Study to Test Rizatriptan in the Early Treatment of Acute Migraine - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00516737

Purpose

The purpose of this study is to test the effectiveness of rizatriptan benzoate in the early treatment of an acute migraine attack.

Condition	Intervention	Phase
Migraine	Drug: Comparator: rizatriptan benzoate Drug: Comparator: Placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Factorial Design Clinical Trial to Study the Efficacy and Safety of MK0462 / Rizatriptan 10 mg for the Early Treatment of Acute Migraine

Resource links provided by NLM:

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Migraine

Drug Information available for: Rizatriptan Rizatriptan Benzoate Potassium benzoate

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Number of Participants Who Are Pain Free at 2 Hours Post-Dose [ Time Frame: 2 hours post-dose ] [ Designated as safety issue: No ]
Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), or 3 (severe). Pain free = rating of 0 (no pain) at 2 hours post-dose.

Secondary Outcome Measures:

Number of Participants With 24-Hour Sustained Pain Freedom [ Time Frame: 24 hours post-dose ] [ Designated as safety issue: No ]
24-hour sustained pain freedom (defined as pain freedom from 2 to 24 hours post-dose and no use of rescue medication). Participants assessed pain severity and use of rescue medication on a paper diary.
Number of Participants With no Rescue Use up to 24 Hours Post-Dose [ Time Frame: 24 hours post-dose ] [ Designated as safety issue: No ]
Participants recorded use of any rescue medication up to 24 hours after dosing with study medication on a paper diary.
Number of Participants With Absence of Photophobia at 2 Hours Post-dose [ Time Frame: 2 hours post-dose ] [ Designated as safety issue: No ]
Absence or presence of photophobia was recorded by the participants on a paper diary. Absence is defined as no photophobia at 2 hours post-dose.
Number of Participants With Absence of Phonophobia at 2 Hours Post-dose [ Time Frame: 2 hours post-dose ] [ Designated as safety issue: No ]
Absence or presence of phonophobia was recorded by the participants on a paper diary. Absence is defined as no phonophobia at 2 hours post-dose.
Number of Participants With Absence of Nausea at 2 Hours Post-dose [ Time Frame: 2 hours post-dose ] [ Designated as safety issue: No ]
Absence or presence of nausea was recorded by the participants on a paper diary. Absence is defined as no nausea at 2 hours post-dose.
Number of Participants With Absence of Functional Disability at 2 Hours Post-Dose [ Time Frame: 2 hours post-dose ] [ Designated as safety issue: No ]
Level of functional disability was assessed on a paper diary by the participants.

Level of functional disability was rated as: normal, mildly impaired, severely impaired or unable to do activities, requires bed rest. Absence of functional disability defined as a rating of normal at 2 hours post-dose.

Enrollment:	207
Study Start Date:	October 2007
Study Completion Date:	April 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Active Drug	Drug: Comparator: rizatriptan benzoate Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack Other Name: MK0462
Placebo Comparator: 2 Matching Pbo Comparator	Drug: Comparator: Placebo Matching placebo; one dose, treatment of a single migraine attack

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Greater than one year history of migraine
Attacks typically mild when they begin and progress to moderate or severe
Experience 1-4 migraine attacks per month

Exclusion Criteria:

More than 15 headache days per month
Heart disease
Uncontrolled high blood pressure

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00516737

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Additional Information:

MedWatch - FDA maintained medical product safety Information This link exits the ClinicalTrials.gov site

Merck: Patient & Caregiver U.S. Product Web Site This link exits the ClinicalTrials.gov site

Publications:

Cady RK, Martin VT, Géraud G, Rodgers A, Zhang Y, Ho AP, Hustad CM, Ho TP, Connor KM, Ramsey KE. Rizatriptan 10-mg ODT for early treatment of migraine and impact of migraine education on treatment response. Headache. 2009 May;49(5):687-96.

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00516737 History of Changes
Other Study ID Numbers:	2007_547, MK0462-081
Study First Received:	August 13, 2007
Results First Received:	March 12, 2009
Last Updated:	April 20, 2010
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
Benzoates
Rizatriptan
Antifungal Agents

Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 12, 2012