E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patient has greater than a 1 year history of migraine with or without aura. |
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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 | 10009236 |
E.1.2 | Term | Classical 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 |
1. To assess dose response of 2-hour pain freedom (PF) post dose across a range of MK-3207 doses. 2. To assess the effectiveness of MK-3207 in the treatment of acute migraine as measured by 2-hour PF post dose. 3. To evaluate the safety and tolerability of various doses of MK-3207 in the treatment of acute migraine. |
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E.2.2 | Secondary objectives of the trial |
To assess the effectiveness of MK-3207 in the treatment of acute migraine as measured by pain relief at 2 hours post dose. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patient is ≥ 18 and ≤ 65 years of age at screening (Visit 1). 2. Patient has greater than a 1 year history of migraine with or without aura as defined by IHS criteria 1.1 and/or 1.2 whose migraines typically last between 4 to 72 hours, if untreated (Refer to Appendix 6.1 and ICHD II Attachment for IHS migraine definitions). 3. Patient has had ≥ 2 and ≤ 8 moderate or severe migraine attacks per month in the 2 months prior to screening (Visit 1). 4. Patient is either a male or:a. a female of reproductive potential and agrees to maintain true abstinence* or use (or have their partner use) two of the listed highly effective methods of birth control within the projected duration of the study: hormonal contraceptives, intrauterine device (IUD), condoms, diaphragm, vasectomy. The use of barrier contraceptive (condom or diaphragm) should always be supplemented with the use of a spermicide. Complete details regarding contraceptive requirements are specified in Section 3.2.2.3. OR b. a female who is not of reproductive potential defined as: one who has either (1) reached natural menopause (defined as at least 46 years old with (a) 12 months spontaneous amenorrhea or (b) 6 months of spontaneous amenorrhea with serum FSH levels in the postmenopausal range as determined by the central laboratory), (2) 6 weeks post surgical bilateral oophorectomy, (3) hysterectomy, or (4) bilateral tubal ligation. * If abstinence is not a locally acceptable method of contraception, then two highly effective birth control methods must be used. Patients taking hormonal contraceptives may continue use during the trial, but must use 2 additional forms of non-hormonal contraception throughout the study period until data regarding potential interaction of MK-3207 with oral contraceptives are available. Patients who have been using hormonal contraceptives for at least 2 months prior to the trial must agree to use 2 additional forms of non-hormonal contraception from the time of signing informed consent up to 2 weeks post treatment. 5. Patient understands the study procedures, alternative treatments available, and risks involved with the study and voluntarily agrees to participate in the study by giving written informed consent. 6. Patient is able to read, understand and complete the study questionnaires, paper diary, and access the Interactive Voice Response System (IVRS) diary. |
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E.4 | Principal exclusion criteria |
1. Patient is pregnant (positive serum β-hCG test at pre-study) or breast-feeding, or is a female expecting to conceive within the projected duration of the study. 2. Patient has difficulty distinguishing his/her migraine attacks from tension-type headaches. 3. Patient has a history of predominantly mild migraine attacks or migraines that usually resolve spontaneously in less than 2 hours. 4. 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 (Visit 1). 5. Patient has basilar-type or hemiplegic migraine headache. 6. Patient was > 50 years old at age of migraine onset. 7. Patient is taking migraine prophylactic medication where the prescribed daily dose has changed during the 3 months prior to screening (Visit 1). 8. Patient is taking a proton pump inhibitor (PPI) or a H2 blocker on a daily or near daily basis (> 3 days per week). 9. Patient has taken any of the following medications in the time frame specified |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy endpoint is the proportion of patients reporting pain freedom from headache (Grade 0) at 2 hours after treatment. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 48 |
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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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 | 4 |
E.8.9.1 | In the Member State concerned days | |
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 | 4 |