NCT00743015

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

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 28, 2008

Completed
4 days until next milestone

Study Start

First participant enrolled

September 1, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Last Updated

November 1, 2013

Status Verified

October 1, 2013

Enrollment Period

6 months

First QC Date

August 27, 2008

Last Update Submit

October 31, 2013

Conditions

Migraine Disorders

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (17)

  • 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

  • %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

  • t1/2 (terminal half-life of BI 44370 BS in plasma)

    48 hours

  • +12 more secondary outcomes

Interventions

BI 44370 TA tabletDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

1246.21.32001 Boehringer Ingelheim Investigational Site

Leuven, Belgium

Location

1246.21.49001 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 27, 2008

First Posted

August 28, 2008

Study Start

September 1, 2008

Primary Completion

March 1, 2009

Last Updated

November 1, 2013

Record last verified: 2013-10

Locations

BE(1)DE(1)