A Phase II, multi-centre, randomised, double-blind, placebo-controlled, parallel group study to investigate the efficacy, safety and tolerability of Cogane (PYM50028), a novel, orally active neurotrophic factor inducer, in male and female subjects with early-stage Parkinson's disease administered once daily for 28 Weeks
Phase 2
- Conditions
- G20Parkinson disease
- Registration Number
- DRKS00000756
- Lead Sponsor
- Phytopharm plc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 425
Inclusion Criteria
Key inclusion criteria:
1) Confirmed diagnosis of early stage idiopathic PD within the 2 years prior to screening
2) Subjects who have not taken and / or are not currently receiving any PD treatment
Other inclusion criteria apply
Exclusion Criteria
Key exclusion criteria:
1) female of child-bearing potential
2) history of neurosurgical procedures for PD
3) history of severe psychiatric illness
Other exclusion criteria apply
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in UPDRS (Unified Parkinson's Disease Rating Scale) parts II & III combined score between baseline and 28 weeks
- Secondary Outcome Measures
Name Time Method Change in SCOPA-COG (Scales for Outcomes of Parkinson's disease – Cognition) total score between baseline and 28 weeks<br>Change in PDQ-39 (Parkinson's Disease Questionnaire) scores between baseline and 28 weeks<br>Change in ESS (Epworth Sleepiness Scale) total score between baseline and 28 weeks<br>Change in NMSS (Non-Motor Symptoms Scale) scores between baseline and 28 weeks