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BI 44370 TA in Acute Migraine Attack

NCT ID: NCT00751803

Last Updated: 2014-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

416 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Brief Summary

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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

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Conditions

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Migraine Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Study Groups

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BI 44370 TA Low Dose

Group Type EXPERIMENTAL

BI 44370 TA Low Dose

Intervention Type DRUG

Placebo

Intervention Type DRUG

BI 44370 TA Medium Dose

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

BI 44370 TA Medium Dose

Intervention Type DRUG

BI 44370 TA High Dose

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

BI 44370 TA Medium Dose

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Eletriptan

Group Type ACTIVE_COMPARATOR

Eletriptan

Intervention Type DRUG

Placebo

Intervention Type DRUG

Interventions

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BI 44370 TA Low Dose

Intervention Type DRUG

Eletriptan

Intervention Type DRUG

Placebo

Intervention Type DRUG

BI 44370 TA Medium Dose

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Boehringer Ingelheim

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1246.4.32004 Boehringer Ingelheim Investigational Site

Antwerp, , Belgium

Site Status

1246.4.32005 Boehringer Ingelheim Investigational Site

Brussels, , Belgium

Site Status

1246.4.32006 Boehringer Ingelheim Investigational Site

Charleroi, , Belgium

Site Status

1246.4.32001 Boehringer Ingelheim Investigational Site

Ghent, , Belgium

Site Status

1246.4.32002 Boehringer Ingelheim Investigational Site

Hasselt, , Belgium

Site Status

1246.4.32009 Boehringer Ingelheim Investigational Site

Leuven, , Belgium

Site Status

1246.4.32007 Boehringer Ingelheim Investigational Site

Liège, , Belgium

Site Status

1246.4.32008 Boehringer Ingelheim Investigational Site

Montegnée, , Belgium

Site Status

1246.4.34004 Boehringer Ingelheim Investigational Site

Oviedo, , El Salvador

Site Status

1246.4.3307A Boehringer Ingelheim Investigational Site

Clermont-Ferrand, , France

Site Status

1246.4.3307B Boehringer Ingelheim Investigational Site

Clermont-Ferrand, , France

Site Status

1246.4.3303A Boehringer Ingelheim Investigational Site

Lille, , France

Site Status

1246.4.3301A Boehringer Ingelheim Investigational Site

Nice, , France

Site Status

1246.4.3301B Boehringer Ingelheim Investigational Site

Nice, , France

Site Status

1246.4.3305B Boehringer Ingelheim Investigational Site

Paris, , France

Site Status

1246.4.3304A Boehringer Ingelheim Investigational Site

Rouen, , France

Site Status

1246.4.3304B Boehringer Ingelheim Investigational Site

Rouen, , France

Site Status

1246.4.3302A Boehringer Ingelheim Investigational Site

Toulouse, , France

Site Status

1246.4.3302B Boehringer Ingelheim Investigational Site

Toulouse, , France

Site Status

1246.4.49002 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

1246.4.49003 Boehringer Ingelheim Investigational Site

Erkelenz, , Germany

Site Status

1246.4.49001 Boehringer Ingelheim Investigational Site

Essen, , Germany

Site Status

1246.4.49006 Boehringer Ingelheim Investigational Site

Göttingen, , Germany

Site Status

1246.4.49004 Boehringer Ingelheim Investigational Site

Grevenbroich, , Germany

Site Status

1246.4.49011 Boehringer Ingelheim Investigational Site

Hüttenberg, , Germany

Site Status

1246.4.49007 Boehringer Ingelheim Investigational Site

Koenigstein Im Taurus, , Germany

Site Status

1246.4.49008 Boehringer Ingelheim Investigational Site

Munich, , Germany

Site Status

1246.4.49009 Boehringer Ingelheim Investigational Site

Munich, , Germany

Site Status

1246.4.49010 Boehringer Ingelheim Investigational Site

Münster, , Germany

Site Status

1246.4.39005 Boehringer Ingelheim Investigational Site

Bologna, , Italy

Site Status

1246.4.39006 Boehringer Ingelheim Investigational Site

Catania, , Italy

Site Status

1246.4.39001 Boehringer Ingelheim Investigational Site

Milan, , Italy

Site Status

1246.4.39004 Boehringer Ingelheim Investigational Site

Milan, , Italy

Site Status

1246.4.39003 Boehringer Ingelheim Investigational Site

Roma, , Italy

Site Status

1246.4.39002 Boehringer Ingelheim Investigational Site

Torino, , Italy

Site Status

1246.4.31001 Boehringer Ingelheim Investigational Site

's-Hertogenbosch, , Netherlands

Site Status

1246.4.31004 Boehringer Ingelheim Investigational Site

Amsterdam, , Netherlands

Site Status

1246.4.31003 Boehringer Ingelheim Investigational Site

Blaricum, , Netherlands

Site Status

1246.4.31002 Boehringer Ingelheim Investigational Site

Breda, , Netherlands

Site Status

1246.4.31005 Boehringer Ingelheim Investigational Site

Nijmegen, , Netherlands

Site Status

1246.4.31006 Boehringer Ingelheim Investigational Site

Zwolle, , Netherlands

Site Status

1246.4.34002 Boehringer Ingelheim Investigational Site

Barcelona, , Spain

Site Status

1246.4.34005 Boehringer Ingelheim Investigational Site

Santiago de Compostela, , Spain

Site Status

1246.4.34001 Boehringer Ingelheim Investigational Site

Valencia, , Spain

Site Status

1246.4.46001 Boehringer Ingelheim Investigational Site

Gothenburg, , Sweden

Site Status

1246.4.46004 Boehringer Ingelheim Investigational Site

Linköping, , Sweden

Site Status

1246.4.46005 Boehringer Ingelheim Investigational Site

Stockholm, , Sweden

Site Status

1246.4.46002 Boehringer Ingelheim Investigational Site

Vällingby, , Sweden

Site Status

1246.4.44013 Boehringer Ingelheim Investigational Site

Liverpool, , United Kingdom

Site Status

1246.4.44001 Boehringer Ingelheim Investigational Site

Oxford, , United Kingdom

Site Status

1246.4.44003 Boehringer Ingelheim Investigational Site

Plymouth, , United Kingdom

Site Status

1246.4.44007 Boehringer Ingelheim Investigational Site

Whitechapel, London, , United Kingdom

Site Status

Countries

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Belgium El Salvador France Germany Italy Netherlands Spain Sweden United Kingdom

Other Identifiers

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EudraCT No : 2008-000079-31

Identifier Type: -

Identifier Source: secondary_id

1246.4

Identifier Type: -

Identifier Source: org_study_id