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Study Matches
Randomized Study in Children and Adolescents With Migraine: Acute Treatment
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.
Ali Zandieh
All
6 Years to 17 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT04649242
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Inclusion Criteria:
1. 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 recall by the participant and/or
participant's parent(s)/legal representative(s).
2. 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.
3. 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.
1. Participants may remain on one (1) medication with possible migraine prophylactic
effects, excluding CGRP antagonists [biologic or small molecule], during the
treatment phases.
2. Concomitant use of a CGRP antagonist, such as erenumab or fremanezumab, is
prohibited.
3. Previously discontinued prophylactic migraine medication must have done so at
least 90 days prior to the Screening Visit.
4. Verbally distinguish between migraine and other types of headaches.
5. Participants must have a weight > 40 kg at the Screening Visit.
6. Adequate venous access for blood sampling.
7. Male and female participants ≥ 6 to < 18 years of age (participants must not reach
their 18th birthday during the study).
Exclusion Criteria:
1. History of cluster headache or hemiplegic migraine headache.
2. Confounding and clinically significant pain syndrome that may interfere with the
participant's ability to participate in this study.
3. 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.
4. History of suicidal behavior or major psychiatric disorder.
5. Current diagnosis or history of substance abuse; positive drug test at Screening.
6. 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.
7. Recent or planned surgery, requiring general anesthesia, <8 weeks prior to the
Screening Visit.
8. Participant has had gastrointestinal surgery that interferes with physiological
absorption and motility (i.e., gastric bypass, duodenectomy, or gastric banding).
9. Current diagnosis of viral hepatitis or a history of liver disease.
10. Conditions considered clinically relevant in the context of the study such as
uncontrolled hypertension (high blood pressure), diabetes, a life-threatening allergy
Long-term Safety Study of Rimegepant in Pediatric Subjects for the Acute Treatment of Migraine
The purpose of this study is to test the long-term safety of rimegepant in the acute
treatment of moderate or severe migraine in children and adolescents (≥ 6 to < 18 years of
age).
Ali Zandieh
All
6 Years to 17 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT04743141
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
1. History of migraine (with or without aura) for ≥ 6 months before Screening
2. History of 1 to 8 moderate or severe attacks per month during the 2 months prior to
enrollment.
3. 1 or more migraine days requiring treatment during the Observation Phase.
4. Prophylactic migraine medication is permitted if the dose has been stable for at least
12 weeks prior to the Baseline Visit
5. Ability to distinguish between migraine and other types of headaches.
6. Weight ≥ 40 kg at the Screening Visit.
7. Adequate venous access for blood sampling.
8. Male and female participants ≥ 6 to < 18 years of age (participants must not reach
their 18th birthday before enrollment into the study)
Exclusion Criteria:
1. History of cluster headache or hemiplegic migraine headache.
2. Confounding and clinically significant pain syndrome
3. 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).
4. History of suicidal behavior or major psychiatric disorder.
5. Current diagnosis or history of substance abuse; positive drug test at Screening.
Acute Treatment of Migraine, Other, Brain & Neurological
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