Actively Recruiting
Safety, Tolerability, Pharmacokinetics and Efficacy Study of Radotinib in Parkinson's Disease
Led by Il-Yang Pharm. Co., Ltd. · Updated on 2024-07-16
40
Participants Needed
7
Research Sites
277 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a safety, tolerability, pharmacokinetic and efficacy study in subjects with Parkinson's disease
CONDITIONS
Official Title
Safety, Tolerability, Pharmacokinetics and Efficacy Study of Radotinib in Parkinson's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and Female from 40 to 80 years old
- Diagnosed with clinically probable Parkinson's Disease within 3 years of screening
- Positive dopamine transporter scan confirmed by local reading
- Hoehn & Yahr stage less than or equal to 2.5
- No previous symptomatic treatment for Parkinson's and not requiring dopaminergic therapy within 6 months from baseline
- No parkinsonian syndrome or other neurovascular comorbidities confirmed by MRI
- Female participants must be not of childbearing potential or using highly effective birth control
- Covered by Health Insurance System
- Able to understand and sign informed consent
- Blood pressure and heart rate considered normal by investigator
- Electrocardiogram considered normal by investigator
- Laboratory parameters within normal or clinically non-relevant range
You will not qualify if you...
- Atypical Parkinsonism or drug-induced Parkinsonism
- Use of any medication for symptomatic treatment or slowing progression of Parkinson's within 60 days prior to screening
- Prior use of dopaminergic therapy for 30 or more days at any time
- Cognitive impairment with MMSE score less than or equal to 24
- Active psychiatric disorders with strong functional impact not controlled by medication or recent
- Severe or uncontrolled chronic diseases
- History of bleeding disorders
- Treatment by Deep Brain Stimulation or continuous infusion of apomorphine/dopa gel
- Impaired cardiac function or significant cardiac conditions listed
- Participation in other drug trials within 30 days prior to screening
- Use of medications that could interfere or put subject at risk
- Gastrointestinal disorders affecting drug absorption
- Recent pancreatitis or severe liver, pancreas, kidney disease
- Seropositive for HIV or active hepatitis B or C, except stable treated cases
- Men unwilling to use contraception during study
- Hypersensitivity to study drug or its components
- Any condition interfering with the protocol
- Unable to comply or attend scheduled visits
- Under legal guardianship or judicial protection
- In exclusion period of another protocol
- No possibility of emergency contact
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
CHRU de Lille - Hôpital Roger Salengro
Lille, France
Not Yet Recruiting
2
CHU Limoges
Limoges, France
Actively Recruiting
3
CHU de Lyon HCL
Lyon, France
Actively Recruiting
4
Hôpital Nantes-Hotel Dieu
Nantes, France
Actively Recruiting
5
Hôpital Pitié-Salpêtrière
Paris, France
Actively Recruiting
6
Chu La Miletrie
Poitiers, France
Actively Recruiting
7
CHU de Rouen
Rouen, France
Actively Recruiting
Research Team
I
IL-YANG CR
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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