Randomized, double-blind, placebo-controlled trial to evaluate the efficacy of continuous subcutaneous apomorphine infusion in Parkinson*s disease patients with refractory visual hallucinations

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 35

Inclusion Criteria

• Female and male subjects aged >=30;
• Diagnosis of clinical established PD, defined by the MDS-PD criteria (Postuma et al., 2015);
• Presence of visual hallucinations, defined as minimal 1 time a week;
• Visual hallucinations must have developed after PD diagnosis;
• Visual hallucinations must have been optimally treated with reduction of dopamine agonists, if appropriate;
• Female subjects must complaint with a highly effective contraceptive method (oral hormonal contraception alone is not considered highly effective and must be used in combination with a barrier method) during the study, if sexually active;
• Subjects should be able and capable of adhering to the protocol, visit schedules, and medication intake according to the judgement of the investigator.

Exclusion Criteria

• Symptomatic, clinically relevant and medically uncontrolled orthostatic hypotension;
• Patients with a prolonged QT interval corrected for heart rate according to Bazett*s formula (QTc) of >450 ms for male and >470 ms for female at screening, or history of a long QT syndrome;
• PD medication change (i.e., dopamine-agonists, amantadine, MAO-B inhibitor, anticholinergics and cholinesterase inhibitors) in last month prior to initiation (van Laar et al., 2010);
• Active psychosis or a history of significant psychosis;
• Any medical condition that is likely to interfere with an adequate participation in the study including e.g. current diagnosis of unstable epilepsy, clinically relevant cardiac dysfunction and/or myocardial infarction or stroke within the last 12 months.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint of this trial is the subjective impression of severity<br /><br>measured with CGI-S.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study endpoints are:<br /><br>• Change in symptoms of visual hallucinations measured with the NPI-Q.<br /><br>• Subjective impression of improvement measured with CGI-I.<br /><br>• Change in cognition measured with MoCA.<br /><br>• Change in sleeping problems measured with PDSS-II.<br /><br>• Change in depression and anxiety measured with HADS.<br /><br>• Change in apathy measured with AS.<br /><br>• Change in motor function measured with MDS-UPDRS III, IV and V.<br /><br>• Change in visual perception measured with VOSP battery.<br /><br>• Change in attention measured with TAP.<br /><br>• Change in symptoms of visual hallucinations measured with VHQ.<br /><br><br /><br>Safety endpoints are:<br /><br>• Change in blood pressure (e.g. orthostatic hypotension).<br /><br>• Occurrence of side effects.</p><br>