6533b7d3fe1ef96bd126092a

RESEARCH PRODUCT

Pathway CH-1 Study: Sphenopalatine Ganglion (SPG) Stimulation for Acute Treatment of Chronic Cluster Headache (CCH) - Initial Experience (S36.002)

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Objective: We aimed to investigate the safety and efficacy of SPG stimulation for the acute treatment of CCH. Background The pain and autonomic symptoms of cluster headache result from activation of the trigeminal parasympathetic reflex, mediated through the SPG. Design/Methods: A multi-center, dose range finding, multiple headache attack (HA), acute treatment study with random insertion of placebo has been initiated. All subjects meet the ICHD-II criteria for CCH with a minimum of 4 HAs/week. Subjects are implanted with a miniaturized neurostimulator which, along with a controller, provides SPG stimulation. Prior to the randomized period, stimulation parameters are adjusted in a titration period. Pain relief at15 minutes (decrease to 9none9 or 9mild9 on the 5-point categorical scale) was analyzed. Results: Of the 28 implanted subjects, 20 have completed the titration period. Of the 20, 17 (85%) achieved pain relief in ≥50% of treated HAs from the titration period and/or a reduction in the average HA frequency to ≤1 HA/week. 11 (55%) achieved pain relief in 67% or more of treated HAs. 9 (45%) experienced an average HA reduction from 10 HAs/week to ≤1 HA/week for an average duration of 3 months (frequency reduction is ongoing in these 9 subjects). 3 of the 20 subjects did not respond. 3 other subjects were explanted due to early lead migration or improper lead placement. 1 subject underwent lead revision surgery and now achieves pain relief with SPG stimulation. Conclusions: The initial experiences indicate SPG stimulation may be a safe and effective novel therapy for CCH. Supported by: Autonomic Technologies, Inc. Disclosure: Dr. Lainez has received personal compensation for activities with Autonomic Technologies as a consultant. Dr. Jensen has received personal compensation for activities with Autonomic Technologies as a consultant. Dr. May has received personal compensation for activities with Autonomic Technologies as a consultant. Dr. Lanteri-Minet has received personal compensation for activities with Allergan, Almirall, Grunenthal, GSK, Lilly, Medtronic, Menarini, Pfizer, Autonomic Technologies and Zambon as a consultant. Dr. Lanteri-Minet has received research support from GSK and Janssen-Cilag. Dr. Gaul has received personal compensation for activities with Merck Sharp & Dohme Limited, Berlin-Chemie, Medtronic, and Boehringer Ingelheim Pharmaceuticals, Inc. as a consultant. Dr. Goodman has received personal compensation for activities with Autonomic Technologies as an employee. Dr. Goodman holds stock and/or stock options in Autonomic Technologies. Dr. Caparso has received personal compensation for activities with Autonomic Technologies as an employee. Dr. Caparso holds stock and/or stock options in Autonomic Technologies. Dr. Schoenen has received personal compensation for activities with Autonomic Technologies as a consultant.