migraine MedDRA version: 9.1 Level: LLT Classification code 10027599 Term: Migraine
Conditions
Interventions
Product Name: MK-3207
Product Code: MK-3207
Pharmaceutical Form: Tablet
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Table
Sponsors
Merck Sharp & Dohme (Sweden) AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Patient has a history of migraine headache with or without aura greater than 1 year. •Women and men of childbearing potential must use acceptable contraception throughout the trial. •Patient is judged to be in satisfactory health based on the 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Patient is pregnant, or breast-feeding, or is a female expecting to conceive within the projected duration of the study. •Patient has a history of predominantly mild headache attacks or migraine headaches that usually resolve spontaneously without treatment in less than 2 hours. •Patient has confounding pain syndromes, uncontrolled 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 assess dose response of 2-hour pain freedeom (PF) post dose across a range of MK-3207 doses and the effectiveness of MK-3207 in the treatment of acute migraine as measured by 2-hour PF post dose. To evaluate the safety and tolerability of various doses of MK-3207 in the treatment of acute migraine.;Secondary Objective: To assess the effectiveness of MK-3207 in the treatment of acute migraine as measured by pain relief at 2 hours post dose.;Primary end point(s): The primary efficacy endpoint is pain freedom at 2 hours postdose, with pain freedom defined in this study as a reduction in migraine headache severity from Grade 3/2 at baseline to Grade 0. Primary safety endpoints include the proportions of patients with the following clinical adverse experiences: (1) drug related, (2) serious, (3) serious and drug related, (4) triptan-associated AE class (chest pain, chest tightness, throat tightness, asthenia, paraesthesia, dysesthesia, or hyperesthesia). | — |
Countries
Belgium, Germany, Italy, Sweden
Outcome results
None listed