BI 44370 TA in Acute Migraine Attack

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00751803
First received: August 25, 2008
Last updated: April 30, 2014
Last verified: April 2014
  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: 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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

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 ] [ Designated as safety issue: No ]

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00751803

  Show 52 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  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: April 30, 2014
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
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

ClinicalTrials.gov processed this record on September 18, 2014