E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
migraine headache with or without aura |
|
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 |
|
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 migrain attack of moderate or severe intensity |
|
E.2.2 | Secondary objectives of the trial |
Assess the safety, tolerability, and efficacy of three doses of BI 44370 TA (50 mg, 200 mg, and 400 mg) for treatment of an acute migraine attack of moderate or severe intensity compared to placebo and an active comparator (eletriptan 40 mg). |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1-Adult male and female migraine patients (age >=18 and <=65 years) with or without aura, diagnosed according to the International Classification of Headache Disorders 2nd Edition. 2-Established migraine diagnosis for >= 1 year. 3-Age at first migraine onset <= 50 years. 4-Medical history of migraine with headache of moderate to severe intensity, with an attack duration of at least 6 hours and migraine frequency of 2-8 times/ month, documented for the preceding 3 months (up to 12 days with migraine/ month). 5-Other forms of headache are permitted if they on average occur up to 10 days/ month and if the patient is able to differentiate migraine headache from other forms of headache. 6-Patients in general good health based on screening assessment. 7-Patient has provided written informed consent in accordance with ICH-GCP and local legislation. |
|
E.4 | Principal exclusion criteria |
EX 1: History of hemiplegic, ophthalmoplegic or basilar migraine, or cluster headache. EX 2: History of treatment-resistant migraine attacks, defined as a lack of response to a range of commonly-used acute anti-migraine compounds, according to the investigators judgement. EX 3: Other pain syndromes possibly interfering with study assessment or use of any pain medication > 10 days / month. EX 4: Use of migraine and other restricted medication listed in Appendix 10.2 EX 5: Pregnancy (to be excluded by serum pregnancy test at screening visit and urine pregnancy test at baseline) or breast-feeding. Female of childbearing potential (less than 2 years post-menopausal and not surgically sterilised including hysterectomy and bilateral ovarectomy) who do not use at the time of entry to the study, throughout the study and at least 1 month after the end of the study highly effective medically approved method of contraception according to the ICH- Note for Guidance (CPMP/ICH/286/95) such as: hormonal therapy (combined oral contraceptives,injectables, or subcutaneous implants) or hormonal intrauterine devices; or alternatively, her partner has undergone vasectomy. EX 6: Men not willing to use adequate contraception (using a condom plus another form of contraception such as spermicide, or after sterilisation; female partner using oral contraceptive, intrauterine device or after having undergone sterilisation) from the time of the first intake of study drug until 3 months after the last intake. EX 7: In the judgement of the investigator, 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. EX 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 (e.g. hypertension, hypercholesterolaemia, smoker, obesity, diabetes, strong family history of coronary artery disease, female with surgical or physiological menopause, or male over 40 years of age). EX 9: Persistent liver enzyme elevation such as ALT, AST or AP > 2x ULN. EX 10: Known history of HIV, or history of cancer within the last 5 years. EX 11: DSM-IV-defined-history of substance abuse or dependence within the past 6 months, excluding nicotine and caffeine, but including alcohol or benzodiazepines. EX 12: Any other past or present medical conditions that would have kept administration of study medication from being in the patients best interest, in the judgement of the clinical investigator. EX 13: History of relevant allergy and/or hypersensitivity (food or drug including eletriptan or any of its ingredients, or ingredients of BI 44370 TA), including conditions of lactose, glucose or galactose intolerance and malabsorption. EX 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 investigators discretion, or patients with legally-appointed custodian. EX 15: Use of another investigational drug within a time span of <=10 half-lives, but never less than 1 month prior to randomisation. Concurrent participation in another investigational protocol. EX 16: Prior exposure to BI 44370. |
|
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 |
|
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) | 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 | Yes |
E.8.2.3.1 | Comparator description |
il braccio 5 (eletriptan) per analisi descrittive |
|
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 | 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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 9 |