migraine headache with and without aura MedDRA version: 9.1 Level: LLT Classification code 10027602 Term: Migraine headache
Conditions
Interventions
Product Code: BI 44370
Pharmaceutical Form: Tablet
Current Sponsor code: BI 44370 TA
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the
Sponsors
Boehringer Ingelheim Pharma GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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. 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. 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. 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 =10 half-lives, but in no case less than 1 month prior to randomisation. Concurrent participation in another investigational protocol 16. Prior exposure to BI 44370.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: 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).;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. | — |
Countries
Belgium, France, Germany, Italy, Netherlands, Spain, Sweden, United Kingdom
Outcome results
None listed