BI 44370 TA in Acute Migraine Attack
- Conditions
- Migraine Disorders
- Interventions
- Registration Number
- NCT00751803
- Lead Sponsor
- Boehringer Ingelheim
- 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 or severe intensity, compared to placebo and an active comparator.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 416
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BI 44370 TA Low Dose Placebo - Placebo Placebo - Eletriptan Placebo - BI 44370 TA Medium Dose Placebo - BI 44370 TA High Dose Placebo - BI 44370 TA Low Dose BI 44370 TA Low Dose - BI 44370 TA Medium Dose BI 44370 TA Medium Dose - BI 44370 TA High Dose BI 44370 TA Medium Dose - Eletriptan Eletriptan -
- Primary Outcome Measures
Name Time Method The primary endpoint is a pain free response, defined as reduction of severe or moderate headache to no headache, 2 hours after dosing. 2 hours
- Secondary Outcome Measures
Name Time Method Changes from baseline in safety laboratory parameters up to 7 days Intensity of headache at the time of intake of study medication, and 0.5, 1, 1.5, 2, 24 and 48 hours after dosing up to 48 h Pain relief, defined as reduction of severe or moderate headache to mild or no headache, 0.5, 1, 1.5, 2, 24 and 48 hours after dosing up to 48 h Sustained pain relief response, defined as reduction of severe or moderate headache to mild or no headache 2 hours after dosing and no worsening up to 24 and 48 hours after dosing up to 48 h Relief of associated migraine symptoms (nausea, vomiting, photophobia, phonophobia) 0.5, 1, 1.5, 2, 24 and 48 hours after dosing up to 48 h Pain-free response 0.5, 1, 1.5, 24 and 48 hours after dosing up to 48 h Sustained pain-free response, defined as reduction of severe or moderate headache to no headache 2 hours after dosing and remaining pain-free up to 24 and 48 hours after dosing up to 48 h Global evaluation of medication by the patient evaluated 48 h after study drug intake up to 48 h Time to meaningful relief, defined by the patient as occurring when relief of pain and associated symptoms becomes meaningful, up to 2 h after dosing up to 2 h Incidences of adverse events up to 7 days Time to and use of rescue medication within 24 and 48 hours up to 48 h Changes from baseline in vital sign parameters up to 7 days Withdrawals due to adverse events up to 7 days Functional disability assessed by the patient measured at the time of intake of study medication, and 0.5, 1, 1.5, 2, 24 and 48 hours post dosing up to 48 h Recurrence / relapse of headache during time-intervals of 2-24 and 2-48 hours post dosing up to 48 h
Trial Locations
- Locations (52)
1246.4.3301A Boehringer Ingelheim Investigational Site
🇫🇷Nice Cedex 1, France
1246.4.3305B Boehringer Ingelheim Investigational Site
🇫🇷Paris, France
1246.4.32004 Boehringer Ingelheim Investigational Site
🇧🇪Antwerpen, Belgium
1246.4.32006 Boehringer Ingelheim Investigational Site
🇧🇪Charleroi, Belgium
1246.4.32007 Boehringer Ingelheim Investigational Site
🇧🇪Liege, Belgium
1246.4.34004 Boehringer Ingelheim Investigational Site
🇸🇻Oviedo, El Salvador
1246.4.3307A Boehringer Ingelheim Investigational Site
🇫🇷Clermont Ferrand, France
1246.4.3307B Boehringer Ingelheim Investigational Site
🇫🇷Clermont Ferrand, France
1246.4.3303A Boehringer Ingelheim Investigational Site
🇫🇷Lille cedex, France
1246.4.3301B Boehringer Ingelheim Investigational Site
🇫🇷Nice Cedex 1, France
1246.4.3304A Boehringer Ingelheim Investigational Site
🇫🇷Rouen, France
1246.4.3302A Boehringer Ingelheim Investigational Site
🇫🇷Toulouse cedex 9, France
1246.4.3302B Boehringer Ingelheim Investigational Site
🇫🇷Toulouse cedex 9, France
1246.4.49002 Boehringer Ingelheim Investigational Site
🇩🇪Berlin, Germany
1246.4.49003 Boehringer Ingelheim Investigational Site
🇩🇪Erkelenz, Germany
1246.4.49001 Boehringer Ingelheim Investigational Site
🇩🇪Essen, Germany
1246.4.49006 Boehringer Ingelheim Investigational Site
🇩🇪Goettingen, Germany
1246.4.49004 Boehringer Ingelheim Investigational Site
🇩🇪Grevenbroich, Germany
1246.4.49011 Boehringer Ingelheim Investigational Site
🇩🇪Huettenberg, Germany
1246.4.49007 Boehringer Ingelheim Investigational Site
🇩🇪Koenigstein im Taurus, Germany
1246.4.49010 Boehringer Ingelheim Investigational Site
🇩🇪Muenster, Germany
1246.4.49008 Boehringer Ingelheim Investigational Site
🇩🇪Munich, Germany
1246.4.49009 Boehringer Ingelheim Investigational Site
🇩🇪Munich, Germany
1246.4.39005 Boehringer Ingelheim Investigational Site
🇮🇹Bologna, Italy
1246.4.39006 Boehringer Ingelheim Investigational Site
🇮🇹Catania, Italy
1246.4.39001 Boehringer Ingelheim Investigational Site
🇮🇹Milano, Italy
1246.4.39002 Boehringer Ingelheim Investigational Site
🇮🇹Torino, Italy
1246.4.31004 Boehringer Ingelheim Investigational Site
🇳🇱Amsterdam, Netherlands
1246.4.31001 Boehringer Ingelheim Investigational Site
🇳🇱's-Hertogenbosch, Netherlands
1246.4.31003 Boehringer Ingelheim Investigational Site
🇳🇱Blaricum, Netherlands
1246.4.31002 Boehringer Ingelheim Investigational Site
🇳🇱Breda, Netherlands
1246.4.31006 Boehringer Ingelheim Investigational Site
🇳🇱Zwolle, Netherlands
1246.4.34002 Boehringer Ingelheim Investigational Site
🇪🇸Barcelona, Spain
1246.4.34005 Boehringer Ingelheim Investigational Site
🇪🇸Santiago de Compostela, Spain
1246.4.34001 Boehringer Ingelheim Investigational Site
🇪🇸Valencia, Spain
1246.4.46001 Boehringer Ingelheim Investigational Site
🇸🇪Goteborg, Sweden
1246.4.46004 Boehringer Ingelheim Investigational Site
🇸🇪Linkoping, Sweden
1246.4.46005 Boehringer Ingelheim Investigational Site
🇸🇪Stockholm, Sweden
1246.4.46002 Boehringer Ingelheim Investigational Site
🇸🇪Vallingby, Sweden
1246.4.44013 Boehringer Ingelheim Investigational Site
🇬🇧Liverpool, United Kingdom
1246.4.44001 Boehringer Ingelheim Investigational Site
🇬🇧Oxford, United Kingdom
1246.4.44003 Boehringer Ingelheim Investigational Site
🇬🇧Plymouth, United Kingdom
1246.4.44007 Boehringer Ingelheim Investigational Site
🇬🇧Whitechapel, London, United Kingdom
1246.4.32005 Boehringer Ingelheim Investigational Site
🇧🇪Bruxelles, Belgium
1246.4.32009 Boehringer Ingelheim Investigational Site
🇧🇪Leuven, Belgium
1246.4.32008 Boehringer Ingelheim Investigational Site
🇧🇪Montegnee, Belgium
1246.4.32002 Boehringer Ingelheim Investigational Site
🇧🇪Hasselt, Belgium
1246.4.31005 Boehringer Ingelheim Investigational Site
🇳🇱Nijmegen, Netherlands
1246.4.32001 Boehringer Ingelheim Investigational Site
🇧🇪Gent, Belgium
1246.4.3304B Boehringer Ingelheim Investigational Site
🇫🇷Rouen, France
1246.4.39004 Boehringer Ingelheim Investigational Site
🇮🇹Milano, Italy
1246.4.39003 Boehringer Ingelheim Investigational Site
🇮🇹Roma, Italy