Estudio aleatorizado, doble ciego, controlado con placebo y tratamiento comparador activo, y de cinco grupos paralelos, para investigar la eficacia y seguridad de BI 44370 TA (50 mg, 200 mg y 400 mg) administrado por vía oral una vez durante una crisis aguda de migraña de intensidad moderada o fuerteA randomised, double-blind, placebo- and active comparator-controlled, five parallel groups study to investigate the efficacy and safety of BI 44370 TA (50 mg, 200 mg, and 400 mg) administered orally once during an acute migraine attack of moderate or severe intensity
- Conditions
- crisis migrañosa con o sin auramigraine headache with and without auraMedDRA version: 9.1Level: LLTClassification code 10027602Term: Migraine headache
- Registration Number
- EUCTR2008-000079-31-ES
- Lead Sponsor
- Boehringer Ingelheim España, S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 410
- Adult male and female migraine patients (age more than 18 and less than 65 years) with or without aura.
- Established migraine diagnosis for equal or more than 1 year.
- Age at migraine onset equal or less than 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
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 equal or less than 10 half-lives, but never less than 1 month. Concurrent participation in another investigational protocol
16. Prior exposure to BI 44370.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method