A Dose-Finding Study of MK0974 in Acute Migraine (MK0974-004)
NCT ID: NCT00246337
Last Updated: 2015-11-02
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
420 participants
INTERVENTIONAL
2005-11-30
2006-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety and Efficacy Study of MK0974 in the Acute Migraine (0974-016)
NCT00432237
MK3207 for Treatment of Acute Migraines (3207-005)
NCT00712725
Multiple Attacks Study to Compare the Efficacy and Safety of MK-0974 With Placebo for Acute Migraine (MK-0974-031)
NCT00483704
Study to Test an Approved Product in the Early Treatment of Migraine (0462-066)
NCT00095004
A Study of the Safety and Efficacy of MK-6096 for Migraine Prophylaxis in Participants With Episodic Migraine (MK-6096-020)
NCT01513291
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo
Placebo to match assigned treatment arm; one orally-administered dose, plus an optional second dose of active drug, per assigned treatment arm, to treat a single moderate-to-severe migraine headache.
Comparator: Placebo
Placebo to match assigned treatment arm; one orally-administered dose
MK0974 25 mg
MK0974 25 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
MK0974
MK0974 25 mg; one orally-administered dose
MK0974 50 mg
MK0974 50 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
MK0974
MK0974 50 mg; one orally-administered dose
MK0974 100 mg
MK0974 100 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
MK0974
MK0974 100 mg; one orally-administered dose
MK0974 200 mg
MK0974 200 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
MK0974
MK0974 200 mg; one orally-administered dose
MK0974 300 mg
MK0974 300 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
MK0974
MK0974 300 mg; one orally-administered dose
MK0974 400 mg
MK0974 400 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
MK0974
MK0974 400 mg; one orally-administered dose
MK0974 600 mg
MK0974 600 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
MK0974
MK0974 600 mg; one orally-administered dose
Rizatriptan 10 mg
Rizatriptan 10 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
Rizatriptan
Rizatriptan 10 mg; one orally-administered dose
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Comparator: Placebo
Placebo to match assigned treatment arm; one orally-administered dose
MK0974
MK0974 25 mg; one orally-administered dose
MK0974
MK0974 50 mg; one orally-administered dose
MK0974
MK0974 100 mg; one orally-administered dose
MK0974
MK0974 200 mg; one orally-administered dose
MK0974
MK0974 300 mg; one orally-administered dose
MK0974
MK0974 400 mg; one orally-administered dose
MK0974
MK0974 600 mg; one orally-administered dose
Rizatriptan
Rizatriptan 10 mg; one orally-administered dose
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Females of childbearing years must use acceptable contraception throughout trial
* Patient is in general good health based on screening assessment
Exclusion Criteria
* Patient has heart disease, uncontrolled hypertension (high blood pressure), uncontrolled diabetes or other significant disease
* Patient has major depression, other pain syndromes that might interfere with study assessments, psychiatric conditions, dementia, or significant neurological disorders (other then migraine)
* Patient has a history of gastric or small intestinal surgery or has a disease that causes malabsorption
* Patient has a history of cancer within the last 5 years
20 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Medical Monitor
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
References
Explore related publications, articles, or registry entries linked to this study.
Ho TW, Mannix LK, Fan X, Assaid C, Furtek C, Jones CJ, Lines CR, Rapoport AM; MK-0974 Protocol 004 study group. Randomized controlled trial of an oral CGRP receptor antagonist, MK-0974, in acute treatment of migraine. Neurology. 2008 Apr 15;70(16):1304-12. doi: 10.1212/01.WNL.0000286940.29755.61. Epub 2007 Oct 3.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2005_082
Identifier Type: -
Identifier Source: secondary_id
0974-004
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.