Clinical Trial: Study of the Safety and Efficacy of Tropicamide Thin Films to Reduce Hypersalivation in Parkinson's Patients
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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 Hyper
Brief 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 Summary:
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.
Sponsor: NeuroHealing Pharmaceuticals Inc.
Current Primary Outcome: modified Teachers Drooling Scale (% responding) [ Time Frame: one week ]
Original Primary Outcome: modified TDS (% responding) [ Time Frame: one week ]
Current Secondary Outcome:
- modified Teachers Drooling Scale (mean) [ Time Frame: one week ]Difference in the mean sialorrhea scores between placebo and tropicamide in the 9-point modified Teachers Drooling Scale (mTDS).
- Sialorrhea Clinical Scale for Parkinson's Disease (mean) [ Time Frame: one week ]- Difference in the mean sialorrhea scores between placebo and tropicamide in the Sialorrhea Clinical Scale for Parkinson's Disease (SCS-PD).
- UPDRS Part II sialorrhea item (mean) [ Time Frame: one week ]Difference in the mean sialorrhea scores between placebo and tropicamide in the UPDRS Part II sialorrhea item (#6).
- Visual Analg Scale [ Time Frame: one week ]Saliva buccal content as measured by a Visual Analog Scale (VAS) score, evaluated before and during 3 hours after treatments administration.
Original Secondary Outcome:
- mTDS (mean) [ Time Frame: one week ]- Difference in the mean sialorrhea scores between placebo and tropicamide in the 9-point mTDS.
- SCS-PD (mean) [ Time Frame: one week ]- Difference in the mean sialorrhea scores between placebo and tropicamide in the SCS-PD.
- UPDRS Part II sialorrhea item (mean) [ Time Frame: one week ]- Difference in the mean sialorrhea scores between placebo and tropicamide in the UPDRS Part II sialorrhea item (#6).
- VAS [ Time Frame: one week ]- Saliva buccal content as measured by a VAS scores, evaluated before and during 3 hours after treatments administration.
Information By: NeuroHealing Pharmaceuticals Inc.
Dates:
Date Received: April 29, 2013
Date Started: April 2013
Date Completion:
Last Updated: December 8, 2015
Last Verified: April 2014