E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Treatment of Acute Migraine when pain severity is mild. |
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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 rizatriptan ODT/oral lyophilisate compared to placebo in the early treatment (while headache is mild) of acute migraine, as measured by pain freedom at 2 hours post-dose |
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E.2.2 | Secondary objectives of the trial |
(1) To evaluate the efficacy of rizatriptan ODT/oral lyophilisate compared to placebo in the early treatment (while headache is mild) of acute migraine, as measured: (a) by associated symptoms (phonophobia, photophobia, nausea & vomiting), functional disability and rescue medication use; (b) pain freedom at 30, 60 and 90 minutes post-dose; (c) 24-hours sustained pain freedom. (2) To assess the level of patient satisfaction with study medication; and, (3) to evaluate the tolerability of rizatriptan ODT/oral lyophilisate. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male or female at least 18 years of age 2. At least a 1 year history of migraine with or without aura 3. A natural history that is typically mild at onset and progresses to moderate or severe 4. Typically, when the patient knows they are having a migraine, their headache pain is mild 5. Migraine frequency that is typically 1 to 4 attacks per month in the 2 months prior to Visit 1 6. Female patients of reproductive potential must agree to use acceptable method of birth control. 7. Understands study procedures, alternative treatments available and risks involved and voluntarily agrees to participate in the study. 8. Able to read, understand and complete questionnaires and diaries.
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E.4 | Principal exclusion criteria |
1. History of chronic-type tension headache 2. Difficulty in distinguishing migraine attacks from episodic tension type headaches 3. 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 Visit 1. 4. History of basilar or hemiplegic migraine 5. Use of monoamine oxidase inhibitors or propranolol within 1 months of Visit 1 6. Daily or near daily use of analgesics (> 3 days out of 7 days) 7. Prescribed daily dose of migraine prophylactic medication or SSRI/SNRI has changed within the 3 months prior to Visit 1 8. History or clinical evidence of stroke or transient ischemic attack, ischemic heart disease (angina pectoris, myocardial infarction or documented silent ischemia) or coronary artery vasospasm or peripheral vascular disease. 9. Uncontrolled hypertension, severe hepatic or renal insufficiency or any other history or concurrent condition, therapy, lab abnormality that might confound results or interfere with patient's participation in the study, such that it is not in the best interest of the patient to participate. 10. Hypersensitivity to rizatriptan or any of its inactive ingredients 11. Participation in a study with an investigational drug or device within 30 days of Visit 1.
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E.5 End points |
E.5.1 | Primary end point(s) |
Pain freedom at 2 hours post-dose |
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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 | 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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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 | Yes |
E.8.1.7.1 | Other trial design description |
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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 | No |
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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End of trial is the last follow-up telephone contact for the last patient in the study or the last patient visit for the last patient which ever is the latest date. |
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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 | 6 |
E.8.9.1 | In the Member State concerned days | 5 |
E.8.9.2 | In all countries concerned by the trial months | 7 |
E.8.9.2 | In all countries concerned by the trial days | 19 |