Data Collection on the ATI Neurostimulation System: SPG Stimulation for Cluster Headache

Cluster Headache Clinical Trial

Official title:

Data Collection on the ATI Neurostimulation System: SPG Stimulation for Cluster Headache

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01677026
• Other study ID #: CP-004
• Status: Completed
• Start date: September 2012
• Est. completion date: April 9, 2018

Study information

• Verified date: June 2018
• Source: Autonomic Technologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The primary objectives of the Registry are to:

1. Monitor the transfer of the ATI Neurostimulation System and its safety/clinical performance to a larger number of centers in the post market phase and

2. Collect additional evidence to support reimbursement and clinical acceptance and long term follow up

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: April 9, 2018
• Est. primary completion date: April 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Subject meets CE marked labeling for cluster headache.

• Subject's typical cluster headache bouts last a minimum of 16 weeks, in the opinion of the Investigator.

• Subject agrees to maintain current preventive headache medication regimens (no change in type, frequency or dose except to manage tolerability) from Study Enrollment through the completion of the Therapy Evaluation Period.

• 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 had a change in type, dosage or frequency of taking preventive headache medications < one (1) month prior to Study Enrollment.

• Per the CE marked labeling: In the opinion of the Investigator, subject has bony facial deformities, inappropriate surgical anatomy or has had facial surgery in the surgical area on the same side as the planned surgery that would prevent the proper placement of the ATI Neurostimulator.

• Subject has other significant pain problem that might confound the study assessments in the opinion of the Investigator.

Related Conditions & MeSH terms

• Cluster Headache
• Headache

Locations

Country	Name	City	State
Denmark	Danish Headache Center	Glostrup
Germany	Berlin Charite Hospital	Berlin
Germany	Neurologische Klinik und Poliklinik	Bochum
Germany	Headache Center, Dept. Of Neurology, Univ. Duisburg-Essen	Essen
Germany	Institut fur systemische Neurowissenschaften, Universitastsklinikum Hamburg-Eppendorf (UKE)	Hamburg
Germany	Universitatsklinikum Jena Klinik f. Neurologie	Jena
Germany	Klinik fur Mund-, Kiefer-und Gesichtschirurgie, Rotes	Kassel
Germany	Migraine- und Kopfschmerzklinik Konigstein	Konigstein
Germany	Neurologie & Kopfschmerzzentrum Munchner Freiheit	Munich
Germany	University of Munich-Klinikum der Universitat Munchen Neurologische Klinik und Poliklinik	Munich
Germany	Universitatsklinikum Munster, Klinik und Poliklinik fur Neurologie	Munster

Sponsors (1)

Lead Sponsor	Collaborator
Autonomic Technologies, Inc.

Countries where clinical trial is conducted

Denmark,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Character of usability and acceptance of the ATI Neurostimulation System, as evaluated by the following:	Implantation of ATI Neurostimulator within the pterygopalatine fossa; Explant and lead-revision rates and reasons	Through study completion
Primary	Characterization of patient response to therapy, as evaluated by the following:	Patient acceptance of the therapy; Responder Analysis, where a responder is any patient who achieves Effective Therapy in at least 50% of evaluable attacks, a 50% attack frequency attack decrease relative to Baseline, or both; Disability and Quality of Life as characterized by the HIT-6 and SF-36v2 compared to Baseline; Subject Overall Evaluation of Therapy; Change in use of acute medications compared to Baseline; Change in preventive medication use and work status compared to Baseline	Through study completion