NCT02439125

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

Status unknown Phase 2 Last updated 20 April 2016

What this trial tests

Phase 2 trial testing Eltoprazine HCl in Parkinson's Disease in 60 participants. Status unknown.

Timeline

1 May 2015

Primary endpoint
1 June 2017

1 December 2017

Quick facts

Lead sponsor	Amarantus BioScience Holdings, Inc.
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	treatment
Enrollment	60
Start date	1 May 2015
Primary completion	1 June 2017
Estimated completion	1 December 2017
Sites	1 location across United States

Drugs / interventions tested

• Eltoprazine HCl — full drug profile →
• Eltoprazine HCl — full drug profile →
• Eltoprazine HCl — full drug profile →
• Placebo

Conditions studied

• Parkinson's Disease — all drugs for Parkinson's Disease →
• Dyskinesia — all drugs for Dyskinesia →

Sponsor

Amarantus BioScience Holdings, Inc. — full company profile →

Who can join

Adults 30 to 85, any sex, with Parkinson's Disease or Dyskinesia. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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

Sponsor's own description

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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Emerging therapies in Parkinson disease - repurposed drugs and new approaches.
   Elkouzi A, Vedam-Mai V, Eisinger RS, Okun MS. · · 2019 · cited 221× · PMID 30867588 · DOI 10.1038/s41582-019-0155-7
2. G protein-coupled receptors in neurodegenerative diseases and psychiatric disorders.
   Wong TS, Li G, Li S, Gao W, et al · · 2023 · cited 113× · PMID 37137892 · DOI 10.1038/s41392-023-01427-2
3. Motor Complications of Dopaminergic Medications in Parkinson's Disease.
   Freitas ME, Hess CW, Fox SH. · · 2017 · cited 83× · PMID 28511255 · DOI 10.1055/s-0037-1602423
4. Pathophysiological Mechanisms and Experimental Pharmacotherapy for L-Dopa-Induced Dyskinesia.
   Fabbrini A, Guerra A. · · 2021 · cited 34× · PMID 33953618 · DOI 10.2147/jep.s265282
5. Soluble Epoxide Hydrolase Inhibition to Face Neuroinflammation in Parkinson's Disease: A New Therapeutic Strategy.
   Pallàs M, Vázquez S, Sanfeliu C, Galdeano C, et al · · 2020 · cited 28× · PMID 32369955 · DOI 10.3390/biom10050703
6. Receptor Ligands as Helping Hands to L-DOPA in the Treatment of Parkinson's Disease.
   Del Bello F, Giannella M, Giorgioni G, Piergentili A, et al · · 2019 · cited 23× · PMID 30970612 · DOI 10.3390/biom9040142
7. An Update on Nondopaminergic Treatments for Motor and Non-motor Symptoms of Parkinson's Disease.
   Jing XZ, Yuan XZ, Luo X, Zhang SY, et al · · 2023 · cited 21× · PMID 35193486 · DOI 10.2174/1570159x20666220222150811
8. CLINICAL TRIAL HIGHLIGHTS - DYSKINESIA.
   McFarthing K, Prakash N, Simuni T. · · 2019 · cited 12× · PMID 31356217 · DOI 10.3233/jpd-199002