Chordate System S020 Acute Migraine Clinical Investigation

Acute Migraine Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02185703
• Other study ID #: PM004
• Status: Terminated
• Phase: N/A
• First received: July 4, 2014
• Last updated: August 3, 2015
• Start date: July 2014
• Est. completion date: July 2015

Study information

• Verified date: August 2015
• Source: Chordate Medical
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Medicinal Products and Medical Devices (BfArM)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 51
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Migraine
• Migraine Disorders

Intervention

Device:
• Chordate System S020 in treatment mode

• Chordate System S020 in placebo mode

Locations

Country	Name	City	State
Germany	Charité - Universitätsmedizin Berlin / Campus Mitte Klinik für Neurologie	Berlin
Germany	Praxis für Neurologie und Psychiatrie, Psychotherapie, Schmerztherapie	Erding	Bayern
Germany	Universitätsklinikum Essen / Neurologische Klinik	Essen	Nordrhein-Westfalen
Germany	Universitätsklinikum Eppendorf	Hamburg
Germany	Migräne-Klinik Königstein	Konigstein im Taunus	Hessen
Germany	Klinikum Großhadern / Neurologische Klinik der Universität München	München	Bayern
Germany	Neurologie- & Kopfschmerzzentrum	München	Bayern
Germany	Universitätsklinikum Tübingen / Zentrum für Neurologie	Tübingen	Baden-Württemberg
Germany	Praxis für spezielle Schmerztherapie	Wegberg	Nordrhein-Westfalen

Sponsors (1)

Lead Sponsor	Collaborator
Chordate Medical

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Incidence of recurrence		48 hours after treatment initiation	No
Secondary	24 hour sustained pain-free rate	percentage of subjects remaining pain-free	24 hours after treatment initiation	No
Secondary	48 hour sustained pain-free rate	percentage of subjects remaining pain-free	48 hours after treatment initiation	No
Secondary	Time to meaningful relief		4 hours post-treatment initiation	No
Secondary	Change in nausea, photophobia, phonophobia, vomiting and disability		2 hours post-treatment initiation	No
Secondary	Subject global impression		48 hours post-treatment initiation.	No
Secondary	Use of rescue medication		48 hours post-treatment initiation	No
Secondary	Frequency, severity, device-relationship and outcome of all adverse events		48 hours post-treatment initiation	Yes