E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
migraine, coronary artery disease |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10027599 |
E.1.2 | Term | Migraine |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10011078 |
E.1.2 | Term | Coronary artery disease |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the efficacy of MK-0974 compared to placebo in the treatment of acute migraine in patients with stable vascular disease, as measured by pain freedom at 2 hours postdose. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the safety and tolerability of MK-0974 compared to acetaminophen/paracetamol in the treatment of acute migraine in patients with stable vascular disease |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Patient has a history of migraine headache with or without aura greater than 1 year. • Patient has a clinical diagnosis of stable coronary artery disease (CAD) for greater than or equal to 3 months prior to Visit 1 (screening). • 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.
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E.4 | Principal exclusion criteria |
• Patient is pregnant, or breast-feeding, or is a female expecting to conceive within the projected duration of the study. • Patient’s ECG is difficult to interpret. • Patient has, within 3 months of screening a class III or IV congestive heart failure, ejection fraction <40%, unstable angina, MI, TIA, any coronary or non-coronary revascularization procedure. • Patient has uncontrolled hypertension (high blood pressure), uncontrolled diabetes, HIV disease, or other significant disease, atrial fibrillation, clinically significant ventricular arrhythmia or any implanted electrical device. • Patient exhibits bradycardia or heart rate extremes that preclude the patient’s safety. • 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy endpoint is pain freedom at 2 hours postdose to treat the first attack in the first period, with pain freedom defined in this study as a reduction in migraine headache severity to Grade 0.
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, (5) the proportion of patients who have at least one of the following AEs - an ALT and/or AST greater than or equal to 3 times the upper limit of normal.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | Information not present in EudraCT |
E.8.5.1 | Number of sites anticipated in the EEA | 8 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last visit of last patient |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 11 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 11 |