A Study of Gastric Delay in Migraine Patients

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00548353
First received: October 19, 2007
Last updated: May 9, 2008
Last verified: May 2008
  Purpose

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


Condition Intervention Phase
Migraine Disorders
Drug: MK3207
Drug: Comparator: Placebo (unspecified)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Safety in migraine patients [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • PK in migraine patients [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Enrollment: 22
Study Start Date: September 2007
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
MK3207 Orally administered to patients with water. During each period (with and without acute migraine).
Drug: MK3207
M3207 (20 mg); patients will be administered a single dose of 100 mg of MK3207 (i.e., 5 x20-mg tablets).
Placebo Comparator: 2
MK3207 placebo as tablets will be Orally administered to patients with water. During each period (with and without acute migraine).
Drug: Comparator: Placebo (unspecified)
M3207 (20 mg) Pbo; patients will be administered a single dose of 100 mg of MK3207 Pbo (i.e., 5 x20-mg tablets).

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00548353

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00548353     History of Changes
Other Study ID Numbers: 2007_599, MK3207-003
Study First Received: October 19, 2007
Last Updated: May 9, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on April 21, 2014