A Study of Efficacy and Safety of Eltoprazine HCl for Treating Levodopa-induced Dyskinesia in Parkinson's Disease Patients

• Status: Unknown status
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety, tolerability and efficacy of eltoprazine to treat levodopa-induced dyskinesia in patients with Parkinson's disease

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amarantus BioScience Holdings, Inc.
• Treatments: Eltoprazine; Levodopa

Criteria

Inclusion Criteria:

• outpatient with idiopathic PD

• stable dose of anti-parkinsonian medication for at least four weeks before the Screening Visit

• daily levodopa dose ≥300 mg per day divided into at least three doses

• treated with levodopa for at least three years prior to study entry

• moderate to severely disabling levodopa-induced dyskinesia for at least three months prior to study entry

• dyskinesia for, on average, >25% of the waking day

Exclusion Criteria:

• inability to use the motion sensors or electronic diaries correctly

• surgical treatment for PD, e.g. Deep Brain Stimulation, within the last six months or planned during the study

• unstable co-existing psychiatric disease including psychosis, depression or cognitive impairment

• Mini Mental State Examination score of <24

• moderate or severe renal, or severe hepatic, impairment

• treatment with selective serotonin re-uptake inhibitors (SSRI) or any combined serotonin-norepinephrine re-uptake inhibitors (SNRI), such as tryptizol, citalopram, escitalopram, sertraline, mianserin, mirtazapin, paroxetin, venlafaxine and St John's Wort, within four weeks prior to the Screening Visit

• treatment with medications with the potential for drug-interactions (MAO-A inhibitors, apomorphine, aripiprazol, carbamazepine, clozapine, phenytoin, tramadol, quetiapine, varfaine, valproic acid). Patients taking amantadine will comprise no more than 25% of the study population

• current history of a clinically significant and uncontrolled medical condition that may affect the safety of the patient or preclude adequate participation in the study

• pregnant or breast-feeding

• received any other investigational medicinal product within 30 days of Screening