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Sphenopalatine Ganglion Stimulation for the Treatment of Chronic Cluster Headache
The primary objective of the study is to demonstrate the safety and efficacy of SPG stimulation with the ATI Neurostimulation System when used to treat acute cluster attacks in chronic cluster headache patients.
Details
| Lead sponsor | Autonomic Technologies, Inc. |
|---|---|
| Phase | NA |
| Status | UNKNOWN |
| Enrolment | 120 |
| Start date | 2014-07 |
| Completion | 2020-03 |
Conditions
- Chronic Cluster Headache
Interventions
- ATI Neurostimulation System
Primary outcomes
- Primary Safety — One year post-implant
Characterization of all serious adverse events in all subjects who undergo an implantation procedure, through the completion of the Open Label Period. - Primary Efficacy — 28 weeks post-implant
Compared between the two study arms: Proportion of stimulation-treated ipsilateral cluster attacks that achieve pain relief at 15 minutes following the start of stimulation without the use of acute medications prior to that time point.
Countries
United States