<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02198339</url>
  </required_header>
  <id_info>
    <org_study_id>1149.2</org_study_id>
    <nct_id>NCT02198339</nct_id>
  </id_info>
  <brief_title>Efficacy, Safety, Tolerability and Pharmacokinetics of BIBN 4096 BS Versus Placebo in the Treatment of a Single Attack of Acute Migraine Headache</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      Efficacy, Safety, Tolerability and Pharmacokinetics of BIBN 4096 BS in patients with a single&#xD;
      acute migraine attack with or without aura&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 1999</start_date>
  <primary_completion_date type="Actual">December 1999</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Headache Response measured on a four-point scale</measure>
    <time_frame>2 hours post start of infusion</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Headache Response measured on a four-point scale</measure>
    <time_frame>30 min, 1, 4 and 24 hours post start of infusion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Headache Free measured on a four-point scale</measure>
    <time_frame>30 min, 1, 2, 4 and 24 hours post start of infusion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maintenance of Headache Response measured on a four-point scale</measure>
    <time_frame>up to 24 hours post start of infusion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relief of associated symptoms</measure>
    <time_frame>30 min, 1, 2, 4 and 24 hours post start of infusion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurence of Meaningful Relief measured by stopwatch</measure>
    <time_frame>up to 4 hours post start of infusion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Meaningful Relief measured by stopwatch</measure>
    <time_frame>up to 4 hours post start of infusion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Disability measured on four-point scale</measure>
    <time_frame>30 min, 1, 2, 4 and 24 hours post start of infusion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of rescue medication</measure>
    <time_frame>within 24 hours post start of infusion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to use of rescue medication</measure>
    <time_frame>within 24 hours post start infusion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>up to day 9</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC (Area under the concentration time curve of the analyte in plasma)</measure>
    <time_frame>up to 4 hours post start of infusion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax (Maximum observed concentration of the analyte in plasma)</measure>
    <time_frame>up to 4 hours post start of infusion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Qualified Headache Response measured on four-point scale</measure>
    <time_frame>up to 24 hours post start of infusion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to sustained Headache Response</measure>
    <time_frame>up to 24 hours post start of infusion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Worsening/Recurrence of Headache pain</measure>
    <time_frame>2 - 24 hours post start of infusion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tmax (Time to maximum concentration of the analyte in plasma)</measure>
    <time_frame>up to 4 hours post start of infusion</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">126</enrollment>
  <condition>Migraine Disorders</condition>
  <arm_group>
    <arm_group_label>BIBN 4096 BS - ranging dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>sequential adaptive design, allocation of verum treated patients to dose groups not fixed in advance&#xD;
IV infusion over 10 minutes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>IV infusion over 10 minutes</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BIBN 4096 BS</intervention_name>
    <arm_group_label>BIBN 4096 BS - ranging dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Man and women with an acute onset of acute migraine headache with or without aura of&#xD;
             moderate to severe intensity&#xD;
&#xD;
          -  Established diagnosis of migraine (with or without aura) according to International&#xD;
             Headache Society (IHS) criteria for &gt;= 1 year; age of onset &lt;= 50 years&#xD;
&#xD;
          -  Current age is 18-65 years&#xD;
&#xD;
          -  Study drug treatment to begin in less than 6 hours of the onset of migraine headache&#xD;
             which is not spontaneously improving. Time of awakening with a migraine headache is&#xD;
             considered as time of onset provided no headache was present prior to sleep&#xD;
&#xD;
          -  History of 1 to 6 migraine headaches per month for the preceding 6 months&#xD;
&#xD;
          -  Ability to give written informed consent in accordance with International Committee on&#xD;
             Harmonisation - Good Clinical Practice (ICH-GCP) and local legislation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of prescription and non-prescription medications for migraine prophylaxis within 2&#xD;
             weeks prior to treatment including Selective Serotonin Reuptake Inhibitors (SSRIs)&#xD;
             (except fluoxetine which should have a 6 weeks washout), flunarizine (which should&#xD;
             have a 4 week washout) and Mono-amino-oxidase-inhibitors drugs (MAOIs)&#xD;
&#xD;
          -  Use of paracetamol (acetaminophen), aspirin, Non-steroidal anti-inflammatory drugs&#xD;
             (NSAIDS), barbiturates or anti-emetics within 12 hours of taking study drug or of any&#xD;
             'triptan', ergotamine preparation or opiate analgesics within 48 hours prior to study&#xD;
             drug administration or the use of analgesics &gt; 10 days/months&#xD;
&#xD;
          -  History of significant medical (i.e. coronary artery disease by history, renal&#xD;
             failure), neurological (including epilepsy and structural brain lesions) or&#xD;
             psychiatric disorders&#xD;
&#xD;
          -  History, clinical evidence or screening or baseline electrocardiogram suggestive of&#xD;
             cardiovascular disease including ischemic heart disease, Prinzmetal angina, coronary&#xD;
             vasospasm, history of atherosclerotic heart disease of cardiac arrhythmia&#xD;
&#xD;
          -  History of known hypertension&#xD;
&#xD;
          -  History of basilar, ophthalmoplegic or hemiplegic migraine headaches or non-migraine&#xD;
             headaches (e.g. tension-type headaches) occurring on average &gt;= 10 days per month for&#xD;
             the preceding 6 months&#xD;
&#xD;
          -  History of treatment resistance migraine attacks defined as a lack of response to a&#xD;
             range of commonly used acute anti-migraine compounds&#xD;
&#xD;
          -  Females who are nursing or pregnant (as determined by a serum pregnancy test at&#xD;
             screening and a urine pregnancy test at baseline) or of childbearing potential (any&#xD;
             woman who is not at least 1 year post-menopausal or surgically sterile is considered&#xD;
             to be of childbearing potential) and not using a medically approved method of birth&#xD;
             control as defined by local country requirements&#xD;
&#xD;
          -  Baseline systolic BP &gt;= 160 mmHg or diastolic BP &gt;= 100 mmHg&#xD;
&#xD;
          -  Any daily intake of prescribed medication within 2 weeks prior to randomization for&#xD;
             diseases in the investigator's judgment that would contraindicate participation in the&#xD;
             trial&#xD;
&#xD;
          -  History of Raynauds' disease&#xD;
&#xD;
          -  A recent history (six months) of current evidence of alcohol or recreational drug&#xD;
             abuse as defined by Diagnostic and Statistical Manual of Mental Disorders, 4th Edition&#xD;
             (DSM- IV) (R97-1072)&#xD;
&#xD;
          -  Post or present medical conditions that would keep administration of study mediation&#xD;
             from being in the patient's best interest in the judgment of the clinical investigator&#xD;
&#xD;
          -  Unwillingness or inability to comply with the protocol (e.g. the patient cannot read&#xD;
             or write and does not have another person to assist in completing the diary; the&#xD;
             patient cannot be followed for 1 weeks). Patients unable to give informed consent are&#xD;
             to be excluded from participation in the trial. Patients with legally appointed&#xD;
             custodian can not be enrolled in the trial. In case of doubt an independent&#xD;
             psychiatrist should testify that the patient is able to give informed consent&#xD;
&#xD;
          -  Use of another investigational drug within a time span of at least ten half-lives but&#xD;
             never less than 1 month. Concurrent participation in another investigational protocol&#xD;
&#xD;
          -  Prior exposure to BIBN 4096 BS&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://trials.boehringer-ingelheim.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 22, 2014</study_first_submitted>
  <study_first_submitted_qc>July 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 23, 2014</study_first_posted>
  <last_update_submitted>July 22, 2014</last_update_submitted>
  <last_update_submitted_qc>July 22, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 23, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Migraine Disorders</mesh_term>
    <mesh_term>Headache</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Olcegepant</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02198339
org study id: 1149.2
nct id: NCT02198339
lead sponsor: 
Efficacy, Safety, Tolerability and Pharmacokinetics of BIBN 4096 BS in patients with a single
      acute migraine attack with or without aura
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double
measure: Headache Response measured on a four-point scale
time frame: 2 hours post start of infusion
measure: Headache Response measured on a four-point scale
time frame: 30 min, 1, 4 and 24 hours post start of infusion
measure: Headache Free measured on a four-point scale
time frame: 30 min, 1, 2, 4 and 24 hours post start of infusion
measure: Maintenance of Headache Response measured on a four-point scale
time frame: up to 24 hours post start of infusion
measure: Relief of associated symptoms
time frame: 30 min, 1, 2, 4 and 24 hours post start of infusion
measure: Occurence of Meaningful Relief measured by stopwatch
time frame: up to 4 hours post start of infusion
measure: Time to Meaningful Relief measured by stopwatch
time frame: up to 4 hours post start of infusion
measure: Clinical Disability measured on four-point scale
time frame: 30 min, 1, 2, 4 and 24 hours post start of infusion
measure: Use of rescue medication
time frame: within 24 hours post start of infusion
measure: Time to use of rescue medication
time frame: within 24 hours post start infusion
measure: Number of patients with adverse events
time frame: up to day 9
measure: AUC (Area under the concentration time curve of the analyte in plasma)
time frame: up to 4 hours post start of infusion
measure: Cmax (Maximum observed concentration of the analyte in plasma)
time frame: up to 4 hours post start of infusion
measure: Qualified Headache Response measured on four-point scale
time frame: up to 24 hours post start of infusion
measure: Time to sustained Headache Response
time frame: up to 24 hours post start of infusion
measure: Worsening/Recurrence of Headache pain
time frame: 2 - 24 hours post start of infusion
measure: Tmax (Time to maximum concentration of the analyte in plasma)
time frame: up to 4 hours post start of infusion
arm group label: BIBN 4096 BS - ranging dose
arm group type: Experimental
description: sequential adaptive design, allocation of verum treated patients to dose groups not fixed in advance
IV infusion over 10 minutes
arm group label: Placebo
arm group type: Placebo Comparator
description: IV infusion over 10 minutes
intervention type: Drug
intervention name: BIBN 4096 BS
arm group label: BIBN 4096 BS - ranging dose
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Migraine Disorders
mesh term: Headache
mesh term: Olcegepant