Clinical Trials

Description

• A study evaluating the efficacy and safety of a CGRP receptor antagonist, Erenumab, compared to placebo in children and adolescents (ages 6 to 17) with episodic migraine.
• This trial requires ~16 in-person visits over one year.

Key Inclusion Criteria

• Children (6 to less than 12 years of age) or adolescent (12 to less than 18 years of age) at the time of signing
• History of migraines for ≥12 months before screening 
• Attacks may last 2 to 72 hours
• History of <15 headache days per month, of which ≥ 4 headache days were assessed by the subject as migraine days in the 3 months prior to screening

Key Exclusion Criteria

• History of cluster headache or hemiplegic migraine
• Lifetime history of suicidal ideation
• History of major psychiatric disorder or current major depressive disorder that is not treated with a stable dose of a single medication medication
• The washout period for medications is 2 weeks, 3 months for devices and 4 months for Botox. 
  
   

BHV311

Description

• A study assessing the efficacy and safety of a CGRP antagonist, Rimegepant, compared to placebo for the treatment of migraine in children and adolescents 6-17 years of age
• This trial requires ~4 visits over five months.
• Upon successful completion, patients can roll over to open-label BHV312 study. 

Key Inclusion Criteria

• Male and female participants ≥ 6 to < 18 years of age
• History of migraine (with or without aura) for > 6 month before screening visit
• 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.

Key Exclusion Criteria

• History of cluster headache or hemiplegic migraine headache
• Confounding and clinically significant pain syndrome that may interfere with the participant's ability to participate in this study
• 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.
• Conditions considered clinically relevant in the context of the study such as uncontrolled hypertension (high blood pressure), diabetes, a life-threatening allergy

BHV312

Description

• This is a roll-over open-label study from BHV311 assessing the long-term safety of Rimegepant for the acute treatment of migraine in children and adolescents aged 6-17 years old.
• This trial requires 13 visits in-person over one year.

Key Inclusion Criteria

• Male and female participants 6 to < 18 years of age
• 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

Key Exclusion Criteria

• History of cluster headache or hemiplegic migraine headache
• Confounding and clinically significant pain syndrome that may interfere with the participant's ability to participate in this study
• 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.