NCT03775538

Safety of CDNF by Brain Infusion in Patients With Parkinson's Disease. Extension to HP-CD-CL-2002 Clinical Study

A Randomised, Double-Blind, Multi-centre, Active Treatment, Extension and Safety Study for Patients With Idiopathic Parkinson's Disease (PD) Who Previously Completed the CDNF/DDS Main Study HP-CD-CL-2002

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Herantis Pharma Plc. · Industry
• Sex: All
• Age: 35 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is an extension to the HP-CD-CL-2002 clinical study. It evaluates the long-term 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). Long-term safety of the DDS is also being evaluated. All patients will receive monthly infusions of either mid- or high-dose of CDNF for a period of 6 months.

Detailed description

A patient's participation in the study will last for six months and will include nine visits: Screening (1 visit, same as HP-CD-CL-2002 End-of-Study visit) Dosing visits: CDNF (6 visits) DAT-PET (1 visit) End-of-study visit (1 visit) Study examinations and assessments * Physical examination: pulse rate, blood pressure, temperature, body weight and height, body mass index (BMI), neurological exam * ECG (electrocardiography) and blood and urine tests * 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 movement recording device * 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) For more information: https://treater.eu/clinical-study/

Conditions

• Parkinson Disease
• Movement Disorders
• Neuro-Degenerative Disease
• 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: 2018-07-05
• Primary completion: 2020-07-08
• Completion: 2020-07-08
• First posted: 2018-12-14
• Last updated: 2020-08-12

Locations

3 sites across 2 countries: Finland, Sweden