A Study of Gastric Delay in Migraine Patients (3207-003)

Phase 1CompletedNCT00548353

Merck Sharp & Dohme LLC22 enrolled

Overview

A study to assess safety and PK of an investigational drug in migraine patients during and between migraine attacks.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Migraine Disorders

Interventions

MK3207DRUG

M3207 (20 mg); patients will be administered a single dose of 100 mg of MK3207 (i.e., 5 x20-mg tablets).

Comparator: Placebo (unspecified)DRUG

M3207 (20 mg) Pbo; patients will be administered a single dose of 100 mg of MK3207 Pbo (i.e., 5 x20-mg tablets).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Non-smoking male or female between 18 to 45 years of age * Patient typically has between 2 and 10 migraine attacks per month, rated as moderate or severe Exclusion Criteria: * Patient has any other medical conditions other than migraine

Outcomes

Primary Outcomes

Safety in migraine patients

Time frame: 12 Weeks

Secondary Outcomes

PK in migraine patients

Time frame: 12 Weeks

Data from ClinicalTrials.gov

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