BI 44370 TA in Acute Migraine Attack

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Migraine Disorders

Intervention / Treatment
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* Drug: BI 44370 TA Low Dose
* Drug: Eletriptan
* Drug: Placebo
* Drug: BI 44370 TA Medium Dose


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BI 44370 TA Low Dose<br> | Drug: BI 44370 TA Low Dose<br> <br> Drug: Placebo<br> <br> |
| Experimental: BI 44370 TA Medium Dose<br> | Drug: Placebo<br> <br> Drug: BI 44370 TA Medium Dose<br> <br> |
| Experimental: BI 44370 TA High Dose<br> | Drug: Placebo<br> <br> Drug: BI 44370 TA Medium Dose<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |
| Active Comparator: Eletriptan<br> | Drug: Eletriptan<br> <br> Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint is a pain free response, defined as reduction of severe or moderate headache to no headache, 2 hours after dosing. |  | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain-free response 0.5, 1, 1.5, 24 and 48 hours after dosing |  | 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 |  | up to 48 h | 
| 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 |  | up to 48 h | 
| 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 |  | up to 48 h | 
| Intensity of headache at the time of intake of study medication, and 0.5, 1, 1.5, 2, 24 and 48 hours after dosing |  | 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 |  | 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 |  | up to 2 h | 
| Global evaluation of medication by the patient evaluated 48 h after study drug intake |  | 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 |  | up to 48 h | 
| Time to and use of rescue medication within 24 and 48 hours |  | up to 48 h | 
| Recurrence / relapse of headache during time-intervals of 2-24 and 2-48 hours post dosing |  | up to 48 h | 
| Incidences of adverse events |  | up to 7 days | 
| Changes from baseline in safety laboratory parameters |  | up to 7 days | 
| Changes from baseline in vital sign parameters |  | up to 7 days | 
| Withdrawals due to adverse events |  | up to 7 days |