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



Status:Completed
Conditions:Migraine Headaches
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - Any
Updated:6/9/2018
Start Date:November 2011
End Date:September 2012

Use our guide to learn which trials are right for you!

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

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

Study Classification: Safety CGRP = Calcitonin gene related peptide

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
We found this trial at
4
sites
100 West Gore St # 202
Orlando, Florida 32806
(407) 426-9299
Compass Research LLC Compass Research is a clinical research company dedicated to testing new medications...
?
mi
from
Orlando, FL
Click here to add this to my saved trials
4460 Red Bank Expressway
Cincinnati, Ohio 45227
513-721-3868
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Glendale, California 91206
?
mi
from
Glendale, CA
Click here to add this to my saved trials
Long Beach, California 90806
?
mi
from
Long Beach, CA
Click here to add this to my saved trials