Clinical trial NCT02439125: A Study of Efficacy and Safety of Eltoprazine HCl for Treating Levodopa-induced Dyskinesia in Parkinson's Disease Patients
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Parkinson's Disease
Dyskinesia
Keywords: levodopa
dyskinesia
parkinsons disease
PD
Lead sponsor: Amarantus BioScience Holdings, Inc.
Sponsor class: INDUSTRY
First posted: 2015-05-08
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Clinical impact of dyskinesia measured by total UDysRS (Unified Dyskinesia Rating Scale) score
timeFrame: 84 days
Secondary outcomes:
measure: • PD motor symptoms assessed by MDS-UPDRS, diaries and physiological measurement with motion sensor system
timeFrame: 84 days
measure: Dyskinesia severity using physiological motion sensor system
timeFrame: 84 days
measure: Patient function using MDS-UPDRS and UDysRS questionnaires quantify dyskinesia and Parkinsonian motor symptoms.
timeFrame: 84 days
measure: Safety and tolerability: adverse events, physical and neurological exams, safety laboratory values, vital signs and ECG
timeFrame: 94 days
Other outcomes:
Locations:
city: Boca Raton
country: United States
facility: Parkinson's Disease and Movement Disorders Center, Boca Raton
state: Florida
Study officials:
affiliation: Amarantus BioScience Holdings, Inc.
name: Charlotte Keywood, MBBS,MRCP,
role: STUDY_DIRECTOR
References:
citation: Svenningsson P, Rosenblad C, Af Edholm Arvidsson K, Wictorin K, Keywood C, Shankar B, Lowe DA, Bjorklund A, Widner H. Eltoprazine counteracts l-DOPA-induced dyskinesias in Parkinson's disease: a dose-finding study. Brain. 2015 Apr;138(Pt 4):963-73. doi: 10.1093/brain/awu409. Epub 2015 Feb 10.
citation: McFarthing K, Prakash N, Simuni T. CLINICAL TRIAL HIGHLIGHTS - DYSKINESIA. J Parkinsons Dis. 2019;9(3):449-465. doi: 10.3233/JPD-199002. No abstract available.