Phase 2, multicenter, randomized, double-blind, placebo-controlled, four-period cross-over, dose-range finding study to evaluate the safety, tolerability and efficacy of Eltoprazine in the treatment of levodopa induced dyskinesia in patients with Parkinson's disease.

Amarantus BioScience Holdings, Inc.0 sites60 target enrollmentMay 18, 2015

Overview

No summary available.

Registry

who.int

Start Date

May 18, 2015

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•A patient will be invited to participate if he/she meets the following inclusion criteria:
•1\. willing and able to provide written informed consent
•2\. age 30 to 85 years, inclusive
•3\. outpatient with idiopathic PD according to the UK Parkinson’s Disease Society Brain Bank Clinical Diagnosis Criteria (UKPDSBBCDC)
•4\. on a PD treatment regimen with a stable dose of anti\-Parkinsonian medication for at least four weeks before the Screening Visit (levodopa, DDIs, COMT inhibitors, dopamine agonists and MAO\-B inhibitors)
•5\. treated with a daily levodopa dose (immediate or extended release formulation) more than 300 mg per day divided into at least three doses
•6\. treated with levodopa for at least three years prior to study entry
•7\. has been experiencing levodopa induced peak\-dose dyskinesia for at least three months prior to study entry
•8\. experiences disabling dyskinesia (Screening Visit MDS\-UPDRS Part IV question 4\.2 score \=2\)
•9\. has dyskinesia for, on average, \>25% of the waking day based on patient reported dyskinesia (tablet diaries) during the second week of the screening period

•A patient will be excluded from study participation if he/she meets any of the following
•1\. inability to use the Kinesia 360 system (tablet or motion sensors) correctly,
•diaries not completed in a timely manner or two or more hours’ worth of missing waking day entries” or times PD\-LID medication taken missing
•2\. surgical treatment for PD (e.g. DBS), within the last six months or planned during the study
•3\. unstable co\-existing psychiatric disease including psychosis, depression or
•cognitive impairment that, according to the Investigator, could interfere with the conduct of the study
•4\. has an MMSE score of \<24
•5\. has a known clinically significant allergy or known hypersensitivity to drugs that, in the opinion of the Investigator, may affect the patient’s safety
•6\. has moderate or severe renal or severe hepatic impairment and/or has clinically significant abnormal laboratory parameters at screening, in particular, liver or renal function tests greater than 1\.5 times the upper limit of normal (ULN) or any other clinically significant biochemical or hematological abnormality as determined by the Investigator
•7\. 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.