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Serotonin receptor agonist

Eltoprazine HCl 5.0 mg for Parkinson's Disease

Phase 2
Waitlist Available
Research Sponsored by Amarantus BioScience Holdings, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 94 days
Awards & highlights

Study 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

Eligible Conditions
  • Parkinson's Disease
  • Dyskinesia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~94 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 94 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinical impact of dyskinesia measured by total UDysRS (Unified Dyskinesia Rating Scale) score
Secondary outcome measures
Dyskinesia severity using physiological motion sensor system
Patient function using MDS-UPDRS and UDysRS questionnaires quantify dyskinesia and Parkinsonian motor symptoms.
Safety and tolerability: adverse events, physical and neurological exams, safety laboratory values, vital signs and ECG
+1 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Eltoprazine HCl 7.5 mgExperimental Treatment1 Intervention
Eltoprazine HCl 7.5 mg capsules to be taken orally b.i.d. (ie, 15 mg/day) for 3 weeks
Group II: Eltoprazine HCl 5.0 mgExperimental Treatment1 Intervention
Eltoprazine HCl 5.0 mg capsules to be taken orally b.i.d. (ie, 10 mg/day) for 3 weeks
Group III: Eltoprazine HCl 2.5 mgExperimental Treatment1 Intervention
Eltoprazine HCl 2.5 mg capsules to be taken orally b.i.d. (ie, 5 mg/day) for 3 weeks
Group IV: PlaceboPlacebo Group1 Intervention
Placebo capsules to be taken orally b.i.d. for 3 weeks

Find a Location

Who is running the clinical trial?

Amarantus BioScience Holdings, Inc.Lead Sponsor
2 Previous Clinical Trials
41 Total Patients Enrolled
Charlotte Keywood, MBBS,MRCP,Study DirectorAmarantus BioScience Holdings, Inc.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study of Efficacy and Safety of Eltoprazine HCl for Treating Levodopa-induced Dyskinesia in Parkinson's Disease Patients
2015. "A Study of Efficacy and Safety of Eltoprazine HCl for Treating Levodopa-induced Dyskinesia in Parkinson's Disease Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02439125.
All > Parkinson
~6 spots leftby Apr 2025
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