Relative Bioavailability of a Single Dose of BI 44370 Tablet During and Between Migraine Attacks

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The general aim is to evaluate the relative oral bioavailability of BI 44370 TA tablets during and between migraine attacks as well as Safety, Tolerability and Pharmacokinetic

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim

Criteria

Inclusion Criteria:

• Adult male and female migraine patients (age 18 to 65 years) with or without aura, diagnosed according to IHS criteria.

• Established migraine diagnosis for >= 1 year.

• Age at migraine onset <= 50 years.

• Well documented (for >= 3 months) retrospective history of migraine with headache of moderate to severe intensity and with an attack duration of at least 6 hours and migraine frequency of 2-8 times / 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.

• Patient has provided written informed consent in accordance with ICH-GCP and local legislation.

• Patient is in general good health based om screening assessment

Exclusion Criteria:

• Women of child-bearing potential without an adequate method of contraception

• Any woman of child-bearing potential not having a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline

• Breastfeeding women

• Males not willing to use adequate contraception (condom use plus another form of contraception e.g. spermicide, oral contraceptive taken by female partner, sterilization, IUD [intrauterine device]) during the whole study period from the time of the first intake of study drug until three months after the last intake.

• History of hemiplegic, ophthalmoplegic, or basilar migraine or cluster headache.

• History of treatment resistant migraine attacks, defined as a lack of response to a range of commonly used acute anti-migraine compounds.

• History of , clinical evidence for, or screening/baseline findings suggestive of significant medical disorders (e.g. cardiovascular, peripheral vascular, hepatic, respiratory, haematological, renal, gastrointestinal, immunological, metabolic, hormonal, neurological or psychiatric disorders)

• Smokers ... (cont.)