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Chordate System S020 Acute Migraine Clinical Investigation (Amici)

Primary Purpose

Acute Migraine

Status
Terminated
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Chordate System S020 in treatment mode
Chordate System S020 in placebo mode
Sponsored by
Chordate Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Migraine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Universitätsklinikum Tübingen / Zentrum für Neurologie
  • Praxis für Neurologie und Psychiatrie, Psychotherapie, Schmerztherapie
  • Neurologie- & Kopfschmerzzentrum
  • Klinikum Großhadern / Neurologische Klinik der Universität München
  • Migräne-Klinik Königstein
  • Universitätsklinikum Essen / Neurologische Klinik
  • Praxis für spezielle Schmerztherapie
  • Charité - Universitätsmedizin Berlin / Campus Mitte Klinik für Neurologie
  • Universitätsklinikum Eppendorf

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Chordate System S020 in treatment mode

Chordate System S020 in placebo mode

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Incidence of recurrence
24 hour sustained pain-free rate
percentage of subjects remaining pain-free
48 hour sustained pain-free rate
percentage of subjects remaining pain-free
Time to meaningful relief
Change in nausea, photophobia, phonophobia, vomiting and disability
Subject global impression
Use of rescue medication
Frequency, severity, device-relationship and outcome of all adverse events

Full Information

First Posted
July 4, 2014
Last Updated
August 3, 2015
Sponsor
Chordate Medical
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1. Study Identification

Unique Protocol Identification Number
NCT02185703
Brief Title
Chordate System S020 Acute Migraine Clinical Investigation
Acronym
Amici
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 Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Terminated
Why Stopped
Too slow recruitment rate
Study Start Date
July 2014 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chordate Medical

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Migraine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chordate System S020 in treatment mode
Arm Type
Experimental
Arm Title
Chordate System S020 in placebo mode
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
Chordate System S020 in treatment mode
Intervention Type
Device
Intervention Name(s)
Chordate System S020 in placebo mode
Primary Outcome Measure Information:
Title
Headache relief
Description
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.
Time Frame
2 hours after treatment initiation
Secondary Outcome Measure Information:
Title
Pain-free rate
Description
Percentage of subjects pain-free (pain intensity rated 'No pain') at 2 hours after treatment initiation with no use of rescue medication.
Time Frame
2 hours after treatment initiation
Title
Incidence of recurrence
Time Frame
48 hours after treatment initiation
Title
24 hour sustained pain-free rate
Description
percentage of subjects remaining pain-free
Time Frame
24 hours after treatment initiation
Title
48 hour sustained pain-free rate
Description
percentage of subjects remaining pain-free
Time Frame
48 hours after treatment initiation
Title
Time to meaningful relief
Time Frame
4 hours post-treatment initiation
Title
Change in nausea, photophobia, phonophobia, vomiting and disability
Time Frame
2 hours post-treatment initiation
Title
Subject global impression
Time Frame
48 hours post-treatment initiation.
Title
Use of rescue medication
Time Frame
48 hours post-treatment initiation
Title
Frequency, severity, device-relationship and outcome of all adverse events
Time Frame
48 hours post-treatment initiation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hans-Christoph Diener, Prof. Dr.
Organizational Affiliation
Universitätsklinikum Essen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitätsklinikum Tübingen / Zentrum für Neurologie
City
Tübingen
State/Province
Baden-Württemberg
ZIP/Postal Code
72076
Country
Germany
Facility Name
Praxis für Neurologie und Psychiatrie, Psychotherapie, Schmerztherapie
City
Erding
State/Province
Bayern
ZIP/Postal Code
85435
Country
Germany
Facility Name
Neurologie- & Kopfschmerzzentrum
City
München
State/Province
Bayern
ZIP/Postal Code
80802
Country
Germany
Facility Name
Klinikum Großhadern / Neurologische Klinik der Universität München
City
München
State/Province
Bayern
ZIP/Postal Code
81377
Country
Germany
Facility Name
Migräne-Klinik Königstein
City
Konigstein im Taunus
State/Province
Hessen
ZIP/Postal Code
61462
Country
Germany
Facility Name
Universitätsklinikum Essen / Neurologische Klinik
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Praxis für spezielle Schmerztherapie
City
Wegberg
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
41844
Country
Germany
Facility Name
Charité - Universitätsmedizin Berlin / Campus Mitte Klinik für Neurologie
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Universitätsklinikum Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany

12. IPD Sharing Statement

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Chordate System S020 Acute Migraine Clinical Investigation

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