A 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 patients.

SANTIAGO PÉREZ LLORET; GABRIELA NANO; ANDREA CARROSELLA; ELKAN GAMZU; MARCELO MERELLO

JOURNAL OF THE NEUROLOGICAL SCIENCES

ELSEVIER SCIENCE BV

Lugar: Amsterdam; Año: 2011 vol. 15 p. 248 - 250

0022-510X

OBJECTIVE: This proof-of-concept, pilot study aimed to explore the safety and anti-sialorrhea efficacy of single doses of intra-oral slow dissolving thin films containing tropicamide (NH004) or placebo. METHODS: Nineteen non-demented, idiopathic stable or fluctuating PD patients who complained of sialorrhea received 3 doses (0.3, 1, 3mg) of tropicamide and placebo in random order, separated by 7 days. A 10-cm visual analog scale (VAS) was used to measure the patient´s subjective feelings 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. Fluctuating patients were evaluated in the ON-condition. RESULTS: The mean age of included patients was 67±12 years, 78% were male. Median disease duration was 8 years. The mean decrease in VAS score from baseline to 120 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 3mg tropicamide, respectively (F=0.6 p=0.6, ANOVA). Tropicamide 1mg resulted in a significant VAS score decrease (95%CI: -2.57 to -0.48). Saliva volume was reduced by 27%, 33% or 20% after tropicamide 0.3, 1 or 3mg vs 5% with placebo (p=0.5, Friedman). No adverse events were detected in any of the treatment sequences. DISCUSSION: Results of this pilot, proof-of-concept study show that NH004 was safe and exerted antisialorrhea effects worthy of further exploration.