BI 44370 TA in Acute Migraine Attack

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00751803
• Date of registration: 25/08/2008
• Prospective Registration: No
• Primary sponsor: Boehringer Ingelheim
• Public title: BI 44370 TA in Acute Migraine Attack
• Scientific 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
• Date of first enrolment: August 2008
• Target sample size: 416
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00751803
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

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

Contacts

• Name: Boehringer Ingelheim
• Affiliation: Boehringer Ingelheim

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Migraine Disorders

Intervention(s)

Drug: BI 44370 TA Low Dose

Drug: BI 44370 TA Medium Dose

Drug: Eletriptan

Drug: Placebo

Primary Outcome(s)

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(s)

Incidences of adverse events [Time Frame: up to 7 days]

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]

Global evaluation of medication by the patient evaluated 48 h after study drug intake [Time Frame: up to 48 h]

Recurrence / relapse of headache during time-intervals of 2-24 and 2-48 hours post dosing [Time Frame: up to 48 h]

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]

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]

Changes from baseline in safety laboratory parameters [Time Frame: up to 7 days]

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]

Changes from baseline in vital sign parameters [Time Frame: up to 7 days]

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]

Pain-free response 0.5, 1, 1.5, 24 and 48 hours after dosing [Time Frame: up to 48 h]

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]

Time to and use of rescue medication within 24 and 48 hours [Time Frame: up to 48 h]

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]

Withdrawals due to adverse events [Time Frame: up to 7 days]

Secondary ID(s)

1246.4

EudraCT No : 2008-000079-31

Source(s) of Monetary Support

Please refer to primary and secondary sponsors