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

April 20, 2016 updated by: Amarantus BioScience Holdings, Inc.

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Parkinson's Disease and Movement Disorders Center, Boca Raton

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Eltoprazine HCl 2.5 mg
Eltoprazine HCl 2.5 mg capsules to be taken orally b.i.d. (ie, 5 mg/day) for 3 weeks
Drug: Eltoprazine HCl
2.5 mg b.i.d. orally for 3 weeks
Drug: Eltoprazine HCl
5.0 mg b.i.d. orally for 3 weeks
Drug: Eltoprazine HCl
7.5 mg b.i.d. orally for 3 weeks
Experimental: Eltoprazine HCl 5.0 mg
Eltoprazine HCl 5.0 mg capsules to be taken orally b.i.d. (ie, 10 mg/day) for 3 weeks
Drug: Eltoprazine HCl
2.5 mg b.i.d. orally for 3 weeks
Drug: Eltoprazine HCl
5.0 mg b.i.d. orally for 3 weeks
Drug: Eltoprazine HCl
7.5 mg b.i.d. orally for 3 weeks
Experimental: Eltoprazine HCl 7.5 mg
Eltoprazine HCl 7.5 mg capsules to be taken orally b.i.d. (ie, 15 mg/day) for 3 weeks
Drug: Eltoprazine HCl
2.5 mg b.i.d. orally for 3 weeks
Drug: Eltoprazine HCl
5.0 mg b.i.d. orally for 3 weeks
Drug: Eltoprazine HCl
7.5 mg b.i.d. orally for 3 weeks
Placebo Comparator: Placebo
Placebo capsules to be taken orally b.i.d. for 3 weeks
Drug: Placebo
b.i.d. orally for 3 weeks

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
• PD motor symptoms assessed by MDS-UPDRS, diaries and physiological measurement with motion sensor system
Time Frame: 84 days
• PD motor symptoms assessed by MDS-UPDRS, diaries and physiological measurement with motion sensor system
84 days
Dyskinesia severity using physiological motion sensor system
Time Frame: 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.
Time Frame: 84 days
Patient function using MDS-UPDRS and UDysRS questionnaires
84 days
Safety and tolerability: adverse events, physical and neurological exams, safety laboratory values, vital signs and ECG
Time Frame: 94 days
Safety and tolerability: adverse events, physical and neurological exams, safety laboratory values, vital signs and ECG
94 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amarantus BioScience Holdings, Inc.

Investigators

  • Study Director: Charlotte Keywood, MBBS,MRCP,, Amarantus BioScience Holdings, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Anticipated)

June 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

April 13, 2015

First Submitted That Met QC Criteria

May 7, 2015

First Posted (Estimate)

May 8, 2015

Study Record Updates

Last Update Posted (Estimate)

April 22, 2016

Last Update Submitted That Met QC Criteria

April 20, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMBS-ELTO-201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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