Clinical trial NCT00443209: Telcagepant (MK-0974) Long-Term Safety Study in Adult Participants With Acute Migraine (MK-0974-012)
Official title: A Multicenter, Double-Blind, Active-Controlled, Parallel Group Study to Examine the Safety, Tolerability and Efficacy of Oral MK-0974 for the Long Term Treatment of 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: 1068
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 safety and tolerability of telcagepant (MK-0974) in the long-term treatment of acute migraine in adult participants. The primary hypothesis of this study is that telcagepant is well tolerated in the long-term treatment of acute migraine in adult participants.


Eligibility criteria: Inclusion Criteria:

* At least 1 year history of migraine (with or without aura)
* Females of child bearing potential must use acceptable contraception throughout trial
* In general good health based on screening assessment

Exclusion Criteria:

* Pregnant/breast-feeding (or is a female expecting to conceive during study period)
* 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
* Major depression, other pain syndromes that might interfere with study assessments, psychiatric conditions, dementia, or significant neurological disorders (other than migraine)
* History of gastric, or small intestinal surgery, or has a disease that causes malabsorption
* History of cancer within the last 5 years

Primary outcomes:
measure: Percentage of Participants With At Least One Triptan-Related Adverse Experience (AE)
timeFrame: Within 14 days of any dose of study drug (Up to 18.5 months)
measure: Percentage of Participants With At Least One Clinical AE
timeFrame: Within 14 days of any dose of study drug (Up to 18.5 months)
measure: Percentage of Participants With At Least One Laboratory AE
timeFrame: Within 14 days of any dose of study drug (Up to 18.5 months)
measure: Percentage of Participants With At Least One Vital Sign Measurement Outside Predefined Limits of Change
timeFrame: Within 14 days of any dose of study drug (Up to 18.5 months)
Secondary outcomes:
measure: Percentage of Participant Migraine Attacks With Pain Freedom (PF) at 2 Hours Post-Dose
timeFrame: 2 hours post-dose (Up to 18 months)
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Connor KM, Aurora SK, Loeys T, Ashina M, Jones C, Giezek H, Massaad R, Williams-Diaz A, Lines C, Ho TW. Long-term tolerability of telcagepant for acute treatment of migraine in a randomized trial. Headache. 2011 Jan;51(1):73-84. doi: 10.1111/j.1526-4610.2010.01799.x. Epub 2010 Nov 10.