Rimegepant for Pediatric Migraine

Recruiting in Palo Alto (17 mi)

+397 other locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Pfizer

Must be taking: Prophylactic migraine

Must not be taking: CGRP antagonists

Disqualifiers: Cluster headache, Uncontrolled psychiatric, Substance abuse, others

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial allows participants to stay on one stable prophylactic migraine medication, as long as it is not a CGRP antagonist. If you are taking a CGRP antagonist, you will need to stop before joining the study.

What data supports the effectiveness of the drug Rimegepant for treating pediatric migraine?

Rimegepant has been shown to be effective in treating migraines in adults, providing pain relief and reducing migraine symptoms with effects lasting up to 48 hours. It is well tolerated with few mild or moderate side effects, and it has been approved by the FDA for acute migraine treatment. ^{1 2 3 4 5}

Is Rimegepant safe for humans?

Rimegepant has been shown to be generally safe in humans, with most side effects being mild or moderate. It was well tolerated in clinical trials for migraine treatment, and ongoing studies are evaluating its long-term safety. ^{1 2 3 4 6}

How is the drug Rimegepant different from other treatments for pediatric migraine?

Rimegepant is unique because it is a calcitonin gene-related peptide (CGRP) receptor antagonist, which works by blocking the protein involved in migraine attacks, offering a different mechanism of action compared to traditional treatments like triptans or NSAIDs (nonsteroidal anti-inflammatory drugs). ^{7 8 9 10 11}

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 over 40 kg. They must be able to tell the difference between migraine and other headaches, may use stable doses of certain migraine prevention meds but not CGRP antagonists, and should have had 1-8 significant migraine attacks per month in the past two months.

Inclusion Criteria

I am between 6 and 17 years old and will not turn 18 during the study.

I have had migraines for more than 6 months.

I've had 1-8 severe attacks a month in the last 2 months, lasting over 3 hours.

Exclusion Criteria

I have had a stable mental health condition for at least 6 months.

I have had or will have surgery with general anesthesia less than 8 weeks before the screening.

I have had surgery on my stomach or intestines that affects how my body processes food.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BHV-3000 or placebo for the acute treatment of moderate or severe migraine

2 to 48 hours post-dose

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Matching placebo (Drug)
• Rimegepant/BHV3000 (Calcitonin Gene-Related Peptide (CGRP) Receptor Antagonist)

Trial Overview The study is testing BHV-3000 (Rimegepant) against a placebo for quickly treating moderate or severe migraines in young people. Participants will randomly receive either the actual medication or a dummy pill without knowing which one they are taking.

Participant Groups

Group I: BHV3000 (active drug) Active Control 1 Intervention

BHV3000 (rimegepant) 75 mg or 50 mg ODT

Group II: Placebo Placebo Group 1 Intervention

Matching 75 mg or 50 mg ODT placebo

Who Is Running the Clinical Trial?

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.

Lead Sponsor

Trials

9

Recruited

6,300+

Findings from Research

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, 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 study involving 36 participants, rimegepant showed a significant increase in systemic exposure in individuals with severe hepatic impairment, with up to a 3.9-fold increase in unbound concentrations compared to healthy controls, indicating a need for caution in this population.

The study found that rimegepant is not recommended for adults with severe hepatic impairment due to the increased risk of adverse effects, as evidenced by a higher concentration of the drug in the bloodstream.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rimegepant 75 mg in Subjects With Hepatic Impairment: Results of a Phase 1, Open-Label, Single-Dose, Parallel-Group Study. Bhardwaj, R., Ivans, A., Stringfellow, J., et al.[2023]

There is a significant need for more pediatric randomized controlled trials for migraine treatment, as current practices are largely based on adult studies and show wide variation among clinicians.

Newly approved treatments for pediatric migraines include over-the-counter anti-inflammatory medications and triptans, which have been shown to be safe and effective for children and adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Newly Approved Agents for the Treatment and Prevention of Pediatric Migraine. Kacperski, J., Hershey, AD.[2022]

In a study involving 674 pediatric patients aged 12-17, rizatriptan was found to be generally safe and well tolerated for the long-term acute treatment of migraines, with 66% experiencing any adverse event but only a small percentage discontinuing due to these events.

The efficacy of rizatriptan was consistent over time, with an average of 46.3% of patients achieving pain freedom within 2 hours after taking the medication, indicating its effectiveness in managing migraine attacks in this age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term open-label safety study of rizatriptan acute treatment in pediatric migraineurs. Hewitt, DJ., Pearlman, E., Hämäläinen, M., et al.[2017]

Rizatriptan significantly improved pain freedom in children and adolescents aged 12-17 years with migraines, with 30.6% of those treated achieving pain relief compared to 22.0% in the placebo group, indicating its efficacy as an acute treatment option.

The safety profile of rizatriptan was comparable to placebo, with similar rates of adverse events reported within 14 days, suggesting it is generally well tolerated in the pediatric population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and tolerability of rizatriptan in pediatric migraineurs: results from a randomized, double-blind, placebo-controlled trial using a novel adaptive enrichment design. Ho, TW., Pearlman, E., Lewis, D., et al.[2012]

Migraine in children is diagnosed using similar criteria as in adults, but attacks are often shorter and can be bilateral, highlighting the need for tailored treatment approaches.

Treatment options for pediatric migraines include safe medications like NSAIDs and triptans for acute attacks, as well as preventive medications such as antidepressants and anticonvulsants, alongside biobehavioral therapies for long-term management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatric migraine: recognition and treatment. Hershey, AD., Winner, PK.[2022]

Rizatriptan 5 mg did not show significant effectiveness over placebo for treating a single migraine attack in adolescents, with similar pain relief rates (68.2% for rizatriptan vs. 68.8% for placebo).

However, in a longer-term study, rizatriptan 5 mg was more effective than standard care for treating multiple migraine attacks, achieving pain relief in 77% of cases compared to 64% with standard care, and it was well tolerated throughout both short- and long-term use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rizatriptan 5 mg for the acute treatment of migraine in adolescents: results from a double-blind, single-attack study and two open-label, multiple-attack studies. Visser, WH., Winner, P., Strohmaier, K., et al.[2012]

References

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

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

2. Spain pubmed.ncbi.nlm.nih.gov

Rimegepant for the treatment of migraine. [2021]

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

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

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

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

5. 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]

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

Rimegepant 75 mg in Subjects With Hepatic Impairment: Results of a Phase 1, Open-Label, Single-Dose, Parallel-Group Study. [2023]

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

Newly Approved Agents for the Treatment and Prevention of Pediatric Migraine. [2022]

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

Long-term open-label safety study of rizatriptan acute treatment in pediatric migraineurs. [2017]

9. England pubmed.ncbi.nlm.nih.gov

Efficacy and tolerability of rizatriptan in pediatric migraineurs: results from a randomized, double-blind, placebo-controlled trial using a novel adaptive enrichment design. [2012]

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

Pediatric migraine: recognition and treatment. [2022]

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

Rizatriptan 5 mg for the acute treatment of migraine in adolescents: results from a double-blind, single-attack study and two open-label, multiple-attack studies. [2012]