A Study of Efficacy and Safety of Eltoprazine HCl for Treating Levodopa-induced Dyskinesia in Parkinson's Disease Patients
NCT ID: NCT02439125
Last Updated: 2016-04-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
60 participants
INTERVENTIONAL
2015-05-31
2017-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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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
Eltoprazine HCl
2.5 mg b.i.d. orally for 3 weeks
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
Eltoprazine HCl
5.0 mg b.i.d. orally for 3 weeks
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
Eltoprazine HCl
7.5 mg b.i.d. orally for 3 weeks
Placebo
Placebo capsules to be taken orally b.i.d. for 3 weeks
Placebo
b.i.d. orally for 3 weeks
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
30 Years
85 Years
ALL
No
Sponsors
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Amarantus BioScience Holdings, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Charlotte Keywood, MBBS,MRCP,
Role: STUDY_DIRECTOR
Amarantus BioScience Holdings, Inc.
Locations
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Parkinson's Disease and Movement Disorders Center, Boca Raton
Boca Raton, Florida, United States
Countries
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References
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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.
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.
Related Links
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Related Info
Other Identifiers
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AMBS-ELTO-201
Identifier Type: -
Identifier Source: org_study_id
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