E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
migraine headache with and 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 | 10027602 |
E.1.2 | Term | Migraine headache |
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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 objective is to achieve a pain free response, defined as reduction of severe or moderate headache to no headache, 2 hours after dosing with BI 44370 TA in comparison with placebo, in patients with an acute migraine attack of moderate or severe intensity. |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives are to assess the safety, tolerability, and efficacy of three doses of BI 44370 TA (50 mg, 200 mg, and 400 mg) in treatment of an acute migraine attack of moderate or severe intensity compared to placebo and to an active comparator (eletriptan 40 mg). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Adult male and female migraine patients (age more than 18 and less than 65 years) with or without aura. - Established migraine diagnosis for ≥ 1 year. - Age at migraine onset ≤ 50 years. - Well documented history of migraine with headache of moderate to severe intensity, with attack duration of at least 6 hours and migraine frequency of 2-8 times / month, during preceding 3 months (but not more than 12 days with migraine / month). - Other forms of headache are permitted if they on average occur on not more than 10 days / month and if the patient is able to differentiate migraine headache from other forms of headache. - Patients in general good health based on screening assessment. - Patient has provided written informed consent in accordance with ICH-GCP and local legislation.
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E.4 | Principal exclusion criteria |
1. History of hemiplegic, ophthalmoplegic or basilar migraine, or cluster headache 2. History of treatment resistant migraine attacks 3. Other pain syndromes possibly interfering with study assessment or use of any pain medication > 10 days / month 4. Use of migraine and other restricted medication listed in Appendix 10.2 5. Females nursing or pregnant or of childbearing potential 6. Men not willing to use adequate contraception (or his partner) 7. History of, clinical evidence for, or screening/baseline findings suggestive of clinically significant cardiovascular, peripheral vascular, hepatic, respiratory, haematological, gastrointestinal, renal, metabolic, immunological, hormonal, neurological and psychiatric disorders. 8. Unless ruled out by cardiovascular evaluation, patients in whom unrecognised coronary artery disease is likely, or who are at risk of coronary artery disease indicated by the presence of risk factors. 9. Persistent liver enzyme elevation such as ALT, AST or AP > 2x ULN. 10. Known history of HIV, or history of cancer within the last 5 years 11. DSM-IV-defined-history of substance abuse or dependence within the past 6 months, excluding nicotine and caffeine, but including alcohol or benzodiazepines 12. Any other past or present medical conditions that would have kept administration of study medication from being in the patient’s best interest, in the judgement of the clinical investigator 13. History of relevant allergy and/or hypersensitivity (to food or drugs, including eletriptan or any of its ingredients, or ingredients of BI 44370 TA), including disorders of lactose, glucose or galactose intolerance and malabsorption 14. Unwillingness or inability to comply with the protocol (e.g. patient not able to read or write, or fails to learn how to use the diary). Patients who are unable to give informed consent, at investigator’s discretion, or patients with legally-appointed custodian. 15. Use of another investigational drug within a time span of its ≤10 half-lives, but never less than 1 month. Concurrent participation in another investigational protocol 16. Prior exposure to BI 44370. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is a pain free response, defined as reduction of severe or moderate headache to no headache, 2 hours after dosing. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | Information not present in EudraCT |
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) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.3 |
The trial involves single site in the Member State concerned
| Information not present in EudraCT |
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 | 53 |
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 | 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 | |
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 |