This trial is active, not recruiting.

Conditions parkinson's disease, dyskinesia
Treatments eltoprazine hcl, placebo
Phase phase 2
Sponsor Amarantus BioScience Holdings, Inc.
Start date May 2015
End date June 2017
Trial size 60 participants
Trial identifier NCT02439125, AMBS-ELTO-201


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Eltoprazine HCl 2.5 mg capsules to be taken orally b.i.d. (ie, 5 mg/day) for 3 weeks
eltoprazine hcl
2.5 mg b.i.d. orally for 3 weeks
Eltoprazine HCl 5.0 mg capsules to be taken orally b.i.d. (ie, 10 mg/day) for 3 weeks
eltoprazine hcl
5.0 mg b.i.d. orally for 3 weeks
Eltoprazine HCl 7.5 mg capsules to be taken orally b.i.d. (ie, 15 mg/day) for 3 weeks
eltoprazine hcl
7.5 mg b.i.d. orally for 3 weeks
(Placebo Comparator)
Placebo capsules to be taken orally b.i.d. for 3 weeks
b.i.d. orally for 3 weeks

Primary Outcomes

Clinical impact of dyskinesia measured by total UDysRS (Unified Dyskinesia Rating Scale) score
time frame: 84 days

Secondary Outcomes

• PD motor symptoms assessed by MDS-UPDRS, diaries and physiological measurement with motion sensor system
time frame: 84 days
Dyskinesia severity using physiological motion sensor system
time frame: 84 days
Patient function using MDS-UPDRS and UDysRS questionnaires quantify dyskinesia and Parkinsonian motor symptoms.
time frame: 84 days
Safety and tolerability: adverse events, physical and neurological exams, safety laboratory values, vital signs and ECG
time frame: 94 days

Eligibility Criteria

Male or female participants from 30 years up to 85 years old.

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

Additional Information

Official title Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, 4-way Crossover, Dose-finding Study, of Eltoprazine Safety, Tolerability and Efficacy in the Treatment of Levodopa-induced Dyskinesia in Patients With Parkinson's Disease
Description A double-blind, placebo-controlled, crossover, dose-range finding study in patients with Parkinson's disease and levodopa-induced dyskinesia. The study will examine the effects of three different doses of eltoprazine HCl, compared to placebo, on severity of dyskinesia, parkinsonian symptoms, patient function, safety and tolerability, using Parkinson's disease rating scales, patient diaries and physiological measurement of abnormal movement by means of motion sensors.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Amarantus BioScience Holdings, Inc..