Chordate System S020 Acute Migraine Clinical Investigation (Amici)

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

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.

Study Overview

• Status: Terminated
• Conditions: Acute Migraine
• Intervention / Treatment: Device: Chordate System S020 in treatment mode; Device: Chordate System S020 in placebo mode

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.

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Charité - Universitätsmedizin Berlin / Campus Mitte Klinik für Neurologie
  • Hamburg, Germany, 20246
    • Universitätsklinikum Eppendorf
  • Baden-Württemberg
    • Tübingen, Baden-Württemberg, Germany, 72076
      • Universitätsklinikum Tübingen / Zentrum für Neurologie
  • Bayern
    • Erding, Bayern, Germany, 85435
      • Praxis für Neurologie und Psychiatrie, Psychotherapie, Schmerztherapie
    • München, Bayern, Germany, 80802
      • Neurologie- & Kopfschmerzzentrum
    • München, Bayern, Germany, 81377
      • Klinikum Großhadern / Neurologische Klinik der Universität München
  • Hessen
    • Konigstein im Taunus, Hessen, Germany, 61462
      • Migräne-Klinik Königstein
  • Nordrhein-Westfalen
    • Essen, Nordrhein-Westfalen, Germany, 45122
      • Universitätsklinikum Essen / Neurologische Klinik
    • Wegberg, Nordrhein-Westfalen, Germany, 41844
      • Praxis für spezielle Schmerztherapie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Headache relief	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.	2 hours after treatment initiation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain-free rate	Percentage of subjects pain-free (pain intensity rated 'No pain') at 2 hours after treatment initiation with no use of rescue medication.	2 hours after treatment initiation
Incidence of recurrence		48 hours after treatment initiation
24 hour sustained pain-free rate	percentage of subjects remaining pain-free	24 hours after treatment initiation
48 hour sustained pain-free rate	percentage of subjects remaining pain-free	48 hours after treatment initiation
Time to meaningful relief		4 hours post-treatment initiation
Change in nausea, photophobia, phonophobia, vomiting and disability		2 hours post-treatment initiation
Subject global impression		48 hours post-treatment initiation.
Use of rescue medication		48 hours post-treatment initiation
Frequency, severity, device-relationship and outcome of all adverse events		48 hours post-treatment initiation

Collaborators and Investigators

• Sponsor: Chordate Medical
• Investigators: Principal Investigator: Hans-Christoph Diener, Prof. Dr., Universitätsklinikum Essen

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: July 4, 2014
• First Submitted That Met QC Criteria: July 4, 2014
• First Posted (Estimate): July 9, 2014

Study Record Updates

• Last Update Posted (Estimate): August 5, 2015
• Last Update Submitted That Met QC Criteria: August 3, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: PM004