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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
35
Continuous subcutaneous infusion of apomorphine during waking day
Continuous subcutaneous infusion of placebo during waking day
Department of Neurology
Groningen, Netherlands
RECRUITINGClinical Global Impression of Severity
Clinical Global Impression of Severity questionnaire
Time frame: Four weeks
Clinical Global Impression of Improvement
Clinical Global Impression of Improvement questionnaire
Time frame: Four weeks
Cognition
Montreal Cognitive Assessment
Time frame: Four weeks
Depression
Hamilton Anxiety and Depression Scale
Time frame: Four weeks
Anxiety
Hamilton Anxiety and Depression Scale
Time frame: Four weeks
Motor symptoms
Part III of Movement Disorders Society - Unified Parkinson's Disease Rating Scale
Time frame: Four weeks
Motor complications
Part IV of Movement Disorders Society - Unified Parkinson's Disease Rating Scale
Time frame: Four weeks
Sleeping problems
Parkinson's Disease Sleep Scale
Time frame: Four weeks
Neuropsychiatric symptoms
Neuropsychiatric Inventory - Questionnaire
Time frame: Four weeks
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Visual Hallucinations
Dutch Visual Hallucinations Questionnaire
Time frame: Four weeks
Attention
Reaction Time Task
Time frame: Four weeks
Visual perception
Visual Object and Space Perception battery
Time frame: Four weeks
Apathy
Apathy Scale
Time frame: Four weeks
Quality of Life
Parkinson's Disease Questionnaire (shortened version)
Time frame: Four weeks