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CTRI Number  CTRI/2025/02/081278 [Registered on: 25/02/2025] Trial Registered Prospectively
Last Modified On: 16/01/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   Efficacy and Safety Study of Rimegepant for the Preventative Treatment of Migraine in adolescent Subjects  
Scientific Title of Study   An Interventional, Efficacy, and Safety, Phase 3, Randomized, Double-Blind, Placebo-Controlled Study With an Open-Label Extension to Investigate Rimegepant in Migraine Prevention in Adolescents 12 to Less Than 18 Years of Age With Chronic Migraine 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
2023-505601-16-00  EudraCT 
C4951013 Protocol Amendment 1 dt 19-Mar-2024  Protocol Number 
NCT05156398  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query  
Name  Dr Seema Pai 
Designation  Senior Director Clinical Site Operations - India Cluster 
Affiliation  Pfizer Limited 
Address  The Capital, 1802-1901, Plot No. C-70, G Block, Bandra Kurla Complex, Bandra (East)

Mumbai
MAHARASHTRA
400051
India 
Phone  02266932000  
Fax    
Email  seema.pai@pfizer.com  
 
Details of Contact Person
Public Query  
Name  Dr Seema Pai 
Designation  Senior Director Clinical Site Operations - India Cluster 
Affiliation  Pfizer Limited 
Address  The Capital, 1802-1901, Plot No. C-70, G Block, Bandra Kurla Complex, Bandra (East)


MAHARASHTRA
400051
India 
Phone  02266932000  
Fax    
Email  seema.pai@pfizer.com  
 
Source of Monetary or Material Support  
Pfizer Inc. 66 Hudson Boulevard East New York, NY 10001 
 
Primary Sponsor  
Name  Pfizer Inc.  
Address  66 Hudson Boulevard East New York, NY 10001 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
Pfizer Limited  The Capital, 1802-1901, Plot No. C-70, G Block, Bandra Kurla Complex, Bandra(E) Mumbai MAHARASHTRA 400051 India  
 
Countries of Recruitment     Canada
Czech Republic
Finland
Hungary
India
Italy
Poland
Slovakia
United States of America
Japan
Spain  
Sites of Study
Modification(s)  
No of Sites = 7  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sheffali Gulati  All India Institute of Medical Sciences  Ansari Nagar, New Delhi, Delhi – 110029, India.
New Delhi
DELHI 		 9810386847

sheffaligulati@gmail.com 
Dr Sumit Singh  Artemis Hospital  Clinical Research Department, 4th Floor HR Building, Sector 51 Gurugram 122001
Gurgaon
HARYANA 		 9810052615

sumit.singh@artemishospitals.com 
Dr Amit Bhalchandra Yeole  Chopda Medicare & Research Centre Pvt. Ltd; Magnum Heart Institute  3/5, Patil Lane No. 1, Laxmi Nagar, Near K.B.H. Vidyalaya, Canada Corner, Nashik – 422005, Maharashtra, India
Nashik
MAHARASHTRA 		 7588554530

amit_yeole37@rediffmail.com  
Dr Saurabh Bansal  Fortis Memorial Research Institute  Clinical Research Department, 2nd Floor, Sector 44, Opp. Millenium City Centre Metro Station, Gurugram 122002, Haryana, India.
Gurgaon
HARYANA 		 7528910202

saurabh.bansal@fortishealthcare.com 
Dr Harsha S  JSS Hospital  Clinical research room, Master health checkup, 2nd floor, MG Road Agrahara Myosore Karnataka 570004
Mysore
KARNATAKA 		 9019423712

drharshaneur@gmail.com 
Dr Shankara Nellikunja  Mallikatta Neuro Centre  3rd Floor, Opp Mallikatta Circle Kadri Mangalore 575002
Dakshina Kannada
KARNATAKA 		 8242444933

dr.shankaramnc@gmail.com 
Dr Anshu Rohtagi  Sir Ganga Ram Hospital  Clinical Research Department, 5th floor, near Lift No 12, Sir Ganga Ram Hospital Marg Rajinder Nagar New Delhi 110060,
New Delhi
DELHI 		 9810159046

rohatgianshu@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 7  
Name of Committee  Approval Status 
Artemis Health Sciences Institutional Ethics Committee  Approved 
Institute Ethics Committee All India Institute of Medical Sciences  Approved 
Institutional Ethics Committee, Fortis Memorial Research Institute  Approved 
Institutional Ethics Committee, JSS Medical College  Approved 
Magna-Care Ethics Committee, Chopda Medicare and Research Centre Pvt. Ltd.,   Approved 
Mangala Institutional Ethics Committee  Approved 
Sir Ganga Ram Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G998||Other specified disorders of nervous system in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Matching Placebo  Participants will receive 75mg Orally disintegrating Placebo tablets to be administered every other day. The study duration is 76 weeks. 
Intervention  Rimegepant (PF-07899801)  Participants will receive Rimegepant 75mg orally disintegrating tablets to be administered every other day. The study duration is 76 weeks. 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Subject has at least a 6 month history of migraine (with or without aura) and including the following:

- 15 or more headache days per month during the 3 month period prior to the Screening Visit
- 8 or more migraine days per month during the 3 month period prior to the Screening Visit
- 15 or more headache days during the Observation Period
- 8 or more migraine days during the OP
- Ability to verbally distinguish migraine attacks from tension/cluster or other types of headaches
- Migraine attacks, on average, lasting 4 to 72 hours if untreated 
 
ExclusionCriteria 
Details  1. Target Disease Exclusion:
- Continuous migraine (defined as an unrelenting headache) within 1 month prior to
Screening Visit.
- Atypical migraine types, complications of a migraine, or a confounding and
clinically significant pain syndrome that may interfere with the participant’s
ability to participate in this study as assessed by the principal investigator (PI).
2. Any medical condition or laboratory abnormality, including any clinically significant
out-of-range vital signs, that may increase the risk of study participation or, in the
investigator’s judgment, make the participant inappropriate for the study
3. Any current psychiatric condition that is uncontrolled and/or untreated.
4. Any “yes” response on the Columbia-Suicide Severity Rating Scale (C-SSRS) for the
period of 30 days prior to Screening.
5. History of alcohol abuse and/or illicit drug use meeting Diagnostic and Statistical
Manual-5 (DSM-5®)2 criteria for substance use disorder within 6 months of screening
(excluding nicotine and caffeine).
6. Allergies and Adverse Drug Reactions:
- History of severe drug allergy (such as anaphylaxis, or known hypersensitivity or
intolerance to rimegepant or its excipients).  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Mean change from the observation phase in the number of migraine days per month over the entire double blind treatment phase   3 months or 12 weeks


 
 
Secondary Outcome  
Outcome  TimePoints 
Mean change from OP in number of moderate to severe headache days per months over entire DBT phase 1 to 12 weeks  1. Treatment effect of rimegepant relative to placebo in adolescent patients with chronic migraine in terms of difference in mean changes from OP in number of moderate or severe headache days per month over entire DBT Phase.
Timeframe - 12 weeks 
Percentage of participants with more than 50 percent reduction from the OP  The difference in the percentage of participants with more than 50 percent reduction from the OP
Time Frame - 12 weeks 
Mean change from baseline in the PedsQL 4.0 Generic core scales total score at week 2 of DBT phase  The difference in mean changes from baseline in the PedsQL total score at week 12 of the DBT phase.
Time frame - 12 weeks 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="12" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   07/03/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  14/12/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
Rimegepant has obtained approval in the United States (US), United Kingdom (UK), European Union (EU), and other countries for the acute treatment of migraine with and without aura in adults, and, in some countries, the preventive treatment of episodic migraine in adults. Currently, rimegepant is being studied for the acute treatment of migraine in children and adolescents, as well as for the prevention of migraine in children and adolescents with episodic migraine.

The purpose of this study is to compare the efficacy and safety of rimegepant to placebo as a preventative treatment for migraine in adolescents of 12 to 18 years of age with chronic migraine. 
 
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