Pathway CH-1 Long-Term Follow-Up

Chronic Cluster Headache Clinical Trial

Official title:

Long-Term Follow-Up for the Pathway CH-1 Trial: Sphenopalatine Ganglion Stimulation for the Acute Treatment of Cluster Headache

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01616511
• Other study ID #: CP-005
• Status: Completed
• Phase: N/A
• First received: June 7, 2012
• Last updated: January 5, 2017
• Start date: June 2012
• Est. completion date: June 2016

Study information

• Verified date: January 2017
• Source: Autonomic Technologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Observational

Clinical Trial Summary

The objective of the study is to demonstrate the long-term safety and performance of the ATI Neurostimulation System when used for stimulation of the sphenopalatine ganglion (SPG) in cluster headache subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Subject has been implanted with an ATI Neurostimulator as a part of the Pathway CH-1 trial.

• Subject has completed the Pathway CH-1 Open Label Final office visit and remains implanted with an ATI Neurostimulator.

• Subject has the ability to read, comprehend and to reliably record information as required by the Protocol.

• Subject is able to provide written informed consent prior to participation in the study.

Exclusion Criteria:

• Subject has or requires a pacemaker/defibrillator or other implantable device having a sense amplifier that is programmed 'On.'

• Subject is not suitable for the study for any reason in the judgment of the Investigator.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Cluster Headache
• Cluster Headache
• Headache

Locations

Country	Name	City	State
Belgium	Headache Research Unit. University Department of Neurology, Citadelle Hospital	Liege
Denmark	Danish Headache Center & Department of Neurology, Glostrup Hospital, University of Copenhagen	Glostrup, Copenhagen
Spain	Servicio de Neurologia, Hospital Clinico Universitario	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Autonomic Technologies, Inc.

Countries where clinical trial is conducted

Belgium,  Denmark,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demonstrate the long-term safety and performance of the ATI Neurostimulation System when used for the stimulation of the SPG in CH Subjects.		Long-Term	Yes