Chordate System S020 Acute Migraine Clinical Investigation

NCT ID: NCT02185703

Last Updated: 2015-08-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2015-07-31

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.

Conditions

Acute Migraine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Chordate System S020 in treatment mode

Group Type: EXPERIMENTAL

Chordate System S020 in treatment mode

Intervention Type: DEVICE

Chordate System S020 in placebo mode

Group Type: SHAM_COMPARATOR

Chordate System S020 in placebo mode

Intervention Type: DEVICE

Interventions

Chordate System S020 in treatment mode

Intervention Type: DEVICE

Chordate System S020 in placebo mode

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chordate Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hans-Christoph Diener, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Essen

Locations

Universitätsklinikum Tübingen / Zentrum für Neurologie

Tübingen, Baden-Wurttemberg, Germany

Praxis für Neurologie und Psychiatrie, Psychotherapie, Schmerztherapie

Erding, Bavaria, Germany

Neurologie- & Kopfschmerzzentrum

München, Bavaria, Germany

Klinikum Großhadern / Neurologische Klinik der Universität München

München, Bavaria, Germany

Universitätsklinikum Eppendorf

Hamburg, City state of Hamburg, Germany

Migräne-Klinik Königstein

Königstein im Taunus, Hesse, Germany

Universitätsklinikum Essen / Neurologische Klinik

Essen, North Rhine-Westphalia, Germany

Praxis für spezielle Schmerztherapie

Wegberg, North Rhine-Westphalia, Germany

Charité - Universitätsmedizin Berlin / Campus Mitte Klinik für Neurologie

Berlin, State of Berlin, Germany

Countries

Germany

Other Identifiers

PM004

Identifier Type: -

Identifier Source: org_study_id