Migraine MedDRA version: 8.1 Level: LLT Classification code 10027599 Term: Migraine
Conditions
Interventions
Product Name: MK-0974
Product Code: MK-0974
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: NA
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
Pharmace
Sponsors
Merck & Co Inc.,
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. • Patient is in general good health based on screening assessment. 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 a history or clinical evidence of stroke/transient ischaemic attacks, ischeamic heart diseaseor other significant underlying cardiovascular disease. • 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 safety and tolerability of MK-0974 compared to rizatriptan group in the long term treatment of acute migraine.;Secondary Objective: To estimate the efficacy of MK-0974 compared to rizatriptan as measured by pain-freedom at 2 hours post-dose in the long term treatment of acute migraine. To evaluate the safety and tolerability of a new dose and formulation of MK-0974 - 280 mg tablet.;Primary end point(s): Primary safety endpoints include the proportions of patients with the following clinical adverse experiences: (1) serious; (2) drug related; (3) serious and drug related; (4) discontinued due to an adverse experience; and (5) the proportion of patients with at least one of the following AEs: chest pain, chest tightness, asthenia, paraesthesia, dysaesthesia, or hyperaesthesia. | — |
Countries
Austria, Denmark, France, Italy, United Kingdom
Outcome results
None listed