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Rimegepant for Migraine Prevention in Children

Phase 3
Recruiting
Research Sponsored by Biohaven Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
14 or less headache days per month during the 3 month period prior to the Screening Visit
6 or more migraine days during the Observation Period
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months (12 weeks)
Awards & highlights

Study Summary

This trial will compare the effects of rimegepant versus placebo on preventing migraines in children and adolescents.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects are not listed here, Rimegepant may cause reactions that could include digestive issues, dizziness, dry mouth, fatigue or allergic responses. The severity and type of side effects vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I've had 14 or fewer headache days each month for the last 3 months.
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I have had 6 or more migraine days recently.
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I had 14 or fewer headache days recently.
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My migraines last between 4 to 72 hours without treatment.
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I have had migraines for at least 6 months.
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I've had 14 or fewer headache days each month for the last 3 months.
Select...
I have had 6 or more migraine days recently.
Select...
I had 14 or fewer headache days recently.
Select...
My migraines last between 4 to 72 hours without treatment.
Select...
I am between 6 and 17 years old.
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I weigh at least 40 kg.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months (12 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months (12 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in the mean number of migraine days per month as measured over the 12-week double-blind phase of the study in adolescents with episodic migraine
Secondary outcome measures
Achievement of at least a 50% reduction from baseline in mean monthly migraine days over the course of the double-blind phase in adolescents with episodic migraine
Change from baseline in the mean number of migraine days per month in the first 4 weeks (Weeks 1 through 4) of the double-blind treatment phase in adolescents with episodic migraine.
Change from baseline in the mean number of migraine days per month over the entire course of the double-blind treatment phase in children and children and adolescents combined with episodic migraine.
+5 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Rimegepant / BHV3000Active Control1 Intervention
Rimegepant 75mg or 50mg (2 X 25mg) ODT
Group II: Matching PlaceboPlacebo Group1 Intervention
Matching placebo 75mg or 50mg (2 X 25mg) ODT

Find a Location

Who is running the clinical trial?

Biohaven Pharmaceuticals, Inc.Lead Sponsor
47 Previous Clinical Trials
36,495 Total Patients Enrolled
13 Trials studying Migraine
18,534 Patients Enrolled for Migraine
Biohaven Pharmaceutical Holding Company Ltd.Industry Sponsor
8 Previous Clinical Trials
13,437 Total Patients Enrolled
5 Trials studying Migraine
10,964 Patients Enrolled for Migraine
PfizerLead Sponsor
4,568 Previous Clinical Trials
10,911,246 Total Patients Enrolled
22 Trials studying Migraine
23,898 Patients Enrolled for Migraine

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT05156398 — Phase 3
Migraine Research Study Groups: Rimegepant / BHV3000, Matching Placebo
Migraine Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT05156398 — Phase 3
Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT05156398 — Phase 3
Migraine Patient Testimony for trial: Trial Name: NCT05156398 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does Rimegepant / BHV3000 have a long history of research?

"Right now, there are 7 ongoing investigations into Rimegepant / BHV3000 with 3 of them being Phase 3 trials. Although the majority of these experiments are based in Vigo, Nebraska, 500 different locations worldwide are participating."

Answered by AI

Does this clinical research include participants who are under 40 years old?

"According to the inclusion criteria, this trial is for patients aged 6-18. Out of the 35 clinical trials that exist for people under 18, this is one of them. In contrast, there are 126 clinical trials for people over 65."

Answered by AI

Are there different test facilities around the country that are researching this new treatment?

"61 clinical trial sites are currently recruiting patients for this study. If you choose to enroll, it would be beneficial to select a location nearest to you in order to reduce travel time and expenses."

Answered by AI

Could I possibly qualify to take part in this research project?

"This study is actively recruiting for 640 participants that suffer from migraines, specifically those aged 6 to 18 years old. It's important to note that potential subjects must have a stable prophylactic medication dosage for at least 3 months and cannot be expected to change the dose during the course of the study. Additionally, candidates should expect 14 or less headache days per month and an average migraine duration of 4-72 hours if left untreated. Finally, those interested in participating must weigh at least 40kg (or 15kg if they are in the child cohort)."

Answered by AI

Have there been other research projects like this one previously?

"Rimegepant / BHV3000 has undergone 7 clinical trials in 9 countries and 252 cities since 2019. The most recent study, sponsored by Biohaven Pharmaceuticals, Inc., was completed in 2020 with 60 participants. It successfully completed Phase 2 of drug approval. In total, 18291 have been conducted for Rimegepant / BHV3000."

Answered by AI

What is the total number of individuals enrolled in this experiment?

"To complete this clinical trial, 640 individuals that satisfy the pre-determined inclusion criteria must be recruited. These patients can come from different medical practices, such as CICR in Fayetteville, North carolina and South Ogden Family Medicine in South Ogden, Utah."

Answered by AI

When will Rimegepant / BHV3000 be available to the public?

"Rimegepant / BHV3000 is estimated to be a safe medication, as it has received a score of 3. This is due to the fact that this drug is currently in Phase 3 clinical trials, meaning that there is some evidence supporting its efficacy and multiple rounds of data supporting its safety."

Answered by AI

If a patient is interested, how can they sign up for this research project?

"Yes, the trial is still open and recruiting patients. According to the listing on clinicaltrials.gov, the study was posted on February 28th, 2022 and last updated November 1st, 2022. They are looking for 640 participants at 61 different sites."

Answered by AI

Who else is applying?

What state do they live in?
California
Colorado
What site did they apply to?
Advanced Investigative Medicine
Velocity Clinical Research, San Diego
OceanMedical Research
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
2
3+

Why did patients apply to this trial?

I have tried two types of migraine medications and I still have 2-3 migraines per week.
PatientReceived 1 prior treatment
I have tried many medications and I want something that will provide better relief for this problem. It can be debilating. I am very interested.
PatientReceived no prior treatments
Can we share your medical record with the trial hospital? This is needed to confirm your eligibility. Date Of Birth Last 4 digits of Social Security Number Home Address Line 1 5974 Overlake Avenue 92120.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

How much can I earn per visit? How long will the screening take? What is the compensation?
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Advanced Investigative Medicine: < 48 hours
Average response time
  • < 2 Days
~372 spots leftby Apr 2027