RecruitingPhase 3

Randomized Study in Children and Adolescents With Migraine: Acute Treatment

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
6 Years to 17 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how safe BHV-3000 is and how well it treats moderate or severe migraine attacks compared with a placebo (a treatment with no active medicine). It is for children and teens ages 6 to 17 who have had migraines for more than 6 months.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 6 to 17 and not turn 18 during the study.
  • Have had migraines for more than 6 months, with or without aura (warning signs such as vision changes).
  • Have had 1 to 8 moderate or severe migraine attacks per month in the past 2 months. Without treatment, attacks must last more than 3 hours and occur more than 24 hours apart.
  • If taking medicine to prevent migraines, take only one allowed medicine. The dose must be unchanged for at least 12 weeks before the baseline visit and be expected to stay the same during the study.
  • Do not use migraine medicines called CGRP blockers, such as erenumab or fremanezumab. Any past migraine prevention medicine must have been stopped at least 90 days before screening.
  • Be able to explain the difference between migraines and other headaches.
  • Weigh more than 40 kilograms (about 88 pounds) at screening.
  • Have veins that allow blood samples to be taken.

Who can't join

  • Have a history of cluster headaches or migraines that cause weakness on one side of the body.
  • Have another serious pain condition that could make it hard to take part.
  • Have a mental health condition that has been uncontrolled or untreated for at least 6 months before screening; or a history of a major mental health disorder, suicidal behavior, psychosis (loss of touch with reality), or mania (extreme high mood or energy).
  • Have current or past substance abuse, or a positive drug test at screening.
  • Have had a moderate or severe head injury, or have another brain or nerve disorder, including seizures, or a disease likely to affect brain and spinal cord function.
  • Have recent or planned surgery needing general anesthesia (medicine that puts you to sleep), within the study’s stated 8-week limit before screening.
  • Have had stomach or bowel surgery that affects how food moves through the body or how nutrients are absorbed.
  • Have viral hepatitis (a liver infection), a history of liver disease, or another condition important to study safety, such as uncontrolled high blood pressure, diabetes, or a life-threatening allergy.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (169)

AL

  • Achieve Clinical Research, LLC d/b/a Accel Research Sites-Neurology and Neurodiagnostic of Alabama · Birmingham, AL 35244More trials in Birmingham

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