Acute Treatment of Migraine study: Rimegepant
Official title Long-term Safety Study of Rimegepant in Pediatric Subjects for the Acute Treatment of Migraine
ClinicalTrials.gov ID: NCT04743141
What this study is testing
What is Rimegepant?
This is an investigational oral medicine being studied to treat acute migraine in children and adolescents. It is designed to block specific receptors in the body that are involved in migraine pain signals.
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
- This study is testing whether rimegepant is safe over time. It looks at how the medicine works for acute migraine treatment.
- Who it's for
- You may be able to join if you are a child or teen between 6 and 17 years old.
- What's involved
- You would take rimegepant to treat your migraines. The team will check on your health to see how you do.
- Time commitment
- The study lasts a long time to watch for safety issues.
- Phase 3: a large, late-stage study
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.
- History of 1 to 8 moderate or severe attacks per month during the 2 months prior to screening.
- 1 or more migraine days requiring treatment during the Observation Phase.
- Prophylactic migraine medication is permitted if the dose has been stable for at least 12 weeks prior to the Screening Visit.
- Ability to distinguish between migraine and other types of headaches.
You likely can't join if
- History of cluster headache or hemiplegic migraine headache.
- Confounding and clinically significant pain syndrome.
- Current uncontrolled and/or untreated psychiatric condition for a minimum of 6 months prior to the Screening Visit (lifetime history of psychosis...
- History of suicidal behavior or at risk of self-harm/harm to others.
- History of major psychiatric disorder.
- Current diagnosis or history of substance abuse
See the full eligibility criteria
- History of migraine (with or without aura) for ≥ 6 months before Screening.
- History of 1 to 8 moderate or severe attacks per month during the 2 months prior to screening.
- 1 or more migraine days requiring treatment during the Observation Phase.
- Prophylactic migraine medication is permitted if the dose has been stable for at least 12 weeks prior to the Screening Visit.
- Ability to distinguish between migraine and other types of headaches.
- Weight \> 15 kg. For EU countries only: Participants 12 to \ 25kg.
- Adequate venous access for blood sampling.
- Male and female participants 6 to \< 18 years of age (participants must not reach their 18th birthday on or before the Baseline visit).
- History of cluster headache or hemiplegic migraine headache.
- Confounding and clinically significant pain syndrome.
- Current uncontrolled and/or untreated psychiatric condition for a minimum of 6 months prior to the Screening Visit (lifetime history of psychosis and/or mania are excluded).
- History of suicidal behavior or at risk of self-harm/harm to others.
- History of major psychiatric disorder.
- Current diagnosis or history of substance abuse
- Reported current use of or tested positive at Screening for drugs of abuse.
The study team makes the final eligibility decision.
Where it is enrolling
- Scottsdale, Arizona, United States
- Anaheim, California, United States
- Fresno, California, United States
- La Jolla, California, United States
- Long Beach, California, United States
- Pomona, California, United States
- Walnut Creek, California, United States
- Aurora, Colorado, United States
- Cromwell, Connecticut, United States
- Stamford, Connecticut, United States
- Washington D.C., District of Columbia, United States
- Miami, Florida, United States
- Orlando, Florida, United States
- Decatur, Georgia, United States
- Chicago, Illinois, United States
- Naperville, Illinois, United States
- Westfield, Indiana, United States
- West Des Moines, Iowa, United States
- Kansas City, Kansas, United States
- Ann Arbor, Michigan, United States
+ 27 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, but 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?
This study is enrolling now at Scottsdale, Arizona, United States; Anaheim, California, United States; Fresno, California, United States; La Jolla, California, United States; Long Beach, California, United States; Pomona, California, United States and 41 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.