Clinical Trial: Apomorphine in Parkinson's Disease Patients With Visual Hallucinations

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy of Continuous Subcutaneous Infusion in Parkinson's Disease Patients With Refractory Visual Hallucinati

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: University Medical Center Groningen

Current Primary Outcome: Clinical Global Impression of Severity [ Time Frame: Four weeks ]

Clinical Global Impression of Severity questionnaire


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Clinical Global Impression of Improvement [ Time Frame: Four weeks ]
    Clinical Global Impression of Improvement questionnaire
  • Cognition [ Time Frame: Four weeks ]
    Montreal Cognitive Assessment
  • Depression [ Time Frame: Four weeks ]
    Hamilton Anxiety and Depression Scale
  • Anxiety [ Time Frame: Four weeks ]
    Hamilton Anxiety and Depression Scale
  • Motor symptoms [ Time Frame: Four weeks ]
    Part III of Movement Disorders Society - Unified Parkinson's Disease Rating Scale
  • Motor complications [ Time Frame: Four weeks ]
    Part IV of Movement Disorders Society - Unified Parkinson's Disease Rating Scale
  • Sleeping problems [ Time Frame: Four weeks ]
    Parkinson's Disease Sleep Scale
  • Neuropsychiatric symptoms [ Time Frame: Four weeks ]
    Neuropsychiatric Inventory - Questionnaire
  • Visual Hallucinations [ Time Frame: Four weeks ]
    Dutch Visual Hallucinations Questionnaire
  • Attention [ Time Frame: Four weeks ]
    Reaction Time Task
  • Visual perception [ Time Frame: Four weeks ]
    Visual Object and Space Perception battery
  • Apathy [ Time Frame: Four weeks ]
    Apathy Scale
  • Quality of Life [ Time Frame: Four weeks ]
    Parkinson's Disease Questionnaire (shortened version)


Original Secondary Outcome: Same as current

Information By: University Medical Center Groningen

Dates:
Date Received: March 2, 2016
Date Started: May 2017
Date Completion: December 2017
Last Updated: May 1, 2017
Last Verified: May 2017