BI 44370 TA in Acute Migraine Attack

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

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.

Study Overview

• Status: Completed
• Conditions: Migraine Disorders
• Intervention / Treatment: Drug: Placebo; Drug: BI 44370 TA Low Dose; Drug: BI 44370 TA Medium Dose; Drug: Eletriptan

• Study Type: Interventional
• Enrollment (Actual): 416
• Phase: Phase 2

Contacts and Locations

Study Locations

• Belgium
  • Antwerpen, Belgium
    • 1246.4.32004 Boehringer Ingelheim Investigational Site
  • Bruxelles, Belgium
    • 1246.4.32005 Boehringer Ingelheim Investigational Site
  • Charleroi, Belgium
    • 1246.4.32006 Boehringer Ingelheim Investigational Site
  • Gent, Belgium
    • 1246.4.32001 Boehringer Ingelheim Investigational Site
  • Hasselt, Belgium
    • 1246.4.32002 Boehringer Ingelheim Investigational Site
  • Leuven, Belgium
    • 1246.4.32009 Boehringer Ingelheim Investigational Site
  • Liege, Belgium
    • 1246.4.32007 Boehringer Ingelheim Investigational Site
  • Montegnee, Belgium
    • 1246.4.32008 Boehringer Ingelheim Investigational Site
• El Salvador
  • Oviedo, El Salvador
    • 1246.4.34004 Boehringer Ingelheim Investigational Site
• France
  • Clermont Ferrand, France
    • 1246.4.3307A Boehringer Ingelheim Investigational Site
  • Clermont Ferrand, France
    • 1246.4.3307B Boehringer Ingelheim Investigational Site
  • Lille cedex, France
    • 1246.4.3303A Boehringer Ingelheim Investigational Site
  • Nice Cedex 1, France
    • 1246.4.3301A Boehringer Ingelheim Investigational Site
  • Nice Cedex 1, France
    • 1246.4.3301B Boehringer Ingelheim Investigational Site
  • Paris, France
    • 1246.4.3305B Boehringer Ingelheim Investigational Site
  • Rouen, France
    • 1246.4.3304A Boehringer Ingelheim Investigational Site
  • Rouen, France
    • 1246.4.3304B Boehringer Ingelheim Investigational Site
  • Toulouse cedex 9, France
    • 1246.4.3302A Boehringer Ingelheim Investigational Site
  • Toulouse cedex 9, France
    • 1246.4.3302B Boehringer Ingelheim Investigational Site
• Germany
  • Berlin, Germany
    • 1246.4.49002 Boehringer Ingelheim Investigational Site
  • Erkelenz, Germany
    • 1246.4.49003 Boehringer Ingelheim Investigational Site
  • Essen, Germany
    • 1246.4.49001 Boehringer Ingelheim Investigational Site
  • Goettingen, Germany
    • 1246.4.49006 Boehringer Ingelheim Investigational Site
  • Grevenbroich, Germany
    • 1246.4.49004 Boehringer Ingelheim Investigational Site
  • Huettenberg, Germany
    • 1246.4.49011 Boehringer Ingelheim Investigational Site
  • Koenigstein im Taurus, Germany
    • 1246.4.49007 Boehringer Ingelheim Investigational Site
  • Muenster, Germany
    • 1246.4.49010 Boehringer Ingelheim Investigational Site
  • Munich, Germany
    • 1246.4.49008 Boehringer Ingelheim Investigational Site
  • Munich, Germany
    • 1246.4.49009 Boehringer Ingelheim Investigational Site
• Italy
  • Bologna, Italy
    • 1246.4.39005 Boehringer Ingelheim Investigational Site
  • Catania, Italy
    • 1246.4.39006 Boehringer Ingelheim Investigational Site
  • Milano, Italy
    • 1246.4.39001 Boehringer Ingelheim Investigational Site
  • Milano, Italy
    • 1246.4.39004 Boehringer Ingelheim Investigational Site
  • Roma, Italy
    • 1246.4.39003 Boehringer Ingelheim Investigational Site
  • Torino, Italy
    • 1246.4.39002 Boehringer Ingelheim Investigational Site
• Netherlands
  • 's-Hertogenbosch, Netherlands
    • 1246.4.31001 Boehringer Ingelheim Investigational Site
  • Amsterdam, Netherlands
    • 1246.4.31004 Boehringer Ingelheim Investigational Site
  • Blaricum, Netherlands
    • 1246.4.31003 Boehringer Ingelheim Investigational Site
  • Breda, Netherlands
    • 1246.4.31002 Boehringer Ingelheim Investigational Site
  • Nijmegen, Netherlands
    • 1246.4.31005 Boehringer Ingelheim Investigational Site
  • Zwolle, Netherlands
    • 1246.4.31006 Boehringer Ingelheim Investigational Site
• Spain
  • Barcelona, Spain
    • 1246.4.34002 Boehringer Ingelheim Investigational Site
  • Santiago de Compostela, Spain
    • 1246.4.34005 Boehringer Ingelheim Investigational Site
  • Valencia, Spain
    • 1246.4.34001 Boehringer Ingelheim Investigational Site
• Sweden
  • Goteborg, Sweden
    • 1246.4.46001 Boehringer Ingelheim Investigational Site
  • Linkoping, Sweden
    • 1246.4.46004 Boehringer Ingelheim Investigational Site
  • Stockholm, Sweden
    • 1246.4.46005 Boehringer Ingelheim Investigational Site
  • Vallingby, Sweden
    • 1246.4.46002 Boehringer Ingelheim Investigational Site
• United Kingdom
  • Liverpool, United Kingdom
    • 1246.4.44013 Boehringer Ingelheim Investigational Site
  • Oxford, United Kingdom
    • 1246.4.44001 Boehringer Ingelheim Investigational Site
  • Plymouth, United Kingdom
    • 1246.4.44003 Boehringer Ingelheim Investigational Site
  • Whitechapel, London, United Kingdom
    • 1246.4.44007 Boehringer Ingelheim Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo
Experimental: BI 44370 TA Low Dose	Drug: Placebo; Drug: BI 44370 TA Low Dose
Experimental: BI 44370 TA Medium Dose	Drug: Placebo; Drug: BI 44370 TA Medium Dose
Experimental: BI 44370 TA High Dose	Drug: Placebo; Drug: BI 44370 TA Medium Dose
Active Comparator: Eletriptan	Drug: Placebo; Drug: Eletriptan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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
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
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
Global evaluation of medication by the patient evaluated 48 h after study drug intake	up to 48 h
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
Time to and use of rescue medication within 24 and 48 hours	up to 48 h
Recurrence / relapse of headache during time-intervals of 2-24 and 2-48 hours post dosing	up to 48 h
Incidences of adverse events	up to 7 days
Changes from baseline in safety laboratory parameters	up to 7 days
Changes from baseline in vital sign parameters	up to 7 days
Withdrawals due to adverse events	up to 7 days

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: August 25, 2008
• First Submitted That Met QC Criteria: September 11, 2008
• First Posted (Estimate): September 12, 2008

Study Record Updates

• Last Update Posted (Estimate): November 24, 2014
• Last Update Submitted That Met QC Criteria: November 12, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Serotonin Agents; Serotonin Receptor Agonists; Eletriptan
• Other Study ID Numbers: 1246.4; EudraCT No : 2008-000079-31