| CTRI Number |
CTRI/2025/11/097643 [Registered on: 18/11/2025] Trial Registered Prospectively |
| Last Modified On: |
26/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
A Study to Learn About the Study Medicine Called Rimegepant in Women When Used for Intermittent Prevention of Menstrual Migraine |
|
Scientific Title of Study
|
An Interventional Efficacy and Safety, Phase 3, Double-Blind, Parallel-Group Study to Investigate Intermittent Prevention of Menstrual Migraine with Rimegepant Compared with Placebo in Women Participants 18 to 45 Years of Age |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NCT06641466 |
ClinicalTrials.gov |
| Protocol C4951063, Final Protocol Amendment 1, 05 Dec 2024 |
Protocol Number |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Designation |
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| Affiliation |
|
| Address |
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| Phone |
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| Fax |
|
| Email |
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Details of Contact Person
Scientific Query
|
| Name |
Dr Seema Pai |
| Designation |
Sr 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-400051,MAHARASHTRA, India
Mumbai
MAHARASHTRA
400051
India |
| Phone |
02266932000 |
| Fax |
|
| Email |
seema.pai@pfizer.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Seema Pai |
| Designation |
Sr 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-400051,MAHARASHTRA, India
Mumbai
MAHARASHTRA
400051
India |
| Phone |
02266932000 |
| Fax |
|
| Email |
seema.pai@pfizer.com |
|
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Source of Monetary or Material Support
|
| Pfizer Inc. 66 Hudson Boulevard East New York, NY 10001 |
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Primary Sponsor
|
| Name |
Pfizer Inc. |
| Address |
66 Hudson Boulevard East New York, NY 10001 United States |
| Type of Sponsor |
Pharmaceutical industry-Global |
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Details of Secondary Sponsor
|
| Name |
Address |
| Ms Pfizer Limited |
The Capital, 1802/1901, Plot No. C - 70, G Block, Bandra Kurla Complex, Bandra(East), Mumbai 400 051 |
|
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Countries of Recruitment
|
Argentina
Canada
China
Denmark
Germany
India
Italy
Japan
Mexico
Netherlands
Poland
Republic of Korea
Spain
United Kingdom
United States of America |
Sites of Study
Modification(s)
|
| No of Sites = 8 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Amit Yeole |
Chopda Medicare and Research Centre Pvt. Ltd |
Magnum Heart Institute,
3/5, Patil Lane 1, Laxmi Nagar, Near K B H Vidyalaya, Canada Corner, Nashik-422005, Maharashtra, India
Nashik
MAHARASHTRA |
7588554530
amit_yeole37@rediffmail.com |
| Dr Prafulla Shembalkar |
Getwell Hospital and Research Institute |
Room G-12, Getwell Hospital and Research Institute,
20/1, Dr. Khare Marg, Dhantoli, Nagpur 440012, Maharashtra, India
Nagpur
MAHARASHTRA |
9096050839
drshembalkar@gmail.com |
| Dr Dilip Nagrawal |
Jawahar Lal Nehru Medical College |
Room 36, Jawahar Lal Nehru Medical College, Ajmer,
Kala Bagh, Ajmer-305001, Rajasthan, India
Ajmer
RAJASTHAN |
7703841956
doctordilip.nagarwal@gmail.com |
| Dr Vijaya Pamidimukkala |
Lalitha Super Specialities Hospital |
Kothapet, Guntur-522001, Andhra Pradesh, India
Guntur
ANDHRA PRADESH |
9940808621
drvijaya.lssh@gmail.com |
| Dr Shankara Nellikunja |
Mallikatta Neuro Centre |
Opp. Mallikatta Circle, Kadri-575002, Mangaluru, Karnataka, India
Dakshina Kannada
KARNATAKA |
8242444933
dr.shankaramnc@gmail.com |
| Dr Mukesh Sharma |
Marengo CIMS Hospital, Ahmedabad |
Plot No. 67/1, Opposite Panchamrut Bunglows, Near Shukan Mall, Off. Science City Road, Sola, Ahmedabad - 380060, Gujarat, India
Ahmadabad
GUJARAT |
9375488882
mukesh.sharma@marengoasia.com |
| Dr Jayantee Kalita |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
Room 10, 11 &12, Sanjay Gandhi Post Graduate Institute of Medical Sciences,
Raebareli Road, Lucknow-226014, Uttar Pradesh, India
Lucknow
UTTAR PRADESH |
9450411673
jayanteek@yahoo.com |
| Dr Rahul Chakor |
Topiwala National Medical College & B. Y. L. Nair Charitable Hospital |
Dr. A. L. Nair Road, Mumbai Central, Mumbai-400008, Maharashtra, India
Mumbai
MAHARASHTRA |
9820747496
rahulchakor@gmail.com |
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Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 8 |
| Name of Committee |
Approval Status |
| Ethics Committee of Marengo Asia Healthcare Private Limited |
Approved |
| Getwell Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee |
Submittted/Under Review |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee TNMC NAIR HOSPITAL |
Submittted/Under Review |
| Lalitha SuperSpecialities Hospital Ethics Committee |
Approved |
| Magna-Care Ethics Committee |
Approved |
| Mangala Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G998||Other specified disorders of nervous system in diseases classified elsewhere, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
Matching placebo oral disintegrating tablets is given once daily orally for 7 days in each cycle. |
| Intervention |
Rimegepant (PF-07899801) |
Rimegepant 75 mg is given once daily orally for 7 days in each cycle. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Participant has regular menstrual cycles greater than equal to 24 days and less than equal to 34 days
2. A minimum 1-year history of migraine (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition
3. A history of menstrual migraine attacks of at least 3 months
4. Participant reported history of experiencing at least 1 migraine attack during the perimenstrual period in at least 2 out of 3 menstrual cycles immediately prior to screening.
5. If the participant is receiving a permitted background continuous prophylactic migraine medication, the medication dose must be stable for at least 3 months prior to the Screening visit and, the dose is not expected to change during the course of the study |
|
| ExclusionCriteria |
| Details |
1. Greater than 6 migraine days per month that are outside of the perimenstrual period in the 3 months prior to Screening
2. A diagnosis of chronic migraine or a history of more than 14 headache days per month on average, in the 3 months prior to Screening
3. History of retinal migraine, basilar migraine or hemiplegic migraine
4. Current diagnosis of schizophrenia, bipolar, or borderline personality disorder
5. Other pain syndromes (eg, fibromyalgia, complex regional pain syndrome), or significant neurological disorders (other than migraine), or other medical conditions (including endocrine and gynecological eg, severe dysmenorrhea |
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Method of Generating Random Sequence
|
Other |
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Method of Concealment
|
Centralized |
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Blinding/Masking
|
Participant and Investigator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Mean change from the Observation Period in number of migraine days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase |
5 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean change from the Observation Period in number of headache days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase |
5 months |
| Percentage of participants with greater than equal to 50 percent reduction from the Observation Period in number of migraine days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase |
5 months |
| Mean change from the Observation Period in number of acute migraine medication days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase |
5 months |
| Mean change from the Observation Period in number of acute migraine-specific medication days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase |
5 months |
| Mean change from the Observation Period in number of migraine days with moderate-severe functional disability per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase |
5 months |
| Mean change from the Observation Period in number of moderate-severe headache days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase |
5 months |
| Mean change from the Observation Period in number of moderate-severe migraine days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase |
5 months |
| Mean change from baseline in the MiCOAS Cognition score at postdosing (ie, 1 day after the 7-day dosing period) across each cycle of the Double-Blind Treatment PhaseMean change from baseline in the MiCOAS Cognition score at postdosing (ie, 1 day after the 7-day dosing period) across each cycle of the Double-Blind Treatment Phase |
5 months |
| Mean change from the Observation Period in monthly migraine days (per cycle, normalized to 28-days) across each cycle of the Double-Blind Treatment Phase |
5 months |
| Mean change from the Observation Period in monthly headache days (per cycle, normalized to 28-days) across each cycle of the Double-Blind Treatment Phase |
5 months |
| Mean change from the Observation Phase in monthly acute migraine-specific medication days (per cycle, normalized to 28-days) across each cycle of the Double-Blind Treatment Phase |
5 months |
|
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Target Sample Size
|
Total Sample Size="470"
Sample Size from India="35"
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)
|
03/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
11/03/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
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Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
The purpose of this study is to evaluate the efficacy and safety of Rimegepant when administered during the peri-menstrual period (PMP) for intermittent prevention of migraine in women who experience menstrual migraine attacks. This study supports the continued development of Rimegepant for use as a short-term preventive treatment for migraine attacks associated with specific and predictable triggers. |