Rimegepant for Migraine Prevention in Children

Recruiting at 185 trial locations

Overseen By Pfizer Pfizer CT.gov Call Center

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Biohaven Pharmaceuticals, Inc.

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

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

640 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether rimegepant (also known as Nurtec ODT, Vydura, BHV-3000, or BMS-927711) can safely and effectively prevent migraines in children and teens. It compares rimegepant to a placebo (a pill with no active medicine) to determine if it reduces the number of migraine days. Children and teens who have experienced migraines for at least six months, with frequent but not constant episodes, might be suitable candidates. As a Phase 3 trial, this is the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking migraine treatment.

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.

Is there any evidence suggesting that rimegepant is likely to be safe for children and adolescents?

Research has shown that rimegepant is safe for children aged 6 to under 12 years. In a study, children tolerated the medication well without major side effects. Rimegepant, also known as Nurtec ODT, treats migraines in adults. When adults took it every other day, it proved effective and generally safe. Since the FDA has already approved rimegepant for adults, it is considered safe for certain age groups. This trial specifically examines its use in children. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for migraine?

Rimegepant is unique because it offers a new approach for preventing migraines in children by targeting a specific receptor in the brain called the CGRP receptor. Unlike traditional migraine treatments that often involve daily medication, Rimegepant is an orally disintegrating tablet (ODT) that can be taken as needed, providing more flexibility and potentially fewer side effects. Researchers are excited about Rimegepant because it not only promises effective migraine prevention but also enhances convenience and comfort for young patients who may struggle with regular pill-taking.

What evidence suggests that rimegepant might be an effective treatment for migraine prevention in children?

Research shows that rimegepant effectively treats migraines. One study found that 59.3% of participants who took rimegepant experienced pain relief within two hours, compared to 43.3% who took a placebo (a pill with no active medicine). Another study demonstrated that rimegepant quickly reduced migraine symptoms and helped individuals return to normal activities within two hours. In this trial, participants will receive either rimegepant or a matching placebo. Rimegepant has also proven more effective than a placebo, regardless of how often someone experiences migraines each month. These results suggest that rimegepant could be a promising option for preventing migraines in children and teenagers. ^{2 3 5 6 7}

Who Is on the Research Team?

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Rimegepant

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 (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]

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, 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]

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]

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 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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10299922/

Rimegepant: A Review in the Acute Treatment and ... Rimegepant was also significantly more effective than placebo irrespective of migraine attack frequency (≤ 4 or > 4 attacks per month) [32], ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03732638

NCT03732638 | Efficacy and Safety Trial of Rimegepant for ... The purpose of this is study is to compare the efficacy of BHV-3000 (rimegepant) to placebo as a preventive treatment for migraine, as measured by the ...

3. nurtec.com nurtec.com/

Treatment of Migraine | Nurtec® ODT (rimegepant) | Safety Info In a study of Nurtec ODT to treat migraine attacks: Pain relief: 59.3% of people taking Nurtec ODT experienced pain relief at 2 hours postdose (vs 43.3% with ...

4. clinicaltrialsregister.eu clinicaltrialsregister.eu/ctr-search/trial/2021-005246-15/IT

Clinical Trials Register To compare the efficacy of rimegepant to placebo as a preventive treatment for migraine in adolescents (= 12 to <18 years of age) with episodic ...

5. pfizer.com pfizer.com/news/press-release/press-release-detail/biohaven-and-pfizer-announce-positive-top-line-results

Biohaven and Pfizer Announce Positive Top-Line Results ... In the study, a single oral dose of rimegepant 75 mg provided significant relief of migraine symptoms and return to normal function at 2 hours ...

6. headachejournal.onlinelibrary.wiley.com headachejournal.onlinelibrary.wiley.com/doi/10.1111/head.15074?af=R

A phase 1, multicenter, open‐label study to evaluate the ... Conclusions. A single weight-adjusted dose of rimegepant ODT demonstrated a favorable safety profile in children aged ≥6 to <12 years with a ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT01430442

NCT01430442 | Dose Ranging Study of Rimegepant (BMS ... The primary purpose of this study is to evaluate the efficacy of rimegepant (BMS-927711) compared with placebo in the acute treatment of migraine as ...