Study of the Safety and Efficacy of Tropicamide Thin Films to Reduce Hypersalivation in Parkinson… (NCT01844648) | Clinical Trial Compass
CompletedPhase 2
Study of the Safety and Efficacy of Tropicamide Thin Films to Reduce Hypersalivation in Parkinson's Patients
France30 participantsStarted 2013-04
Plain-language 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.
Who can participate
Age range30 Years
SexALL
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Inclusion criteria:
* Patients with idiopathic Parkinson's disease, according to the UK Brain Bank criteria.
* Patients complaining of drooling, with a score of at least 6 points in the SCS-PD scale.
* Patients above 30 years old.
* Patients with Hoehn \& Yahr score between I-IV.
* Male or non-pregnant female. Females of child-bearing potential will be required to have undergone a pregnancy test with negative results prior to entry to the study and agree to use contraceptive measures for the duration of the study.
* Patients must have used the same antiparkinsonian medications and at the same dose for the last month. No changes in the medication for PD are expected during the study.
Exclusion criteria:
* Pregnant women.
* Patients with a secondary parkinsonian syndrome, parkinsonism-plus syndromes, heredodegenerative disorders or benign parkinsonism.
* Patients with a diagnosis of major depression or psychosis according to the DSM-IV.
* Patients with MMSE score equal to or lower than 24.
* Patients with a current diagnosis of substance abuse (DSM-IV) or history of alcohol or drug abuse in the past 3 months.
* Patients with hallucinations.
* Patients with a current clinically significant gastrointestinal, renal, hepatic, endocrine, pulmonary or cardiovascular disease, including hypertension that is not well-controlled, asthma, chronic obstructive pulmonary disease (COPD) and Type I diabetes.
* Patients with a second- or third-degree atrioventricular block or sick sinus synd…