Study of the Safety and Efficacy of Tropicamide Thin Films to Reduce Hypersalivation in Parkinson's Patients
- Conditions
- Sialorrhea (Excessive Drooling)
- Interventions
- Drug: NH004 Placebo
- Registration Number
- NCT01844648
- Lead Sponsor
- NeuroHealing Pharmaceuticals Inc.
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description NH004 placebo NH004 Placebo placebo thin film, twice daily for 7 days NH004 tropicamide NH004 tropicamide tropicamide 1 mg thin film, twice daily for 7 days
- Primary Outcome Measures
Name Time Method modified Teachers Drooling Scale (% responding) 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).
- Secondary Outcome Measures
Name Time Method Visual Analg Scale one week Saliva buccal content as measured by a Visual Analog Scale (VAS) score, evaluated before and during 3 hours after treatments administration.
modified Teachers Drooling Scale (mean) 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) 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) one week Difference in the mean sialorrhea scores between placebo and tropicamide in the UPDRS Part II sialorrhea item (#6).
Trial Locations
- Locations (3)
Hôpital Paul de Viguier
🇫🇷Toulouse, Cedrex 9, France
Hôpital Haut Lévêque
🇫🇷Bordeaux, Pessac, France
Hôpital de la Salpêtrière
🇫🇷Paris, Cedrex 13, France