Timolol Eye Drops in the Treatment of Acute Migraine Headache
Phase: NA
Conditions: Migraine
Sponsor: University of Missouri, Kansas City

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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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.
-------------------------------------------------------------------------------------
 
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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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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.
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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.
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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.
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 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
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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.
-------------------------------------------------------------------------------------
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Significant Financial Interest: Please check Yes or No for each item below.
 
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Minimizing Risks and Disclosure to Subjects
 
L
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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.
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.
-------------------------------------------------------------------------------------
* * * HIPAA * * *
 
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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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Please click "Check for Completeness" to your left to continue to the next step.  If the protocol is complete and
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