A Study to Examine the Efficacy and Safety of Eltoprazine HCl for Treatment of Levodopa-induced Dyskinesia in Parkinson's Disease Patients

Parkinson's Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02439125
• Other study ID #: AMBS-ELTO-201
• Status: Recruiting
• Phase: Phase 2
• First received: April 13, 2015
• Last updated: June 1, 2015
• Start date: May 2015
• Est. completion date: December 2016

Study information

• Verified date: June 2015
• Source: Amarantus BioScience Holdings, Inc.
• Contact: Erik Nicolai
• Email: erik.nicolai[@]chiltern.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyskinesia
• Dyskinesias
• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• Eltoprazine HCl
2.5 mg b.i.d. orally for 3 weeks
• Eltoprazine HCl
5.0 mg b.i.d. orally for 3 weeks
• Eltoprazine HCl
7.5 mg b.i.d. orally for 3 weeks
• Placebo
b.i.d. orally for 3 weeks

Locations

Country	Name	City	State
United States	Parkinson's Disease and Movement Disorders Center, Boca Raton	Boca Raton	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Amarantus BioScience Holdings, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Svenningsson P, Rosenblad C, Af Edholm Arvidsson K, Wictorin K, Keywood C, Shankar B, Lowe DA, Björklund 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: 1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	• 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	84 days	No
Secondary	Dyskinesia severity using physiological motion sensor system	Dyskinesia severity using physiological motion sensor system	84 days	No
Secondary	Patient function using MDS-UPDRS and UDysRS questionnaires quantify dyskinesia and Parkinsonian motor symptoms.	Patient function using MDS-UPDRS and UDysRS questionnaires	84 days	No
Secondary	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	94 days	Yes

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