BI 44370 TA in Acute Migraine Attack

Condition(s) targeted: Migraine Disorders

Intervention: BI 44370 TA Low Dose (Drug); Eletriptan (Drug); Placebo (Drug); BI 44370 TA Medium Dose (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Boehringer Ingelheim

Official(s) and/or principal investigator(s):
Boehringer Ingelheim, Study Chair, Affiliation: Boehringer Ingelheim

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.

Official title: A Randomised, Double-blind, Placebo- and Active Comparator-controlled, Five Parallel Groups Study to Investigate the Efficacy and Safety of BI 44370 TA (50 mg, 200 mg, and 400 mg) Administered Orally Once During an Acute Migraine Attack of Moderate or Severe Intensity

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Primary outcome: The primary endpoint is a pain free response, defined as reduction of severe or moderate headache to no headache, 2 hours after dosing.

Secondary outcome:

Pain-free response 0.5, 1, 1.5, 24 and 48 hours after dosing

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

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

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

Intensity of headache at the time of intake of study medication, and 0.5, 1, 1.5, 2, 24 and 48 hours after dosing

Relief of associated migraine symptoms (nausea, vomiting, photophobia, phonophobia) 0.5, 1, 1.5, 2, 24 and 48 hours after dosing

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

Global evaluation of medication by the patient evaluated 48 h after study drug intake

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

Time to and use of rescue medication within 24 and 48 hours

Recurrence / relapse of headache during time-intervals of 2-24 and 2-48 hours post dosing

Incidences of adverse events

Changes from baseline in safety laboratory parameters

Changes from baseline in vital sign parameters

Withdrawals due to adverse events

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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 Criteria:

- 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.

1246.4.32004 Boehringer Ingelheim Investigational Site, Antwerpen, Belgium

1246.4.32005 Boehringer Ingelheim Investigational Site, Bruxelles, Belgium

1246.4.32006 Boehringer Ingelheim Investigational Site, Charleroi, Belgium

1246.4.32001 Boehringer Ingelheim Investigational Site, Gent, Belgium

1246.4.32002 Boehringer Ingelheim Investigational Site, Hasselt, Belgium

1246.4.32009 Boehringer Ingelheim Investigational Site, Leuven, Belgium

1246.4.32007 Boehringer Ingelheim Investigational Site, Liege, Belgium

1246.4.32008 Boehringer Ingelheim Investigational Site, Montegnee, 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

1246.4.3301A Boehringer Ingelheim Investigational Site, Nice Cedex 1, France

1246.4.3301B Boehringer Ingelheim Investigational Site, Nice Cedex 1, France

1246.4.3305B Boehringer Ingelheim Investigational Site, Paris, France

1246.4.3304A Boehringer Ingelheim Investigational Site, Rouen, France

1246.4.3304B 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

1246.4.39004 Boehringer Ingelheim Investigational Site, Milano, Italy

1246.4.39003 Boehringer Ingelheim Investigational Site, Roma, Italy

1246.4.39002 Boehringer Ingelheim Investigational Site, Torino, Italy

1246.4.31001 Boehringer Ingelheim Investigational Site, 's-Hertogenbosch, Netherlands

1246.4.31004 Boehringer Ingelheim Investigational Site, Amsterdam, Netherlands

1246.4.31003 Boehringer Ingelheim Investigational Site, Blaricum, Netherlands

1246.4.31002 Boehringer Ingelheim Investigational Site, Breda, Netherlands

1246.4.31005 Boehringer Ingelheim Investigational Site, Nijmegen, 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

Starting date: August 2008
Last updated: November 12, 2014