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Completed

NCT Number: NCT00751803

BI 44370 TA in Acute Migraine Attack

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.

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Key information

Conditions

Migraine Disorders Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

1246.4.32004 Boehringer Ingelheim Investigational Site, Antwerp, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BI 44370 TA Low Dose

Drug

eletriptan

Drug

Placebo

Drug

BI 44370 TA Medium Dose

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
First posted
Sep 12, 2008
Registry last updated
Nov 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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