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

• Register: ClinicalTrials.gov
• Last refreshed on: 2 May 2016
• Main ID: NCT02439125
• Date of registration: 13/04/2015
• Prospective Registration: Yes
• Primary sponsor: Amarantus BioScience Holdings, Inc.
• Public title: A Study of Efficacy and Safety of Eltoprazine HCl for Treating Levodopa-induced Dyskinesia in Parkinson's Disease Patients
• Scientific 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
• Date of first enrolment: May 2015
• Target sample size: 60
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02439125
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Charlotte Keywood, MBBS,MRCP,
• Affiliation: Amarantus BioScience Holdings, Inc.

Key inclusion & exclusion 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



Age minimum: 30 Years
Age maximum: 85 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Dyskinesia

Parkinson's Disease

Intervention(s)

Drug: Placebo

Drug: Eltoprazine HCl

Primary Outcome(s)

Clinical impact of dyskinesia measured by total UDysRS (Unified Dyskinesia Rating Scale) score [Time Frame: 84 days]

Secondary Outcome(s)

Dyskinesia severity using physiological motion sensor system [Time Frame: 84 days]

• PD motor symptoms assessed by MDS-UPDRS, diaries and physiological measurement with 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]

Secondary ID(s)

AMBS-ELTO-201

Source(s) of Monetary Support

Please refer to primary and secondary sponsors