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 | 7.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10027599 |
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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 |
The primary study objective is to demonstrate tolerability and efficacy of CAP3 in the treatment of acute migraine of mild, moderate or severe intensity.
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E.2.2 | Secondary objectives of the trial |
1. Pain-free status at 15, 30, 45, 60 minutes and 4 and 24 hours post first dose administration, 2. Sustained pain-free response between 2 and 24 hours (freedom of pain at 2 hrs with no rescue medication and with no headache recurrence within 24 hrs), 3. Pain relief at 2 hrs (defined as a decrease in headache pain intensity from severe or moderate headache pain at baseline to mild or no pain at 2 hrs), (only for moderate/ severe at entry), 4. Early treatment pain improvement at 2 hours (defined as decrease in headache pain intensity from severe or moderate to mild or no pain or decrease from mild to no pain at 2 hours) for all migraines treated within 2 hours of onset. 5. Relief of associated symptoms such as nausea, and photophobia and phonophobia at 2 hours, 6. Safety and tolerability of study drug, 7. Subject treatment satisfaction, 8. Use of rescue medication, 9. Functional disability. 10. Consistency of response in at least 2 of 3 attacks.
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Subject has a minimum 12-month migraine history that the investigator determines meets the IHS Migraine Diagnostic Criteria for migraine with or without aura. 2. Subject is between 18-65 years of age. 3. Subject experiences an average of 2-6 migraines per month. 4. If on preventive migraine therapy, medication regimen has been stable for 3 months and will remain stable for the duration of participation. 5. Subject is able to communicate adequately and comply with the requirements of the study as determined by the investigator. 6. Subject is able to read and understand the informed consent and voluntarily agrees to sign the informed consent form
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E.4 | Principal exclusion criteria |
1. Subject’s age of migraine onset is greater than 50 years. 2. Subject has more than 10 non-migraine headache days per month. 3. Subject has less than 48 hours of freedom from headache between attacks of migraine. 4. Subject is pregnant or lactating. 5. Subject has history of alcohol or drug abuse within the past 2 years. 6. Subject has existing serious medical condition (i.e., severe emphysema) that precludes participation. 7. Subject participating in another clinical trial during or within 30 days prior to study enrolment. 8. Subject has participated in more than 2 acute migraine attack studies in the 2 years prior to study enrollment.
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E.5 End points |
E.5.1 | Primary end point(s) |
There are two primary endpoints: · Percentage of migraine attacks who reached the status of pain-free at 2 hours post first administration of CAP3 for all migraine attacks · Percentage of patients who are pain-free at 2 hours post first administration of CAP3 after the first migraine attack
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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 | Yes |
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 | Information not present in EudraCT |
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.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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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The study will be completed when the last enrolled subject completes the study, approximately 9 months after the enrollment of the first subject. |
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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 | 9 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 9 |