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New treatment option for Pediatric Migraine
Official title Randomized Study in Children and Adolescents With Migraine: Acute Treatment
ClinicalTrials.gov ID: NCT04649242
What this study is testing
What is Rimegepant/BHV3000?
Rimegepant/BHV3000 is an investigational medicine, being studied as a potential treatment for pediatric migraine.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 17
You may be able to join if
- History of migraine (with or without aura) for \> 6 months before Screening according to the IHS Classification ICHD-319 specifications for pediatric...
- History of 1 to 8 moderate or severe attacks per month during the 2 months prior to enrollment, with attacks lasting \> 3 hours without treatment...
- Prophylactic migraine medication are permitted if the dose has been stable for at least 12 weeks prior to the Baseline Visit, and the dose is not...
- Participants may remain on one (1) medication with possible migraine prophylactic effects, excluding CGRP antagonists [biologic or small molecule]...
- Concomitant use of a CGRP antagonist, such as erenumab or fremanezumab, is prohibited.
You likely can't join if
- History of cluster headache or hemiplegic migraine headache.
- Confounding and clinically significant pain syndrome that may interfere with the participant's ability to participate in this study.
- Current psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the Screening Visit. Participants with a...
- History of suicidal behavior or major psychiatric disorder.
- Current diagnosis or history of substance abuse; positive drug test at Screening.
- History of moderate or severe head trauma or other neurological disorder (including seizure disorder) or systemic medical disease that is likely to...
See the full eligibility criteria
- History of migraine (with or without aura) for \> 6 months before Screening according to the IHS Classification ICHD-319 specifications for pediatric migraine. History may be verified using both medical records and...
- History of 1 to 8 moderate or severe attacks per month during the 2 months prior to enrollment, with attacks lasting \> 3 hours without treatment, and attacks occurring at intervals \> 24 hours.
- Prophylactic migraine medication are permitted if the dose has been stable for at least 12 weeks prior to the Baseline Visit, and the dose is not expected to change during the course of the study.
- Participants may remain on one (1) medication with possible migraine prophylactic effects, excluding CGRP antagonists [biologic or small molecule], during the treatment phases.
- Concomitant use of a CGRP antagonist, such as erenumab or fremanezumab, is prohibited.
- Previously discontinued prophylactic migraine medication must have done so at least 90 days prior to the Screening Visit.
- Verbally distinguish between migraine and other types of headaches.
- Participants must have a weight \> 40 kg at the Screening Visit.
- Adequate venous access for blood sampling.
- Male and female participants ≥ 6 to \< 18 years of age (participants must not reach their 18th birthday during the study).
- History of cluster headache or hemiplegic migraine headache.
- Confounding and clinically significant pain syndrome that may interfere with the participant's ability to participate in this study.
- Current psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the Screening Visit. Participants with a lifetime history of psychosis and/or mania.
- History of suicidal behavior or major psychiatric disorder.
- Current diagnosis or history of substance abuse; positive drug test at Screening.
- History of moderate or severe head trauma or other neurological disorder (including seizure disorder) or systemic medical disease that is likely to affect central nervous system functioning.
- Recent or planned surgery, requiring general anesthesia, \<8 weeks prior to the Screening Visit.
- Participant has had gastrointestinal surgery that interferes with physiological absorption and motility (i.e., gastric bypass, duodenectomy, or gastric banding).
- Current diagnosis of viral hepatitis or a history of liver disease.
- Conditions considered clinically relevant in the context of the study such as uncontrolled hypertension (high blood pressure), diabetes, a life-threatening allergy
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Scottsdale, Arizona, United States
- Tempe, Arizona, United States
- Anaheim, California, United States
- Costa Mesa, California, United States
- Culver City, California, United States
- Fountain Valley, California, United States
- Fresno, California, United States
- La Jolla, California, United States
- Long Beach, California, United States
- Los Angeles, California, United States
- North Hollywood, California, United States
- Orange, California, United States
- Pomona, California, United States
- Sacramento, California, United States
- San Bernardino, California, United States
- Upland, California, United States
- Walnut Creek, California, United States
- Aurora, Colorado, United States
- Colorado Springs, Colorado, United States
+ 155 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Scottsdale, Arizona, United States; Tempe, Arizona, United States; Anaheim, California, United States; Costa Mesa, California, United States; Culver City, California, United States and 169 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.