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Trial record 2 of 2 for:    eltoprazine

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

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ClinicalTrials.gov Identifier: NCT02439125
Recruitment Status : Unknown
Verified April 2016 by Amarantus BioScience Holdings, Inc..
Recruitment status was:  Active, not recruiting
First Posted : May 8, 2015
Last Update Posted : April 22, 2016
Sponsor:
Information provided by (Responsible Party):
Amarantus BioScience Holdings, Inc.

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

Condition or disease Intervention/treatment Phase
Parkinson's Disease Dyskinesia Drug: Eltoprazine HCl Drug: Placebo Phase 2

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  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : May 2015
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Levodopa

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

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
5.0 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
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. • 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

  2. Dyskinesia severity using physiological motion sensor system [ Time Frame: 84 days ]
    Dyskinesia severity using physiological motion sensor system

  3. 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

  4. 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



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Ages Eligible for Study:   30 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02439125


Locations
United States, Florida
Parkinson's Disease and Movement Disorders Center, Boca Raton
Boca Raton, Florida, United States, 33486
Sponsors and Collaborators
Amarantus BioScience Holdings, Inc.
Investigators
Study Director: Charlotte Keywood, MBBS,MRCP, Amarantus BioScience Holdings, Inc.

Additional Information:
Publications of Results:
Responsible Party: Amarantus BioScience Holdings, Inc.
ClinicalTrials.gov Identifier: NCT02439125     History of Changes
Other Study ID Numbers: AMBS-ELTO-201
First Posted: May 8, 2015    Key Record Dates
Last Update Posted: April 22, 2016
Last Verified: April 2016

Keywords provided by Amarantus BioScience Holdings, Inc.:
levodopa
dyskinesia
parkinsons disease
PD

Additional relevant MeSH terms:
Eltoprazine
Parkinson Disease
Dyskinesias
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurologic Manifestations
Signs and Symptoms
Levodopa
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Serotonin Receptor Agonists
Serotonin Agents