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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01677026
Other study ID # CP-004
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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