # 15-152
 Date Printed: 03/26/2015
Protocol Title:
Timolol Eye Drops in the Treatment of Acute Migraine Headache
Protocol Type:
Expedited/Full Board Application
Date Submitted:
03/18/2015
Approval Period:
Draft
Important Note:
This Print View may not reflect all comments and contingencies for approval.
Please check the comments section of the online protocol.
Questions that appear to not have been answered may not have been required
for this submission. Please see the system application for more details.
-------------------------------------------------------------------------------------
 
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Page 17 of 30
17
PROTOCOL
Expedited/Full Board Application
UMKC
Protocol # 15-152
 Date Printed: 03/26/2015
Protocol Title:
Timolol Eye Drops in the Treatment of Acute Migraine Headache
Protocol Type:
Expedited/Full Board Application
Date Submitted:
03/18/2015
Approval Period:
Draft
Important Note:
This Print View may not reflect all comments and contingencies for approval.
Please check the comments section of the online protocol.
Questions that appear to not have been answered may not have been required
for this submission. Please see the system application for more details.
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Page 18 of 30
18
PROTOCOL
Expedited/Full Board Application
UMKC
Protocol # 15-152
 Date Printed: 03/26/2015
Protocol Title:
Timolol Eye Drops in the Treatment of Acute Migraine Headache
Protocol Type:
Expedited/Full Board Application
Date Submitted:
03/18/2015
Approval Period:
Draft
Important Note:
This Print View may not reflect all comments and contingencies for approval.
Please check the comments section of the online protocol.
Questions that appear to not have been answered may not have been required
for this submission. Please see the system application for more details.
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Page 19 of 30
19
PROTOCOL
Expedited/Full Board Application
UMKC
Protocol # 15-152
 Date Printed: 03/26/2015
Protocol Title:
Timolol Eye Drops in the Treatment of Acute Migraine Headache
Protocol Type:
Expedited/Full Board Application
Date Submitted:
03/18/2015
Approval Period:
Draft
Important Note:
This Print View may not reflect all comments and contingencies for approval.
Please check the comments section of the online protocol.
Questions that appear to not have been answered may not have been required
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Page 20 of 30
20
PROTOCOL
Expedited/Full Board Application
UMKC
Protocol # 15-152
 Date Printed: 03/26/2015
Protocol Title:
Timolol Eye Drops in the Treatment of Acute Migraine Headache
Protocol Type:
Expedited/Full Board Application
Date Submitted:
03/18/2015
Approval Period:
Draft
Important Note:
This Print View may not reflect all comments and contingencies for approval.
Please check the comments section of the online protocol.
Questions that appear to not have been answered may not have been required
for this submission. Please see the system application for more details.
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Page 21 of 30
21
PROTOCOL
Expedited/Full Board Application
UMKC
Protocol # 15-152
 Date Printed: 03/26/2015
Protocol Title:
Timolol Eye Drops in the Treatment of Acute Migraine Headache
Protocol Type:
Expedited/Full Board Application
Date Submitted:
03/18/2015
Approval Period:
Draft
Important Note:
This Print View may not reflect all comments and contingencies for approval.
Please check the comments section of the online protocol.
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Page 22 of 30
22
PROTOCOL
Expedited/Full Board Application
UMKC
Protocol # 15-152
 Date Printed: 03/26/2015
Protocol Title:
Timolol Eye Drops in the Treatment of Acute Migraine Headache
Protocol Type:
Expedited/Full Board Application
Date Submitted:
03/18/2015
Approval Period:
Draft
Important Note:
This Print View may not reflect all comments and contingencies for approval.
Please check the comments section of the online protocol.
Questions that appear to not have been answered may not have been required
for this submission. Please see the system application for more details.
-------------------------------------------------------------------------------------
 
L
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WKHHQGRIWKHSURMHFWWKLVOLVWZLOOEHGHVWUR\HG
 
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* * * Potential Conflict of Interest * * *
 
 
3RWHQWLDO&RQIOLFWRI,QWHUHVW
Conflict of Interest and the definitions related to the Conflict of Interest Policy and the following questions, please
refer to the Help Screen.
 
Conflict of Interest: Please check Yes or No for each item below.
 
D
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F
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Page 23 of 30
23
PROTOCOL
Expedited/Full Board Application
UMKC
Protocol # 15-152
 Date Printed: 03/26/2015
Protocol Title:
Timolol Eye Drops in the Treatment of Acute Migraine Headache
Protocol Type:
Expedited/Full Board Application
Date Submitted:
03/18/2015
Approval Period:
Draft
Important Note:
This Print View may not reflect all comments and contingencies for approval.
Please check the comments section of the online protocol.
Questions that appear to not have been answered may not have been required
for this submission. Please see the system application for more details.
-------------------------------------------------------------------------------------
HQUROOPHQWFRQGXFWRIWKHUHVHDUFKDQGUHSRUWLQJRQWKHUHVXOWVLQFOXGLQJEXWQRWOLPLWHG
WRILQGHUVIHHVUHIHUUDOIHHVUHFUXLWPHQWERQXVHVDQGDQHQUROOPHQWERQXVIRUUHDFKLQJ
DQDFFUXDOJRDORUVLPLODUW\SHVRISD\PHQWV"
H
1
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LQWHUHVWRUDQDSSHDUDQFHRIFRQIOLFWRILQWHUHVWLQFRQQHFWLRQZLWKWKHUHVHDUFKSURMHFW"
I
1
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YDOXHIRUWKRVHVHUYLFHV"
 
Significant Financial Interest: Please check Yes or No for each item below.
 
J
1
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UR\DOWLHVDQGRURWKHUSD\PHQWVIRUVHUYLFHVHJFRQVXOWLQJIHHVKRQRUDULDUHVHDUFK
GHVLJQPDQDJHPHQWSRVLWLRQLQGHSHQGHQWFRQWUDFWRUVHUYLFHRQDGYLVRU\RUUHYLHZ
FRPPLWWHHVERDUGPHPEHUVKLSVHPLQDUVOHFWXUHVRUWHDFKLQJHQJDJHPHQWVZKHQWRWDOHG
WRJHWKHUH[FHHGHGGXULQJWKHSUHYLRXVPRQWKVRUDUHH[SHFWHGWRH[FHHG
RYHUWKHQH[WPRQWKV"7KLVH[FOXGHVUHDVRQDEOHFRVWVRIFRQGXFWLQJWKH
UHVHDUFKDVVSHFLILHGLQWKHUHVHDUFKDJUHHPHQW
K
1
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RZQHUVKLSLQWHUHVWVLQFOXGLQJVWRFNVERQGVRUVWRFNRSWLRQVWKDWH[FHHGDQGRU
WKDWFRQVWLWXWHPRUHWKDQDILYHSHUFHQWRZQHUVKLSLQWHUHVWLQWKHVSRQVRULQJ
RUJDQL]DWLRQ"7KLVGRHVQRWLQFOXGHDQ\LQWHUHVWVKHOGVROHO\E\UHDVRQRILQYHVWPHQWLQD
EXVLQHVVE\DPXWXDOSHQVLRQRURWKHULQVWLWXWLRQDOLQYHVWPHQWIXQGRYHUZKLFKWKH
LQYHVWLJDWRUDQGRUKLVRUKHULPPHGLDWHIDPLO\GRQRWH[HUFLVHGD\WRGD\FRQWURORI
LQYHVWPHQWGHFLVLRQV
 
Minimizing Risks and Disclosure to Subjects
 
L
1
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IRUP"5HVHDUFK3HUVRQQHODUHUHTXLUHGWRGLVFORVHDOOVXFKFRQIOLFWVWRDOOUHVHDUFK
SDUWLFLSDQWVLQWKHUHVHDUFKFRQVHQWIRUP
 
M
:KDWVWHSVLIDQ\KDYH\RXWDNHQRUZLOO\RXWDNHWRPDQDJHWKHFRQIOLFWRILQWHUHVWDQGPLQLPL]HWKHULVNV
DVVRFLDWHGZLWKDQ\DFWXDOSRWHQWLDORUSHUFHLYHGFRQIOLFWVRILQWHUHVWDULVLQJRXWRIWKLVUHVHDUFK"
 
If you checked Yes to any statement (a-h, except f) above, please identify the research team member(s) below
and provide details concerning the potential conflict of interest.
 
 
By submitting this form, you are attesting that you have read the UMKC HRPP Policy on Conflict of Interest and
agree to abide by its terms. You will update this disclosure form when new or changes in conflict of interest arise,


Page 24 of 30
24
PROTOCOL
Expedited/Full Board Application
UMKC
Protocol # 15-152
 Date Printed: 03/26/2015
Protocol Title:
Timolol Eye Drops in the Treatment of Acute Migraine Headache
Protocol Type:
Expedited/Full Board Application
Date Submitted:
03/18/2015
Approval Period:
Draft
Important Note:
This Print View may not reflect all comments and contingencies for approval.
Please check the comments section of the online protocol.
Questions that appear to not have been answered may not have been required
for this submission. Please see the system application for more details.
-------------------------------------------------------------------------------------
and that you will comply with any conflict management plan required by the Institutional Review Board (IRB) to
manage, reduce, or eliminate any actual or potential conflict of interest for the duration of the research.
 
Link to UMKC's Conflict of Interest Policy: http://ors.umkc.edu/office-of-research-services/conflict-of-interest.
---------------------------------------------------------------------------------------------
* * * Informed Consent * * *
 
,QIRUPHG&RQVHQW
6HHVDPSOHFRQVHQWIRUPVDWKWWSRUVXPNFHGXUHVHDUFKFRPSOLDQFHLUELUEIRUPV
 
3OHDVHSURYLGHFRQVHQWSURFHVVEDFNJURXQGLQIRUPDWLRQEHORZ
 
Informed Consent


Page 25 of 30
25
PROTOCOL
Expedited/Full Board Application
UMKC
Protocol # 15-152
 Date Printed: 03/26/2015
Protocol Title:
Timolol Eye Drops in the Treatment of Acute Migraine Headache
Protocol Type:
Expedited/Full Board Application
Date Submitted:
03/18/2015
Approval Period:
Draft
Important Note:
This Print View may not reflect all comments and contingencies for approval.
Please check the comments section of the online protocol.
Questions that appear to not have been answered may not have been required
for this submission. Please see the system application for more details.
-------------------------------------------------------------------------------------
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Page 26 of 30
26
PROTOCOL
Expedited/Full Board Application
UMKC
Protocol # 15-152
 Date Printed: 03/26/2015
Protocol Title:
Timolol Eye Drops in the Treatment of Acute Migraine Headache
Protocol Type:
Expedited/Full Board Application
Date Submitted:
03/18/2015
Approval Period:
Draft
Important Note:
This Print View may not reflect all comments and contingencies for approval.
Please check the comments section of the online protocol.
Questions that appear to not have been answered may not have been required
for this submission. Please see the system application for more details.
-------------------------------------------------------------------------------------
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Page 27 of 30
27
PROTOCOL
Expedited/Full Board Application
UMKC
Protocol # 15-152
 Date Printed: 03/26/2015
Protocol Title:
Timolol Eye Drops in the Treatment of Acute Migraine Headache
Protocol Type:
Expedited/Full Board Application
Date Submitted:
03/18/2015
Approval Period:
Draft
Important Note:
This Print View may not reflect all comments and contingencies for approval.
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Page 28 of 30
28
PROTOCOL
Expedited/Full Board Application
UMKC
Protocol # 15-152
 Date Printed: 03/26/2015
Protocol Title:
Timolol Eye Drops in the Treatment of Acute Migraine Headache
Protocol Type:
Expedited/Full Board Application
Date Submitted:
03/18/2015
Approval Period:
Draft
Important Note:
This Print View may not reflect all comments and contingencies for approval.
Please check the comments section of the online protocol.
Questions that appear to not have been answered may not have been required
for this submission. Please see the system application for more details.
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Page 29 of 30
29
PROTOCOL
Expedited/Full Board Application
UMKC
Protocol # 15-152
 Date Printed: 03/26/2015
Protocol Title:
Timolol Eye Drops in the Treatment of Acute Migraine Headache
Protocol Type:
Expedited/Full Board Application
Date Submitted:
03/18/2015
Approval Period:
Draft
Important Note:
This Print View may not reflect all comments and contingencies for approval.
Please check the comments section of the online protocol.
Questions that appear to not have been answered may not have been required
for this submission. Please see the system application for more details.
-------------------------------------------------------------------------------------
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Page 30 of 30
30
PROTOCOL
Expedited/Full Board Application
UMKC
Protocol # 15-152
 Date Printed: 03/26/2015
Protocol Title:
Timolol Eye Drops in the Treatment of Acute Migraine Headache
Protocol Type:
Expedited/Full Board Application
Date Submitted:
03/18/2015
Approval Period:
Draft
Important Note:
This Print View may not reflect all comments and contingencies for approval.
Please check the comments section of the online protocol.
Questions that appear to not have been answered may not have been required
for this submission. Please see the system application for more details.
-------------------------------------------------------------------------------------
 
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