A phase III, Multicenter, Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Efficacy of Oral MK-0974 in the Acute Treatment of Migraine with or Without Aura.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-006187-35-FR

Enrollment

1600

Registered

2007-02-15

Start date

2007-04-10

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute treatment of Migraine MedDRA version: 8.1 Level: LLT Classification code 10027599 Term: Migraine

Interventions

Product Name: MK-0974 Product Code: MK-0974 Pharmaceutical Form: Capsule, soft INN or Proposed INN: NA Current Sponsor code: MK-0974

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patient has at least 1 year history of migraine (with or without aura). Females of child bearing potential must use acceptable contraception throughout trial. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patient is pregnant/breast-feeding (or is a female expecting to conceive during study period). Patient has uncontrolled hypertension (high blood pressure), uncontrolled diabetes, HIV disease, or other significant disease. Patient has major depression, other pain syndromes that might interfere with study assessments, psychiatric conditions, dementia, or significant neurological disorders (other than migraine). Patient has a history of gastric, or small intestinal surgery, or has a disease that causes malabsorption. Patient has a history of cancer within the last 5 years.

Design outcomes

Primary

Measure	Time frame
Main Objective: - To evaluate the efficacy of MK-0974 (300 mg and 150 mg) compared to placebo in the treatment of acute migraine as measured using pain freedom, pain relief, freedom from photophobia, freedom from phonophobia and freedom from nausea. - To evaluate the safety and tolerability of MK-0974 in the treatment of acute migraine ; Secondary Objective: - To evaluate the efficacy of MK-0974 (300 mg and 150 mg) compared to placebo in the treatment of acute migraine as measured using sustained pain freedom and total migraine freedom. - Examine dose response of MK-0974 for pain freedom and pain relief at 2 hours accross all doses studied (50 mg, 150 mg, 300mg) ;Primary end point(s): 1) headache freedom (to Grade 0); 2) freedom from photophobia; 3) freedom from phonophobia, 4) freedom from nausea and 5) headache relief (to Grade 0 or 1), respectively, at 2 hours post treatment.	—

Measure

Time frame

Main Objective: - To evaluate the efficacy of MK-0974 (300 mg and 150 mg) compared to placebo in the treatment of acute migraine as measured using pain freedom, pain relief, freedom from photophobia, freedom from phonophobia and freedom from nausea. - To evaluate the safety and tolerability of MK-0974 in the treatment of acute migraine ; Secondary Objective: - To evaluate the efficacy of MK-0974 (300 mg and 150 mg) compared to placebo in the treatment of acute migraine as measured using sustained pain freedom and total migraine freedom. - Examine dose response of MK-0974 for pain freedom and pain relief at 2 hours accross all doses studied (50 mg, 150 mg, 300mg) ;Primary end point(s): 1) headache freedom (to Grade 0); 2) freedom from photophobia; 3) freedom from phonophobia, 4) freedom from nausea and 5) headache relief (to Grade 0 or 1), respectively, at 2 hours post treatment.

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Countries

Austria, France, Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026