A Retrospective Controlled Survey Study to Assess the Safety of Treating Migraine With Nerivio During Pregnancy and 3 Months Postpartum
Conditions: Migraine, Pregnancy Related
Sponsor: Theranica

TCH-011 Clinical Study 
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Approval 
Name 
Position 
Date 
Signature 
Revised by 
Alit Stark-Inbar 
VP Medical Information 
Reviewed by 
Dagan Harris 
VP clinical and regulatory 
affairs 
Approved by 
Alon Ironi 
CEO 
Effective date of the document is from the date of approval. 
Change History 
Rev 
Rev. Date 
Revised by 
Change description and reason for change 
Training is 
required? Y/N 
1.0 
01-Jun-2022
Alit Stark-Inbar 
Initial version 
N 

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CLINICAL INVESTIGATION PLAN 
STUDY TITLE:  
A retrospective controlled survey-study to assess the safety of treating 
migraine with Nerivio during pregnancy and 3 months postpartum. 
PROTOCOL NUMBER: 
TCH-011 
REVISION: 
1.0 
RELEASE DATE:  
01/June/2022 
INVESTIGATOR:   
_____________________ 
SPONSOR: 
Theranica Bio-Electronics Ltd 
4 Ha-Omanut st, Netanya, Israel 
CONTACT DETAILS: 
Dagan Harris, VP Clinical & Regulatory 
Tel: +972.72.390.9758 
Fax: + 972.72.390.9762 
Mobile: +972-0542220121 
EMAIL: daganh@theranica.com 
APPROVED BY: 
POSITION: 
DATE: (DDMMYY) 
SIGNATURE: 
___________ 
____________ 
  _ _ /_ _ /_ _ 
______________ 
___________ 
____________ 
  _ _ /_ _ /_ _ 
______________ 

 
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Table of Contents  
Table of Contents ............................................................................................................................. 3 
Synopsis ............................................................................................................................................ 4 
Goal .................................................................................................................................................. 4 
Study Design .................................................................................................................................... 4 
Eligibility ........................................................................................................................................... 4 
Study Design and Recruitment ........................................................................................................ 5 
Endpoints ......................................................................................................................................... 5 
Data analysis .................................................................................................................................... 6 
Statistical Hypothesis .................................................................................................................. 6 
Planned Sample Size .................................................................................................................... 7 
Appendix 1: Screening and Eligibility .............................................................................................. 8 
Eligibility messages: ................................................................................................................... 10 
Appendix 2: Survey Questionnaire ............................................................................................... 12 
Part 1 – Demographics and medical history prior to “study pregnancy” ................................ 12 
Part 2 – Study pregnancy ........................................................................................................... 17 
Part 3 – Migraine during the study pregnancy ......................................................................... 19 
Part 4 – Migraine postpartum ................................................................................................... 23 
Part 5 – Baby’s health ................................................................................................................ 23 
 
 
 

 
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Synopsis  
This is a retrospective controlled survey-study to assess the safety of treating migraine with 
Nerivio during pregnancy and 3 months postpartum. We will compare migraine and pregnancy 
related health and baby health between women with migraine who treated migraine attacks 
during pregnancy with Nerivio (Nerivio group), to women with migraine who did not treat 
migraine attacks during pregnancy with Nerivio (control group). Nerivio group participants will 
be recruited from Theranica’s user base. Control group participants will be recruited by health 
care providers, including headache specialists and OBGYNs (study co-investigators). The study is 
fully electronic, including an e-eligibility questionnaire, an e-ICF, and an e-survey. Participants 
will be compensated for their time.  
 
Goal  
Assess the safety of treating migraine with Nerivio during pregnancy and 3 months postpartum.   
Study Design  
Retrospective controlled survey-study.  
Study group: Postpartum patients with migraine who used Nerivio at least 3 times during their 
“study pregnancy” 
Control group: Postpartum patients with migraine who did not use Nerivio during their “study 
pregnancy” 
 
Eligibility  
Inclusion criteria: 
1. Diagnosed with migraine 
2. History of migraine pre-pregnancy with an average of at least 4 migraine days per 
month, in the six months prior to the last pregnancy  
3. History of pregnancy with last menstrual period (LMP) between November 1st, 2019 – 
March 31st, 2021. Pregnancy within this time window is the pregnancy of study, termed 
“study pregnancy”  
4. Between 18 and 42 years of age at first day of the last menstrual period (LMP) of “study 
pregnancy”  
5. History of at least 4 migraine attacks during “study pregnancy” 
6. In the study group: usage of Nerivio for at least 3 treatments (≥30 minutes/treatment) 
during “study pregnancy”  
7. In the control group: No history of using Nerivio, ever  

 
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Exclusion criteria: 
1. History of preterm birth (gestational age at deliver<37 weeks) in previous pregnancies 
prior to the “study pregnancy”  
2. History of congenital malformations or birth defects in previous pregnancies prior to the 
“study pregnancy”  
3. Severe other diseases which started before the “study pregnancy” and lasted into the 
“study pregnancy” period, including congenital heart disease, arrhythmia, history of 
myocardial infarction (MI), history of stroke, or active cancer 
4. Serious physical injury that occurred during the “study pregnancy”: severe car collision 
injury, serious injury at home/work, etc. Multiple gestation (i.e., pregnancy with more 
than one baby at a time, such as pregnancy with twins, triplets, and quadruplets) in the 
“study pregnancy” 
 
Study Design and Recruitment  
Study group: Study group participants will be recruited from Nerivio’s user base. An invitation 
message will be sent via in-app notification and/or email to all Nerivio users who are (1) female, 
AND (2) between 18 and 42 years of age as of November 1st, 2019 - March 31st, 2021. Users who 
meet these criteria will be invited to fill in a screening and eligibility questionnaire. If they meet 
the eligibility criteria, they will be offered the opportunity to participate in the study. 
Participants will complete and sign an electronic informed consent form. Following consent, 
participants will be asked to complete the questionnaire. Once complete, participants will be 
compensated for their time.   
Control group: Control group participants will be referred to the study by site co-investigators, 
who are US licensed healthcare providers seeing women with headache disorders and/or 
women during their pre-pregnancy and/or pregnancy period. Patients interested in participating 
will be directed to the same screening and eligibility questionnaire and will follow the same 
study design.  
 
Endpoints  
Endpoints focus on the health of the mother and the baby, during pregnancy and three months 
postpartum.  
Primary endpoint: 
Demonstrate that the study group is not different than the control group in regard to 
gestational age at delivery (measured in pregnancy weeks).   

 
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Secondary endpoints:  
Demonstrate that the study group is not different from the control group in:  
1. Baby’s birth weight (average birth weight) 
2. Miscarriage rate (% of miscarriage cases) 
3. Preterm birth rate (% cases of preterm pregnancies, as measured in % of pregnancy 
weeks less than 37) 
4. Birth deficits rate (% of birth deficits) 
5. Still births rate (% of still births) 
6. Meeting developmental milestones following 3 months postnatal (% of babies) 
7. Visits to the emergency room or urgent care due to pregnancy and/or migraine 
symptoms during pregnancy and 3 months postpartum period (# of events) 
 
Exploratory endpoints: Difference between the study group and the control group in:  
1. Overall subjective feeling of safety using acute migraine treatments during pregnancy 
(in subjects who used such treatments). 
2. Overall subjective satisfaction with the acute migraine therapies used during the 
pregnancy (in subjects who used such treatments). 
3. APGAR score at 5 minutes.  
 
Data analysis  
Statistical Hypothesis 
The goal of the proposed study is to test the null hypothesis that treating with Nerivio during 
pregnancy does not impose a safety risk relative to standard care migraine treatment for pregnant 
women. In other words, the hypothesis is that the means of the two populations are equal. Thus, 
in this study, the following hypotheses will be tested: 
• 
Null hypothesis:  
H0:  GAt = GAc  
• 
Alternate hypothesis:     H1: GAt ≠ GAc  
Where GAt and GAc are the average Gestational Age in the study group and control group, 
respectively. If the null hypothesis is not rejected, the study will be deemed successful. The 
criterion for significance has been set at 0.05. The test is 2-tailed.   

 
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Planned Sample Size 
Based on USA data from 2020 [Osterman M, et al. Births: Final Data for 2020. Natl Vital Stat Rep. 
2021] we assume mean gestational age (GA) of 38.4 with standard deviation of 2.7 (range 26-42).   
With the proposed sample size of 114 for each group, the study will have power of 80% to yield a 
statistically significant result. This computation assumes that the mean difference is less than 1.0 
week, and the common within-group standard deviation is 2.7. This effect was selected as the 
smallest effect that would be important to detect.  
Precision for estimating the effect size: We further estimate the mean difference between the 
two populations. On average, a study of this design would enable us to report the mean difference 
with a precision (95% confidence level) of plus/minus 0.70 weeks.  
Given this statistical requirement up to 400 participants will be recruited per group.  
Statistical Analysis Plan  
Data will be collected from all patients recruited to the study. Data analysis will not include 
patients who are:  
• 
Obese (BMI>=40) at the beginning of the study pregnancy  
• 
Did not have their last menstrual period (LMP) between November 1st, 2019 – March 
31st, 2021 
• 
In the study group, did not use Nerivio for at least 3 treatments (≥30 
minutes/treatment) during the “study pregnancy” 
• 
In the control group, did use Nerivio before, during, or in the 3 months following the 
“study pregnancy” 
 
 
 
 

 
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Appendix 1: Screening and Eligibility Procedure 
Thank you for your interest in this study. We will be assessing the effect of having migraine and 
using Nerivio, an acute migraine treatment, on the health of mothers and babies during 
pregnancy and 3 months postpartum, in mothers who suffer from migraine.  
To assess your eligibility for the study, please answer the following screening questions.  
If you meet the eligibility criteria, you will be directed to an electronic informed consent form, 
followed by the study questionnaire.  
Eligible participants who complete the study questionnaire will be compensated for their time, 
with a $100 gift card. 
The following questions refer to your latest, completed, pregnancy (if you are currently 
pregnant, do not refer to the current pregnancy when answering the following questions). We 
will refer to that pregnancy (i.e., the completed pregnancy) as the “study pregnancy”.  
 
Page break  
1. Was your entire “study pregnancy” period (from conception to delivery) between 
November 1st, 2019, and March 31st, 2022?  
• 
Yes 
• 
No  
No = not eligible 
 
2. Were you between 18 and 42 years of age when your “study pregnancy” began (at the 
date of the last menstrual period, LMP)?   
• 
Yes 
• 
No 
No = not eligible 
3. Did the “study pregnancy” have more than one baby, such as pregnancy with twins, 
triplets, and quadruplets (i.e., multiple gestation pregnancy) 
• 
Yes 
• 
No 
Yes = not eligible 
4. Have you ever diagnosed with migraine by a licensed healthcare provider?  

 
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• 
Yes  
• 
No 
No = not eligible  
5. Were you diagnosed with migraine prior to your “study pregnancy”?  
• 
Yes 
• 
No  
No = not eligible 
6. Did you have migraine attacks during your “study pregnancy”?  
• 
Yes  
• 
No  
No = not eligible 
7. On average, did you have migraine at least 4 days a month, during the six months 
prior to the “study pregnancy”? 
• 
Yes 
• 
No 
No = not eligible 
8. Did you have at least 4 migraine attacks during your “study pregnancy”? 
• 
Yes 
• 
No 
No = not eligible 
9. Did you suffer from congenital heart disease, arrhythmia, history of myocardial 
infarction (MI), history of stroke, or active cancer before/during the “study 
pregnancy”?  
• 
Yes 
• 
No 
Multiple choice; If Yes = not eligible 
10. Were you seriously injured during your “study pregnancy”, e.g., had a car accident, 
work injury, home accident, assault, etc.?  
• 
Yes 

 
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• 
No 
Yes = not eligible   
11. Do you have a history of preterm birth (delivery at gestational age under 37 weeks) 
with any of your previous pregnancies (before the “study pregnancy”)?  
• 
Yes 
• 
No 
Yes = not eligible 
12. Do you have a history of congenital malformations or birth defects in any of your 
previous pregnancies (before the “study pregnancy”)?  
• 
Yes 
• 
No 
Yes = not eligible   
 
Eligibility messages:  
Not eligible message: Message presented to subjects if they do not meet the eligibility criteria 
as identified during the screening questionnaire:  
 
Thank you for your interest in the study on migraine treatments during pregnancy.  
However, the information you provided indicates that you do not meet the study eligibility 
requirements, and therefore cannot participate in this survey study.  
 
Eligible message: Message presented to subjects upon the completion of the screening 
questionnaire, if they meet the eligibility criteria as identified during the screening 
questionnaire:  
 
Thank you for your interest in the study on migraine treatments during pregnancy.  
The information you provided indicates that you are eligible to participate in this survey study.  
You will now be directed to an electronic informed consent form. Please read the consent form 
carefully. If you consent, please provide your details and electronic signature at the bottom of 
the consent form.  
 
Once signed, you will be directed to the survey study questionnaire.  
The questionnaire contains 52 questions. It should take approximately 30-40 min to complete the 
questionnaire.  
In order to make it easier and faster to answer the survey questions, we recommend you prepare 
documents you received upon hospital discharge following delivery of your “study pregnancy”, 
prior to answering the questionnaire.   
Please select your referral clinic:  

 
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1. Clinic A  
2. Clinic B  
3. Clinic C  
4. Clinic D   
5. Clinic E  
6. Other  
• 
Please specify __________________ 
Single choice    
 
Present the matching ICF, based on participant’s clinic  
 
 

 
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Appendix 2: Survey Questionnaire 
This questionnaire asks about your general health with a focus on your migraine, your health 
during and after your “study pregnancy”, and about your child’s health.  
Please refer to your latest, completed, pregnancy (if you are currently pregnant, please do not 
refer to the current pregnancy when answering the following questions). We will refer to the 
latest, completed, pregnancy as the “study pregnancy”.  
It will take approximately 30-40 minutes to complete the questionnaire.  
 
Part 1 – Demographics and medical history prior to “study pregnancy”  
1. What is your date of birth?  
Mark on Calendar  
2. Are you of Hispanic, Latino, or of Spanish origin? 
• 
Yes  
• 
No  
 
3. How would you describe yourself? 
• 
American Indian or Alaska Native 
• 
Asian 
• 
Black or African American  
• 
Hispanic or Latino 
• 
Native Hawaiian or Other Pacific Islander 
• 
White or Caucasian 
• 
Other  
 
4. What is your height (feet, inches) 
Choose: Pull down menu between 4.0 to 7.0 with 0.1 jumps. Allow other. 
 
5. Weight (lb) at the beginning of your study pregnancy  
Choose: Pull down menu between 85 and 300 lb, with jumps of 5 units. Allow other.  
  
6. Do you have a history of any of the following medical conditions, that was diagnosed 
prior to your study pregnancy? Check all that apply 

 
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• 
AIDS/HIV 
• 
Anemia 
• 
Asthma 
• 
Autoimmune disease (such as lupus, rheumatoid arthritis etc) 
• 
Clinically diagnosed depression or any other psychiatric diseases 
• 
Clinical obesity (body mass index, BMI, greater than 30) 
• 
Endometriosis 
• 
Epilepsy  
• 
Kidney disease 
• 
High blood pressure 
• 
Pre-pregnancy diabetes  
• 
Polycystic ovary syndrome (PCOS) 
• 
Sexually transmitted disorders 
• 
Thyroid disease 
• 
Other diseases  
• 
Please specify __________  
Check all that applies 
7. Prior to your “study pregnancy”, do you have a history of (Check all that applies) 
• 
Smoking 
• 
Excessive alcohol consumption (more than 1 glass of wine/day or any other alcohol 
equivalent) 
• 
Using medical marijuana  
• 
Using recreational drugs  
Multiple choice  
8. On average, how many days per month did you experience migraine in the 6 months 
prior to the “study pregnancy”?  
• 
Less than 4 days per month 
• 
4-8 days per a month 

 
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• 
9-14 days per month 
• 
15 days or more per month  
Multiple choice  
9. How often did you use acute treatments for migraine (either pharmaceutical drugs 
and/or devices) in the six months prior to the “study pregnancy”?  
• 
Less than 4 times per month 
• 
4-8 times per a month 
• 
9-14 times per month 
• 
15 times or more per month  
Multiple choice  
10. Please read carefully and mark all types of ACUTE treatments (either pharmaceutical 
drugs and/or devices) you used for migraine in the six months prior to the study 
pregnancy. Please include any treatment, even if used only once. In cases where two 
names are used, one is the generic name and one is the branded name (Check all that 
applies) 
• 
Tylenol®, or any other acetaminophen/paracetamol 
• 
Excedrin® (Aspirin and paracetamol and caffeine) -  
• 
Advil®, Motrin®, or any other ibuprofen 
• 
Aleve®, Anaprox®, or any other Naproxen sodium 
• 
Other over-the-counter medications 
• 
Cambia® (Diclofenac) 
• 
Cafergot®, Ergomar® (Ergotamines) 
• 
Tivorbex® (Indomethacin) 
• 
Imitrex® (sumatriptan) 
• 
Maxalt® (rizatriptan) 
• 
Relpax® (Eletriptan) 
• 
Treximet® (sumatriptan/naproxen sodium) 
• 
Axert (Almotriptan), Zomig® (zolmitriptan) 
• 
Other Oral Triptan 

 
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• 
Nurtec® ODT (Rimegepant)  
• 
Ubrelvy® (Ubrogepant) 
• 
Tosymra® (sumatriptan nasal spray) 
• 
Onzetra Xsail® (sumatriptan nasal poder) 
• 
Zembrace SymTouch® (sumatriptan injection) 
• 
Zomig® nasal spray (Zolmitriptan) 
• 
Migranal® (Dihydroergotamine Mesylate Spray) 
• 
TrudhesaTM (dihydroergotamine mesylate nasal spray) 
• 
Other nasal / injectable medication 
• 
Reyvow (Lasmiditan®) 
• 
Nerivio® (Remote Electrical Neuromodulation) 
• 
Other devices (e.g., gammaCoreTM, Cefaly®, Relivion®)  
• 
Zofran® (Ondansetron) 
• 
Reglan® (Metoclopramide) 
• 
Compazine® (Prochlorperazine) 
• 
Phenergan® (Promethazine) 
• 
Other medication for nausea/vomiting 
• 
Other medications  
• 
None 
Check all that applies 
11. Please mark the PREVENTIVE migraine treatment (either pharmaceutical drugs and/or 
devices) you used during the six months prior to the study pregnancy. (Check all that 
applies) 
• 
Amitriptyline, or any other generic tricyclic antidepressants 
• 
Inderal® (Propranolol) 
• 
Topiramate® (Topamax) 
• 
Other generic oral preventive medication  
• 
Nortriptyline (Pamelor), or any othernon-generic tricyclic antidepressants 

 
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• 
Botox® injection for migraine prevention (Botulinum toxin) 
• 
Aimovig® (Erenumab) 
• 
Ajovy® (Fremanezumab) 
• 
Emgality® (galcanezumab-gnlm) 
• 
Vyepti® (eptinezumab-jjmr)  
• 
Nurtec® ODT (Rimegepant)  
• 
Devices (e.g., gammaCore, Cefaly) 
• 
Other  
• 
Did not use any preventive treatment  
Check all that applies 
12. Have you been diagnosed with migraine with aura by a licensed healthcare provider? 
(Aura is a neurologic symptom that occurs typically before or during migraine that 
lasts 5-60 minutes and is characterized by an evolution of neurologic symptoms such 
as flashing lights or colors that grow in your visual field) 
• 
Yes 
• 
No 
 
13. Do you usually experience aura right before your headache attacks? 
• 
Always  
• 
Sometimes  
• 
Never 
 
14. Have you ever used Nerivio® to treat your migraine attacks?  
• 
Yes  
• 
No  
 
15. How many prior pregnancies before the “study pregnancy” have you had? 
Choose from 0 to 10 and “more than 10” 
 
16. How many of these were completed pregnancies? 

 
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Show question if >0 in the previous question. Responses: Choose from 0 to 10 and “more 
than 10” 
 
17. Is there a family history of congenital defects or malformations? 
• 
Yes 
• 
No  
 
Part 2 – Study pregnancy   
The following questions refer to you latest, completed, pregnancy, termed “study pregnancy” 
(if you are currently pregnant, please do not refer to this pregnancy when answering the 
questionnaire).  
18. What was the first day of the last menstrual period (LMP) before your “study 
pregnancy”? (Please provide accurate month and year. If you do not recall the exact 
day within the month, please choose 1st day of the month).   
• 
Choose on calendar / enter date (month, year; day is optional)  
Year and month are good enough. Day is optional.  
19. What was the delivery date of your “study pregnancy”?  
• 
Choose on calendar 
 
20. What was your baby’s gestational age at delivery or at the end of pregnancy 
(pregnancy length measured by number of weeks and days) of your “study pregnancy”  
Choose on “roller”, allow weeks (6 to 42 weeks) and days (+0 to 6 days). If possible, allow 
weeks and days separately..  
21. What is the status of your “study pregnancy”? 
• 
Live birth 
• 
Elective termination 
• 
Spontaneous abortion (or miscarriage) 
• 
Late fetal death 
 
22. If you had a miscarriage, what was its cause?  
• 
I did not experience a miscarriage  
• 
Abnormal fetal development  

 
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• 
Abnormal placenta (such as abruption) 
• 
Blood disorders such as thrombophilias 
• 
Cervical insufficiency 
• 
Chromosomal abnormalities 
• 
Maternal anatomic abnormalities such as uterine fibroids, polyps or adhesions in 
uterus 
• 
Physical trauma 
• 
Unknown cause 
• 
Other 
 
23. Delivery circumstances (Check all that applies) 
• 
Spontaneous labor  
• 
Induction of labor 
• 
Past due date 
• 
Decreased fetal movement 
• 
Cardiac arrhythmia in fetus 
• 
Pregnancy induced hypertension such as gestational hypertension or pre-eclampsia 
• 
HELLP syndrome 
• 
Premature rupture of membranes 
• 
Other complications or medical concerns 
Check all that apply   
24. What was the mode of delivery? 
• 
Repeat Cesarean Delivery 
• 
Primary Cesarean delivery 
• 
Spontaneous vaginal delivery  
 
25. During your “study pregnancy”, did you do any of the following (select all that apply)  
• 
Smoking 

 
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• 
Excessively consuming alcohol (more than 1 glass of wine/day or any other 
equivalent) 
• 
Using medical marijuana  
• 
Using recreational drugs  
 Check all that apply 
26. Was the baby discharged from the hospital at the same time with you?  
• 
Yes 
• 
No  
 
27. Did you use Nerivio to treat your migraine attacks during your “study pregnancy”? 
• 
Yes 
• 
No 
   
28. During your “study pregnancy”, did you use Nerivio for migraine treatment at least 3 
times? 
• 
Yes 
• 
No 
 
Part 3 – Migraine during the study pregnancy  
The following questions refer to your latest, completed, pregnancy referred to as the “study 
pregnancy” (if you are currently pregnant, please do not refer to this pregnancy when 
answering the questionnaire).  
29. How many migraine days per month (on average) did you have during the FIRST 
trimester of your “study pregnancy”? 
• 
Less than 4 days per month 
• 
4-8 days per a month 
• 
9-14 days per month 
• 
15 days or more per month  
Multiple choice 
30. How often did you use ACUTE treatments for migraine during the FIRST trimester of 
your “study pregnancy”? 

 
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• 
Less than 4 times per month 
• 
4-8 times per a month 
• 
9-14 times per month 
• 
15 times or more per month  
Multiple choice 
31. How many migraine days per month (on average) did you have during the SECOND 
trimester of your “study pregnancy”? 
• 
Less than 4 days per month 
• 
4-8 days per a month 
• 
9-14 days per month 
• 
15 days or more per month  
Multiple choice 
32. How often did you use ACUTE treatments for migraine during the SECOND trimester of 
your “study pregnancy”? 
• 
Less than 4 times per month 
• 
4-8 times per a month 
• 
9-14 times per month 
• 
15 times or more per month  
Multiple choice 
33. How many migraine days per month (on average) did you have during the THIRD 
trimester of your “study pregnancy”? 
• 
Less than 4 days per month 
• 
4-8 days per a month 
• 
9-14 days per month 
• 
15 days or more per month  
Multiple choice 
34. How often did you use ACUTE treatments for migraine during the THIRD trimester of 
your “study pregnancy”? 
• 
Less than 4 times per month 

 
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• 
4-8 times per a month 
• 
9-14 times per month 
• 
15 times or more per month  
Multiple choice 
35. Please mark all types of ACUTE treatments (either pharmaceutical drugs and/or 
devices) you used for migraine during the “study pregnancy”. Please include any 
treatment, even if used only once.  
For each treatment type used, please indicate if you felt SAFE using it during the 
pregnancy by choosing the matching option of the dropdown menu.  
• 
Tylenol®, or any other acetaminophen/paracetamol 
Did you feel safe using this medication during the pregnancy?  
• 
Yes 
• 
No  
• 
Excedrin® (Aspirin and paracetamol and caffeine) -  
• 
Advil®, Motrin®, or any other ibuprofen 
• 
Aleve®, Anaprox®, or any other Naproxen sodium 
• 
Other over-the-counter medications 
• 
Cambia® (Diclofenac) 
• 
Cafergot®, Ergomar® (Ergotamines) 
• 
Tivorbex® (Indomethacin) 
• 
Imitrex® (sumatriptan), Maxalt® (rizatriptan), Relpax® (Eletriptan), Treximet® 
(sumatriptan/naproxen sodium), Axert (Almotriptan), Zomig® (zolmitriptan), or any 
other Oral Triptan 
• 
Nurtec® ODT (Rimegepant)  
• 
Ubrelvy® (Ubrogepant) 
• 
Tosymra® (sumatriptan nasal spray), Onzetra Xsail® (sumatriptan nasal poder), 
Zembrace SymTouch® (sumatriptan injection); Zomig® nasal spray (Zolmitriptan), 
Migranal® (Dihydroergotamine Mesylate Spray);  TrudhesaTM (dihydroergotamine 
mesylate nasal spray), or any other nasal / injectable medication 
• 
Reyvow (Lasmiditan®) 
• 
Nerivio® (Remote Electrical Neuromodulation) 

 
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• 
Other devices (e.g., gammaCoreTM, Cefaly®, Relivion®)  
• 
Zofran® (Ondansetron), Reglan® (Metoclopramide), Compazine® (Prochlorperazine), 
Phenergan® (Promethazine), or any other medication for nausea/vomiting 
• 
Other medications  
• 
None 
Check all that applies 
36. Rate your overall satisfaction with your acute migraine treatment during your “study 
pregnancy”, when 1 = Highly dissatisfied, 10 = Highly satisfied  
Drop Down menu, with options 1-to-10 AND Not relevant (I did not use acute migraine 
treatment during my pregnancy)  
 
37. Please mark all types of PREVENTIVE treatments (either pharmaceutical drugs and/or 
devices) you used for migraine during the “study pregnancy”. Please include any 
treatment, even if used only once.  
For each treatment type used, please indicate if you felt safe using it during the 
pregnancy by choosing the matching option of the dropdown menu.  
• 
Amitriptyline, or any other generic tricyclic antidepressants 
• 
Inderal® (Propranolol) 
• 
Topiramate® (Topamax) 
• 
Other generic oral preventive medication  
• 
Nortriptyline (Pamelor), or any othernon-generic tricyclic antidepressants 
• 
Botox® injection for migraine prevention (Botulinum toxin)Aimovig® (Erenumab), 
Ajovy® (Fremanezumab), Emgality® (galcanezumab-gnlm), Vyepti® (eptinezumab-
jjmr) , that is any CGRP monoclonal antibodies (CGRP mAbs)   
• 
Nurtec® ODT (Rimegepant)  
• 
Devices (e.g., gammaCore, Cefaly) 
• 
Other  
• 
Did not use any preventive treatment  
 
38. Rate your overall satisfaction with your PREVENTIVE migraine treatment during your 
“study pregnancy”, when 1 = Highly dissatisfied, 10 = Highly satisfied  
Drop Down menu, with options 1-to-10 AND Not relevant (I did not use preventive 
migraine treatment during my pregnancy)  

 
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TCH-011 Clinical Study 
Protocol  
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Revision #: 1.0 
Page: 23 of 25 
 
This document is a property of Theranica Ltd. All Rights are Reserved 
 Template ID: CLI-I00101 Rev: 1.0 
 
 
39. Were you admitted to the emergency room (ER) or hospital for 
management/evaluation of headache during your “study pregnancy”?  
• 
Yes 
• 
No 
 
Part 4 – Migraine postpartum 
40. How many migraine days per month (on average) did you have in the 3 months 
postpartum after your “study pregnancy”?  
• 
Less than 4 days per month 
• 
4-8 days per a month 
• 
9-14 days per month 
• 
15 days or more per month  
 
41. Did you breast-feed during the first 3 months postpartum following your “study 
pregnancy”?  
• 
Yes 
• 
No  
 
Part 5 – Baby’s health  
42. For your “study pregnancy”, what is your baby’s sex at birth?  
• 
Male 
• 
Female 
 
43. What was the baby’s birth weight (lbs)? 
Choose on a drop-down menu, including the following answers:  
• 
Less than 1.5 kg / 3.4 pounds 
• 
Between 1.5 and 2.49 kg / between 3 pounds 4 ounces and 5 pounds 8 ounces 
• 
Weights with jumps of 100 gram up to 4 kg and the equivalent in pounds (2.5, 
2.6, 2.7, …. 4) 
• 
More than 4 kg / 8 pounds and 13 ounces  
 

 
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Protocol  
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 Template ID: CLI-I00101 Rev: 1.0 
 
44. Was the baby diagnosed with any birth defects?  
• 
No  
• 
Yes  
 
45. Were there any complications with the baby after delivery? 
• 
No  
• 
Yes 
If Yes, what type of complication?  
• 
Neonatal jaundice, ….  
• 
Newborn required admission to the neonatal intensive care unit 
• 
Respiratory distress syndrome 
• 
Infection such as sepsis 
• 
Failure to thrive 
• 
Low birth weight 
• 
Other 
 
46. Did your baby meet routine developmental milestones at 3 months? of life (such as 
smiling, gurgle, visually tracking objects, and rolling over within the first 3 months)  
• 
No  
• 
Yes 
 
47. What was your baby’s APGAR scores at 1 minute after birth?  
We know it might be difficult to remember this score. Please check your discharge 
notes to find the 1 minute APGAR score, although not all notes include this 
information:  
• 
Choose 1-10  
• 
Don’t know / Can’t find the 5 min APGAR score  
Use a dropdown menu, and add the option can’t find  
 
48. What was your baby’s APGAR scores 5 minutes after birth? We know it might be 
difficult to remember this score. Please check your discharge notes to find the 5 
minutes APGAR score, although not all notes include this information:  

 
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TCH-011 Clinical Study 
Protocol  
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Revision #: 1.0 
Page: 25 of 25 
 
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 Template ID: CLI-I00101 Rev: 1.0 
 
• 
Choose 1-10  
• 
Don’t know / Can’t find the 5 min APGAR score  
Use a dropdown menu, and add the option can’t find 
49. Does the baby have any additional APGAR scores at 10, 15 or 20 minutes?  
• 
Yes 
• 
No  
• 
Don’t know   
If Yes, go to the next page, and ask for APGAR scores at 3 additional time points. 
Otherwise (answer: No or Don’t know), go directly to the last page.  
Page break  
50. What was your baby’s APGAR scores 10 minutes after birth? We know it might be 
difficult to remember this score. Please check your discharge notes to find the 5 
minutes APGAR score:  
• 
Choose 1-10  
• 
Don’t know / Can’t find the 5 min APGAR score  
 
51. What was your baby’s APGAR scores 15 minutes after birth? We know it might be 
difficult to remember this score. Please check your discharge notes to find the 5 
minutes APGAR score:  
• 
Choose 1-10  
• 
Don’t know / Can’t find the 5 min APGAR score  
 
52. What was your baby’s APGAR scores 20 minutes after birth? We know it might be 
difficult to remember this score. Please check your discharge notes to find the 5 
minutes APGAR score:  
• 
Choose 1-10  
• 
Don’t know / Can’t find the 5 min APGAR score  
 
Page break  
Thank you for your participation in this study. The payment will be sent to your email 
following the verification of your participation with the clinic (approximately 48 hours). Please 
contact tch011@theranica.com if you did not receive the payment within this time.