BI 44370 TA in Acute Migraine Attack
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| ClinicalTrials.gov Identifier: NCT00751803 |
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Recruitment Status :
Completed
First Posted : September 12, 2008
Last Update Posted : November 24, 2014
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Sponsor:
Boehringer Ingelheim
Information provided by:
Boehringer Ingelheim
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Brief Summary:
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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Migraine Disorders | Drug: BI 44370 TA Low Dose Drug: Eletriptan Drug: Placebo Drug: BI 44370 TA Medium Dose | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 416 participants |
| Allocation: | Randomized |
| 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 |
| Study Start Date : | August 2008 |
| Actual Primary Completion Date : | May 2009 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Migraine
MedlinePlus related topics:
Migraine
| Arm | Intervention/treatment |
|---|---|
| Experimental: BI 44370 TA Low Dose |
Drug: BI 44370 TA Low Dose Drug: Placebo |
| Experimental: BI 44370 TA Medium Dose |
Drug: Placebo Drug: BI 44370 TA Medium Dose |
| Experimental: BI 44370 TA High Dose |
Drug: Placebo Drug: BI 44370 TA Medium Dose |
| Placebo Comparator: Placebo |
Drug: Placebo |
| Active Comparator: Eletriptan |
Drug: Eletriptan Drug: Placebo |
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 :
- Pain-free response 0.5, 1, 1.5, 24 and 48 hours after 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 ]
- 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 ]
- 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 ]
- 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 ]
- 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 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 ]
- Global evaluation of medication by the patient evaluated 48 h after study drug intake [ 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 ]
- Time to and use of rescue medication within 24 and 48 hours [ 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 ]
- Incidences of adverse events [ Time Frame: up to 7 days ]
- Changes from baseline in safety laboratory parameters [ Time Frame: up to 7 days ]
- Changes from baseline in vital sign parameters [ Time Frame: up to 7 days ]
- Withdrawals due to adverse events [ Time Frame: up to 7 days ]
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00751803
Locations
Show 52 study locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim |
| Responsible Party: | Boehringer Ingelheim, Study Chair, Boehringer Ingelheim |
| ClinicalTrials.gov Identifier: | NCT00751803 |
| Other Study ID Numbers: |
1246.4 EudraCT No : 2008-000079-31 |
| First Posted: | September 12, 2008 Key Record Dates |
| Last Update Posted: | November 24, 2014 |
| Last Verified: | November 2014 |
Additional relevant MeSH terms:
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Migraine Disorders Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Eletriptan Serotonin Receptor Agonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |