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

February 21, 2023 updated by: Pfizer

BHV3000-401: An Open-label, Intermediate-size, Expanded Access Study of BHV-3000 in the Acute Treatment of Migraine

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)

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Study Type

Expanded Access

Expanded Access Type

  • Treatment IND/Protocol

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. History of basilar migraine or hemiplegic migraine
  2. History with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease
  3. HIV history
  4. Uncontrolled hypertension or uncontrolled diabetes
  5. 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
  6. History of gastric, or small intestinal surgery, or has a disease that causes malabsorption

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

April 29, 2019

First Submitted That Met QC Criteria

April 29, 2019

First Posted (Actual)

May 1, 2019

Study Record Updates

Last Update Posted (Estimate)

February 23, 2023

Last Update Submitted That Met QC Criteria

February 21, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BHV3000-401

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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