A Phase IIb, Multicenter, Randomized, Double-Blind, Placebo- Controlled, Dose-Finding Study of MK-3207 in the Treatment of Acute Migraine - Dose Finding

• Conditions: migraine; MedDRA version: 9.1Level: LLTClassification code 10027599Term: Migraine

• Registration Number: EUCTR2008-001226-14-DE
• Lead Sponsor: Merck & Co., Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06-11
• Last Update Posted: 1 May 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 652

Inclusion Criteria

•Patient has a history of migraine headache with or without aura greater than 1 year.
•Women and men of childbearing potential must use acceptable contraception throughout the trial.
•Patient is judged to be in satisfactory health based on the screening assessment
•Patient is = 18 and = 65 years of age at screening (Visit 1)
•Patient has had = 2 and = 8 moderate or severe migraine attacks per month in the 2 months prior to screening (Visit 1)
•Patient understands the study procedures, alternative treatments available, and risks involved with the study and voluntarily agrees to participate in the study by giving written informed consent
•Patient is able to read, understand and complete the study questionnaires, paper diary, and access the Interactive Voice Response System (IVRS) diary

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Patient is pregnant, or breast-feeding, or is a female expecting to conceive within the projected duration of the study.
•Patient has a history of predominantly mild headache attacks or migraine headaches that usually resolve spontaneously without treatment in less than 2 hours.
•Patient has confounding pain syndromes, uncontrolled 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 malabsorption.
•Patient has a history of cancer within the last 5 years.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified