Early Stage Parkinson's Disease
Conditions
Keywords
Parkinson's disease
Brief summary
This study is a multicenter, randomized, double blind, parallel group study of 6 months' treatment with SLV308 administered as a monotherapy in patients with early stage PD. An open label safety extension to this study is planned as a separate protocol for patients who are willing and eligible to participate.
Interventions
Sponsors
Solvay Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of idiopathic Parkinson's Disease, * Early stage of disease, Modified Hoehn & Yahr up to stage III, * UPDRS motor score (part III) 10 at baseline.
Exclusion criteria
* Diagnosis is unclear or a suspicion of other parkinsonian syndromes, * Patients who have undergone surgery for the treatment of PD, * Presence of dyskinesias, * Motor fluctuations or loss of postural reflexes, * Clinically significant abnormalities, * Patients treated with L-dopa or dopamine agonists currently or in the past (for more than 3 months in total), * Antipsychotic.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| UPDRS part 3 (motor score)and change from baseline to 24 weeks maintenance treatment | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| UPDRS part 2 (ADL score); CGI-Improvement; PDQ-39 total score: all change from baseline to 24 weeks maintenance treatment | 6 months |
Countries
Argentina, Belgium, Bulgaria, Canada, Chile, Colombia, Croatia, Finland, India, Israel, Mexico, New Zealand, Peru, Romania, Russia, Serbia, Slovakia, South Africa, Sweden, Ukraine, United States
Outcome results
None listed