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 - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00701389

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 I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Crossover Assignment, Safety Study
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:

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Migraine

Drug Information available for: Sumatriptan Sumatriptan succinate

U.S. FDA Resources

Further study details as provided by Merck:

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
A: Experimental drug-drug	Drug: MK0974 MK0974; 600 mg (2 x300 mg capsule) Duration of Treatment: 2 Days Drug: sumatriptan single, oral dose of 100 mg sumatriptan Duration of Treatment: 2 Days
B: Active Comparator 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
C: Experimental placebo drug	Drug: MK0974 MK0974; 600 mg (2 x300 mg capsule) Duration of Treatment: 2 Days Drug: placebo (unspecified) Pbo sumatriptan Duration of Treatment: 2 Days
D: Placebo Comparator 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00701389

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2008_500, MK0974-026
Study First Received:	June 17, 2008
Last Updated:	June 18, 2008
ClinicalTrials.gov Identifier:	NCT00701389 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Serotonin Agonists
Sumatriptan
Neurotransmitter Agents
Migraine Disorders
Headache
Vasoconstrictor Agents

Central Nervous System Diseases
Headache Disorders, Primary
Cardiovascular Agents
Brain Diseases
Serotonin
Headache Disorders

Additional relevant MeSH terms:

Serotonin Agonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Nervous System Diseases
Central Nervous System Diseases
Headache Disorders, Primary
Cardiovascular Agents

Brain Diseases
Pharmacologic Actions
Headache Disorders
Sumatriptan
Serotonin Agents
Migraine Disorders
Therapeutic Uses
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on July 02, 2009