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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00548353
Recruitment Status : Completed
First Posted : October 23, 2007
Last Update Posted : December 19, 2014
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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

Condition or disease Intervention/treatment Phase
Migraine Disorders Drug: MK3207 Drug: Comparator: Placebo (unspecified) Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : August 2007
Primary Completion Date : April 2008
Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine
U.S. FDA Resources

Arm Intervention/treatment
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).



Primary Outcome Measures :
  1. Safety in migraine patients [ Time Frame: 12 Weeks ]

Secondary Outcome Measures :
  1. PK in migraine patients [ Time Frame: 12 Weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00548353


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

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00548353     History of Changes
Other Study ID Numbers: 3207-003
MK3207-003
2007_599
First Posted: October 23, 2007    Key Record Dates
Last Update Posted: December 19, 2014
Last Verified: December 2014

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