A Study of Efficacy and Safety of Eltoprazine HCl for Treating Levodopa-induced Dyskinesia in Parkinson's Disease Patients
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
1 other identifier
interventional
60
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 13, 2015
CompletedStudy Start
First participant enrolled
May 1, 2015
CompletedFirst Posted
Study publicly available on registry
May 8, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedApril 22, 2016
April 1, 2016
2.1 years
April 13, 2015
April 20, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical impact of dyskinesia measured by total UDysRS (Unified Dyskinesia Rating Scale) score
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
84 days
Secondary Outcomes (4)
• PD motor symptoms assessed by MDS-UPDRS, diaries and physiological measurement with motion sensor system
84 days
Dyskinesia severity using physiological motion sensor system
84 days
Patient function using MDS-UPDRS and UDysRS questionnaires quantify dyskinesia and Parkinsonian motor symptoms.
84 days
Safety and tolerability: adverse events, physical and neurological exams, safety laboratory values, vital signs and ECG
94 days
Study Arms (4)
Eltoprazine HCl 2.5 mg
EXPERIMENTALEltoprazine HCl 2.5 mg capsules to be taken orally b.i.d. (ie, 5 mg/day) for 3 weeks
Eltoprazine HCl 5.0 mg
EXPERIMENTALEltoprazine HCl 5.0 mg capsules to be taken orally b.i.d. (ie, 10 mg/day) for 3 weeks
Eltoprazine HCl 7.5 mg
EXPERIMENTALEltoprazine HCl 7.5 mg capsules to be taken orally b.i.d. (ie, 15 mg/day) for 3 weeks
Placebo
PLACEBO COMPARATORPlacebo capsules to be taken orally b.i.d. for 3 weeks
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Parkinson's Disease and Movement Disorders Center, Boca Raton
Boca Raton, Florida, 33486, United States
Related Publications (2)
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.
PMID: 25669730RESULTMcFarthing 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.
PMID: 31356217DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Charlotte Keywood, MBBS,MRCP,
Amarantus BioScience Holdings, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 13, 2015
First Posted
May 8, 2015
Study Start
May 1, 2015
Primary Completion
June 1, 2017
Study Completion
December 1, 2017
Last Updated
April 22, 2016
Record last verified: 2016-04