Phase 1/2CompletedAge-related condition
Clinical Study to Test the Safety of CDNF by Brain Infusion in Patients With Parkinson's Disease
Phase 1-2, Randomised, Double-Blind, Placebo Controlled, Safety and Tolerability Study of Intraputamenal Cerebral Dopamine Neurotrophic Factor (CDNF) Infusions Via an Investigational Drug Delivery System to Patients With Parkinson's Disease
- Sponsor
- Herantis Pharma Plc. (Industry)
- Enrolment
- 17 enrolled
- Conditions
- Parkinson Disease; Movement Disorders; Neurodegenerative Diseases; Nervous System Diseases; Brain Diseases
- Interventions
- Cerebral Dopamine Neurotrophic Factor; Renishaw Drug Delivery System
- Ages
- adults, older adults
- Registry
- NCT03295786
Full record on ClinicalTrials.gov
From the registry
This study evaluates the safety and tolerability of CDNF in patients with Parkinson's disease, when dosed directly into the brain using an implanted investigational drug delivery system (DDS). Safety and accuracy of the DDS is also being evaluated. One-third of the patients will receive monthly infusions with placebo and two-third of the patients will receive monthly infusions with either mid- or high-doses of CDNF for a period of 6 months.
Primary outcomes
- Adverse events (AEs)
- Electrocardiogram (ECG)
- Beck Depression Inventory (BDI) score
- Questionnaire for impulsive-compulsive disorder in Parkinson's disease rating scale (QUIP_RS)
History
Last registry update
Primary completion
Registered
Started