Study of the Safety and Efficacy of Tropicamide Thin Films to Reduce Hypersalivation in Parkinson's Patients
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|ClinicalTrials.gov Identifier: NCT01844648|
Recruitment Status : Completed
First Posted : May 1, 2013
Last Update Posted : December 10, 2015
|Condition or disease||Intervention/treatment||Phase|
|Sialorrhea (Excessive Drooling)||Drug: NH004 tropicamide Drug: NH004 Placebo||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||October 2015|
|Actual Study Completion Date :||December 2015|
Experimental: NH004 tropicamide
tropicamide 1 mg thin film, twice daily for 7 days
Drug: NH004 tropicamide
Intra-oral slow dissolving muco-adhesive thin film containing 1 mg tropicamide
Placebo Comparator: NH004 placebo
placebo thin film, twice daily for 7 days
Drug: NH004 Placebo
Intra-oral slow dissolving muco-adhesive thin film
- 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).
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01844648
|Hôpital de la Salpêtrière|
|Paris, Cedrex 13, France, 75651|
|Hôpital Paul de Viguier|
|Toulouse, Cedrex 9, France, 31059|
|Hôpital Haut Lévêque|
|Bordeaux, Pessac, France, 33604|
|Study Director:||Elkan R Gamzu, PhD||NeuroHealing Pharmaceuticals Inc.|