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BI 44370 TA in Acute Migraine Attack

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00751803
First received: August 25, 2008
Last updated: June 25, 2009
Last verified: June 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Migraine Disorders
 Drug: BI 44370 TA
Drug: Eletriptan
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: PoC / Dose-Finding Study

Resource links provided by NLM:

MedlinePlus related topics: Headache Migraine
U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

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. [ Time Frame: 2 hours ]

Secondary Outcome Measures:
  • Efficacy: pain relief, sustain pain free and pain relief, relief of associated migraine symptoms, relapse and recurrence, global evaluation of medication, use of rescue medication, time to meaningful relief Safety: adverse events, laboratory parameters [ Time Frame: up to 48 h ]

Enrollment: 416
Study Start Date: August 2008
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult migraine patients with or without aura, diagnosed according to the ICH.
  • Established migraine diagnosis for more than 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00751803

  Show 52 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00751803     History of Changes
Other Study ID Numbers: 1246.4, EudraCT No : 2008-000079-31
Study First Received: August 25, 2008
Last Updated: June 25, 2009
Health Authority: Belgium: Federal Agency for Medicines and Health Products
France: French Health Products Safety Agency
Germany: Federal Institute for Drugs and Medical Devices
Great Britain: MHRA
Italy: Ethics Committee of IRCCS Fondazione S. Raffaele del Monte Tabor di Milano
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Spain: Agencia Espanola de Medicamentos y Productos Santarios
Sweden: Medical Products Agency Regional Ethics Committee of Gothenburg

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Eletriptan
 Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2013