Status:
COMPLETED
Relative Bioavailability of a Single Dose of BI 44370 Tablet During and Between Migraine Attacks
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Migraine Disorders
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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
Eligibility Criteria
Inclusion
- 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
- 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.)
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00743015
Start Date
September 1 2008
Last Update
November 1 2013
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
1246.21.32001 Boehringer Ingelheim Investigational Site
Leuven, Belgium
2
1246.21.49001 Boehringer Ingelheim Investigational Site
Berlin, Germany