A Study of Efficacy and Safety of Eltoprazine HCl for Treating Levodopa-induced Dyskinesia in Parkinson's Disease Patients
Status unconfirmed · Phase 2 · Has a placebo group
Conditions studied: Parkinson's Disease, Dyskinesia
In brief
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
Key facts
- Study ID
- NCT02439125
- Run by
- Amarantus BioScience Holdings, Inc.
- People needed
- 60
- Starts
- 2015-05-01
- Expected to finish
- 2017-12-01
- Last updated by the study team
- 2016-04-22
Who can join
Age: 30 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Parkinson's Disease and Movement Disorders Center, Boca Raton — Boca Raton, Florida, United States
Full record on ClinicalTrials.gov
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