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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 94 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~94 days
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 moreTrial 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
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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.
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