Clinical trial NCT00751803: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Migraine Disorders
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2008-09-12
Enrollment: 416
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: The primary endpoint is a pain free response, defined as reduction of severe or moderate headache to no headache, 2 hours after dosing.
timeFrame: 2 hours
Secondary outcomes:
measure: Pain-free response 0.5, 1, 1.5, 24 and 48 hours after dosing
timeFrame: up to 48 h
measure: 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
timeFrame: up to 48 h
measure: 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
timeFrame: up to 48 h
measure: 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
timeFrame: up to 48 h
measure: Intensity of headache at the time of intake of study medication, and 0.5, 1, 1.5, 2, 24 and 48 hours after dosing
timeFrame: up to 48 h
measure: Relief of associated migraine symptoms (nausea, vomiting, photophobia, phonophobia) 0.5, 1, 1.5, 2, 24 and 48 hours after dosing
timeFrame: up to 48 h
measure: 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
timeFrame: up to 2 h
measure: Global evaluation of medication by the patient evaluated 48 h after study drug intake
timeFrame: up to 48 h
measure: 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
timeFrame: up to 48 h
measure: Time to and use of rescue medication within 24 and 48 hours
timeFrame: up to 48 h
measure: Recurrence / relapse of headache during time-intervals of 2-24 and 2-48 hours post dosing
timeFrame: up to 48 h
measure: Incidences of adverse events
timeFrame: up to 7 days
measure: Changes from baseline in safety laboratory parameters
timeFrame: up to 7 days
measure: Changes from baseline in vital sign parameters
timeFrame: up to 7 days
measure: Withdrawals due to adverse events
timeFrame: up to 7 days
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: 1246.4.32004 Boehringer Ingelheim Investigational Site
city: Bruxelles
country: Belgium
facility: 1246.4.32005 Boehringer Ingelheim Investigational Site
city: Charleroi
country: Belgium
facility: 1246.4.32006 Boehringer Ingelheim Investigational Site
city: Gent
country: Belgium
facility: 1246.4.32001 Boehringer Ingelheim Investigational Site
city: Hasselt
country: Belgium
facility: 1246.4.32002 Boehringer Ingelheim Investigational Site
city: Leuven
country: Belgium
facility: 1246.4.32009 Boehringer Ingelheim Investigational Site
city: Liege
country: Belgium
facility: 1246.4.32007 Boehringer Ingelheim Investigational Site
city: Montegnee
country: Belgium
facility: 1246.4.32008 Boehringer Ingelheim Investigational Site
city: Oviedo
country: El Salvador
facility: 1246.4.34004 Boehringer Ingelheim Investigational Site
city: Clermont Ferrand
country: France
facility: 1246.4.3307A Boehringer Ingelheim Investigational Site
city: Clermont Ferrand
country: France
facility: 1246.4.3307B Boehringer Ingelheim Investigational Site
city: Lille cedex
country: France
facility: 1246.4.3303A Boehringer Ingelheim Investigational Site
city: Nice Cedex 1
country: France
facility: 1246.4.3301A Boehringer Ingelheim Investigational Site
city: Nice Cedex 1
country: France
facility: 1246.4.3301B Boehringer Ingelheim Investigational Site
city: Paris
country: France
facility: 1246.4.3305B Boehringer Ingelheim Investigational Site
city: Rouen
country: France
facility: 1246.4.3304A Boehringer Ingelheim Investigational Site
city: Rouen
country: France
facility: 1246.4.3304B Boehringer Ingelheim Investigational Site
city: Toulouse cedex 9
country: France
facility: 1246.4.3302A Boehringer Ingelheim Investigational Site
city: Toulouse cedex 9
country: France
facility: 1246.4.3302B Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 1246.4.49002 Boehringer Ingelheim Investigational Site
city: Erkelenz
country: Germany
facility: 1246.4.49003 Boehringer Ingelheim Investigational Site
city: Essen
country: Germany
facility: 1246.4.49001 Boehringer Ingelheim Investigational Site
city: Goettingen
country: Germany
facility: 1246.4.49006 Boehringer Ingelheim Investigational Site
city: Grevenbroich
country: Germany
facility: 1246.4.49004 Boehringer Ingelheim Investigational Site
city: Huettenberg
country: Germany
facility: 1246.4.49011 Boehringer Ingelheim Investigational Site
city: Koenigstein im Taurus
country: Germany
facility: 1246.4.49007 Boehringer Ingelheim Investigational Site
city: Muenster
country: Germany
facility: 1246.4.49010 Boehringer Ingelheim Investigational Site
city: Munich
country: Germany
facility: 1246.4.49008 Boehringer Ingelheim Investigational Site
city: Munich
country: Germany
facility: 1246.4.49009 Boehringer Ingelheim Investigational Site
city: Bologna
country: Italy
facility: 1246.4.39005 Boehringer Ingelheim Investigational Site
city: Catania
country: Italy
facility: 1246.4.39006 Boehringer Ingelheim Investigational Site
city: Milano
country: Italy
facility: 1246.4.39001 Boehringer Ingelheim Investigational Site
city: Milano
country: Italy
facility: 1246.4.39004 Boehringer Ingelheim Investigational Site
city: Roma
country: Italy
facility: 1246.4.39003 Boehringer Ingelheim Investigational Site
city: Torino
country: Italy
facility: 1246.4.39002 Boehringer Ingelheim Investigational Site
city: 's-Hertogenbosch
country: Netherlands
facility: 1246.4.31001 Boehringer Ingelheim Investigational Site
city: Amsterdam
country: Netherlands
facility: 1246.4.31004 Boehringer Ingelheim Investigational Site
city: Blaricum
country: Netherlands
facility: 1246.4.31003 Boehringer Ingelheim Investigational Site
city: Breda
country: Netherlands
facility: 1246.4.31002 Boehringer Ingelheim Investigational Site
city: Nijmegen
country: Netherlands
facility: 1246.4.31005 Boehringer Ingelheim Investigational Site
city: Zwolle
country: Netherlands
facility: 1246.4.31006 Boehringer Ingelheim Investigational Site
city: Barcelona
country: Spain
facility: 1246.4.34002 Boehringer Ingelheim Investigational Site
city: Santiago de Compostela
country: Spain
facility: 1246.4.34005 Boehringer Ingelheim Investigational Site
city: Valencia
country: Spain
facility: 1246.4.34001 Boehringer Ingelheim Investigational Site
city: Goteborg
country: Sweden
facility: 1246.4.46001 Boehringer Ingelheim Investigational Site
city: Linkoping
country: Sweden
facility: 1246.4.46004 Boehringer Ingelheim Investigational Site
city: Stockholm
country: Sweden
facility: 1246.4.46005 Boehringer Ingelheim Investigational Site
city: Vallingby
country: Sweden
facility: 1246.4.46002 Boehringer Ingelheim Investigational Site
city: Liverpool
country: United Kingdom
facility: 1246.4.44013 Boehringer Ingelheim Investigational Site
city: Oxford
country: United Kingdom
facility: 1246.4.44001 Boehringer Ingelheim Investigational Site
city: Plymouth
country: United Kingdom
facility: 1246.4.44003 Boehringer Ingelheim Investigational Site
city: Whitechapel, London
country: United Kingdom
facility: 1246.4.44007 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: