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

Primary Purpose

Parkinson's Disease, Dyskinesia

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Eltoprazine HCl
Eltoprazine HCl
Eltoprazine HCl
Placebo
Sponsored by
Amarantus BioScience Holdings, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring levodopa, dyskinesia, parkinsons disease, PD

Eligibility Criteria

30 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Parkinson's Disease and Movement Disorders Center, Boca Raton

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Eltoprazine HCl 2.5 mg

Eltoprazine HCl 5.0 mg

Eltoprazine HCl 7.5 mg

Placebo

Arm Description

Eltoprazine HCl 2.5 mg capsules to be taken orally b.i.d. (ie, 5 mg/day) 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 7.5 mg capsules to be taken orally b.i.d. (ie, 15 mg/day) for 3 weeks

Placebo capsules to be taken orally b.i.d. for 3 weeks

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 13, 2015
Last Updated
April 20, 2016
Sponsor
Amarantus BioScience Holdings, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02439125
Brief Title
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

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2015 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amarantus BioScience Holdings, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease, Dyskinesia
Keywords
levodopa, dyskinesia, parkinsons disease, PD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Eltoprazine HCl 2.5 mg
Arm Type
Experimental
Arm Description
Eltoprazine HCl 2.5 mg capsules to be taken orally b.i.d. (ie, 5 mg/day) for 3 weeks
Arm Title
Eltoprazine HCl 5.0 mg
Arm Type
Experimental
Arm Description
Eltoprazine HCl 5.0 mg capsules to be taken orally b.i.d. (ie, 10 mg/day) for 3 weeks
Arm Title
Eltoprazine HCl 7.5 mg
Arm Type
Experimental
Arm Description
Eltoprazine HCl 7.5 mg capsules to be taken orally b.i.d. (ie, 15 mg/day) for 3 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo capsules to be taken orally b.i.d. for 3 weeks
Intervention Type
Drug
Intervention Name(s)
Eltoprazine HCl
Intervention Description
2.5 mg b.i.d. orally for 3 weeks
Intervention Type
Drug
Intervention Name(s)
Eltoprazine HCl
Intervention Description
5.0 mg b.i.d. orally for 3 weeks
Intervention Type
Drug
Intervention Name(s)
Eltoprazine HCl
Intervention Description
7.5 mg b.i.d. orally for 3 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
b.i.d. orally for 3 weeks
Primary Outcome Measure Information:
Title
Clinical impact of dyskinesia measured by total UDysRS (Unified Dyskinesia Rating Scale) score
Description
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
Time Frame
84 days
Secondary Outcome Measure Information:
Title
• PD motor symptoms assessed by MDS-UPDRS, diaries and physiological measurement with motion sensor system
Description
• PD motor symptoms assessed by MDS-UPDRS, diaries and physiological measurement with motion sensor system
Time Frame
84 days
Title
Dyskinesia severity using physiological motion sensor system
Description
Dyskinesia severity using physiological motion sensor system
Time Frame
84 days
Title
Patient function using MDS-UPDRS and UDysRS questionnaires quantify dyskinesia and Parkinsonian motor symptoms.
Description
Patient function using MDS-UPDRS and UDysRS questionnaires
Time Frame
84 days
Title
Safety and tolerability: adverse events, physical and neurological exams, safety laboratory values, vital signs and ECG
Description
Safety and tolerability: adverse events, physical and neurological exams, safety laboratory values, vital signs and ECG
Time Frame
94 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charlotte Keywood, MBBS,MRCP,
Organizational Affiliation
Amarantus BioScience Holdings, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Parkinson's Disease and Movement Disorders Center, Boca Raton
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25669730
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.
Results Reference
result
PubMed Identifier
31356217
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.
Results Reference
derived
Links:
URL
http://foxtrialfinder.michaeljfox.org/
Description
Related Info

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

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