BI 44370 TA in Acute Migraine Attack - Full Text View

Sponsored by:	Boehringer Ingelheim Pharmaceuticals
Information provided by:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00751803

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 II

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Headache Migraine

Drug Information available for: Eletriptan Eletriptan Hydrobromide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Parallel Assignment, Safety/Efficacy Study
Official Title:	PoC / Dose-Finding Study

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 ]

Estimated Enrollment:	410
Study Start Date:	August 2008
Estimated 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

Contacts

Contact: Boehringer Ingelheim Study Coordinator

800-542-6257 ext Option 4

clintriage.rdg@boehringer-ingelheim.com

Show 52 Study Locations

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

More Information

Responsible Party:	Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers:	1246.4, EudraCT No : 2008-000079-31
Study First Received:	August 25, 2008
Last Updated:	December 10, 2008
ClinicalTrials.gov Identifier:	NCT00751803
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

Study placed in the following topic categories:

Eletriptan
Signs and Symptoms
Migraine Disorders
Headache
Central Nervous System Diseases

Headache Disorders, Primary
Brain Diseases
Serotonin
Headache Disorders

Additional relevant MeSH terms:

Serotonin Agonists
Neurotransmitter Agents
Serotonin Agents
Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs
Nervous System Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009