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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

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
  • Involuntary Movement
  • Parkinson's Disease

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Clinical impact of dyskinesia measured by total UDysRS (Unified Dyskinesia Rating Scale) score
Secondary study objectives
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.
~6 spots leftby Nov 2025