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Randomized Study in Children and Adolescents With Migraine: Acute Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04649242
Recruitment Status : Recruiting
First Posted : December 2, 2020
Last Update Posted : April 27, 2023
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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Brief Summary:
The purpose of this study is to test the safety and efficacy of BHV-3000 versus placebo in the acute treatment of moderate or severe migraine in children and adolescents.

Condition or disease Intervention/treatment Phase
Pediatric Migraine Drug: Rimegepant/BHV3000 Drug: Matching placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2100 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Phase 3, Multicenter, Randomized, Double-blind, Group Sequential, Placebo-controlled Study to Assess Efficacy and Safety of Rimegepant for the Treatment of Migraine (With or Without Aura) in Children and Adolescents ≥ 6 to < 18 Years of Age
Actual Study Start Date : January 15, 2021
Estimated Primary Completion Date : October 30, 2026
Estimated Study Completion Date : October 30, 2026

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: BHV3000 (active drug)
BHV3000 (rimegepant) 75 mg or 50 mg ODT
 Drug: Rimegepant/BHV3000
BHV3000 (rimegepant) 75 mg or 50 mg ODT
Placebo Comparator: Placebo
Matching 75 mg or 50 mg ODT placebo
 Drug: Matching placebo
Matching 75 mg or 50 mg ODT placebo


Outcome Measures
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Primary Outcome Measures :
  1. To evaluate the efficacy of rimegepant compared with placebo in the acute treatment of migraine in adolescent population (≥ 12 to <18 years of age) as measured by pain freedom using the number of patients reporting no pain. [ Time Frame: 2 hours post-dose ]
    Pain freedom will be assessed in adolescent population (≥ 12 to < 18 years of age) on a 4-point numeric rating scale (0=none, 1=mild, 2=moderate, 3=severe).


Secondary Outcome Measures :
  1. To compare rimegepant with placebo for pain freedom in children and adolescents combined. [ Time Frame: 2 hours post-dose ]

    Pain freedom will be assessed in children and adolescents (≥ 6 to < 18 years of age) using a 4-point numeric rating scale (0=none, 1=mild, 2=moderate, 3=severe).

    Pain freedom will be assessed in children (> 6 to < 12 years of age) using the 5-Face VAS (Face 5 = 'severe pain', Faces 4 and 3 = 'moderate pain', Face 2 = 'mild pain', Face 1 = 'no pain').


  2. To compare rimegepant with placebo on freedom from the most bothersome symptom (MBS) associated with migraine in adolescents. [ Time Frame: 2 hours post-dose ]
    Freedom from MBS (nausea, phonophobia or photophobia) will be measured using a binary scale (0=absent, 1=present).

  3. To compare rimegepant with placebo on the probabilities of requiring rescue medication within in adolescents. [ Time Frame: Within 24 hours and 48 hours of initial treatment ]
    Use of rescue medication will be assessed using the numbers of participants that take rescue medication.

  4. To compare rimegepant with placebo on sustained pain freedom in adolescents. [ Time Frame: 2 to 24 hours post-dose ]
    Sustained pain freedom will be assessed using the number of participants that do not use any rescue medications and do not experience any headache pain post dose.

  5. To compare rimegepant with placebo on sustained pain freedom in adolescents. [ Time Frame: 2 to 48 hours post-dose ]
    Sustained pain freedom will be assessed using the number of participants that do not use any rescue medications and do not experience any headache pain post dose.

  6. To compare rimegepant with placebo on the ability to function normally as reported on the Functional Disability scale in adolescents. [ Time Frame: 2 hours post-dose ]
    The proportion of participants able to function normally will be assessed using the number that self-report as "normal" on the Functional Disability scale.

  7. To compare rimegepant with placebo for pain freedom in children. [ Time Frame: 2 hours post-dose ]
    Pain freedom will be assessed using the number of children (≥ 6 to < 12 years of age) that report no pain measured by a 5-Face VAS (Face 5 = 'severe pain', Faces 4 and 3 = 'moderate pain', Face 2 = 'mild pain', Face 1 = 'no pain').

  8. To compare rimegepant with placebo on freedom from the most bothersome symptom (MBS) associated with migraine in children and combined children and adolescents. [ Time Frame: 2 hours post-dose ]
    Freedom from the most bothersome symptom (nausea, phonophobia or photophobia) will be assessed using the number of participants that report the absence of MBS measured using a binary scale (0=absent, 1=present).

  9. To compare rimegepant with placebo on the probabilities of requiring rescue medication in children and combined children and adolescents. [ Time Frame: Within 24 hours and 48 hours of initial treatment. ]
    The probabilities of requiring rescue medication will be assessed using the numbers of participants that take rescue medication within initial treatment.

  10. To compare rimegepant with placebo on sustained pain freedom in children and combined children and adolescents. [ Time Frame: 2 to 24 hours post-dose ]
    Sustained pain freedom will be assessed using the number of participants that do not use any rescue medications and do not experience any headache pain post dose.

  11. To compare rimegepant with placebo on sustained pain freedom in children and combined children and adolescents. [ Time Frame: 2 to 48 hours post-dose ]
    Sustained pain freedom will be assessed using the number of participants that do not use any rescue medications and do not experience any headache pain post dose.

  12. To compare rimegepant with placebo on freedom from photophobia in adolescents, children and combined children and adolescents. [ Time Frame: 2 hours post-dose ]
    Freedom from photophobia will be assessed by the number of participants that report the absence of photophobia post dose that reported the presence of photophobia at baseline.

  13. To compare rimegepant with placebo on freedom from phonophobia in adolescents, children and combined children and adolescents. [ Time Frame: 2 hours post-dose ]
    Freedom from phonophobia will be assessed by the number of participants that report the absence of phonophobia post dose that reported the presence of phonophobia at baseline.

  14. To compare rimegepant with placebo on freedom from nausea in adolescents, children and combined children and adolescents. [ Time Frame: 2 hours post-dose ]
    Freedom from nausea will be assessed by the number of participants that report the absence of nausea post dose that reported the presence of nausea at baseline.

  15. To compare rimegepant with placebo on pain relief in adolescents, children and combined children and adolescents. [ Time Frame: 2 hours post-dose ]
    Pain relief will be assessed using the number of participants that report a pain level of moderate or severe at baseline and then report a pain level of none or mild post dose.

  16. To compare rimegepant with placebo in adolescents, children and combined children and adolescents on pain relief. [ Time Frame: Time to patients first report of pain relief of none or mild post dose up to 48 hours. ]
    Time to first report of pain relief will be based on the first time point a participant reports a pain level of none or mild.


Eligibility Criteria
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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. History of migraine (with or without aura) for > 6 months before Screening according to the IHS Classification ICHD-319 specifications for pediatric migraine. History may be verified using both medical records and recall by the participant and/or participant's parent(s)/legal representative(s).
  2. History of 1 to 8 moderate or severe attacks per month during the 2 months prior to enrollment, with attacks lasting > 3 hours without treatment, and attacks occurring at intervals > 24 hours.

  3. Prophylactic migraine medication are permitted if the dose has been stable for at least 12 weeks prior to the Baseline Visit, and the dose is not expected to change during the course of the study.

    1. Participants may remain on one (1) medication with possible migraine prophylactic effects, excluding CGRP antagonists [biologic or small molecule], during the treatment phases.
    2. Concomitant use of a CGRP antagonist, such as erenumab or fremanezumab, is prohibited.
    3. Previously discontinued prophylactic migraine medication must have done so at least 90 days prior to the Screening Visit.
  4. Verbally distinguish between migraine and other types of headaches.
  5. Participants must have a weight > 40 kg at the Screening Visit.
  6. Adequate venous access for blood sampling.
  7. Male and female participants ≥ 6 to < 18 years of age (participants must not reach their 18th birthday during the study).

Exclusion Criteria:

  1. History of cluster headache or hemiplegic migraine headache.
  2. Confounding and clinically significant pain syndrome that may interfere with the participant's ability to participate in this study.
  3. Current psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the Screening Visit. Participants with a lifetime history of psychosis and/or mania.
  4. History of suicidal behavior or major psychiatric disorder.
  5. Current diagnosis or history of substance abuse; positive drug test at Screening.
  6. History of moderate or severe head trauma or other neurological disorder (including seizure disorder) or systemic medical disease that is likely to affect central nervous system functioning.
  7. Recent or planned surgery, requiring general anesthesia, <8 weeks prior to the Screening Visit.
  8. Participant has had gastrointestinal surgery that interferes with physiological absorption and motility (i.e., gastric bypass, duodenectomy, or gastric banding).
  9. Current diagnosis of viral hepatitis or a history of liver disease.
  10. Conditions considered clinically relevant in the context of the study such as uncontrolled hypertension (high blood pressure), diabetes, a life-threatening allergy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04649242


Contacts
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Contact: Pfizer Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04649242    
Other Study ID Numbers: BHV3000-311
C4951002 ( Other Identifier: Alias Study Number )
2020-003517-35 ( Registry Identifier: CTIS (EU) )
First Posted: December 2, 2020    Key Record Dates
Last Update Posted: April 27, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
Migraine
Acute treatment
Phonophobia
Photophobia
Nausea
 Pediatric
Children
Adolescent
Pediatric Migraine
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases