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

NCT ID: NCT01445067

Last Updated: 2023-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2012-09-30

Brief 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

Conditions

Migraine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1: BMS-927711 (300 mg)

Group Type: ACTIVE_COMPARATOR

BMS-927711 (CGRP Antagonist)

Intervention Type: DRUG

Capsule, Oral, 300 mg, Once, One day

Arm 2: BMS-927711 (600 mg)

Group Type: ACTIVE_COMPARATOR

BMS-927711 (CGRP Antagonist)

Intervention Type: DRUG

Capsule, Oral, 600 mg, Once, One day

Interventions

BMS-927711 (CGRP Antagonist)

Capsule, Oral, 300 mg, Once, One day

Intervention Type: DRUG

BMS-927711 (CGRP Antagonist)

Capsule, Oral, 600 mg, Once, One day

Intervention Type: DRUG

Eligibility Criteria

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
• History of ergotamine, any acute therapy or triptan intake on greater than/equal 10 days per month on a regular basis for greater than/equal 3 months
• History of simple analgesic intake on greater than/equal 10 days per month for greater than/equal 3 months
• History of use of opioid or combination medication intake or butalbital containing analgesic greater than 5 days per month for greater than/equal to 3 months
• Do not receive migraine relief from a triptan migraine treatment
• Evidence of renal impairment - calculated creatinine clearance <60ml/min or clinically relevant finding on urinalysis

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

United States

Related Links

http://www.bms.com/studyconnect/Pages/home.aspx

BMS clinical trial educational resource

http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx

Investigator Inquiry form

Other Identifiers

CN170-004

Identifier Type: -

Identifier Source: org_study_id