Biohaven Pharmaceuticals, Inc is testing rimegepant for the Acute Treatment of Migraine in children

 

The condition is Acute Treatment of Migraine.

A new clinical trial is recruiting patients in the following locations: United States.

The trial officially began on the April 30, 2021 and is planned to complete on October 14, 2023.

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).

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) 9. Participants must have participated in prior pediatric rimegepant 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.

The link to the complete study profile: https://ichgcp.net/clinical-trials-registry/NCT04743141

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