BI 44370 TA in Acute Migraine Attack

Boehringer Ingelheim

Status and phase: Completed; Phase 2

Conditions: Migraine Disorders

Treatments: Drug: Placebo; Drug: BI 44370 TA Medium Dose; Drug: Eletriptan; Drug: BI 44370 TA Low Dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT00751803

EudraCT No : 2008-000079-31

1246.4

Details and patient eligibility

About

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.

Enrollment: 416 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

416 participants in 5 patient groups, including a placebo group

BI 44370 TA Low Dose

Experimental group

Treatment:

Drug: Placebo

Drug: BI 44370 TA Low Dose

BI 44370 TA Medium Dose

Experimental group

Treatment:

Drug: Placebo

Drug: BI 44370 TA Medium Dose

BI 44370 TA High Dose

Experimental group

Treatment:

Drug: Placebo

Drug: BI 44370 TA Medium Dose

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Eletriptan

Active Comparator group

Treatment:

Drug: Placebo

Drug: Eletriptan