Treatment of Multiple Attacks of Acute Migraine (0462-025)

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ClinicalTrials.gov Identifier: NCT00899379

Recruitment Status : Completed

First Posted : May 12, 2009

Results First Posted : July 15, 2010

Last Update Posted : February 3, 2022

Sponsor:

Information provided by (Responsible Party):

Organon and Co

Study Description

Brief Summary:

A study to evaluate rizatriptan for the treatment of multiple attacks of acute migraine compared to placebo.

Condition or disease	Intervention/treatment	Phase
Migraine Headache	Drug: rizatriptan benzoate Drug: Comparator: Placebo	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	473 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	A Randomized, Triple-Blind, Placebo-Controlled, Outpatient Study to Examine the Safety and Efficacy of MK462 10 mg p.o. in the Treatment of Multiple Attacks of Migraine Headache
Study Start Date :	April 1995
Actual Primary Completion Date :	January 1996
Actual Study Completion Date :	April 1996

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine

MedlinePlus related topics: Headache Migraine

Drug Information available for: Rizatriptan Rizatriptan benzoate

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Treatment Sequence 1 Placebo-Rizatriptan-Rizatriptan-Rizatriptan	Drug: rizatriptan benzoate Rizatriptan 10 mg p.o. at onset of moderate to severe migraine headache Other Name: MK0462 Drug: Comparator: Placebo Placebo to Rizatriptan, Oral Tablet
Experimental: Treatment Sequence 2 Rizatriptan-Placebo-Rizatriptan-Rizatriptan	Drug: rizatriptan benzoate Rizatriptan 10 mg p.o. at onset of moderate to severe migraine headache Other Name: MK0462 Drug: Comparator: Placebo Placebo to Rizatriptan, Oral Tablet
Experimental: Treatment Sequence 3 Rizatriptan-Rizatriptan-Placebo-Rizatriptan	Drug: rizatriptan benzoate Rizatriptan 10 mg p.o. at onset of moderate to severe migraine headache Other Name: MK0462 Drug: Comparator: Placebo Placebo to Rizatriptan, Oral Tablet
Experimental: Treatment Sequence 4 Rizatriptan-Rizatriptan-Rizatriptan-Placebo	Drug: rizatriptan benzoate Rizatriptan 10 mg p.o. at onset of moderate to severe migraine headache Other Name: MK0462 Drug: Comparator: Placebo Placebo to Rizatriptan, Oral Tablet
Experimental: Treatment Sequence 5 Rizatriptan-Rizatriptan-Rizatriptan-Rizatriptan	Drug: rizatriptan benzoate Rizatriptan 10 mg p.o. at onset of moderate to severe migraine headache Other Name: MK0462

Outcome Measures

Primary Outcome Measures :

Pain Relief at 2 Hours During the First Migraine Attack Period [ Time Frame: 2 hours ]
Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe) at baseline to grades 0 or 1 (no headache or mild) at 2 hours after initial dosing for the first migraine attack

Secondary Outcome Measures :

Pain Relief at 2 Hours During the Second Migraine Attack Period [ Time Frame: 2 hours ]
Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe) to grades 0 or 1 (no headache or mild) at 2 hours after dosing for the second migraine attack
Pain Relief at 2 Hours During the Third Migraine Attack Period [ Time Frame: 2 hours ]
Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe) to grades 0 or 1 (no headache or mild) at 2 hours after dosing for the third migraine attack
Pain Relief at 2 Hours During the Fourth Migraine Attack Period [ Time Frame: 2 hours ]
Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe) to grades 0 or 1 (no headache or mild) at 2 hours after dosing for the fourth migraine attack

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient had at least a 6-month history of migraine, with or without aura
Patient was male, or if female must have been postmenopausal, surgically sterilized, or taking adequate contraceptive precautions.
Patient was judged to be in good health, apart from migraine

Exclusion Criteria:

Patient was pregnant or a nursing mother.
Patient had abused drugs or alcohol within 12 months prior to entering the study
Patient had a history of cardiovascular disease
Patient had clinically significant ECG abnormality
Patient had a resting systolic blood pressure of greater than 145 mm Hg or diastolic of less than 95 mm Hg at screening
Patient received treatment with an investigational device or compound within 30 days of the study start
Patient typically suffered from less then 1 or more than 8 attacks of migraine per month
Patient had difficulty in distinguishing his/her migraine attacks from tension or interval headaches
Patient had prior exposure to rizatriptan

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00899379

Sponsors and Collaborators

Organon and Co

Investigators

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Study Director:	Medical Monitor	Merck Sharp & Dohme Corp.

More Information

Publications of Results:

Kramer MS, Matzura-Wolfe D, Polis A, Getson A, Amaraneni PG, Solbach MP, McHugh W, Feighner J, Silberstein S, Reines SA. A placebo-controlled crossover study of rizatriptan in the treatment of multiple migraine attacks. Rizatriptan Multiple Attack Study Group. Neurology. 1998 Sep;51(3):773-81.

Block GA, Goldstein J, Polis A, Reines SA, Smith ME. Efficacy and safety of rizatriptan versus standard care during long-term treatment for migraine. Rizatriptan Multicenter Study Groups. Headache. 1998 Nov-Dec;38(10):764-71.

Other Publications:

Ho TW, Rodgers A, Bigal ME. Impact of recent prior opioid use on rizatriptan efficacy. A post hoc pooled analysis. Headache. 2009 Mar;49(3):395-403. doi: 10.1111/j.1526-4610.2009.01346.x. Epub 2008 Feb 12.

Ho TW, Fan X, Rodgers A, Lines CR, Winner P, Shapiro RE. Age effects on placebo response rates in clinical trials of acute agents for migraine: pooled analysis of rizatriptan trials in adults. Cephalalgia. 2009 Jul;29(7):711-8. doi: 10.1111/j.1468-2982.2008.01788.x. Epub 2009 Feb 3.

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Responsible Party:	Organon and Co
ClinicalTrials.gov Identifier:	NCT00899379
Other Study ID Numbers:	0462-025 MK0462-025 2009_590
First Posted:	May 12, 2009 Key Record Dates
Results First Posted:	July 15, 2010
Last Update Posted:	February 3, 2022
Last Verified:	February 2022

Additional relevant MeSH terms:

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Migraine Disorders Headache Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Pain	Neurologic Manifestations Rizatriptan Serotonin Receptor Agonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs

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