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

NCT ID: NCT00743015

Last Updated: 2013-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30

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

Conditions

Migraine Disorders

Study Design

• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT

Interventions

BI 44370 TA tablet

Intervention Type: DRUG

Eligibility 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.)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Boehringer Ingelheim

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

1246.21.32001 Boehringer Ingelheim Investigational Site

Leuven, , Belgium

1246.21.49001 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Countries

Belgium; Germany

Other Identifiers

EudraCT 2008-001356-42

Identifier Type: -

Identifier Source: secondary_id

1246.21

Identifier Type: -

Identifier Source: org_study_id