600 Participants Needed

Rimegepant for Pediatric Migraine

Recruiting at 217 trial locations
ES
PC
PP
Overseen ByPfizer Pfizer CT.gov Call Center
Age: < 18
Sex: Any
Trial Phase: Phase 3
Sponsor: Biohaven Pharmaceuticals, Inc.
Must be taking: Prophylactic migraine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

This trial aims to test the safety of rimegepant, a medication for treating migraines. The study focuses on children and adolescents aged 6 to 17 years who experience moderate to severe migraines. Rimegepant works by blocking a protein that triggers migraine pain, helping to alleviate symptoms.

Will I have to stop taking my current medications?

The trial allows participants to continue taking their current migraine prevention medication if the dose has been stable for at least 12 weeks before the study starts. The protocol does not specify about other medications, so it's best to discuss with the trial team.

Is Rimegepant safe for humans?

Rimegepant has been generally well tolerated in clinical trials for migraine treatment in adults, with no evidence of liver or heart toxicity. Most side effects were mild or moderate and did not lead to stopping the trials.12345

How is the drug Rimegepant unique for treating pediatric migraine?

Rimegepant is unique because it is a calcitonin gene-related peptide (CGRP) receptor antagonist available as an orally disintegrating tablet, which can offer convenience and potentially faster relief compared to conventional tablets. It is the first drug approved for both the acute treatment and prevention of migraine, making it a versatile option for managing migraines.13467

Research Team

PC

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

This trial is for children and teens aged 6 to under 18 with a history of migraines, weighing at least 40 kg. They should have experienced 1-8 moderate or severe migraine attacks per month in the last two months and be able to tell migraines apart from other headaches. Stable use of preventive migraine medication is allowed.

Inclusion Criteria

I am between 6 and 17 years old.
I needed treatment for a migraine at least once during the observation period.
You can tell the difference between migraines and other kinds of headaches.
See 9 more

Exclusion Criteria

You are currently using or have a history of using drugs, and your drug test at the screening shows positive results.
I have not had untreated mental health issues for the past 6 months.
I have a history of cluster or hemiplegic migraine headaches.
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive rimegepant for the acute treatment of migraine

58 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Rimegepant / BHV3000
Trial OverviewThe study tests the long-term safety of Rimegepant (BHV3000) for treating acute, moderate or severe migraines in young participants. It aims to understand how well they tolerate this medication over an extended period.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: ActiveExperimental Treatment1 Intervention
rimegepant 75 mg, 50 mg or 35 mg ODT

Rimegepant / BHV3000 is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Nurtec ODT for:
  • Acute treatment of migraine
🇪🇺
Approved in European Union as Vydura for:
  • Acute treatment of migraine

Find a Clinic Near You

Who Is Running the Clinical Trial?

Biohaven Pharmaceuticals, Inc.

Lead Sponsor

Trials
49
Recruited
30,100+

Pfizer

Lead Sponsor

Trials
4,712
Recruited
50,980,000+
Known For
Vaccine Innovations
Top Products
Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni profile image

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Findings from Research

Rimegepant, an oral CGRP receptor antagonist, has shown significant efficacy in treating migraines, providing pain relief and symptom improvement for up to 48 hours after a single dose, based on completed phase II and III trials.
The medication was well tolerated with only mild to moderate adverse events reported, leading to its FDA approval for acute migraine treatment on February 27, 2020.
Rimegepant for the treatment of migraine.Negro, A., Martelletti, P.[2021]
Rimegepant, an orally disintegrating tablet approved by the FDA, has been shown in three phase 3 trials to significantly improve pain relief and reduce bothersome migraine symptoms within 2 hours of administration.
This medication offers a new mechanism of action for treating migraines, making it a suitable option for patients who do not respond well to traditional treatments like triptans or who experience adverse effects from them.
Rimegepant Orally Disintegrating Tablet for Acute Migraine Treatment: A Review.DeFalco, AP., Lazim, R., Cope, NE.[2021]
Rimegepant is an effective treatment for migraines, showing significant pain relief and reduction in bothersome symptoms compared to placebo in phase III trials, and it can also reduce the number of monthly migraine days when used preventively.
The medication is generally well tolerated, with no signs of liver or heart-related side effects, making it a safe option for adults managing migraines.
Rimegepant: A Review in the Acute Treatment and Preventive Treatment of Migraine.Blair, HA.[2023]

References

Rimegepant for the treatment of migraine. [2021]
Rimegepant Orally Disintegrating Tablet for Acute Migraine Treatment: A Review. [2021]
Rimegepant: A Review in the Acute Treatment and Preventive Treatment of Migraine. [2023]
Efficacy and Safety of Rimegepant for Migraine Patients: A Meta-analysis of Randomized Controlled Studies. [2023]
Safety of Rimegepant, an Oral CGRP Receptor Antagonist, Plus CGRP Monoclonal Antibodies for Migraine. [2021]
Oral rimegepant for preventive treatment of migraine: a phase 2/3, randomised, double-blind, placebo-controlled trial. [2021]
Efficacy, safety, and tolerability of rimegepant orally disintegrating tablet for the acute treatment of migraine: a randomised, phase 3, double-blind, placebo-controlled trial. [2020]