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Migraine DisordersPhase 2NCT02198339

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

A Phase 2 study testing BIBN 4096 BS in people with Migraine Disorders, run by Boehringer Ingelheim.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Migraine Disorders
What is being tested?
BIBN 4096 BS
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
126 participants
Where
No sites listed yet
Study dates
Feb 1999to Dec 1999
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 16Show fewer
  • 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

About this study

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

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

Being tested
BIBN 4096 BS, Placebo
Medical subject headings
Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BIBN 4096 BSDrug

  • PlaceboDrug

Study groups in NCT02198339
Study groupRoleWhat they receive
BIBN 4096 BS - ranging doseExperimentalsequential adaptive design, allocation of verum treated patients to dose groups not fixed in advance IV infusion over 10 minutes
Receives: Drug: BIBN 4096 BS
PlaceboPlacebo comparatorIV infusion over 10 minutes
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Headache Response measured on a four-point scale

    Measured: 2 hours post start of infusion

Secondary outcomes (16)

  1. Headache Response measured on a four-point scale

    Measured: 30 min, 1, 4 and 24 hours post start of infusion

  2. Headache Free measured on a four-point scale

    Measured: 30 min, 1, 2, 4 and 24 hours post start of infusion

  3. Maintenance of Headache Response measured on a four-point scale

    Measured: up to 24 hours post start of infusion

  4. Relief of associated symptoms

    Measured: 30 min, 1, 2, 4 and 24 hours post start of infusion

  5. Occurence of Meaningful Relief measured by stopwatch

    Measured: up to 4 hours post start of infusion

  6. Time to Meaningful Relief measured by stopwatch

    Measured: up to 4 hours post start of infusion

  7. Clinical Disability measured on four-point scale

    Measured: 30 min, 1, 2, 4 and 24 hours post start of infusion

  8. Use of rescue medication

    Measured: within 24 hours post start of infusion

  9. Time to use of rescue medication

    Measured: within 24 hours post start infusion

  10. Number of patients with adverse events

    Measured: up to day 9

  11. AUC (Area under the concentration time curve of the analyte in plasma)

    Measured: up to 4 hours post start of infusion

  12. Cmax (Maximum observed concentration of the analyte in plasma)

    Measured: up to 4 hours post start of infusion

  13. Qualified Headache Response measured on four-point scale

    Measured: up to 24 hours post start of infusion

  14. Time to sustained Headache Response

    Measured: up to 24 hours post start of infusion

  15. Worsening/Recurrence of Headache pain

    Measured: 2 - 24 hours post start of infusion

  16. Tmax (Time to maximum concentration of the analyte in plasma)

    Measured: up to 4 hours post start of infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2014 (estimated)
  2. Study startFeb 1999
  3. Primary completionDec 1999

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
126 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02198339
Sponsor's protocol ID
1149.2
Status last verified
Jul 2014
First submitted
22 Jul 2014
Last updated
23 Jul 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BIBN 4096 BS in people with Migraine Disorders, run by Boehringer Ingelheim.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Headache Response measured on a four-point scale (time frame: 2 hours post start of infusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02198339.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2014.

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