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

Sponsor
Biohaven Pharmaceuticals, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05156398
Collaborator
Biohaven Pharmaceutical Holding Company Ltd. (Industry)
640
Enrollment
51
Locations
2
Arms
54.1
Anticipated Duration (Months)
12.5
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
640 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
A Phase 3, Randomized, Doubleblind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rimegepant in Migraine Prevention in Children and Adolescents ≥ 6 to <18 Years of Age
Actual Study Start Date :
Feb 28, 2022
Anticipated Primary Completion Date :
Sep 2, 2026
Anticipated Study Completion Date :
Sep 2, 2026

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Rimegepant / BHV3000

Rimegepant 75mg or 50mg (2 X 25mg) ODT

Drug: Rimegepant
Rimegepant 75mg or 50mg (2 X 25mg) ODT
Other Names:
  • BHV3000

    		•
    Placebo Comparator: Matching Placebo

    Matching placebo 75mg or 50mg (2 X 25mg) ODT

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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 [3 months (12 weeks)]

      Reduction from baseline in mean number of migraine days per month

    Secondary Outcome Measures

    1. 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)]

    2. 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]

    3. 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]

    4. 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)]

    5. 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. [3 months (12 weeks)]

      Measured over the entire course of the double-blind treatment phase in children and children and adolescents combined with episodic migraine.

    6. Compare the use of acute migraine-specific medications (triptans) based on the change from baseline in monthly acute migraine specific medication days. [3 months (12 weeks)]

      Measured in each month and over the course of the entire double-blind treatment phase in adolescents, children and adolescents and children combined.

    7. Evaluate the safety and tolerability of rimegepant as a preventative treatment for migraine in children and adolescents. [72 Weeks]

      This will be evaluated by the number of subjects with treatment related adverse events by severity.

    8. Evaluate the frequency of hepatic-related adverse events in subjects treated with rimegepant. [72 Weeks]

      Measured by discontinuations in treated subjects due to elevated liver function tests.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

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

    2. 14 or less headache days per month during the 3 month period prior to the Screening Visit

    3. 6 or more migraine days during the Observation Period

    4. 14 or less headache days during the Observation Period

    5. 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

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

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

    8. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 SCLA Management Fort Smith Arkansas United States 72916
    2 Advanced Investigative Medicine Hawthorne California United States 90250
    3 Velocity Clinical Research, San Diego La Mesa California United States 91942
    4 Palo Alto Medical Foundation Palo Alto California United States 94301
    5 Clinical Research of California Walnut Creek California United States 94598
    6 CSNA Colorado Springs Colorado United States 80907
    7 Advanced Neurosciences Research, LLC Fort Collins Colorado United States 80528
    8 Meridian Clinical Research, Llc Washington District of Columbia United States 20016
    9 Synergy Healthcare Bradenton Florida United States 34208
    10 Vertex Research Group Clermont Florida United States 34711
    11 Complete Health Research Edgewater Florida United States 32132
    12 Direct Helpers Research Center Hialeah Florida United States 33012
    13 New Med Research, Inc Hollywood Florida United States 33020
    14 Axcess Medical Research Loxahatchee Groves Florida United States 33470
    15 Sanitas Research (SR) Miami Florida United States 33155
    16 APG Research, LLC Orlando Florida United States 32803
    17 Complete Health Research Ormond Beach Florida United States 32174
    18 Etna Medical Center Llc Tamarac Florida United States 33321
    19 WR-Mount Vernon Clinical Research, LLC Sandy Springs Georgia United States 30328
    20 Meridian Clinical Research Savannah Georgia United States 31406
    21 Renew Health Clinical Research LLC Snellville Georgia United States 30078
    22 Northwest Clinical Trials Boise Idaho United States 83704
    23 Diamond Headache Clinic Chicago Illinois United States 60642
    24 Research Works INC New Orleans Louisiana United States 70125
    25 MU Child Health Columbia Missouri United States 65201
    26 AMR Kansas City Kansas City Missouri United States 64114
    27 Meridian Clinical Research Hastings Nebraska United States 68847
    28 MCHRI Lincoln Nebraska United States 68504
    29 Renown Regional Medical Center Reno Nevada United States 89502
    30 OceanMedical Research Toms River New Jersey United States 08755
    31 IMA Evaluations, LLC dba Albuquerque Neuroscience Inc. Albuquerque New Mexico United States 87118
    32 Dent Neurosciences Research Center, Inc. Amherst New York United States 14226
    33 Montefiore Medical Center; Headache Center Bronx New York United States 10461
    34 Rochester Clinical Research, Inc. Rochester New York United States 14609
    35 Velocity Clinical Research Cincinnati Cincinnati Ohio United States 45242
    36 Cincinnati Children's Hospital Medical Center Cincinnati Ohio United States 45299
    37 Lynn Health Science Institute Oklahoma City Oklahoma United States 73112
    38 Coastal Pediatric Research Charleston South Carolina United States 29414
    39 Meridian Clinical Research Charleston South Carolina United States 29414
    40 Tribe Clinical Research Greenville South Carolina United States 29607
    41 Avera McKennan d/b/a Avera Research Institute Sioux Falls South Dakota United States 57108
    42 TIND Arlington Texas United States 76015
    43 DM Clinical - Cyfair Houston Texas United States 77065
    44 SCLA Management Houston Texas United States 77077
    45 Red Star Research Lake Jackson Texas United States 77566
    46 FMC Science Lampasas Texas United States 76550
    47 DCT-McAllen Primary Care Research dba Discovery Clinical Trials McAllen Texas United States 78503
    48 DCT-Baxter Research, LLC dba Discovery Clinical Trials San Antonio Texas United States 78230
    49 DCT-Stone Oak, LLC dba Discovery Clinical Trials San Antonio Texas United States 78258
    50 Victoria Clinical Research Group Victoria Texas United States 77901
    51 Meridian Clinical Research Portsmouth Virginia United States 23703

    Sponsors and Collaborators

    • Biohaven Pharmaceuticals, Inc.
    • Biohaven Pharmaceutical Holding Company Ltd.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Biohaven Pharmaceuticals, Inc.
    ClinicalTrials.gov Identifier:
    NCT05156398
    Other Study ID Numbers:
    • BHV3000-315
    First Posted:
    Dec 14, 2021
    Last Update Posted:
    Aug 5, 2022
    Last Verified:
    Aug 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Biohaven Pharmaceuticals, Inc.
    Migraine
    Migraine prevention
    Phonophobia
    Photophobia
    Nausea
    Pediatric migraine
    Adolescent migraine
    Additional relevant MeSH terms:
    Migraine Disorders

    Study Results

    No Results Posted as of Aug 5, 2022