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Tests treatment safety and results for Migraine
Official title Efficacy and Safety Study of Rimegepant for the Preventative Treatment of Migraine in Pediatric Subjects
ClinicalTrials.gov ID: NCT05156398
What this study is testing
What is Rimegepant?
Rimegepant is an investigational medicine, being studied as a potential treatment for migraine.
Also referred to as BHV3000.
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 compare the efficacy and safety of rimegepant to placebo as a preventative treatment for migraine in children and adolescents ≥ 6 to \<18 years with episodic migraine.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
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
- Subject has at least a 6 month history of migraine (with or without aura) and including the following:
- 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
- 14 or less headache days during the Observation Period
- Pediatric Migraine Disability Assessment Scale (PedMIDAS) Disability Score of \>10 to ≤50, indicating mild (score of 11 to 30) or moderate (score of...
You likely can't join if
- people with a history of basilar migraine, cluster headaches, or hemiplegic migraine
- The subject has a continuous migraine (defined as an unrelenting headache) within 1 month prior to Screening Visit.
- The subject has a history or diagnosis of complications of migraine
- The subject has a confounding and clinically significant pain syndrome that may interfere with the subject's ability to participate in this study.
- The subject has any current psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the Screening Visit...
- History of suicidal behavior or the subject is at risk of self-harm or harm to others.
See the full eligibility criteria
- Subject has at least a 6 month history of migraine (with or without aura) and including the following:
- 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
- 14 or less headache days during the Observation Period
- Pediatric Migraine Disability Assessment Scale (PedMIDAS) Disability Score of \>10 to ≤50, indicating mild (score of 11 to 30) or moderate (score of 31 to 50) disruption in daily activities, as assessed at the Baseline...
- Ability to verbally distinguish migraine attacks from tension/cluster or other types of headaches
- Migraine attacks, on average, lasting 4 - 72 hours if untreated
- people on prophylactic migraine medication are permitted to remain on therapy if the dose has been stable for at least 3 months (12 weeks) prior to the Screening Phase, and the dose is not expected to change during the...
- people with a history of basilar migraine, cluster headaches, or hemiplegic migraine
- The subject has a continuous migraine (defined as an unrelenting headache) within 1 month prior to Screening Visit.
- The subject has a history or diagnosis of complications of migraine
- The subject has a confounding and clinically significant pain syndrome that may interfere with the subject's ability to participate in this study.
- The subject has any current psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the Screening Visit. people with a lifetime history of psychosis and/or mania are excluded.
- History of suicidal behavior or the subject is at risk of self-harm or harm to others.
- History of major psychiatric disorder.
- The subject has a current diagnosis or history of substance abuse
- The subject has a history of moderate or severe head trauma or other neurological disorder (including seizure disorder) or systemic medical disease that is, in the investigator's opinion, likely to affect central...
The study team makes the final eligibility decision.
Where it's taking place
- Fort Smith, Arkansas, United States
- Hawthorne, California, United States
- La Mesa, California, United States
- Colorado Springs, Colorado, United States
- Fort Collins, Colorado, United States
- Washington D.C., District of Columbia, United States
- Edgewater, Florida, United States
- Hialeah, Florida, United States
- Hollywood, Florida, United States
- Ormond Beach, Florida, United States
- Tamarac, Florida, United States
- Tampa, Florida, United States
- Augusta, Georgia, United States
- Sandy Springs, Georgia, United States
- Savannah, Georgia, United States
- Snellville, Georgia, United States
- Boise, Idaho, United States
- Chicago, Illinois, United States
- New Orleans, Louisiana, United States
- Clinton, Mississippi, United States
+ 59 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 Fort Smith, Arkansas, United States; Hawthorne, California, United States; La Mesa, California, United States; Colorado Springs, Colorado, United States; Fort Collins, Colorado, United States; Washington D.C., District of Columbia, United States and 73 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.