An Open-label, Intermediate Size, Expanded Access Study of BHV-3000 in the Acute Treatment of Migraine

NCT03934086 | Unknown

• 1 other identifier: BHV3000-401
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this protocol is to allow subjects who completed any BHV3000 (rimegepant) clinical study to continue to have access to rimegepant while collecting ongoing safety data. (NOTE: ONLY FOR PATIENTS who participated in a previous BHV-3000/Rimegepant Clinical Trial in the past)

Conditions

Migraine

Keywords

Migraine prevention, phonophobia, photophobia, nausea

Interventions

rimegepant DRUG

rimegepant 75 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who have completed any BHV3000 (rimegepant) clinical study without significant protocol violations.

You may not qualify if:

• History of basilar migraine or hemiplegic migraine
• History with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease
• HIV history
• Uncontrolled hypertension or uncontrolled diabetes
• Current diagnosis of major depression, other pain syndromes, psychiatric conditions (e.g., schizophrenia), dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion, might interfere with study assessments
• History of gastric, or small intestinal surgery, or has a disease that causes malabsorption

Sponsors & Collaborators

• Pfizer: lead

MeSH Terms

Conditions

Migraine Disorders; Hyperacusis; Photophobia; Nausea

Interventions

rimegepant sulfate

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vision Disorders; Eye Diseases; Signs and Symptoms, Digestive

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2019
• First Posted: May 1, 2019
• Last Updated: February 23, 2023

Record last verified: 2023-02