Study to Evaluate the Safety, Tolerability, and Blood Pressure Effect of an Oral Dose of Sumatriptan Alone and in Combination With MK0974 in Migraine Patients

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00701389
First received: June 17, 2008
Last updated: June 18, 2008
Last verified: June 2008
  Purpose

Study to understand the effects of blood pressure in patients with migraine.


Condition Intervention Phase
Migraine Disorders
Drug: MK0974
Drug: sumatriptan
Drug: placebo (unspecified)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Placebo-Controlled, 3-Period, Single Dose Crossover Study to Evaluate the Safety, Tolerability, and Blood Pressure Effect of an Oral Dose of Sumatriptan Alone and in Combination With MK0974 in Migraine Patients

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Assessment of the blood pressure effect of a single dose of comparator alone versus comparator with investigational product in migraineurs. [ Time Frame: Up to 6 hours postdose. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assessment of the safety and tolerability of a single dose of comparator alone versus comparator with investigational product in migraineurs. Assessment of the blood pressure effect of a single dose of investigational product vs. placebo in migraineurs. [ Time Frame: Up to 6 hours postdose. ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: December 2007
Study Completion Date: April 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
drug-drug
Drug: MK0974
MK0974; 600 mg (2 x300 mg capsule) Duration of Treatment: 2 Days
Other Name: MK0974
Drug: sumatriptan
single, oral dose of 100 mg sumatriptan Duration of Treatment: 2 Days
Active Comparator: B
drug placebo
Drug: sumatriptan
single, oral dose of 100 mg sumatriptan Duration of Treatment: 2 Days
Drug: placebo (unspecified)
Pbo MK0974 Duration of Treatment: 2 Days
Experimental: C
placebo drug
Drug: MK0974
MK0974; 600 mg (2 x300 mg capsule) Duration of Treatment: 2 Days
Other Name: MK0974
Drug: placebo (unspecified)
Pbo sumatriptan Duration of Treatment: 2 Days
Placebo Comparator: D
placebo, placebo
Drug: placebo (unspecified)
Pbo sumatriptan Duration of Treatment: 2 Days
Drug: placebo (unspecified)
Pbo MK0974 Duration of Treatment: 2 Days

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient has history of migraine for longer than 6 months.
  • Patient is free from migraine 24 hours before each dosing.
  • Patient is judged to be in good health.
  • Nonsmoker

Exclusion Criteria:

  • Under age of legal consent.
  • Legally or mentally incapacitated or has significant emotional problems.
  • Patient is taking any medications from about 2 weeks before the first dose of study medication.
  • Patient has had surgery or donated blood or participated in another investigation study within 4 weeks prior to screening
  • Patient is currently a regular user of any illicit drugs or has a history of drug/alcohol abuse within about 2 years
  • Patient consumes more than 6 caffeinated beverages per day
  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: NCT00701389

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: NCT00701389     History of Changes
Other Study ID Numbers: 2008_500, MK0974-026
Study First Received: June 17, 2008
Last Updated: June 18, 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
Sumatriptan
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014