BI 44370 TA in Acute Migraine Attack

Migraine Disorders Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00751803
• Other study ID #: 1246.4
• Secondary ID: EudraCT No : 200
• Status: Completed
• Phase: Phase 2
• First received: August 25, 2008
• Last updated: November 12, 2014
• Start date: August 2008

Study information

• Verified date: November 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHPFrance: French Health Products Safety AgencyGermany: Federal Institute for Drugs and Medical DevicesGreat Britain: MHRAItaly: Ethics Committee of IRCCS Fondazione S. Raffaele del Monte Tabor di MilanoNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Spain: Agencia Espanola de Medicamentos y Productos SantariosSweden: Medical Products Agency Regional Ethics Committee of Gothenburg
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 416
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Migraine Disorders

Intervention

Drug:
• BI 44370 TA Low Dose

• Eletriptan

• Placebo

• BI 44370 TA Medium Dose

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

Belgium,  El Salvador,  France,  Germany,  Italy,  Netherlands,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Pain-free response 0.5, 1, 1.5, 24 and 48 hours after dosing		up to 48 h	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Global evaluation of medication by the patient evaluated 48 h after study drug intake		up to 48 h	No
Secondary	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	No
Secondary	Time to and use of rescue medication within 24 and 48 hours		up to 48 h	No
Secondary	Recurrence / relapse of headache during time-intervals of 2-24 and 2-48 hours post dosing		up to 48 h	No
Secondary	Incidences of adverse events		up to 7 days	No
Secondary	Changes from baseline in safety laboratory parameters		up to 7 days	No
Secondary	Changes from baseline in vital sign parameters		up to 7 days	No
Secondary	Withdrawals due to adverse events		up to 7 days	No