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BI 44370 TA in Acute Migraine Attack

Primary Purpose

Migraine Disorders

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BI 44370 TA Low Dose
Eletriptan
Placebo
BI 44370 TA Medium Dose
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine Disorders

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • 1246.4.32004 Boehringer Ingelheim Investigational Site
  • 1246.4.32005 Boehringer Ingelheim Investigational Site
  • 1246.4.32006 Boehringer Ingelheim Investigational Site
  • 1246.4.32001 Boehringer Ingelheim Investigational Site
  • 1246.4.32002 Boehringer Ingelheim Investigational Site
  • 1246.4.32009 Boehringer Ingelheim Investigational Site
  • 1246.4.32007 Boehringer Ingelheim Investigational Site
  • 1246.4.32008 Boehringer Ingelheim Investigational Site
  • 1246.4.34004 Boehringer Ingelheim Investigational Site
  • 1246.4.3307A Boehringer Ingelheim Investigational Site
  • 1246.4.3307B Boehringer Ingelheim Investigational Site
  • 1246.4.3303A Boehringer Ingelheim Investigational Site
  • 1246.4.3301A Boehringer Ingelheim Investigational Site
  • 1246.4.3301B Boehringer Ingelheim Investigational Site
  • 1246.4.3305B Boehringer Ingelheim Investigational Site
  • 1246.4.3304A Boehringer Ingelheim Investigational Site
  • 1246.4.3304B Boehringer Ingelheim Investigational Site
  • 1246.4.3302A Boehringer Ingelheim Investigational Site
  • 1246.4.3302B Boehringer Ingelheim Investigational Site
  • 1246.4.49002 Boehringer Ingelheim Investigational Site
  • 1246.4.49003 Boehringer Ingelheim Investigational Site
  • 1246.4.49001 Boehringer Ingelheim Investigational Site
  • 1246.4.49006 Boehringer Ingelheim Investigational Site
  • 1246.4.49004 Boehringer Ingelheim Investigational Site
  • 1246.4.49011 Boehringer Ingelheim Investigational Site
  • 1246.4.49007 Boehringer Ingelheim Investigational Site
  • 1246.4.49010 Boehringer Ingelheim Investigational Site
  • 1246.4.49008 Boehringer Ingelheim Investigational Site
  • 1246.4.49009 Boehringer Ingelheim Investigational Site
  • 1246.4.39005 Boehringer Ingelheim Investigational Site
  • 1246.4.39006 Boehringer Ingelheim Investigational Site
  • 1246.4.39001 Boehringer Ingelheim Investigational Site
  • 1246.4.39004 Boehringer Ingelheim Investigational Site
  • 1246.4.39003 Boehringer Ingelheim Investigational Site
  • 1246.4.39002 Boehringer Ingelheim Investigational Site
  • 1246.4.31001 Boehringer Ingelheim Investigational Site
  • 1246.4.31004 Boehringer Ingelheim Investigational Site
  • 1246.4.31003 Boehringer Ingelheim Investigational Site
  • 1246.4.31002 Boehringer Ingelheim Investigational Site
  • 1246.4.31005 Boehringer Ingelheim Investigational Site
  • 1246.4.31006 Boehringer Ingelheim Investigational Site
  • 1246.4.34002 Boehringer Ingelheim Investigational Site
  • 1246.4.34005 Boehringer Ingelheim Investigational Site
  • 1246.4.34001 Boehringer Ingelheim Investigational Site
  • 1246.4.46001 Boehringer Ingelheim Investigational Site
  • 1246.4.46004 Boehringer Ingelheim Investigational Site
  • 1246.4.46005 Boehringer Ingelheim Investigational Site
  • 1246.4.46002 Boehringer Ingelheim Investigational Site
  • 1246.4.44013 Boehringer Ingelheim Investigational Site
  • 1246.4.44001 Boehringer Ingelheim Investigational Site
  • 1246.4.44003 Boehringer Ingelheim Investigational Site
  • 1246.4.44007 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Active Comparator

Arm Label

BI 44370 TA Low Dose

BI 44370 TA Medium Dose

BI 44370 TA High Dose

Placebo

Eletriptan

Arm Description

Outcomes

Primary Outcome Measures

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 Measures

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

Full Information

First Posted
August 25, 2008
Last Updated
November 12, 2014
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00751803
Brief Title
BI 44370 TA in Acute Migraine Attack
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 Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Allocation
Randomized
Enrollment
416 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BI 44370 TA Low Dose
Arm Type
Experimental
Arm Title
BI 44370 TA Medium Dose
Arm Type
Experimental
Arm Title
BI 44370 TA High Dose
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Eletriptan
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
BI 44370 TA Low Dose
Intervention Type
Drug
Intervention Name(s)
Eletriptan
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
BI 44370 TA Medium Dose
Primary Outcome Measure Information:
Title
The primary endpoint is a pain free response, defined as reduction of severe or moderate headache to no headache, 2 hours after dosing.
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Pain-free response 0.5, 1, 1.5, 24 and 48 hours after dosing
Time Frame
up to 48 h
Title
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
Time Frame
up to 48 h
Title
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
Time Frame
up to 48 h
Title
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
Time Frame
up to 48 h
Title
Intensity of headache at the time of intake of study medication, and 0.5, 1, 1.5, 2, 24 and 48 hours after dosing
Time Frame
up to 48 h
Title
Relief of associated migraine symptoms (nausea, vomiting, photophobia, phonophobia) 0.5, 1, 1.5, 2, 24 and 48 hours after dosing
Time Frame
up to 48 h
Title
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
Time Frame
up to 2 h
Title
Global evaluation of medication by the patient evaluated 48 h after study drug intake
Time Frame
up to 48 h
Title
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 Frame
up to 48 h
Title
Time to and use of rescue medication within 24 and 48 hours
Time Frame
up to 48 h
Title
Recurrence / relapse of headache during time-intervals of 2-24 and 2-48 hours post dosing
Time Frame
up to 48 h
Title
Incidences of adverse events
Time Frame
up to 7 days
Title
Changes from baseline in safety laboratory parameters
Time Frame
up to 7 days
Title
Changes from baseline in vital sign parameters
Time Frame
up to 7 days
Title
Withdrawals due to adverse events
Time Frame
up to 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
1246.4.32004 Boehringer Ingelheim Investigational Site
City
Antwerpen
Country
Belgium
Facility Name
1246.4.32005 Boehringer Ingelheim Investigational Site
City
Bruxelles
Country
Belgium
Facility Name
1246.4.32006 Boehringer Ingelheim Investigational Site
City
Charleroi
Country
Belgium
Facility Name
1246.4.32001 Boehringer Ingelheim Investigational Site
City
Gent
Country
Belgium
Facility Name
1246.4.32002 Boehringer Ingelheim Investigational Site
City
Hasselt
Country
Belgium
Facility Name
1246.4.32009 Boehringer Ingelheim Investigational Site
City
Leuven
Country
Belgium
Facility Name
1246.4.32007 Boehringer Ingelheim Investigational Site
City
Liege
Country
Belgium
Facility Name
1246.4.32008 Boehringer Ingelheim Investigational Site
City
Montegnee
Country
Belgium
Facility Name
1246.4.34004 Boehringer Ingelheim Investigational Site
City
Oviedo
Country
El Salvador
Facility Name
1246.4.3307A Boehringer Ingelheim Investigational Site
City
Clermont Ferrand
Country
France
Facility Name
1246.4.3307B Boehringer Ingelheim Investigational Site
City
Clermont Ferrand
Country
France
Facility Name
1246.4.3303A Boehringer Ingelheim Investigational Site
City
Lille cedex
Country
France
Facility Name
1246.4.3301A Boehringer Ingelheim Investigational Site
City
Nice Cedex 1
Country
France
Facility Name
1246.4.3301B Boehringer Ingelheim Investigational Site
City
Nice Cedex 1
Country
France
Facility Name
1246.4.3305B Boehringer Ingelheim Investigational Site
City
Paris
Country
France
Facility Name
1246.4.3304A Boehringer Ingelheim Investigational Site
City
Rouen
Country
France
Facility Name
1246.4.3304B Boehringer Ingelheim Investigational Site
City
Rouen
Country
France
Facility Name
1246.4.3302A Boehringer Ingelheim Investigational Site
City
Toulouse cedex 9
Country
France
Facility Name
1246.4.3302B Boehringer Ingelheim Investigational Site
City
Toulouse cedex 9
Country
France
Facility Name
1246.4.49002 Boehringer Ingelheim Investigational Site
City
Berlin
Country
Germany
Facility Name
1246.4.49003 Boehringer Ingelheim Investigational Site
City
Erkelenz
Country
Germany
Facility Name
1246.4.49001 Boehringer Ingelheim Investigational Site
City
Essen
Country
Germany
Facility Name
1246.4.49006 Boehringer Ingelheim Investigational Site
City
Goettingen
Country
Germany
Facility Name
1246.4.49004 Boehringer Ingelheim Investigational Site
City
Grevenbroich
Country
Germany
Facility Name
1246.4.49011 Boehringer Ingelheim Investigational Site
City
Huettenberg
Country
Germany
Facility Name
1246.4.49007 Boehringer Ingelheim Investigational Site
City
Koenigstein im Taurus
Country
Germany
Facility Name
1246.4.49010 Boehringer Ingelheim Investigational Site
City
Muenster
Country
Germany
Facility Name
1246.4.49008 Boehringer Ingelheim Investigational Site
City
Munich
Country
Germany
Facility Name
1246.4.49009 Boehringer Ingelheim Investigational Site
City
Munich
Country
Germany
Facility Name
1246.4.39005 Boehringer Ingelheim Investigational Site
City
Bologna
Country
Italy
Facility Name
1246.4.39006 Boehringer Ingelheim Investigational Site
City
Catania
Country
Italy
Facility Name
1246.4.39001 Boehringer Ingelheim Investigational Site
City
Milano
Country
Italy
Facility Name
1246.4.39004 Boehringer Ingelheim Investigational Site
City
Milano
Country
Italy
Facility Name
1246.4.39003 Boehringer Ingelheim Investigational Site
City
Roma
Country
Italy
Facility Name
1246.4.39002 Boehringer Ingelheim Investigational Site
City
Torino
Country
Italy
Facility Name
1246.4.31001 Boehringer Ingelheim Investigational Site
City
's-Hertogenbosch
Country
Netherlands
Facility Name
1246.4.31004 Boehringer Ingelheim Investigational Site
City
Amsterdam
Country
Netherlands
Facility Name
1246.4.31003 Boehringer Ingelheim Investigational Site
City
Blaricum
Country
Netherlands
Facility Name
1246.4.31002 Boehringer Ingelheim Investigational Site
City
Breda
Country
Netherlands
Facility Name
1246.4.31005 Boehringer Ingelheim Investigational Site
City
Nijmegen
Country
Netherlands
Facility Name
1246.4.31006 Boehringer Ingelheim Investigational Site
City
Zwolle
Country
Netherlands
Facility Name
1246.4.34002 Boehringer Ingelheim Investigational Site
City
Barcelona
Country
Spain
Facility Name
1246.4.34005 Boehringer Ingelheim Investigational Site
City
Santiago de Compostela
Country
Spain
Facility Name
1246.4.34001 Boehringer Ingelheim Investigational Site
City
Valencia
Country
Spain
Facility Name
1246.4.46001 Boehringer Ingelheim Investigational Site
City
Goteborg
Country
Sweden
Facility Name
1246.4.46004 Boehringer Ingelheim Investigational Site
City
Linkoping
Country
Sweden
Facility Name
1246.4.46005 Boehringer Ingelheim Investigational Site
City
Stockholm
Country
Sweden
Facility Name
1246.4.46002 Boehringer Ingelheim Investigational Site
City
Vallingby
Country
Sweden
Facility Name
1246.4.44013 Boehringer Ingelheim Investigational Site
City
Liverpool
Country
United Kingdom
Facility Name
1246.4.44001 Boehringer Ingelheim Investigational Site
City
Oxford
Country
United Kingdom
Facility Name
1246.4.44003 Boehringer Ingelheim Investigational Site
City
Plymouth
Country
United Kingdom
Facility Name
1246.4.44007 Boehringer Ingelheim Investigational Site
City
Whitechapel, London
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

BI 44370 TA in Acute Migraine Attack

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