Trial to evaluate the efficacy of continuous subcutaneous apomorphine infusion in Parkinson’s disease patients with refractory visual hallucinations.

Phase 1

• Conditions: Parkinson's disease patients with refractory visual hallucinations; MedDRA version: 19.0Level: PTClassification code 10061536Term: Parkinson's diseaseSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2016-000102-11-NL
• Lead Sponsor: niversity Medical Center Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-08
• Last Update Posted: 28 November 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Female and male subjects aged =30;
- Diagnosis of established PD, defined by the MDS-PD criteria (Postuma et al., 2015);
- Presence of visual severe hallucinations defined as more than 3 times a week (van Laar et al., 2010);
- Visual hallucinations must have developed after PD diagnosis;
- Visual hallucinations must have been optimally treated with reduction of dopamine agonists if possible, and prescription of clozapine and/or cholinesterase inhibitors if needed;
- 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

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 clinical trial of medicinal product
• Study Design: Not specified