A Phase II, double-blind, placebo-controlled, randomized, crossover pilot study of the safety and efficacy of multiple doses of intra-oral tropicamide films for the short-term relief of sialorrhea symptoms in Parkinson's Disease (PD) patients.

SANTIAGO PEREZ-LLORET; ELKAN GAMZU; MARCELO MERELLO

Toronto, Canada

Congreso; Congreso Internacional de Movimientos Anormales; 2011

Objective: To explore the anti-sialorrhea effect of single doses of tropicamide administered in a slowdissolving, muco-adhesive, intra-oral thin film.Background: Sialorrhea in is a common non-motor symptom in PD. Short-acting anticholinergic agents, suchas tropicamide (plasma half-life of 30 min), have the potential to reduce saliva secretion without the sideeffects associated with long-acting cholinergic blockers.Methods: 19 non-demented, idiopathic PD patients in the ON state who complained of sialorrhea according tothe SCS-PD received 3 doses (0.3, 1, 3 mg) of tropicamide and placebo delivered in a muco-adhesive film, inrandom order, separated by at least 7 days. A 10-cm visual analog scale (VAS) was used to measure thepatient´s subjective assessment of saliva levels. VAS was assessed at baseline and at 15, 30, 45, 90 and 120min after treatment administration. For the last 7 patients, saliva volume was measured at baseline and 75min after treatment by weighing cotton rolls placed into buccal cavity for 5 minutes. Vital signs were monitoredResults: The mean age of the patients was 67 12 years, 15 of whom (78%) were male. Median diseaseduration was 8 years. VAS score differences (baseline to120 min) were -0.55 0.54, -1.08 0.54, -1.53 0.52and -0.81 0.51 for placebo and 0.3, 1 and 3 mg tropicamide, respectively. While treatment effects werenon-significant (F=0.6 p=0.6, ANOVA), the 1 mg tropicamide resulted in a significant decrease from 0 to 120min in the VAS score. Saliva volume was reduced by 11-26% after tropicamide vs 5% with placebo (p=0.5,Friedman). No adverse events were detected in any of the treatment sequences.Conclusions: Results of this pilot, proof-of-concept study show that NH004 (intra-orally deliveredtropicamide) was safe and exerted effects worthy of further exploration as a possible treatment for sialorrhea inParkinson´s disease.