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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
30
Intra-oral slow dissolving muco-adhesive thin film containing 1 mg tropicamide
Intra-oral slow dissolving muco-adhesive thin film
Hôpital de la Salpêtrière
Paris, Cedrex 13, France
Hôpital Paul de Viguier
Toulouse, Cedrex 9, France
Hôpital Haut Lévêque
Bordeaux, Pessac, France
modified Teachers Drooling Scale (% responding)
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).
Time frame: one week
modified Teachers Drooling Scale (mean)
Difference in the mean sialorrhea scores between placebo and tropicamide in the 9-point modified Teachers Drooling Scale (mTDS).
Time frame: one week
Sialorrhea Clinical Scale for Parkinson's Disease (mean)
\- Difference in the mean sialorrhea scores between placebo and tropicamide in the Sialorrhea Clinical Scale for Parkinson's Disease (SCS-PD).
Time frame: one week
UPDRS Part II sialorrhea item (mean)
Difference in the mean sialorrhea scores between placebo and tropicamide in the UPDRS Part II sialorrhea item (#6).
Time frame: one week
Visual Analg Scale
Saliva buccal content as measured by a Visual Analog Scale (VAS) score, evaluated before and during 3 hours after treatments administration.
Time frame: one week
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.