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Relative Bioavailibility of a Single Dose of BI 44370 Tablet During and Between Migraine Attacks
This study is currently recruiting participants.
Verified by Boehringer Ingelheim Pharmaceuticals, December 2008
Sponsored by: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00743015
  Purpose

The general aim of the present study is to obtain information about the relative oral bioavailability of a single dose of BI 44370 TA tablets during and between migraine attacks in male and female migraine patients.


Condition Intervention Phase
Migraine Disorders
Drug: BI 44370 TA tablet
Phase I

Genetics Home Reference related topics: familial hemiplegic migraine
MedlinePlus related topics: Migraine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Crossover Assignment, Bio-availability Study
Official Title: Relative Bioavailability Following Single Oral Administration of BI 44370 During and Between Migraine Attacks in Male and Female Migraine Patients. An Open-Label, Fixed-Sequence, Two Period Study With Intraindividual Comparison.

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • Pharmakokinetics will be assessed in a descriptive way based on Cmax, AUC (0 to 2), AUC (0 to infinite) and tmax during and between migraine attacks. [ Time Frame: 48 hours ]

Secondary Outcome Measures:
  • additional pharmacokinetic parameters, if feasible: AUC (0 to tz; tz to infinite; t1 to t2), terminal half life, lambda z, MRT p.o., CL, Vz, Ae (0 to 12), fe (0 to 12) [ Time Frame: 48 hours ]

Estimated Enrollment: 16
Study Start Date: August 2008
Estimated Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 (condome use plus another form of contraception e.g. spermicide, oral contraceptive taken by female partner, sterilisation, 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.)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00743015

Contacts
Contact: Boehringer Ingelheim Study Coordinator 800-542-6257 ext Option 4 clintriage.rdg@boehringer-ingelheim.com

Locations
Belgium
1246.21.32001 Boehringer Ingelheim Investigational Site Recruiting
Leuven, Belgium
Germany
1246.21.49001 Boehringer Ingelheim Investigational Site Recruiting
Berlin, Germany
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

Responsible Party: Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers: 1246.21, EudraCT 2008-001356-42
Study First Received: August 27, 2008
Last Updated: December 10, 2008
ClinicalTrials.gov Identifier: NCT00743015  
Health Authority: Belgium: Federal Agency for Medicines and Health Products;   Germany: BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)

Study placed in the following topic categories:
Migraine Disorders
Headache
Central Nervous System Diseases
Headache Disorders, Primary
Brain Diseases
Headache Disorders

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009