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Open- label study in children and adolescents with migraine: Acute Treatment
EU CTIS ID: 2024-512744-32-00
What this study is testing
To evaluate the safety and tolerability of rimegepant in children and adolescents (age ≥ 6 to < 18 years of age).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
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.
- Participant had 1 or more migraine days requiring treatment during the Observation Phase.
- Participants on prophylactic migraine medication are permitted to remain on therapy if the dose has been stable for at least 12 weeks prior to the Screening Visit.
- Participants are required to verbally distinguish between migraine and other types of headaches.
- Participants must have a body weight > 15 kg. For EU countries only: Participants 12 to < 18 years of age must have a body weight of >25 kg.
You likely can't join if
- Participant has a history of cluster headache or hemiplegic migraine headache. 2.
- The participant has a confounding and clinically significant pain syndrome that may interfere with their ability to participate in this study.
- The participant has any 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 are excluded.
- History of suicidal behavior or the participant is at risk of self-harm or harm to others.
- History of major psychiatric disorder.
- The participant has a 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.
- Participant had 1 or more migraine days requiring treatment during the Observation Phase.
- Participants on prophylactic migraine medication are permitted to remain on therapy if the dose has been stable for at least 12 weeks prior to the Screening Visit.
- Participants are required to verbally distinguish between migraine and other types of headaches.
- Participants must have a body weight > 15 kg. For EU countries only: Participants 12 to < 18 years of age must have a body weight of >25 kg.
- Participants must have adequate venous access for blood sampling. 8.
- Participants 6 to < 18 years of age (participants must not reach their 18th birthday on or before enrollment into the study).Baseline visit).
- Participant has a history of cluster headache or hemiplegic migraine headache. 2.
- The participant has a confounding and clinically significant pain syndrome that may interfere with their ability to participate in this study.
- The participant has any 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 are excluded.
- History of suicidal behavior or the participant is at risk of self-harm or harm to others.
- History of major psychiatric disorder.
- The participant has a current diagnosis or history of substance abuse.
- The participant has reported current use of or has tested positive at the Screening visit for drugs of abuse.
The study team makes the final eligibility decision.
Where it's taking place
- United States
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, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States. 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 EU CTIS; the study team decides eligibility.