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BI 44370 TA in Acute Migraine Attack

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00751803
Recruitment Status : Completed
First Posted : September 12, 2008
Last Update Posted : November 24, 2014
Sponsor:
Information provided by:
Boehringer Ingelheim

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

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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 :
  1. 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 :
  1. Pain-free response 0.5, 1, 1.5, 24 and 48 hours after dosing [ Time Frame: up to 48 h ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]
  7. 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 ]
  8. Global evaluation of medication by the patient evaluated 48 h after study drug intake [ Time Frame: up to 48 h ]
  9. 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 ]
  10. Time to and use of rescue medication within 24 and 48 hours [ Time Frame: up to 48 h ]
  11. Recurrence / relapse of headache during time-intervals of 2-24 and 2-48 hours post dosing [ Time Frame: up to 48 h ]
  12. Incidences of adverse events [ Time Frame: up to 7 days ]
  13. Changes from baseline in safety laboratory parameters [ Time Frame: up to 7 days ]
  14. Changes from baseline in vital sign parameters [ Time Frame: up to 7 days ]
  15. Withdrawals due to adverse events [ Time Frame: up to 7 days ]


Information from the National Library of Medicine

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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
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Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
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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