Efficacy and Safety Study of Rimegepant for the Preventative Treatment of Migraine in Pediatric Subjects

Migraine Clinical Trial

Official title:

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rimegepant in Migraine Prevention in Children and Adolescents ≥ 6 to <18 Years of Age

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05156398
• Other study ID #: BHV3000-315
• Secondary ID: C49510092021-005
• Status: Recruiting
• Phase: Phase 3
• Start date: February 28, 2022
• Est. completion date: April 29, 2027

Study information

• Verified date: June 2024
• Source: Pfizer
• Contact: Pfizer Pfizer CT.gov Call Center
• Phone: 1-800-718-1021
• Email: ClinicalTrials.gov_Inquiries[@]pfizer.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the efficacy and safety of rimegepant to placebo as a preventative treatment for migraine in children and adolescents ≥ 6 to <18 years with episodic migraine.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 640
• Est. completion date: April 29, 2027
• Est. primary completion date: April 29, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

Inclusion Criteria:

1. Subject has at least a 6 month history of migraine (with or without aura) and including the following:

1. 14 or less headache days per month during the 3 month period prior to the Screening Visit

2. 6 or more migraine days during the Observation Period

3. 14 or less headache days during the Observation Period

4. Pediatric Migraine Disability Assessment Scale (PedMIDAS) Disability Score of >10 to =50, indicating mild (score of 11 to 30) or moderate (score of 31 to 50) disruption in daily activities, as assessed at the Baseline (Randomization) Visit

5. Ability to verbally distinguish migraine attacks from tension/cluster or other types of headaches

6. Migraine attacks, on average, lasting 4 - 72 hours if untreated

7. Subjects on prophylactic migraine medication are permitted to remain on therapy if the dose has been stable for at least 3 months (12 weeks) prior to the Screening Phase, and the dose is not expected to change during the course of the study. 2) Male and female subjects = 6 to <18 years; subjects must be less than 18 at the time of signing assent / consent.

3)Subjects must have a weight of =40 kg (child cohort requirement =15 kg) at the Screening Visit.

Exclusion Criteria:

1. Subjects with a history of basilar migraine, cluster headaches, or hemiplegic migraine

2. The subject has a continuous migraine (defined as an unrelenting headache) within 1 month prior to Screening Visit.

3. The subject has a history or diagnosis of complications of migraine

4. The subject has a confounding and clinically significant pain syndrome that may interfere with the subject's ability to participate in this study.

5. The subject has any current psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the Screening Visit. Subjects with a lifetime history of psychosis and/or mania are excluded.

6. History of suicidal behavior or the subject is at risk of self-harm or harm to others.

7. History of major psychiatric disorder.

8. The subject has a current diagnosis or history of substance abuse

9. The subject has a history of moderate or severe head trauma or other neurological disorder (including seizure disorder) or systemic medical disease that is, in the investigator's opinion, likely to affect central nervous system functioning.

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• Rimegepant
Rimegepant 75mg or 50mg (2 X 25mg) ODT
• Placebo
Matching placebo 75mg or 50mg (2 X 25mg) ODT

Locations

Country	Name	City	State
Canada	The Kids Clinic	Ajax	Ontario
Canada	The Kids Clinic Inc	Ajax	Ontario
Canada	Children's Hospital of Eastern Ontario	Ottawa	Ontario
Canada	Children's and Women's Health Centre of British Columbia	Vancouver	British Columbia
France	Centre Hospitalier Intercommunal de Créteil	Créteil
France	Centre Hospitalier Universitaire de Montpellier	Montpellier
France	CHU Gui de Chauliac	Montpellier
France	Hopital des Enfants	Toulouse
Italy	Unita di Neurologia, Azienda Ospedaliera San Giuseppe Moscati	Avellino	Avellino/campania
Italy	Presidio Ospedaliero San Paolo	Bari
Italy	UOSVD Centro Epilessia ed EEG dellEta Evolutiva	Bari	BARI / Puglia
Italy	Spedali Civili di Brescia	Brescia	Brescia/lombardy
Italy	U.O. di Neurologia- ASST Spedali Civili di Brescia	Brescia	Lombardy
Italy	Azienda Ospedaliero Universitaria Meyer	Firenze	Florence
Italy	Azienda Ospedaliero Universitaria Meyer	Florence	Florence/tuscany
Italy	Azienda Ospedaliero Universitaria Meyer	Florence	Florence/tuscany
Italy	Sapienza Universita di Roma Polo Pontino - ICOT, Headache clinic	Latina	Latina/lazio
Italy	SS Centro Cefalee - UOC di Neurologia 3	Milan	Milan/lombardy
Italy	Istituto neurologico Carlo Besta	Milano
Italy	Fondazione Mondino - Istituto Neurologico Nazionale IRCCS	Pavia	Padua
Italy	U.O. Neuropsichiatria Infantile, IRCCS Fondazione Mondino	Pavia	Pavia/lombardy
Italy	Dipartimento Materno Infantile e Scienze UroGinecologiche - UOC Pediatria	Roma
Italy	Ospedale Pediatrico Bambino Gesu	Roma	Lazio
Italy	Divisione di Neurologia, Ospedale Pediatrico Bambino Gesu	Rome	Rome/lazio
Italy	IRCCS San Raffaele	Rome	ROME / Latium
Italy	IRCCS San Raffaele	Rome	ROME / Latium
Italy	IRCCS San Raffaele Roma	Rome
Japan	Tennouji Dai Brain Clinic	Abeno-ku Osaka-shi	Osaka
Japan	Saitama Neuropsychiatric Institute	Chuo-ku Saitama-shi	Saitama
Japan	Konan Medical Center	Higashinada-ku Kobe-shi	Hyogo
Japan	LIAC Hiroshima City Hospital Organization Hiroshima City Hiroshima Citizens Hospital	Hiroshima
Japan	Tanaka Neurosurgical Clinic	Kagoshima-shi	Kagoshima
Japan	Jinnouchi Neurosurgical Clinic	Kasuga-shi	Fukuoka
Japan	Hikita Pediatric Clinic	Kiryu-shi	Gunma
Japan	Atago Hospital	Kochi-shi	Kochi
Japan	Medical Corporation Seikokai Takanoko Hospital	Matsuyama-shi	Ehime
Japan	Mito Kyodo General Hospital	Mito-shi	Ibaraki
Japan	Hiroshima City Hiroshima Citizens Hospital	Naka-ku Hiroshima-shi	Hiroshima
Japan	Tominaga Clinic	Naniwa-ku, Osaka-shi	Osaka
Japan	Yamaguchi Clinic	Nishinomiya-shi	Hyogo
Japan	Tokyo Headache Clinic	Shibuya-ku	Tokyo
Japan	Tokyo Medical University Hospital	Shinjuku-ku	Tokyo
Japan	Tokyo Medical University Hospital	Shinjyuku-ku	Tokyo
Japan	Sendai Headache and Neurology Clinic	Taihaku-ku Sendai-shi	Miyagi
Poland	Neurologia Slaska Centrum Medyczne	Katowice	Slaskie
Poland	NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS	Katowice	Slaskie
Poland	Wojewodzki Specjalistyczny Szpital Dzieciecy	Krakow	Malopolskie
Poland	Wojewodzki Specjalistyczny Szpital Dzieciecy im. sw. Ludwika w Krakowie	Krakow
Poland	Indywidualna Praktyka Lekarska Dr Hab. Med. Anna Szczepanska-Szerej	Lublin	Lubelskie
Poland	NZOZ Neuromed M. i M. Nastaj Sp. P.	Lublin	Lubelskie
Poland	NZOZ Neuromed M. i M. Nastaj Sp. P.	Lublin
Poland	Clinical Research Center Sp. z o.o. MEDIC-R Sp. k.	Poznan	Wielkopolskie
Poland	Clinical Research Center Sp. z o.o. MEDIC-R Sp. k.	Poznan	Wielkopolskie
Poland	MTZ Clinical Research Powered by Pratia	Warszawa	Mazowieckie
Poland	MTZ Clinical Research Sp. z o.o.	Warszawa
Poland	Next Stage Sp. Z o.o.	Warszawa	Mazowieckie
Poland	MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak	Wroclaw	Dolnoslaskie
Spain	Instituto de Investigaciones del Sueno	Madrid
Spain	Hospital Universitari Parc Tauli	Sabadell	Barcelona
Spain	Hospital Clinico Universitario de Santiago de Compostela	Santiago de Compostela	LA Coruna
Spain	Virgen del Rocio Hospital	Sevilla
Spain	Hospital Universitario y Politecnico La Fe	Valencia
Spain	Hospital Clinico Universitario de Valladolid (HCUV)	Valladolid	Castilla Y LEON
Spain	Hospital Alvaro Cunqueiro	Vigo	Galicia
United States	Albuquerque Neuroscience Inc.	Albuquerque	New Mexico
United States	Dent Neurosciences Research Center, Inc.	Amherst	New York
United States	Augusta University	Augusta	Georgia
United States	Northwest Clinical Trials, Inc.	Boise	Idaho
United States	Synergy Healthcare	Bradenton	Florida
United States	Montefiore Medical Center	Bronx	New York
United States	Coastal Pediatric Research	Charleston	South Carolina
United States	Meridian Clinical Research, LLC	Charleston	South Carolina
United States	Diamond Headache Clinic	Chicago	Illinois
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Velocity Clinical Research	Cincinnati	Ohio
United States	Vertex Research Group	Clermont	Florida
United States	Safe Haven Clinical Research	Clinton	Mississippi
United States	Colorado Springs Neurological Associates	Colorado Springs	Colorado
United States	University of Missouri Health Care - Clinical Research Center	Columbia	Missouri
United States	University of Missouri Health Care - Investigation Pharmacy (IP to be shipped here)	Columbia	Missouri
United States	University of Missouri Health Care - Pathology Department	Columbia	Missouri
United States	University of Missouri School of Medicine	Columbia	Missouri
United States	DCT-Baxter Research, LLC dba Discovery Clinical Trials	Dallas	Texas
United States	Accel Research Sites Network - Edgewater Clinical Research Unit	Edgewater	Florida
United States	Complete Health Research	Edgewater	Florida
United States	Carolina Institute for Clinical Research, LLC	Fayetteville	North Carolina
United States	Advanced Neurosciences Research, LLC	Fort Collins	Colorado
United States	The Belinga Clinic	Fort Smith	Arkansas
United States	North Texas Center for Clinical Research	Frisco	Texas
United States	Tribe Clinical Research LLC	Greenville	South Carolina
United States	Meridian Clinical Research, LLC	Hastings	Nebraska
United States	Advanced Investigative Medicine, Inc.	Hawthorne	California
United States	Direct Helpers Research Center	Hialeah	Florida
United States	New Med Research, Inc	Hollywood	Florida
United States	DM Clinical Research - Cy Fair	Houston	Texas
United States	SCLA Management	Houston	Texas
United States	Velocity Clinical Research San Diego	La Mesa	California
United States	Red Star Research, LLC	Lake Jackson	Texas
United States	Midwest Children's Health Research Institute, LLC	Lincoln	Nebraska
United States	Axcess Medical Research	Loxahatchee Groves	Florida
United States	DCT-McAllen Primary Care Research, LLC dba Discovery Clinical Trials	McAllen	Texas
United States	Sanitas Research, LLC	Miami	Florida
United States	Monroe Carell Jr Children's Hospital at Vanderbilt	Nashville	Tennessee
United States	Lynn Health Science Institute	Oklahoma City	Oklahoma
United States	APG Research, LLC	Orlando	Florida
United States	Complete Health Research	Ormond Beach	Florida
United States	Papillion Research Center/CCT Research	Papillion	Nebraska
United States	Meridian Clinical Research, LLC	Portsmouth	Virginia
United States	Renown Regional Medical Center	Reno	Nevada
United States	DCT-Stone Oak, LLC dba Discovery Clinical Trials	San Antonio	Texas
United States	WR-Mount Vernon Clinical Research, LLC	Sandy Springs	Georgia
United States	Meridian Clinical Research, LLC	Savannah	Georgia
United States	Texas Institute for Neurological Disorders	Sherman	Texas
United States	Avera McKennan Hospital & University Health Center	Sioux Falls	South Dakota
United States	Avera Medical Group Pediatric Specialists	Sioux Falls	South Dakota
United States	Avera Research Institute	Sioux Falls	South Dakota
United States	Extraordinary Family Healthcare	Snellville	Georgia
United States	Renew Health Clinical Research LLC	Snellville	Georgia
United States	South Ogden Family Medicine Ogden Clinic/CCT Research	South Ogden	Utah
United States	D&H Tamarac Research Center LLC	Tamarac	Florida
United States	Santos Research Center, CORP	Tampa	Florida
United States	DM Clinical Research (Administrative Office Only)	Tomball	Texas
United States	Ocean Medical Research	Toms River	New Jersey
United States	Victoria Clinical Research Group	Victoria	Texas
United States	Clinical Research of California	Walnut Creek	California
United States	Meridian Clinical Research, LLC	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada,  France,  Italy,  Japan,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in the mean number of migraine days per month as measured over the 12-week double-blind phase of the study in adolescents with episodic migraine	Reduction from baseline in mean number of migraine days per month	3 months (12 weeks)
Secondary	Achievement of at least a 50% reduction from baseline in mean monthly migraine days over the course of the double-blind phase in adolescents with episodic migraine		3 months (12 weeks)
Secondary	Change from baseline in the mean number of migraine days per month in the first 4 weeks (Weeks 1 through 4) of the double-blind treatment phase in adolescents with episodic migraine.		Weeks 1 through 4 of treatment
Secondary	The mean change from baseline in the Pediatric Quality of Life (PedsQL™) total score at Week 12 of the double-blind treatment phase in adolescents with episodic migraine.		Total score at week 12
Secondary	Change from baseline in the mean number of migraine days per month over the entire course of the double-blind treatment phase in children and children and adolescents combined with episodic migraine.		3 months (12 weeks)
Secondary	Change from baseline on the proportion of subjects that have at least a 50% reduction in the mean number of moderate to severe migraine days per month.	Measured over the entire course of the double-blind treatment phase in children and children and adolescents combined with episodic migraine.	3 months (12 weeks)
Secondary	Compare the use of acute migraine-specific medications (triptans) based on the change from baseline in monthly acute migraine specific medication days.	Measured in each month and over the course of the entire double-blind treatment phase in adolescents, children and adolescents and children combined.	3 months (12 weeks)
Secondary	Evaluate the safety and tolerability of rimegepant as a preventative treatment for migraine in children and adolescents.	This will be evaluated by the number of subjects with treatment related adverse events by severity.	72 Weeks
Secondary	Evaluate the frequency of hepatic-related adverse events in subjects treated with rimegepant.	Measured by discontinuations in treated subjects due to elevated liver function tests.	72 Weeks

External Links

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