Clinical trial NCT00897104: MK0462 5 mg, Sumatriptan 50 mg, and Placebo Comparison Study (0462-029)
Official title: A Randomized, Placebo-Controlled, Parallel-Groups, Outpatient Study to Compare the Efficacy and Safety of MK0462 5 mg p.o. and Sumatriptan 50 mg p.o. for the Acute Treatment of Migraine
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: 933
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 compare rizatriptan (MK0462) 5 mg by mouth (p.o.) and sumatriptan 50 mg p.o. for the acute treatment of a migraine attack.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Participant was Pregnant or a nursing mother
* Participant had a history or current evidence of drug or alcohol abuse
* Participant had a history or clinical evidence of cardiovascular disease
* Participant had a clinically significant Electrocardiography (ECG) abnormality
* Participant had a resting systolic blood pressure of greater than 145 mm Hg or diastolic of less than 95 mm Hg at screening
* Participant had received treatment with an investigational device or compound within 30 days of the study
* Participant typically suffered from less then 1 or more than 8 attacks of migraine per month
* Participant had difficulty in distinguishing his/her migraine attacks from tension or interval headaches
* Participant was currently taking monoamine oxidase inhibitors, methysergide or lithium

Primary outcomes:
measure: Pain Relief at 2 Hours After Treatment
timeFrame: 2 hours after treatment
measure: Time to Relief Within 2 Hours After Treatment
timeFrame: within 2 hours after treatment
Secondary outcomes:
measure: Pain Free at 2 Hours After Treatment
timeFrame: 2 hours after treatment
measure: Lack of Functional Disability at 2 Hours After Treatment as Measured by the Level of Impairment in Daily Activities
timeFrame: 2 hours after treatment
measure: Presence or Absence of Associated Symptoms (Photophobia, Phonophobia, Nausea, and Vomiting) at 2 Hours After Treatment
timeFrame: 2 hours after treatment
measure: Participants Who Used Escape Medication 2 Hours After the Treatment Dose
timeFrame: 2 hours after treatment
measure: Duration of Relief (Time to Recurrence From the Time of First Recorded Pain Relief [Grade = 0 or 1])
timeFrame: 24 hours
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
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: Ferrari MD, Loder E, McCarroll KA, Lines CR. Meta-analysis of rizatriptan efficacy in randomized controlled clinical trials. Cephalalgia. 2001 Mar;21(2):129-36. doi: 10.1046/j.1468-2982.2001.00169.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.