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

Migraine Disorders Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02198339
• Other study ID #: 1149.2
• Status: Completed
• Phase: Phase 2
• First received: July 22, 2014
• Last updated: July 22, 2014
• Start date: February 1999

Study information

• Verified date: July 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesNetherlands: Ministry of Health, Welfare and SportDenmark: Danish Health and Medicines AuthorityUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. primary completion date: December 1999
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Migraine Disorders

Intervention

Drug:
• BIBN 4096 BS

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Headache Response measured on a four-point scale		2 hours post start of infusion	No
Secondary	Headache Response measured on a four-point scale		30 min, 1, 4 and 24 hours post start of infusion	No
Secondary	Headache Free measured on a four-point scale		30 min, 1, 2, 4 and 24 hours post start of infusion	No
Secondary	Maintenance of Headache Response measured on a four-point scale		up to 24 hours post start of infusion	No
Secondary	Relief of associated symptoms		30 min, 1, 2, 4 and 24 hours post start of infusion	No
Secondary	Occurence of Meaningful Relief measured by stopwatch		up to 4 hours post start of infusion	No
Secondary	Time to Meaningful Relief measured by stopwatch		up to 4 hours post start of infusion	No
Secondary	Clinical Disability measured on four-point scale		30 min, 1, 2, 4 and 24 hours post start of infusion	No
Secondary	Use of rescue medication		within 24 hours post start of infusion	No
Secondary	Time to use of rescue medication		within 24 hours post start infusion	No
Secondary	Number of patients with adverse events		up to day 9	No
Secondary	AUC (Area under the concentration time curve of the analyte in plasma)		up to 4 hours post start of infusion	No
Secondary	Cmax (Maximum observed concentration of the analyte in plasma)		up to 4 hours post start of infusion	No
Secondary	Qualified Headache Response measured on four-point scale		up to 24 hours post start of infusion	No
Secondary	Time to sustained Headache Response		up to 24 hours post start of infusion	No
Secondary	Worsening/Recurrence of Headache pain		2 - 24 hours post start of infusion	No
Secondary	Tmax (Time to maximum concentration of the analyte in plasma)		up to 4 hours post start of infusion	No

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