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

Migraine Disorders Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00548353
• Other study ID #: 3207-003
• Secondary ID: MK3207-0032007_5
• Status: Completed
• Phase: Phase 1
• First received: October 19, 2007
• Last updated: December 18, 2014
• Start date: August 2007
• Est. completion date: February 2010

Study information

• Verified date: December 2014
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: February 2010
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Migraine Disorders

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety in migraine patients		12 Weeks	Yes
Secondary	PK in migraine patients		12 Weeks	No