NCT01616511

Brief 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.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2012

Longer than P75 for all trials

Geographic Reach
3 countries

3 active sites

Status
completed

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

June 1, 2012

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

June 7, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 11, 2012

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

January 9, 2017

Status Verified

January 1, 2017

Enrollment Period

4 years

First QC Date

June 7, 2012

Last Update Submit

January 5, 2017

Conditions

Chronic Cluster Headache

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Pathway CH-1 Subjects

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects who have been implanted with an ATI Neurostimulator as a part of the Pathway CH-1 trial, who have completed the Pathway CH-1 trial, and who remain implanted with an ATI Neurostimulator.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Headache Research Unit. University Department of Neurology, Citadelle Hospital

Liège, B-4000, Belgium

Location

Danish Headache Center & Department of Neurology, Glostrup Hospital, University of Copenhagen

Glostrup, Copenhagen, Denmark, DK-2600, Denmark

Location

Servicio de Neurologia, Hospital Clinico Universitario

Valencia, Spain, 46010, Spain

Location

MeSH Terms

Conditions

Cluster Headache

Condition Hierarchy (Ancestors)

Trigeminal Autonomic CephalalgiasHeadache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Jean Schoenen, MD, PhD

    Citadelle Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2012

First Posted

June 11, 2012

Study Start

June 1, 2012

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

January 9, 2017

Record last verified: 2017-01

Locations

DK(1)BE(1)ES(1)