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Trial record 5 of 263 for:    Migraine AND Acute Migraine

Chordate System S020 Acute Migraine Clinical Investigation (Amici)

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ClinicalTrials.gov Identifier: NCT02185703
Recruitment Status : Terminated (Too slow recruitment rate)
First Posted : July 9, 2014
Last Update Posted : August 5, 2015
Sponsor:
Information provided by (Responsible Party):
Chordate Medical

Brief Summary:
The main purpose of the study is to evaluate the impact of treatment with the Chordate System S020 (medical device) on acute migraine headache pain.

Condition or disease Intervention/treatment Phase
Acute Migraine Device: Chordate System S020 in treatment mode Device: Chordate System S020 in placebo mode Not Applicable

Detailed Description:

One single migraine attack will be treated either with the Chordate System S020 or with Chordate System in placebo mode.

After a screening visit, up to 3 months before treatment, eligible subjects will be asked to return to the center at the onset of their next moderate to severe migraine attack. Subjects will be re-checked for eligibility, randomized and treated at the center (treatment visit). The subjects will record their response over the next 48 hours using a diary card. A follow-up visit will be scheduled 3 to 7 days after the treatment. In addition the subjects will be contacted within 24 to 48 hours after treatment initiation via a telephone contact to discuss their health including new or ongoing AEs.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-controlled, Double-blind, Multi-center Clinical Investigation to Evaluate the Performance and Safety of the Chordate System When Used in the Treatment of Acute Migraine Attacks of Moderate to Severe Intensity
Study Start Date : July 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine

Arm Intervention/treatment
Experimental: Chordate System S020 in treatment mode Device: Chordate System S020 in treatment mode
Sham Comparator: Chordate System S020 in placebo mode Device: Chordate System S020 in placebo mode



Primary Outcome Measures :
  1. Headache relief [ Time Frame: 2 hours after treatment initiation ]
    Percentage of subjects with a decrease in migraine headache pain from severe or moderate prior treatment to mild or none at 2 hours after treatment initiation with no use of rescue medication during this time period.


Secondary Outcome Measures :
  1. Pain-free rate [ Time Frame: 2 hours after treatment initiation ]
    Percentage of subjects pain-free (pain intensity rated 'No pain') at 2 hours after treatment initiation with no use of rescue medication.

  2. Incidence of recurrence [ Time Frame: 48 hours after treatment initiation ]
  3. 24 hour sustained pain-free rate [ Time Frame: 24 hours after treatment initiation ]
    percentage of subjects remaining pain-free

  4. 48 hour sustained pain-free rate [ Time Frame: 48 hours after treatment initiation ]
    percentage of subjects remaining pain-free

  5. Time to meaningful relief [ Time Frame: 4 hours post-treatment initiation ]
  6. Change in nausea, photophobia, phonophobia, vomiting and disability [ Time Frame: 2 hours post-treatment initiation ]
  7. Subject global impression [ Time Frame: 48 hours post-treatment initiation. ]
  8. Use of rescue medication [ Time Frame: 48 hours post-treatment initiation ]
  9. Frequency, severity, device-relationship and outcome of all adverse events [ Time Frame: 48 hours post-treatment initiation ]


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

Inclusion Criteria:

  • Subjects with migraine, with or without aura according to International Headache Society (IHS) classification (International Classification of Headache Disorders [ICHD]-III beta).
  • History of 1 to 6 migraine attacks per month for at least 12 previous months.
  • At least 50% of previous migraine attacks had moderate or severe pain intensity.
  • History of at least 48 hours of freedom from headache between migraine attacks.
  • The majority of the previous untreated migraine attacks lasted at least 8 hours.
  • Migraine onset before the age of 50 years.

Exclusion Criteria:

  • History (within one year prior to inclusion into this clinical investigation) of 15 or more headache days per month (i.e. headaches of any kind).
  • More than 6 days per month with non-migraine headaches (within one year prior to inclusion into this clinical investigation).
  • Unable to distinguish between migraine headaches and other headache types at the onset of a migraine attack.
  • Treatment with Botox in the head/neck area within 6 months of the screening visit, or between the screening and treatment visit.
  • Previously treated with an implantable stimulator or any implantable devices in the head and/or neck.
  • Pronounced anterior septal nasal deviation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02185703


Locations
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Germany
Universitätsklinikum Tübingen / Zentrum für Neurologie
Tübingen, Baden-Württemberg, Germany, 72076
Praxis für Neurologie und Psychiatrie, Psychotherapie, Schmerztherapie
Erding, Bayern, Germany, 85435
Neurologie- & Kopfschmerzzentrum
München, Bayern, Germany, 80802
Klinikum Großhadern / Neurologische Klinik der Universität München
München, Bayern, Germany, 81377
Migräne-Klinik Königstein
Konigstein im Taunus, Hessen, Germany, 61462
Universitätsklinikum Essen / Neurologische Klinik
Essen, Nordrhein-Westfalen, Germany, 45122
Praxis für spezielle Schmerztherapie
Wegberg, Nordrhein-Westfalen, Germany, 41844
Charité - Universitätsmedizin Berlin / Campus Mitte Klinik für Neurologie
Berlin, Germany, 10117
Universitätsklinikum Eppendorf
Hamburg, Germany, 20246
Sponsors and Collaborators
Chordate Medical
Investigators
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Principal Investigator: Hans-Christoph Diener, Prof. Dr. Universitätsklinikum Essen

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Responsible Party: Chordate Medical
ClinicalTrials.gov Identifier: NCT02185703     History of Changes
Other Study ID Numbers: PM004
First Posted: July 9, 2014    Key Record Dates
Last Update Posted: August 5, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases