E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Acute treatment of the headache phase of migraine attacks with or without aura |
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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 |
To evaluate the efficacy of Almotriptan in patients with a history of migraine headache pain reaching at least a moderate intensity when treatment is administered while headache pain is still mild (and during the first hour of pain onset) and when treatment is administered while migraine pain has become moderate or severe. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Subjects must have a history of a confirmed diagnosis of migraine that meets the IHS diagnosis criteria for the classification of migraine with or without aura for at least one year. 2. Patients with a history of migraine headaches progressing from mild to at least moderate pain intensity on a scale of no pain (0), mild (1), moderate (2), or severe (3) within the past year. 3. Patients must have a migraine headache frequency of 2 to 6 per month for the past 3 months. 4. Patients must have had a history of duration of untreated or unsuccessfully treated migraine headache of 4 hours or longer in the past. 5. Patients must be male or female aged 18 to 65 years. |
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E.4 | Principal exclusion criteria |
1. Patients, who in the opinion of the investigator, should not be enrolled in the trial because of the precautions, warnings or contraindications sections of the almotriptan Summary of Product Characteristics (see Appendix 3 of the protocol). 2. Patients who have had 15 or more headache days per month in the previous 6 months (chronic daily headache), or patients having a migraine headache frequency of more than 6 per month for the past 3 months. 3. Patients with onset of migraine after age 50. 4. Patients who routinely experience any other type of headache that would confound discrimination from a migraine headache (e.g., headaches related to allergies, food, alcohol, and/or medications, sinus headaches, withdrawal headaches related to changes in the normal intake of substances such as caffeine or nicotine, rebound headaches due to overuse of certain headache medications), or tension-type headache for more than four days per month for the past 3 months. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Number and percentage of patients being pain free at 2 hours after IMP administration. |
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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) | 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 | 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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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 | 10 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 10 |