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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 16, 2014