A Study to Test the Safety and Effectiveness of MK-0974 (Telcagepant) Co-administered With Ibuprofen or Acetaminophen in Patients With Migraines With or Without Aura (MK-0974-046)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: Migraine

Treatments: Drug: ibuprofen; Drug: acetominophen; Drug: placebo; Drug: telcagepant

Study type: Interventional

Funder types: Industry

Identifiers

NCT00758836

0974-046

CTRI/2009/091/000291 (Registry Identifier)

2008_551 (Other Identifier)

Details and patient eligibility

About

This study will test the safety and how effective telcagepant is when taken with ibuprofen or acetaminophen in participants with migraine with or without aura. The primary study hypothesis is that at least one drug combination is superior to telecagepant alone in the treatment of acute migraines.

Enrollment: 683 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Must be 18 years of age or older
• History of migraine with or without aura for more than 1 year with 1-8 moderate or severe migraine attacks per month in the 2 months prior to starting in the study
• Willing to stay awake for at least 2 hours after taking study drug
• Able to read, understand and complete questionnaires and diaries

Exclusion criteria

• Breast-feeding, pregnant, or plan to become pregnant during the study
• Not able to tell migraine attack from other headaches
• Older than 50 years of age at migraine onset
• Have more than 15 headache days per month or have taken medication for acute headache on more than 10 days per month in any of the 3 months before starting in the study
• History of gastric or small intestinal surgery
• History of heart attack, stroke, unstable angina, coronary artery bypass surgery or transient ischemic attack in the 3 months before starting in the study
• Currently participating or have participated in a study with in investigational compound or device in the last 30 days

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

683 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants take two placebo tablets and two placebo capsules, orally, at onset of migraine

Treatment:

Drug: placebo

Telcagepant 280 mg +Ibuprofen 400 mg

Experimental group

Description:

Participants take one telcagepant 280 mg tablet, one ibuprofen 400 mg tablet, and two placebo capsules, orally, at onset of migraine

Treatment:

Drug: telcagepant

Drug: ibuprofen

Telcagepant 280 mg +APAP 1000 mg

Experimental group

Description:

Participants take one telcagepant 280 mg tablet, one placebo tablet, and two 500-mg APAP capsules, orally, at onset of migraine

Treatment:

Drug: telcagepant

Drug: acetominophen

Telcagepant 280 mg

Placebo Comparator group

Description:

Participants take one telcagepant 280 mg tablet, one placebo tablet, and two placebo capsules, orally, at onset of migraine

Treatment:

Drug: telcagepant