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

Pfizer

Status and phase

Completed

Phase 1

Conditions

Migraine

Treatments

Drug: BMS-927711 (CGRP Antagonist)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01445067

CN170-004

Details and patient eligibility

About

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

Full description

Study Classification: Safety CGRP = Calcitonin gene related peptide

Enrollment

48 patients

Sex

All

Ages

18+ years old

Volunteers

No 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
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