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Migraine DisordersPhase 1NCT00743015

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

A Phase 1 study testing BI 44370 TA tablet in people with Migraine Disorders, run by Boehringer Ingelheim at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Migraine Disorders
What is being tested?
BI 44370 TA tablet
Type of treatment
Pill or oral medicine
How many people
19 participants
Where
2 sitesin 2 countries
Study dates
Sep 2008to Mar 2009
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.)

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Belgium1 site

  • 1246.21.32001 Boehringer Ingelheim Investigational Site

    Leuven

Other trials in Belgium

Germany1 site

  • 1246.21.49001 Boehringer Ingelheim Investigational Site

    Berlin

Other trials in Germany

About this study

Official title: Relative Bioavailability Following Single Oral Administration of 200 mg 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

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

Being tested
BI 44370 TA tablet
Medical subject headings
Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BI 44370 TA tabletDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cmax (maximum concentration of BI 44370 BS in plasma)

    Measured: 48 hours

  2. 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)

    Measured: 48 hours

  3. AUC0-∞ (area under the concentration-time curve of BI 44370 BS in plasma over the time interval from 0 extrapolated to infinity)

    Measured: 48 hours

  4. tmax (time from dosing to maximum measured concentration)

    Measured: 48 hours

Secondary outcomes (17)

  1. 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)

    Measured: 48 hours

  2. %AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation)

    Measured: 48 hours

  3. AUCt1-t2 (Area under the concentration-time curve of BI 44370 BS in plasma over the time interval t1 to t2)

    Measured: 48 hours

  4. λz (terminal rate constant in plasma)

    Measured: 48 hours

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

    Measured: 48 hours

  6. MRTp.o. (mean residence time of BI 44370 BS in the body after p.o. administration)

    Measured: 48 hours

  7. CL/F (Apparent clearance of BI 44370 BS in plasma after extravascular administration)

    Measured: 48 hours

  8. Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)

    Measured: 48 hours

  9. Ae0-12 (amount of BI 44370 BS eliminated in urine from time point 0 - 12 h after drug administration)

    Measured: 48 hours

  10. fe0-12 (fraction of BI 44370 BS eliminated in urine from time point 0 - 12 h after drug administration)

    Measured: 48 hours

  11. CLR,0-12 (renal clearance of BI 44370 BS from time point 0 - 12 h after drug administration)

    Measured: 48 hours

  12. Changes from baseline in Physical examination

    Measured: 48 hours

  13. Changes from baseline in Vital signs: Blood pressure (BP) and pulse rate (PR)

    Measured: 48 hours

  14. Changes from baseline in 12-lead electrocardiogram (ECG)

    Measured: 48 hours

  15. Occurrence of Adverse events (AEs)

    Measured: 48 hours

  16. Assessment of tolerability by investigator

    Measured: 48 hours

  17. Number of participants with abnormalities in clinical laboratory parameters

    Measured: 48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2008 (estimated)
  2. Study startSep 2008
  3. Primary completionMar 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Intervention model
Crossover
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00743015
Sponsor's protocol ID
1246.21
Other IDs
EudraCT 2008-001356-42
Status last verified
Oct 2013
First submitted
27 Aug 2008
Last updated
1 Nov 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BI 44370 TA tablet in people with Migraine Disorders, run by Boehringer Ingelheim at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Belgium, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cmax (maximum concentration of BI 44370 BS in plasma) (time frame: 48 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00743015.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2013.

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