BI 44370 TA in Acute Migraine Attack

• ClinicalTrials.gov Identifier: NCT00751803
• Recruitment Status: Completed
• First Posted: September 12, 2008
• Last Update Posted: November 24, 2014
• Sponsor: Boehringer Ingelheim
• Information provided by: Boehringer Ingelheim

Tracking Information

• First Submitted Date: August 25, 2008
• First Posted Date: September 12, 2008
• Last Update Posted Date: November 24, 2014
• Study Start Date: August 2008
• Actual Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: September 11, 2008): 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 ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 30, 2013)

• 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 ]

• Original Secondary Outcome Measures (submitted: September 11, 2008): Efficacy: pain relief, sustain pain free and pain relief, relief of associated migraine symptoms, relapse and recurrence, global evaluation of medication, use of rescue medication, time to meaningful relief Safety: adverse events, laboratory parameters [ Time Frame: up to 48 h ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: BI 44370 TA in Acute Migraine Attack
• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Primary Purpose: Treatment
• Condition: Migraine Disorders

Intervention

• Drug: BI 44370 TA Low Dose
• Drug: Eletriptan
• Drug: Placebo
• Drug: BI 44370 TA Medium Dose

Study Arms

• Experimental: BI 44370 TA Low Dose
  Interventions:

  • Drug: BI 44370 TA Low Dose
  • Drug: Placebo
• Experimental: BI 44370 TA Medium Dose
  Interventions:

  • Drug: Placebo
  • Drug: BI 44370 TA Medium Dose
• Experimental: BI 44370 TA High Dose
  Interventions:

  • Drug: Placebo
  • Drug: BI 44370 TA Medium Dose
• Placebo Comparator: Placebo
  Intervention: Drug: Placebo
• Active Comparator: Eletriptan
  Interventions:

  • Drug: Eletriptan
  • Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 25, 2009): 416
• Original Estimated Enrollment (submitted: September 11, 2008): 410
• Study Completion Date: Not Provided
• Actual Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Belgium, El Salvador, France, Germany, Italy, Netherlands, Spain, Sweden, United Kingdom

Administrative Information

• NCT Number: NCT00751803
• Other Study ID Numbers: 1246.4; EudraCT No : 2008-000079-31
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
• Original Responsible Party: Same as current
• Current Study Sponsor: Boehringer Ingelheim
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Chair: Boehringer Ingelheim; Boehringer Ingelheim

• PRS Account: Boehringer Ingelheim
• Verification Date: November 2014