BI 44370 TA in Acute Migraine Attack

NCT00751803 | Completed Phase 2

• 2 other identifiers: 1246.4EudraCT No : 2008-000079-31
• Study Type: interventional
• Target: 416
• Locations: 9 countries
• Sites: 52

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.

Conditions

Migraine Disorders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• Pain-free response 0.5, 1, 1.5, 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-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

• 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

• 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

Study Arms (5)

BI 44370 TA Low Dose

EXPERIMENTAL

Drug: BI 44370 TA Low Dose; Drug: Placebo

BI 44370 TA Medium Dose

EXPERIMENTAL

Drug: Placebo; Drug: BI 44370 TA Medium Dose

BI 44370 TA High Dose

EXPERIMENTAL

Drug: Placebo; Drug: BI 44370 TA Medium Dose

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Eletriptan

ACTIVE COMPARATOR

Drug: Eletriptan; Drug: Placebo

Interventions

BI 44370 TA Low Dose DRUG

BI 44370 TA Low Dose

Eletriptan DRUG

Eletriptan

Placebo DRUG

BI 44370 TA High Dose; BI 44370 TA Low Dose; BI 44370 TA Medium Dose; Eletriptan; Placebo

BI 44370 TA Medium Dose DRUG

BI 44370 TA High Dose; BI 44370 TA Medium Dose

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (52)

1246.4.32004 Boehringer Ingelheim Investigational Site

Antwerp, Belgium

Location

1246.4.32005 Boehringer Ingelheim Investigational Site

Brussels, Belgium

Location

1246.4.32006 Boehringer Ingelheim Investigational Site

Charleroi, Belgium

Location

1246.4.32001 Boehringer Ingelheim Investigational Site

Ghent, Belgium

Location

1246.4.32002 Boehringer Ingelheim Investigational Site

Hasselt, Belgium

Location

1246.4.32009 Boehringer Ingelheim Investigational Site

Leuven, Belgium

Location

1246.4.32007 Boehringer Ingelheim Investigational Site

Liège, Belgium

Location

1246.4.32008 Boehringer Ingelheim Investigational Site

Montegnée, Belgium

Location

1246.4.34004 Boehringer Ingelheim Investigational Site

Oviedo, El Salvador

Location

1246.4.3307A Boehringer Ingelheim Investigational Site

Clermont-Ferrand, France

Location

1246.4.3307B Boehringer Ingelheim Investigational Site

Clermont-Ferrand, France

Location

1246.4.3303A Boehringer Ingelheim Investigational Site

Lille, France

Location

1246.4.3301A Boehringer Ingelheim Investigational Site

Nice, France

Location

1246.4.3301B Boehringer Ingelheim Investigational Site

Nice, France

Location

1246.4.3305B Boehringer Ingelheim Investigational Site

Paris, France

Location

1246.4.3304A Boehringer Ingelheim Investigational Site

Rouen, France

Location

1246.4.3304B Boehringer Ingelheim Investigational Site

Rouen, France

Location

1246.4.3302A Boehringer Ingelheim Investigational Site

Toulouse, France

Location

1246.4.3302B Boehringer Ingelheim Investigational Site

Toulouse, France

Location

1246.4.49002 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1246.4.49003 Boehringer Ingelheim Investigational Site

Erkelenz, Germany

Location

1246.4.49001 Boehringer Ingelheim Investigational Site

Essen, Germany

Location

1246.4.49006 Boehringer Ingelheim Investigational Site

Göttingen, Germany

Location

1246.4.49004 Boehringer Ingelheim Investigational Site

Grevenbroich, Germany

Location

1246.4.49011 Boehringer Ingelheim Investigational Site

Hüttenberg, Germany

Location

1246.4.49007 Boehringer Ingelheim Investigational Site

Koenigstein Im Taurus, Germany

Location

1246.4.49008 Boehringer Ingelheim Investigational Site

Munich, Germany

Location

1246.4.49009 Boehringer Ingelheim Investigational Site

Munich, Germany

Location

1246.4.49010 Boehringer Ingelheim Investigational Site

Münster, Germany

Location

1246.4.39005 Boehringer Ingelheim Investigational Site

Bologna, Italy

Location

1246.4.39006 Boehringer Ingelheim Investigational Site

Catania, Italy

Location

1246.4.39001 Boehringer Ingelheim Investigational Site

Milan, Italy

Location

1246.4.39004 Boehringer Ingelheim Investigational Site

Milan, Italy

Location

1246.4.39003 Boehringer Ingelheim Investigational Site

Roma, Italy

Location

1246.4.39002 Boehringer Ingelheim Investigational Site

Torino, Italy

Location

1246.4.31001 Boehringer Ingelheim Investigational Site

's-Hertogenbosch, Netherlands

Location

1246.4.31004 Boehringer Ingelheim Investigational Site

Amsterdam, Netherlands

Location

1246.4.31003 Boehringer Ingelheim Investigational Site

Blaricum, Netherlands

Location

1246.4.31002 Boehringer Ingelheim Investigational Site

Breda, Netherlands

Location

1246.4.31005 Boehringer Ingelheim Investigational Site

Nijmegen, Netherlands

Location

1246.4.31006 Boehringer Ingelheim Investigational Site

Zwolle, Netherlands

Location

1246.4.34002 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

1246.4.34005 Boehringer Ingelheim Investigational Site

Santiago de Compostela, Spain

Location

1246.4.34001 Boehringer Ingelheim Investigational Site

Valencia, Spain

Location

1246.4.46001 Boehringer Ingelheim Investigational Site

Gothenburg, Sweden

Location

1246.4.46004 Boehringer Ingelheim Investigational Site

Linköping, Sweden

Location

1246.4.46005 Boehringer Ingelheim Investigational Site

Stockholm, Sweden

Location

1246.4.46002 Boehringer Ingelheim Investigational Site

Vällingby, Sweden

Location

1246.4.44013 Boehringer Ingelheim Investigational Site

Liverpool, United Kingdom

Location

1246.4.44001 Boehringer Ingelheim Investigational Site

Oxford, United Kingdom

Location

1246.4.44003 Boehringer Ingelheim Investigational Site

Plymouth, United Kingdom

Location

1246.4.44007 Boehringer Ingelheim Investigational Site

Whitechapel, London, United Kingdom

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

eletriptan

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 25, 2008
• First Posted: September 12, 2008
• Study Start: August 1, 2008
• Primary Completion: May 1, 2009
• Last Updated: November 24, 2014

Record last verified: 2014-11

Locations

FR (10); BE (8); SE (4); GB (4); IT (6); ES (3); EL (1); DE (10); NL (6)