At a glance
ClinicalIndex Comparison RecordPhase 2Recruiting· 40 target
Drug / intervention
Radotinib HCl 50 mg +1 moredrug
Likely dose
Radotinib HCl 50 mgfrom record
Key inclusion· 12
- ✓Age 40-80 years
- ✓Clinically Probable Parkinson's Disease per MDS criteria with symptom onset within 3 years
- ✓Positive DAT-scan showing striatal dopamine transporter deficit
- ✓Hoehn & Yahr stage ≤2.5
Key exclusion· 32
- ✕Atypical or drug-induced Parkinsonism
- ✕PD symptomatic treatment within 60 days of screening
- ✕Prior dopaminergic therapy (≥30 days)
- ✕Cognitive impairment (MMSE ≤24)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT04691661Phase 2RecruitingUpdate OverdueUpdated 23mo ago · Completion was 6mo agoEnrollment Stalled
Long Recruiting
Update Overdue
A Randomized Double-blind Placebo-controlled Multicentre Study to Assess Safety, Tolerability, Pharmacokinetics and Efficacy of Radotinib in Parkinson's Disease
In Brief
A Phase 2 clinical trial evaluating Radotinib HCl 50 mg and Placebo for Parkinson Disease. Currently recruiting, targeting 40 participants across 7 sites.
Signals
Enrollment appears stalled
Detailed Summary
This is a safety, tolerability, pharmacokinetic and efficacy study in subjects with Parkinson's disease
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParkinson Disease
CountriesFrance
Collaborators--
Timeline
Phase 2Recruiting
2021202220232024202520262027
First PostedDec 2020
Enrollment StartSep 2021
Primary CompletionDec 2025
TodayJul 2026
Study CompletionDec 2026
First PostedDec 31, 2020
Enrollment StartSep 9, 2021
Primary CompletionDec 31, 2025
Study CompletionDec 31, 2026
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 5.5 years ago
Interventions
Radotinib HCl 50 mgdrug
Enrolled subject will continue to administer Radotinib 50mg/day, 100mg/day, 150mg/day, 200mg/day, depending on the dose level once daily for 6 months.
Placebodrug
Placebo