Clinical trial NCT00897949: MK0462 in Treatment of Migraine With Recurrence (MK0462-022)
Official title: A Randomized, Triple-Blind, Double-Dummy, Placebo-Controlled, Parallel Groups, Outpatient Study to Examine the Safety and Efficacy of MK0462 10 mg p.o. and MK0462 5 mg p.o. for the Treatment of Acute Migraine and Migraine Recurrence
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: 1473
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/MK0462 (5 and 10 mg) for the treatment of acute migraine attack and treatment of up to two headache recurrences compared to placebo.

The long term extension study which pools patients from MK0462-022, -025, and -029 is described in NCT01286207.


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 After the Initial Dose of Test Drug
timeFrame: 2 hours after initial dose of test drug
Secondary outcomes:
measure: Pain Free at 2 Hours After the Initial Dose of Test Drug
timeFrame: 2 hours after initial dose of test drug
measure: No Disability at 2 Hours After the Initial Dose of Test Drug
timeFrame: 2 hours after initial dose of test drug
measure: Use of Escape Medication at 2 Hours After the Initial Dose of Test Drug
timeFrame: 2 hours after initial dose of test drug
measure: Pain Relief 2 Hours After Treatment for Headache Recurrence
timeFrame: 2 hours after treatment for recurrence
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: Teall J, Tuchman M, Cutler N, Gross M, Willoughby E, Smith B, Jiang K, Reines S, Block G. Rizatriptan (MAXALT) for the acute treatment of migraine and migraine recurrence. A placebo-controlled, outpatient study. Rizatriptan 022 Study Group. Headache. 1998 Apr;38(4):281-7. doi: 10.1046/j.1526-4610.1998.3804281.x.
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.