Clinical trial NCT00442936: Study of Telcagepant (MK-0974) in Participants With Moderate to Severe Acute Migraine With or Without Aura (MK-0974-011)
Official title: A Multicenter, Double-Blind, Placebo-Controlled, Parallel Group Study to Compare the Response to a Single Treatment With Oral MK0974 With Placebo and Comparator in Subjects With Moderate to Severe Acute Migraine With or Without Aura
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-03-05
Enrollment: 1380
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 this study is to investigate the efficacy and safety of telcagepant (MK-0974) compared to an approved medication for acute migraine. This study was conducted as a "triple-dummy" design; for each dose of study drug, participants each received 3 forms of study drug (2 capsules of active and/or placebo and 1 tablet of active and/or placebo) and were instructed to take one of each form of study drug at dosing time.

The primary hypotheses of this study are that telcagepant is superior to placebo in Pain Freedom at 2 Hours Post-Dose, Pain Relief at 2 Hours Post-Dose, Absence of Photophobia at 2 Hours Post-Dose, Absence of Phonophobia at 2 Hours Post-Dose and Absence of Nausea at 2 Hours Post-Dose.


Eligibility criteria: Inclusion Criteria:

* Has at least 1 year history of migraine (with or without aura)
* Females of child bearing potential must use acceptable contraception throughout trial.

Exclusion Criteria:

* Is pregnant/breast-feeding (or is a female expecting to conceive during study period)
* Has history or evidence of stroke/transient ischemic attacks, heart disease, coronary artery vasospasm, other significant underlying cardiovascular diseases, uncontrolled hypertension (high blood pressure), uncontrolled diabetes, or human immunodeficiency virus (HIV) disease
* Has major depression, other pain syndromes that might interfere with study assessments, psychiatric conditions, dementia, or significant neurological disorders (other than migraine)
* Has a history of gastric, or small intestinal surgery, or has a disease that causes malabsorption
* Has a history of cancer within the last 5 years.

Primary outcomes:
measure: Number of Participants With Pain Freedom (PF) at 2 Hours Post-Dose
timeFrame: 2 hours post-dose
measure: Number of Participants With Pain Relief (PR) at 2 Hours Post-Dose
timeFrame: 2 hours post-dose
measure: Number of Participants With Absence of Photophobia at 2 Hours Post-Dose
timeFrame: 2 hours post-dose
measure: Number of Participants With Absence of Phonophobia at 2 Hours Post-Dose
timeFrame: 2 hours post-dose
measure: Number of Participants With Absence of Nausea at 2 Hours Post-Dose
timeFrame: 2 hours post-dose
measure: Number of Participants Who Experience At Least One Adverse Event (AE)
timeFrame: Up to 14 days after last dose of study drug
measure: Number of Participants Who Discontinue Study Drug Due to an AE
timeFrame: Up to 48 hours after first dose of study drug
Secondary outcomes:
measure: Number of Participants With Sustained Pain Freedom (SPF) From 2 to 24 Hours Post-Dose
timeFrame: 2 to 24 hours post-dose
measure: Number of Participants With Total Migraine Freedom (TMF) at 2 Hours Post-Dose
timeFrame: 2 hours post-dose
measure: Number of Participants With Total Migraine Freedom (TMF) at 2 to 24 Hours Post-Dose
timeFrame: 2 to 24 hours post-dose
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Ho TW, Ferrari MD, Dodick DW, Galet V, Kost J, Fan X, Leibensperger H, Froman S, Assaid C, Lines C, Koppen H, Winner PK. Efficacy and tolerability of MK-0974 (telcagepant), a new oral antagonist of calcitonin gene-related peptide receptor, compared with zolmitriptan for acute migraine: a randomised, placebo-controlled, parallel-treatment trial. Lancet. 2008 Dec 20;372(9656):2115-23. doi: 10.1016/S0140-6736(08)61626-8. Epub 2008 Nov 25.
citation: Ho TW, Olesen J, Dodick DW, Kost J, Lines C, Ferrari MD. Antimigraine efficacy of telcagepant based on patient's historical triptan response. Headache. 2011 Jan;51(1):64-72. doi: 10.1111/j.1526-4610.2010.01790.x. Epub 2010 Nov 4.