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

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

Completed

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Key information

Conditions

Migraine Disorders Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Nervous System Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MK3207

Drug

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).

Primary outcomes

Safety in migraine patients

Time frame: 12 Weeks

Secondary outcomes

PK in migraine patients

Time frame: 12 Weeks

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo Controlled, 2-Period, Fixed-Sequence Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of Orally Administered MK3207 in Patients During and Between Their Acute Migraine Attacks

Important dates

Study start: 2007
Primary completion: 2008
Study completion: 2010
First posted: Oct 23, 2007
Registry last updated: Dec 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed