Rimegepant for Migraine Prevention in Children

Recruiting at175 trial locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Biohaven Pharmaceuticals, Inc.

Disqualifiers: Basilar migraine, Cluster headaches, Hemiplegic migraine, Psychiatric disorder, Substance abuse, others

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing rimegepant, a medication that prevents migraines, in children and teens who have occasional migraines. It works by blocking a protein that causes migraine pain. Rimegepant is taken orally and has shown effectiveness in treating migraines.

Will I have to stop taking my current medications?

If you are already taking medication to prevent migraines, you can continue using it as long as the dose has been stable for at least 3 months before the study and won't change during the study.

What data supports the effectiveness of the drug Rimegepant for migraine prevention in children?

Rimegepant has been shown to be effective in adults for both treating and preventing migraines, reducing the number of migraine days and improving quality of life. It is generally well tolerated, with no significant liver or heart-related side effects observed in clinical trials. ^{1 2 3 4 5}

Is Rimegepant safe for use in humans?

Rimegepant has been generally well tolerated in clinical trials for migraine treatment, with no evidence of liver or heart toxicity, and any side effects were mild or moderate. ^{1 2 3 5 6}

How is the drug Rimegepant unique for migraine prevention in children?

Rimegepant is unique because it is a dual agent approved for both the acute treatment and prevention of migraines, and it comes in an orally disintegrating tablet form, which can be more convenient and faster-acting than traditional tablets. ^{1 3 5 7 8}

Research Team

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

This trial is for children and adolescents aged 6 to under 18 who experience episodic migraines, with an average of 14 or fewer headache days per month. They must have a history of migraine lasting between 4-72 hours if untreated and weigh at least 15 kg (or ≥40 kg for certain cohorts). Participants can be on stable migraine medication.

Inclusion Criteria

I've been on a stable dose of migraine prevention medication for at least 3 months.

I am between 6 and 17 years old.

I weigh at least 40 kg.

Exclusion Criteria

I have not had untreated psychiatric conditions in the last 6 months.

You have a serious mental health condition in your medical history.

I have had a serious head injury or neurological condition that could affect my brain function.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive rimegepant or placebo for migraine prevention

12 weeks

Monthly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Long-term safety evaluation

Evaluate the safety and tolerability of rimegepant over an extended period

72 weeks

Treatment Details

Interventions

• Placebo (Drug)
• Rimegepant (Calcitonin Gene-Related Peptide (CGRP) Antagonist)

Trial Overview The study aims to determine the effectiveness and safety of Rimegepant compared to a placebo in preventing migraines in young people. It involves giving some participants the actual drug while others receive a placebo, without knowing which one they are taking.

Participant Groups

Group I: Rimegepant / BHV3000 Active Control 1 Intervention

Rimegepant 75mg or 50mg (2 X 25mg) ODT

Group II: Matching Placebo Placebo Group 1 Intervention

Matching placebo 75mg or 50mg (2 X 25mg) ODT

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

Biohaven Pharmaceutical Holding Company Ltd.

Industry Sponsor

Trials

9

Recruited

6,300+

Findings from Research

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]

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 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]

Rimegepant, an oral CGRP receptor antagonist, has shown significant efficacy in reducing monthly migraine days (MMDs) and improving health-related quality of life (HRQoL) compared to placebo, based on a study involving 257 participants with a history of 4-14 MMDs.

When compared to injectable anti-CGRP monoclonal antibodies like galcanezumab and erenumab, rimegepant demonstrated similar effectiveness in reducing MMDs and improving migraine-related disability and quality of life, supporting its use for both acute and preventive migraine treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Matching-adjusted indirect comparisons of oral rimegepant versus placebo, erenumab, and galcanezumab examining monthly migraine days and health-related quality of life in the treatment of migraine. Popoff, E., Johnston, K., Croop, R., et al.[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 (NURTEC ODT®) is an orally disintegrating tablet that acts as a highly-selective antagonist of calcitonin gene-related peptide, specifically designed for the acute treatment of migraines.

In February 2020, rimegepant ODT received its first global approval in the USA for treating migraines with or without aura in adults, marking a significant milestone in its development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rimegepant: First Approval. Scott, LJ.[2022]

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. England pubmed.ncbi.nlm.nih.gov

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

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

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

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

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

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

Matching-adjusted indirect comparisons of oral rimegepant versus placebo, erenumab, and galcanezumab examining monthly migraine days and health-related quality of life in the treatment of migraine. [2021]

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

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

6. Spain pubmed.ncbi.nlm.nih.gov

Rimegepant for the treatment of migraine. [2021]

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

Rimegepant: First Approval. [2022]

8. 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]