E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
a. To evaluate the efficacy and safety of MK-0974 compared to placebo in the treatment of acute migraine. b. To evaluate the safety and the consistency of efficacy of MK-0974 across multiple migraine attacks.
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E.2.2 | Secondary objectives of the trial |
a. To evaluate the efficacy of MK-0974 (280 mg and 140 mg) compared to placebo in the treatment of acute migraine, as measured using sustained pain freedom from 2-24 hours and 2-48 hours post-dose and total migraine freedom at 2 hours and from 2-24 hours postdose (first attack only) |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
a. Patient has had a history of migraine with or without aura > 1 year with ≥ 1 and ≤ 8 moderate or severe migraine attacks per month in the 2 months prior to screening that typically last between 4 to 72 hours untreated (see Appendix 6.1 and ICHD II Attachment for IHS migraine definitions). b. Women and men of childbearing potential must use acceptable contraception throughout the trial. |
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E.4 | Principal exclusion criteria |
a. Patient has a history of predominantly mild migraine attacks or migraines that usually resolve spontaneously in less than 2 hours. b. Patient has basilar or hemiplegic migraine headache. c. Patient has more than 15 headache-days per month or has taken medication for acute headache on more than 10 days per month in any of the 3 months prior to screening. d. Patient is taking migraine prophylactic medication where the prescribed daily dose has changed during the 3 months prior to screening. e. Patient was > 50 years old at age of migraine onset. f. Patient has clinical, laboratory, or ECG evidence of uncontrolled hypertension (defined as SBP of ≥150 mm Hg and/or DBP of ≥95 mm Hg), uncontrolled diabetes, HIV disease, or significant pulmonary, renal, hepatic, endocrine, or other systemic disease in the opinion of the investigator. g. Patient has myocardial infarction, unstable angina, coronary artery bypass surgery, or other revascularization procedure, stroke, or transient ischemic attack within 3 months of screening. h. Patient has taken any of the following medications in 1 mo. prior to screening and throughout the study period:
-Potent CYP3A4 inhibitors, including but not limited to: (e.g. cyclosporine, systemic (oral/IV) itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, nefazodone, HIV protease inhibitors) -Potent CYP3A4 inducers, including but not limited to: rifampicin, rifabutin, carbamazepine, phenytoin, barbiturates, systemic glucocorticoids (replacements and inhaled are permitted), nevirapine, efavirenz, pioglitazone, primidone, St. Johns wort -Specific CYP3A4 substrates: cisapride, pimozide, astemizole, terfenadine. Concomitant use of other CYP3A4 substrates is permitted, however, these medications should be administered with appropriate caution due to the potential for drug-drug interaction (e.g., theophylline, ergot derivatives)
i. Patient has previously treated with study medication in a MK-0974 study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary Efficacy Endpoints a. Pain Freedom (PF) at 2 hours post-dose, with pain freedom defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 0. b. Pain Relief (PR) at 2 hours post-dose, with pain relief defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 1/0. c. Pain Freedom Consistency (PFC) at 2 hours post-dose, defined as having achieved PF at 2 hours post-dose on at least 3 treated attacks. Note that for the control groups, a positive PF response arising from the administration of the one MK-0974 treated attack will count as one of the 3 positive PF responses needed to fulfill the criteria for PFC. d. Pain Relief Consistency (PRC) at 2 hours post-dose, defined as having achieved PR at 2 hours post-dose on at least 3 treated attacks. Note that for the control groups, a positive PR response arising from the administration of the one MK-0974 treated attack will count as one of the 3 positive PR responses needed to fulfill the criteria for PRC. e. Absence of Photophobia at 2 hours post-dose.
f. Absence of Phonophobia at 2 hours post-dose.
g. Absence of Nausea at 2 hours post-dose.
Primary Safety Endpoints
a. Safety and tolerability will be assessed by review of all safety parameters, including adverse experiences, laboratory values, ECGs, and vital signs.
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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 | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
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 | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 85 |
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 | No |
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 | 0 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 8 |
E.8.9.2 | In all countries concerned by the trial days | 0 |