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Randomized Study in Children and Adolescents With Migraine: Acute Treatment

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ClinicalTrials.gov Identifier: NCT04649242
Recruitment Status : Recruiting
First Posted : December 2, 2020
Last Update Posted : July 27, 2021
Sponsor:
Information provided by (Responsible Party):
Biohaven Pharmaceuticals, Inc. ( Biohaven Pharmaceutical Holding Company Ltd. )

Tracking Information
First Submitted Date  ICMJE November 23, 2020
First Posted Date  ICMJE December 2, 2020
Last Update Posted Date July 27, 2021
Actual Study Start Date  ICMJE January 15, 2021
Estimated Primary Completion Date January 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 30, 2020)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2020)
  • 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').
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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').
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomized Study in Children and Adolescents With Migraine: Acute Treatment
Official Title  ICMJE Phase 3, Multicenter, Randomized, Double-blind,Group Sequential, Placebo-controlled Study to Assess Efficacy and Safety of Rimegepant or the Treatment of Migraine (With or Without Aura) in Children and Adolescents ≥ 6 to <18 Years of Age
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Migraine
Intervention  ICMJE
  • Drug: Rimegepant/BHV3000
    BHV3000 (rimegepant) 75 mg or 50 mg ODT
  • Drug: Matching placebo
    Matching 75 mg or 50 mg ODT placebo
Study Arms  ICMJE
  • Active Comparator: BHV3000 (active drug)
    BHV3000 (rimegepant) 75 mg or 50 mg ODT
    Intervention: Drug: Rimegepant/BHV3000
  • Placebo Comparator: Placebo
    Matching 75 mg or 50 mg ODT placebo
    Intervention: Drug: Matching placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 31, 2020)
1440
Original Estimated Enrollment  ICMJE
 (submitted: November 30, 2020)
1350
Estimated Study Completion Date  ICMJE January 2023
Estimated Primary Completion Date January 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 6 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Canada,   Germany,   Poland,   Spain,   Sweden,   United Kingdom,   United States
Removed Location Countries Argentina
 
Administrative Information
NCT Number  ICMJE NCT04649242
Other Study ID Numbers  ICMJE BHV3000-311
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Biohaven Pharmaceuticals, Inc. ( Biohaven Pharmaceutical Holding Company Ltd. )
Study Sponsor  ICMJE Biohaven Pharmaceutical Holding Company Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Biohaven Pharmaceuticals, Inc.
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP