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Tests treatment safety and results for Acute Treatment of Migraine
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 (PF-07899801)?
Rimegepant (PF-07899801) is an investigational medicine, being studied as a potential treatment for acute treatment of 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 long-term safety of rimegepant in the acute treatment of migraine in children and adolescents (≥ 6 to \< 18 years of age).
- 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's taking place
- Scottsdale, Arizona, United States
- Tempe, Arizona, United States
- Anaheim, California, United States
- Culver City, California, United States
- Fresno, California, United States
- La Jolla, California, United States
- Long Beach, California, United States
- North Hollywood, 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
- Grand Junction, Colorado, United States
- Cromwell, Connecticut, United States
- Stamford, Connecticut, United States
- Washington D.C., District of Columbia, United States
- Miami, Florida, United States
+ 67 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 Scottsdale, Arizona, United States; Tempe, Arizona, United States; Anaheim, California, United States; Culver City, California, United States; Fresno, California, United States; La Jolla, California, United States and 81 more location(s). Enter your location above to see the nearest site and check your eligibility.
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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.