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 | 10066635 |
E.1.2 | Term | Acute 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 |
To evaluate the efficacy of MK-0462 compared to placebo in the treatment of acute migraine in patients on topiramate for migraine prophylaxis, as measured by the proportion of treated attacks resulting in pain relief (PR) at 2 hours post-dose. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the efficacy of rizatriptan compared to placebo in the treatment of acute migraine in patients on topiramate for migraine prophylaxis as measured by: (1) Sustained pain relief (SPR) from 2-24 hours post dose; (2) pain freedom (PF) at 2 hours post-dose; (3) Functional disability at 2 hours post-dose; (4) Patient satisfaction with treatment at 24 hours post-dose. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Male or female at least 18 years of age. • Patient has a history of migraine with or without aura > 1 year with ≥2 and ≤8 moderate or severe migraine attacks per month in the 3 months prior to screening. • Patient is currently taking topiramate for migraine prophylaxis, at a minimum daily dose of 50 mg and where the prescribed dose has been stable for at least 3 months. • Female patients of reproductive potential must agree to use acceptable method of birth control. • Patient understands study procedures, alternative treatments available, and risks involved with the study, and voluntarily agrees to participate by giving written informed consent. • Patient is able to complete the study questionnaire(s) and paper diaries. |
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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 has a history of predominantly mild migraine attacks or migraines that usually resolve spontaneously in less than 2 hours. • Patient was > 50 years old at age of migraine onset. • Aside from topiramate, patient is taking more than one other medication for migraine prophylaxis. • Patient has a history or clinical evidence of cerebrovascular accident (CVA) or transient ischemic attack (TIA), ischemic heart disease, or other significant underlying cardiovascular disease or peripheral vascular disease. • Patient has uncontrolled hypertension as determined by the investigator. • Patient is taking or has been newly prescribed selective serotonin reuptake inhibitors (SSRI) or serotonin norepinephrine reuptake inhibitors (SNRI) where the prescribed daily dose has changed during the 3 months prior to screening. • Patient is taking other migraine prophylactic medication where the prescribed daily dose has changed during the 3 months prior to screening. • Patient has either demonstrated a hypersensitivity reaction, anaphylaxis or anaphylactoid reaction to or experienced a serious adverse event in response to rizatriptan. • Patient has a history of hypersensitivity to more than two chemical classes of drugs, including prescriptions and over-the-counter medications. • Patient has taken any of the following medications in the time frame specified: (1) Non-steroidal anti-inflammatory drugs (NSAIDS), COX-2 inhibitors, or other analgesics daily or nearly daily (typically >3 days out of 7 days average); (2) Monoamine oxidase inhibitors (MAOIs) or Propranolol within 1 month prior to screening and during the study. (Note: Aspirin ≤ 325 mg daily is allowed for cardioprotection.) • Patient has a history of neoplastic disease ≤5 years. • Patient is legally or mentally incapacitated. • Patient is currently participating or has participated in a study with an investigational compound or device within 30 days of screening. • Patient has a history (within the past 1 year) or current evidence of drug or alcohol abuse or is a 'recreational user' of illicit drugs or prescription medications.
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E.5 End points |
E.5.1 | Primary end point(s) |
Efficacy: 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 Grade1/0. Safety: Safety and tolerability will be assessed by review of all safety parameters, including adverse experiences 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 | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
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 | Yes |
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 | 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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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) | 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
| Yes |
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 | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 5 |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 1 |