Status:
COMPLETED
BI 44370 TA in Acute Migraine Attack
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Migraine Disorders
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The objective of this trial is to assess the safety, tolerability, and efficacy of three doses of BI 44370 TA in the treatment of patients with an acute migraine attack and headache pain of moderate o...
Eligibility Criteria
Inclusion
- Adult migraine patients with or without aura, diagnosed according to the ICH.
- Established migraine diagnosis greater than or equal to 1 year.
- Age at first migraine onset latest at 50 years of age.
- Medical history of migraine with headache of moderate to severe intensity and migraine frequency of 2-8 times/ month.
- Patient has provided written informed consent in accordance with ICH-GCP and local legislation.
Exclusion
- History of hemiplegic, ophthalmoplegic or basilar migraine, or cluster headache.
- History of treatment-resistant migraine attacks.
- Other pain syndromes possibly interfering with study assessment or use of any pain medication \> 10 days / month.
- Use of migraine and other restricted medication, or other restrictions as per protocol.
- Pregnancy or breast-feeding. Female of childbearing potential who do not use contraception.
- Clinically significant cardiovascular, peripheral vascular, hepatic, respiratory, haematological, gastrointestinal, renal, metabolic, immunological, hormonal, neurological and psychiatric disorders.
- Patients in whom unrecognised coronary artery disease is likely, or who are at risk of coronary artery disease indicated by the presence of risk factors.
- Persistent liver enzyme elevation such as ALT, AST or AP \> 2x ULN.
- Known history of HIV, or history of cancer within the last 5 years.
- DSM-IV-defined-history of substance abuse or dependence within the past 6 months, excluding nicotine and caffeine, but including alcohol or benzodiazepines.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
416 Patients enrolled
Trial Details
Trial ID
NCT00751803
Start Date
August 1 2008
Last Update
November 24 2014
Active Locations (52)
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1
1246.4.32004 Boehringer Ingelheim Investigational Site
Antwerp, Belgium
2
1246.4.32005 Boehringer Ingelheim Investigational Site
Brussels, Belgium
3
1246.4.32006 Boehringer Ingelheim Investigational Site
Charleroi, Belgium
4
1246.4.32001 Boehringer Ingelheim Investigational Site
Ghent, Belgium