Randomized Study in Children and Adolescents With Migraine: Acute Treatment
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.
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 6 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