Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy, Safety, Tolerability and Pharmacokinetics of BIBN 4096 BS Versus Placebo in the Treatment of a Single Attack of Acute Migraine Headache

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: NCT02198339
Recruitment Status : Completed
First Posted : July 23, 2014
Last Update Posted : July 23, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
Efficacy, Safety, Tolerability and Pharmacokinetics of BIBN 4096 BS in patients with a single acute migraine attack with or without aura

Condition or disease Intervention/treatment Phase
Migraine Disorders Drug: BIBN 4096 BS Drug: Placebo Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Phase II a, Double-Blind, Randomised, Group Sequential Adaptive Assignment Design Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of Seven Fixed Doses of Intravenous BIBN 4096 BS Ranging From 0.1 to 10.0 mg Versus Placebo in the Treatment of a Single Attach of Acute Migraine Headache
Study Start Date : February 1999
Actual Primary Completion Date : December 1999

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine

Arm Intervention/treatment
Experimental: BIBN 4096 BS - ranging dose

sequential adaptive design, allocation of verum treated patients to dose groups not fixed in advance

IV infusion over 10 minutes

Drug: BIBN 4096 BS
Placebo Comparator: Placebo
IV infusion over 10 minutes
Drug: Placebo



Primary Outcome Measures :
  1. Headache Response measured on a four-point scale [ Time Frame: 2 hours post start of infusion ]

Secondary Outcome Measures :
  1. Headache Response measured on a four-point scale [ Time Frame: 30 min, 1, 4 and 24 hours post start of infusion ]
  2. Headache Free measured on a four-point scale [ Time Frame: 30 min, 1, 2, 4 and 24 hours post start of infusion ]
  3. Maintenance of Headache Response measured on a four-point scale [ Time Frame: up to 24 hours post start of infusion ]
  4. Relief of associated symptoms [ Time Frame: 30 min, 1, 2, 4 and 24 hours post start of infusion ]
  5. Occurence of Meaningful Relief measured by stopwatch [ Time Frame: up to 4 hours post start of infusion ]
  6. Time to Meaningful Relief measured by stopwatch [ Time Frame: up to 4 hours post start of infusion ]
  7. Clinical Disability measured on four-point scale [ Time Frame: 30 min, 1, 2, 4 and 24 hours post start of infusion ]
  8. Use of rescue medication [ Time Frame: within 24 hours post start of infusion ]
  9. Time to use of rescue medication [ Time Frame: within 24 hours post start infusion ]
  10. Number of patients with adverse events [ Time Frame: up to day 9 ]
  11. AUC (Area under the concentration time curve of the analyte in plasma) [ Time Frame: up to 4 hours post start of infusion ]
  12. Cmax (Maximum observed concentration of the analyte in plasma) [ Time Frame: up to 4 hours post start of infusion ]
  13. Qualified Headache Response measured on four-point scale [ Time Frame: up to 24 hours post start of infusion ]
  14. Time to sustained Headache Response [ Time Frame: up to 24 hours post start of infusion ]
  15. Worsening/Recurrence of Headache pain [ Time Frame: 2 - 24 hours post start of infusion ]
  16. Tmax (Time to maximum concentration of the analyte in plasma) [ Time Frame: up to 4 hours post start of infusion ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Man and women with an acute onset of acute migraine headache with or without aura of moderate to severe intensity
  • Established diagnosis of migraine (with or without aura) according to International Headache Society (IHS) criteria for >= 1 year; age of onset <= 50 years
  • Current age is 18-65 years
  • Study drug treatment to begin in less than 6 hours of the onset of migraine headache which is not spontaneously improving. Time of awakening with a migraine headache is considered as time of onset provided no headache was present prior to sleep
  • History of 1 to 6 migraine headaches per month for the preceding 6 months
  • Ability to give written informed consent in accordance with International Committee on Harmonisation - Good Clinical Practice (ICH-GCP) and local legislation

Exclusion Criteria:

  • Use of prescription and non-prescription medications for migraine prophylaxis within 2 weeks prior to treatment including Selective Serotonin Reuptake Inhibitors (SSRIs) (except fluoxetine which should have a 6 weeks washout), flunarizine (which should have a 4 week washout) and Mono-amino-oxidase-inhibitors drugs (MAOIs)
  • Use of paracetamol (acetaminophen), aspirin, Non-steroidal anti-inflammatory drugs (NSAIDS), barbiturates or anti-emetics within 12 hours of taking study drug or of any 'triptan', ergotamine preparation or opiate analgesics within 48 hours prior to study drug administration or the use of analgesics > 10 days/months
  • History of significant medical (i.e. coronary artery disease by history, renal failure), neurological (including epilepsy and structural brain lesions) or psychiatric disorders
  • History, clinical evidence or screening or baseline electrocardiogram suggestive of cardiovascular disease including ischemic heart disease, Prinzmetal angina, coronary vasospasm, history of atherosclerotic heart disease of cardiac arrhythmia
  • History of known hypertension
  • History of basilar, ophthalmoplegic or hemiplegic migraine headaches or non-migraine headaches (e.g. tension-type headaches) occurring on average >= 10 days per month for the preceding 6 months
  • History of treatment resistance migraine attacks defined as a lack of response to a range of commonly used acute anti-migraine compounds
  • Females who are nursing or pregnant (as determined by a serum pregnancy test at screening and a urine pregnancy test at baseline) or of childbearing potential (any woman who is not at least 1 year post-menopausal or surgically sterile is considered to be of childbearing potential) and not using a medically approved method of birth control as defined by local country requirements
  • Baseline systolic BP >= 160 mmHg or diastolic BP >= 100 mmHg
  • Any daily intake of prescribed medication within 2 weeks prior to randomization for diseases in the investigator's judgment that would contraindicate participation in the trial
  • History of Raynauds' disease
  • A recent history (six months) of current evidence of alcohol or recreational drug abuse as defined by Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM- IV) (R97-1072)
  • Post or present medical conditions that would keep administration of study mediation from being in the patient's best interest in the judgment of the clinical investigator
  • Unwillingness or inability to comply with the protocol (e.g. the patient cannot read or write and does not have another person to assist in completing the diary; the patient cannot be followed for 1 weeks). Patients unable to give informed consent are to be excluded from participation in the trial. Patients with legally appointed custodian can not be enrolled in the trial. In case of doubt an independent psychiatrist should testify that the patient is able to give informed consent
  • Use of another investigational drug within a time span of at least ten half-lives but never less than 1 month. Concurrent participation in another investigational protocol
  • Prior exposure to BIBN 4096 BS

Additional Information:
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02198339     History of Changes
Other Study ID Numbers: 1149.2
First Posted: July 23, 2014    Key Record Dates
Last Update Posted: July 23, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
Layout table for MeSH terms
Migraine Disorders
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms