NCT03295786

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Herantis Pharma Plc. · Industry
• Sex: All
• Age: 35 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

A patient's participation in the study will last for ten months and will include sixteen to seventeen visits: * Screening (2 visits) * Planning of surgery - Surgery: implantation of drug delivery system - Post-surgery follow-up (3 visits) * Test infusions with vehicle (1-2 visits) * Positron emission tomography (PET) examinations before the first and after the last dose (2 visits) * Baseline and randomisation to CDNF or placebo group (1 visit) * Dosing visits: CDNF or placebo (6 visits) * End-of-study visit (1 visit) Study examinations and assessments \- Physical examination: pulse rate, blood pressure, temperature, body weight and height * ECG (electrocardiography) and blood and urine tests * HIV, hepatitis B and C blood tests (on first visit) * Pregnancy tests for women of childbearing age * Completion of a patient diary to record mobility and time asleep * Parkinson's Kinetigraph (PKGTM) Data Logger: a watch-type device worn on the wrist for certain periods during the study to record movements * Questionnaires, rating scales and forms: quality of life, mood, memory, impulse control, mental health * Assessment of the port and the skin around the port * Cerebrospinal fluid sampling by lumbar puncture * Magnetic resonance imaging (MRI) * Positron emission tomography scans (PET) * Computed tomography (CT) For more information: https://treater.eu/clinical-study/

Conditions

• Parkinson Disease
• Movement Disorders
• Neurodegenerative Diseases
• Nervous System Diseases
• Brain Diseases

Interventions

Type	Name	Description
DRUG	Cerebral Dopamine Neurotrophic Factor	Repeated intracerebral infusions
DEVICE	Renishaw Drug Delivery System	Stereotactically implanted device

Timeline

• Start date: 2017-09-26
• Primary completion: 2019-12-19
• Completion: 2019-12-19
• First posted: 2017-09-28
• Last updated: 2020-01-13

Locations

3 sites across 2 countries: Finland, Sweden