NCT02185703

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2014

Geographic Reach
1 country

9 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

July 4, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 9, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

August 5, 2015

Status Verified

August 1, 2015

Enrollment Period

1 year

First QC Date

July 4, 2014

Last Update Submit

August 3, 2015

Conditions

Acute Migraine

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Pain-free rate

    2 hours after treatment initiation

  • Incidence of recurrence

    48 hours after treatment initiation

  • 24 hour sustained pain-free rate

    24 hours after treatment initiation

  • 48 hour sustained pain-free rate

    48 hours after treatment initiation

  • Time to meaningful relief

    4 hours post-treatment initiation

  • +4 more secondary outcomes

Study Arms (2)

Chordate System S020 in treatment mode

EXPERIMENTAL
Device: Chordate System S020 in treatment mode

Chordate System S020 in placebo mode

SHAM COMPARATOR
Device: Chordate System S020 in placebo mode

Interventions

Chordate System S020 in treatment modeDEVICE
Chordate System S020 in treatment mode
Chordate System S020 in placebo modeDEVICE
Chordate System S020 in placebo mode

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Universitätsklinikum Tübingen / Zentrum für Neurologie

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Praxis für Neurologie und Psychiatrie, Psychotherapie, Schmerztherapie

Erding, Bavaria, 85435, Germany

Location

Neurologie- & Kopfschmerzzentrum

München, Bavaria, 80802, Germany

Location

Klinikum Großhadern / Neurologische Klinik der Universität München

München, Bavaria, 81377, Germany

Location

Universitätsklinikum Eppendorf

Hamburg, Hamburg, 20246, Germany

Location

Migräne-Klinik Königstein

Königstein im Taunus, Hesse, 61462, Germany

Location

Universitätsklinikum Essen / Neurologische Klinik

Essen, North Rhine-Westphalia, 45122, Germany

Location

Praxis für spezielle Schmerztherapie

Wegberg, North Rhine-Westphalia, 41844, Germany

Location

Charité - Universitätsmedizin Berlin / Campus Mitte Klinik für Neurologie

Berlin, State of Berlin, 10117, Germany

Location

Study Officials

  • Hans-Christoph Diener, Prof. Dr.

    Universitätsklinikum Essen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2014

First Posted

July 9, 2014

Study Start

July 1, 2014

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

August 5, 2015

Record last verified: 2015-08

Locations

DE(9)