Dyskinesia, Parkinson's Disease
Conditions
Keywords
levodopa, dyskinesia, parkinsons disease, PD
Brief 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
Detailed 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.
Interventions
DRUGEltoprazine HCl
2.5 mg b.i.d. orally for 3 weeks
DRUGPlacebo
b.i.d. orally for 3 weeks
Sponsors
Amarantus BioScience Holdings, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical impact of dyskinesia measured by total UDysRS (Unified Dyskinesia Rating Scale) score | 84 days | Clinical impact on dyskinesia measured by total UDysRS (Unified Dyskinesia Rating Scale) score at the end of each Treatment Period on Days 21, 42, 63 and 84 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| • PD motor symptoms assessed by MDS-UPDRS, diaries and physiological measurement with motion sensor system | 84 days | • PD motor symptoms assessed by MDS-UPDRS, diaries and physiological measurement with motion sensor system |
| Dyskinesia severity using physiological motion sensor system | 84 days | Dyskinesia severity using physiological motion sensor system |
| Patient function using MDS-UPDRS and UDysRS questionnaires quantify dyskinesia and Parkinsonian motor symptoms. | 84 days | Patient function using MDS-UPDRS and UDysRS questionnaires |
| Safety and tolerability: adverse events, physical and neurological exams, safety laboratory values, vital signs and ECG | 94 days | Safety and tolerability: adverse events, physical and neurological exams, safety laboratory values, vital signs and ECG |
Countries
United States
Outcome results
None listed