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Study to Evaluate the PK of BMS-927711 in Patient With Migraine During Acute Migraine and Non-migraine Condition | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Study to Evaluate the PK of BMS-927711 in Patient With Migraine During Acute Migraine and Non-migraine Condition

Phase I, Open-Label, Randomized, Single Sequence Study With Two Dose Groups to Compare the Pharmacokinetics of BMS-927711 in Migraine Subjects During an Acute Migraine Attack and During Non-Migraine Period

NCT01445067•Pfizer

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the pharmacokinetics (PK) of BMS-927711 during migraine and non-migraine condition.

Detailed Description

Study Classification: Safety CGRP = Calcitonin gene related peptide

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients with migraine with or without aura who are otherwise healthy as determined by medical history, physical examination, clinical laboratory evaluations and 12-lead electrocardiogram (ECG), will be eligible
•Men or women \[women of childbearing potential (WOCBP) or Women of non childbearing potential (WONCBP)\] ages 18-55 years inclusive, with a body mass index (BMI) of 18.0 to 32.0 kg/m2 with not more than 8 migraines a month
•Patient has at least 1 year history of migraines (with or without aura) including the following:
•1. Meet the diagnostic criteria for migraine with history of at least 1 year (with or without aura) at the screening visit
•2. Migraine attacks with the age of onset prior to 55 years old
•3. Migraine attacks, on average, lasts about 4-72 hours if untreated in the 3 months prior to screening visit
•2-8 moderate or severe migraine attacks per month in the 3 months prior to screening visit. The migraine, for which the patient receives treatment during the study, must have at least one of the associated symptoms: nausea, photophobia, phonophobia, or migraine with aura

Exclusion Criteria

•Female patient is pregnant/breast-feeding (or is a female expecting to conceive during study period)
•Patient has history or evidence of stroke/transient ischemic attacks, heart disease, coronary artery vasospasm, other significant underlying cardiovascular diseases, uncontrolled hypertension (high blood pressure), uncontrolled diabetes, or Human Immunodeficiency Virus (HIV)
•Patient will be excluded if they take medications for acute migraine more than 10 days per month, had very frequent chronic tension type headaches for 15 or more days per month (or were unable to distinguish between tension-type headaches and migraine)
•Patient has major depression, other pain syndromes that might interfere with study assessments, psychiatric conditions, dementia, or significant neurological disorders (other than migraine)
•Patient has a history of gastric, or small intestinal surgery, or has a disease that causes mal absorption
•Patient has a history or current evidence of any unstable medical conditions (eg, history of congenital heart disease or arrhythmia, known suspected infection, hepatitis B or C, or cancer) that, in the investigator's opinion, would expose them to undue risk of a significant adverse event (AE) or interfere with assessments of safety or efficacy during the course of the trial
•Patient has basilar migraine and hemiplegic migraine
•Patient taking narcotic medication
•History of alcohol, substance or drug abuse within the last year
•Uses an opiate as first line acute treatment for migraine attacks
+5 more criteria

Locations (4)

California Clinical Trials Medical Group

Glendale, California, United States

Collaborative Neuroscience Network, Inc.

Long Beach, California, United States

Compass Research, Llc

Orlando, Florida, United States

Community Research

Cincinnati, Ohio, United States

Key Dates

Start Date

November 1, 2011

Primary Completion Date

September 1, 2012

Completion Date

September 1, 2012

Last Updated

March 1, 2023

Enrollment

ACTUAL participants

Conditions

Migraine

Interventions

BMS-927711 (CGRP Antagonist)

DRUG

BMS-927711 (CGRP Antagonist)

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 1, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study to Evaluate the PK of BMS-927711 in Patient With Migraine During Acute Migraine and Non-migraine Condition

Inclusion Criteria

Exclusion Criteria

A Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Chronic Migraine

A Study to Learn About the Study Medicine Called Rimegepant in Women When Used for Intermittent Prevention of Menstrual Migraine

Mind Body Balance for Pediatric Migraine

Light Exposure, Migraine Outcomes, and Sleep Quality

A Study to Learn About the Study Medicine Called Rimegepant in Adolescents With Frequent Migraine

Prophylactic Treatment With Atorvastatin for Episodic Migraine.