A double-blind, placebo-controlled, randomized, crossover pilot study of thesafety and short-term antisialorrheic efficacy of multiple doses of intra-oral tropicamide films in Parkinson\'s disease
Dr. Santiago Perez Lloret
Disclosure : I received honoraria from NeuroHealing Pharmaceuticals Inc for conducting this study.
10 slide(s) – English – 2011-09-10
Background: Sialorrhea is a common non-motor symptom in PD. Short-acting antimuscarinic, such as tropicamide, may reduce saliva secretion without the side effects associated with long-acting antimuscarinics.
Objective: To explore the anti-sialorrhea effect of single doses of tropicamide administered in a slow dissolving, muco-adhesive, intra-oral thin film.
Methods: 19 PD patients who complained of sialorrhea received 3 doses (0.3,1,3 mg) of tropicamide and placebo delivered in a muco-adhesive film, in random order, separated by at least 7 days. A 10-cm visual analog scale (VAS) was used to measure the patient’s subjective assessment of saliva levels, at baseline and at 15, 30, 45, 90 and 120 min after treatment administration. For the last 7 patients, saliva volume was measured at baseline and 75 min after treatment by weighing cotton rolls placed into buccal cavity for 5 minutes. Vital signs were monitored and ECGs were performed.
Results: The mean age of the patients was 67±12 years, 78% were males. Median disease duration=8 years. VAS score differences (baseline to120 min) were -0.55±0.54, -1.08±0.54, -1.53±0.52 and -0.81±0.51 for placebo and 0.3, 1 and 3 mg tropicamide, respectively. While treatment effects were non-significant (F=0.6 p=0.6, ANOVA), the 1 mg tropicamide resulted in a significant decrease in the VAS score. Saliva volume was reduced by 11-33% after tropicamide vs 5% with placebo (p=0.3, Friedman). No adverse events were detected.
Conclusion: Results of this pilot, proof-of-concept study show that NH004 was safe and exerted effects worthy of further exploration as a possible treatment for sialorrhea in Parkinson’s disease.