Sialorrhea (Excessive Drooling) Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled, Crossover Study of the Safety and Efficacy of Tropicamide 1 mg Intra-oral Slow Dissolving Muco-adhesive Thin Films to Reduce Hypersalivation in PD Patients Manifesting Sialorrhea Complaints
To study the safety and efficacy of tropicamide 1 mg intra-oral slow dissolving muco-adhesive thin films compared to placebo to reduce hypersalivation in PD patients manifesting sialorrhea complaints.
This is a double-blind, placebo-controlled, randomized, crossover, multicentre study
comparing intra-oral slow dissolving muco-adhesive thin films containing tropicamide 1 mg or
Placebo. Patients will receive each treatment twice daily (1 h after breakfast and 1 h after
lunch) for 1-week.
Patients will be evaluated for eligibility during the 14-day screening period. Those
patients meeting all entry criteria at baseline will be randomized (1:1) to receive first
tropicamide followed by placebo films or vice versa. Patients will return for regularly
scheduled visits at Weeks 1 and 3 or at early discontinuation.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment