Clinical trial NCT00899379: Treatment of Multiple Attacks of Acute Migraine (0462-025)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine Headache
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2009-05-12
Enrollment: 473
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Pain Relief at 2 Hours During the First Migraine Attack Period
timeFrame: 2 hours
Secondary outcomes:
measure: Pain Relief at 2 Hours During the Second Migraine Attack Period
timeFrame: 2 hours
measure: Pain Relief at 2 Hours During the Third Migraine Attack Period
timeFrame: 2 hours
measure: Pain Relief at 2 Hours During the Fourth Migraine Attack Period
timeFrame: 2 hours
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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. doi: 10.1212/wnl.51.3.773.
citation: 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. doi: 10.1046/j.1526-4610.1998.3810764.x.