Rimegepant for Pediatric Migraine

Recruiting at 217 trial locations

Overseen By Pfizer Pfizer CT.gov Call Center

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Biohaven Pharmaceuticals, Inc.

Must be taking: Prophylactic migraine

Must not be taking: Drugs of abuse

Disqualifiers: Cluster headache, Hemiplegic migraine, others

No Placebo Group All 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 Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 58 weeks

600 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 3 4 6 7}

Research Team

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.

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.

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 Overview The 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

Group I: Active Experimental Treatment 1 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

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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rimegepant: A Review in the Acute Treatment and Preventive Treatment of Migraine. Blair, HA.[2023]

Rimegepant significantly improves outcomes for migraine patients, including freedom from pain and pain relief at 2 hours, with odds ratios indicating strong efficacy compared to placebo.

The treatment shows sustained benefits at 24 hours and does not appear to increase the risk of adverse events, suggesting it is a safe option for migraine management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Rimegepant for Migraine Patients: A Meta-analysis of Randomized Controlled Studies. Yang, C., Zhang, Y.[2023]

In a study involving 13 patients with migraines, rimegepant was found to be well tolerated when used as an acute treatment alongside CGRP monoclonal antibodies (mAbs) for preventive treatment, with no serious adverse events reported.

Out of the patients, 38% experienced mild to moderate adverse events, primarily nasopharyngitis, indicating that while some side effects occurred, they were generally not severe and did not lead to treatment discontinuation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Rimegepant, an Oral CGRP Receptor Antagonist, Plus CGRP Monoclonal Antibodies for Migraine. Berman, G., Croop, R., Kudrow, D., et al.[2021]

Rimegepant, taken every other day, significantly reduced the mean number of migraine days per month compared to placebo, with a difference of -0.8 days, indicating its efficacy as a preventive treatment for migraines.

The safety profile of rimegepant was comparable to that of placebo, with similar rates of adverse events and no serious safety concerns reported during the study involving 747 participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral rimegepant for preventive treatment of migraine: a phase 2/3, randomised, double-blind, placebo-controlled trial. Croop, R., Lipton, RB., Kudrow, D., et al.[2021]

In a phase 3 trial involving 1466 participants, the orally disintegrating tablet formulation of rimegepant (75 mg) was significantly more effective than placebo in providing freedom from pain (21% vs 11%) and freedom from the most bothersome symptom (35% vs 27%) at 2 hours post-dose.

The safety profile of rimegepant was comparable to placebo, with no serious adverse events reported, and the most common side effects were mild, such as nausea and urinary tract infections, indicating good tolerability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy, safety, and tolerability of rimegepant orally disintegrating tablet for the acute treatment of migraine: a randomised, phase 3, double-blind, placebo-controlled trial. Croop, R., Goadsby, PJ., Stock, DA., et al.[2020]

References

1. Spain pubmed.ncbi.nlm.nih.gov

Rimegepant for the treatment of migraine. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Rimegepant Orally Disintegrating Tablet for Acute Migraine Treatment: A Review. [2021]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Rimegepant: A Review in the Acute Treatment and Preventive Treatment of Migraine. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Rimegepant for Migraine Patients: A Meta-analysis of Randomized Controlled Studies. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Safety of Rimegepant, an Oral CGRP Receptor Antagonist, Plus CGRP Monoclonal Antibodies for Migraine. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Oral rimegepant for preventive treatment of migraine: a phase 2/3, randomised, double-blind, placebo-controlled trial. [2021]

7. England pubmed.ncbi.nlm.nih.gov

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]