NCT01844648

Study of the Safety and Efficacy of Tropicamide Thin Films to Reduce Hypersalivation in Parkinson's Patients

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: NeuroHealing Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Sialorrhea (Excessive Drooling)

Interventions

Type	Name	Description
DRUG	NH004 tropicamide	Intra-oral slow dissolving muco-adhesive thin film containing 1 mg tropicamide
DRUG	NH004 Placebo	Intra-oral slow dissolving muco-adhesive thin film

Timeline

• Start date: 2013-04-01
• Primary completion: 2015-10-01
• Completion: 2015-12-01
• First posted: 2013-05-01
• Last updated: 2015-12-10

Locations

3 sites across 1 country: France