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 ]

The primary endpoint for this trial is the difference in responder rate between tropicamide and placebo. Responders will be defined as subjects whose mean sialorrhea score improved by at least 30% as compared to baseline in the 9-point modified Teachers Drooling Scale (mTDS).


Original Primary Outcome: modified TDS (% responding) [ Time Frame: one week ]

The primary endpoint for this trial is the difference in responder rate between tropicamide and placebo. Responders will be defined as subjects whose mean sialorrhea score improved by at least 30% as compared to baseline in the 9-point modified Teachers Drooling Scale (mTDS).


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