Parkinson's Disease Clinical Trial
Official title:
Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy of Continuous Subcutaneous Infusion in Parkinson's Disease Patients With Refractory Visual Hallucinations
This randomised, double-blind, placebo-controlled trial will evaluate the efficacy of continuous apomorphine infusion compared to placebo in PD patients with visual hallucinations, inadequately controlled with clozapine and cholinesterase inhibitors.
Introduction Visual hallucinations occur frequently in Parkinson's disease (PD). The
prevalence of visual hallucinations ranges from 22 to 38%, increasing after long-term
follow-up to more than 60%. Risk factors for visual hallucinations are age, disease
duration, and cognitive impairment. The treatment of visual hallucinations is cumbersome and
options are limited. Only clozapine has been proven to be efficacious without deteriorating
the motor symptoms of PD. Instead of oral dopamine agonists and rotigotine, continuous
infusion of apomorphine is well-tolerated in PD patients with cognitive impairments and/or
visual hallucinations. Even beneficial effect of apomorphine on visual hallucinations are
suggested, however there is lack of a randomized controlled trial.
The purpose of this randomised, double-blind, placebo-controlled trial is to evaluate the
efficacy of continuous apomorphine infusion compared to placebo in PD patients with visual
hallucinations, inadequately controlled with clozapine and cholinesterase inhibitors.
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