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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Amarantus BioScience Holdings, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 13, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 8, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 22, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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