Migraine Disorders
Conditions
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
Interventions
Sponsors
Boehringer Ingelheim
Study design
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax (maximum concentration of BI 44370 BS in plasma) | 48 hours |
| AUC0-2 (area under the concentration-time curve of BI 44370 BS in plasma over the time interval from 0 to 2 h after drug administration) | 48 hours |
| AUC0-∞ (area under the concentration-time curve of BI 44370 BS in plasma over the time interval from 0 extrapolated to infinity) | 48 hours |
| tmax (time from dosing to maximum measured concentration) | 48 hours |
Secondary
| Measure | Time frame |
|---|---|
| t1/2 (terminal half-life of BI 44370 BS in plasma) | 48 hours |
| MRTp.o. (mean residence time of BI 44370 BS in the body after p.o. administration) | 48 hours |
| CL/F (Apparent clearance of BI 44370 BS in plasma after extravascular administration) | 48 hours |
| Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose) | 48 hours |
| Ae0-12 (amount of BI 44370 BS eliminated in urine from time point 0 - 12 h after drug administration) | 48 hours |
| fe0-12 (fraction of BI 44370 BS eliminated in urine from time point 0 - 12 h after drug administration) | 48 hours |
| AUC0-tz (area under the concentration-time curve of BI 44370 BS in plasma over the time interval from 0 to the time of the last quantifiable data point) | 48 hours |
| Changes from baseline in Physical examination | 48 hours |
| Changes from baseline in Vital signs: Blood pressure (BP) and pulse rate (PR) | 48 hours |
| Changes from baseline in 12-lead electrocardiogram (ECG) | 48 hours |
| Occurrence of Adverse events (AEs) | 48 hours |
| Assessment of tolerability by investigator | 48 hours |
| Number of participants with abnormalities in clinical laboratory parameters | 48 hours |
| CLR,0-12 (renal clearance of BI 44370 BS from time point 0 - 12 h after drug administration) | 48 hours |
| %AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation) | 48 hours |
| AUCt1-t2 (Area under the concentration-time curve of BI 44370 BS in plasma over the time interval t1 to t2) | 48 hours |
| λz (terminal rate constant in plasma) | 48 hours |
Countries
Belgium, Germany
Outcome results
None listed