Clinical trial NCT00483704: Multiple Attacks Study to Compare the Efficacy and Safety of MK-0974 With Placebo for Acute Migraine (MK-0974-031)
Official title: A Multicenter, Double-Blind, Placebo-Controlled, Parallel Group Multiple Attacks Study to Compare the Efficacy and Safety of Oral MK-0974 With Placebo for the Acute Treatment of Migraine With or Without Aura
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraines
Keywords: multiple attacks of moderate to severe migraine headaches
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-06-07
Enrollment: 1935
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to assess the safety and efficacy of telcagepant (MK-0974) in acute treatment of multiple migraine attacks with or without aura. Primary hypotheses of this study are that telcagepant is superior to placebo, as measured by the proportion of participants who have pain freedom, pain relief, pain freedom consistency, pain relief consistency, and absence of photophobia, phonophobia, and nausea at 2 hours post-dose.


Eligibility criteria: Inclusion Criteria:

* History of migraines within the past year
* 1 to 8 moderate or severe migraine attacks per month in the past 2 months that lasted between 4 to 72 hours if untreated
* Use acceptable contraception throughout the study
* Able to complete the study questionnaire(s) and paper diary
* Limit consumption of grapefruit juice to no more than one 8 ounce glass a day

Exclusion Criteria:

* Pregnant or breast-feeding or is expecting to become pregnant during the study
* Difficulty distinguishing his/her migraine attacks from tension or interval headaches
* A history of mostly mild migraine attacks or migraines that usually resolve spontaneously in less than 2 hours
* More than 15 headache-days per month or has taken medication for acute headache on more than 10 days a month in the past 3 months
* Greater than 50 years old at the age of migraine onset
* Previously taken telcagepant

Primary outcomes:
measure: Percentage of Participants Reporting Pain Freedom at 2 Hours Post-dose (First Migraine Attack)
timeFrame: 2 hours post-dose for the first migraine attack (up to 6 months)
measure: Percentage of Participants Reporting Pain Relief at 2 Hours Post-dose (First Migraine Attack)
timeFrame: 2 hours post-dose for the first migraine attack (up to 6 months)
measure: Percentage of Participants Reporting Pain Freedom Consistency at 2 Hours Post-dose
timeFrame: 2 hours post-dose (up to 6 months)
measure: Percentage of Participants Reporting Pain Relief Consistency at 2 Hours Post-dose
timeFrame: 2 hours post-dose (up to 6 months)
measure: Percentage of Participants Reporting Absence of Photophobia at 2 Hours Post-dose (First Migraine Attack)
timeFrame: 2 hours post-dose for the first migraine attack (up to 6 months)
measure: Percentage of Participants Reporting Absence of Phonophobia at 2 Hours Post-dose (First Migraine Attack)
timeFrame: 2 hours post-dose for the first migraine attack (up to 6 months)
measure: Percentage of Participants Reporting Absence of Nausea 2 Hours Post-dose (First Migraine Attack)
timeFrame: 2 hours post-dose for the first migraine attack (up to 6 months)
measure: Number of Participants Experiencing an Adverse Event (AE) Within 48 Hours Post-dose (First Migraine Attack)
timeFrame: Up to 48 hours post-dose for the first migraine attack (up to 6 months)
measure: Number of Participants Discontinuing Study Medication Due to an AE
timeFrame: Up to the 4th dose of study medication (up to 6 months)
Secondary outcomes:
measure: Percentage of Participants Reporting Sustained Pain Freedom From 2 to 24 Hours Post-dose (First Migraine Attack)
timeFrame: From 2 to 24 hours post-dose for the first migraine attack (up to 6 months)
measure: Percentage of Participants Reporting Sustained Pain Freedom From 2 to 48 Hours Post-dose (First Migraine Attack)
timeFrame: From 2 to 48 hours post-dose for the first migraine attack (up to 6 months)
measure: Percentage of Participants Reporting Total Migraine Freedom at 2 Hours Post-dose (First Migraine Attack)
timeFrame: 2 hours post-dose for the first migraine attack (up to 6 months)
measure: Percentage of Participants Reporting Total Migraine Freedom From 2 to 24 Hours Post-dose (First Migraine Attack)
timeFrame: From 2 to 24 hours post-dose for the first migraine attack (up to 6 months)
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Ho AP, Dahlof CG, Silberstein SD, Saper JR, Ashina M, Kost JT, Froman S, Leibensperger H, Lines CR, Ho TW. Randomized, controlled trial of telcagepant over four migraine attacks. Cephalalgia. 2010 Dec;30(12):1443-57. doi: 10.1177/0333102410370878. Epub 2010 Jun 8.