NCT04228653

Long-Term Follow-up Safety After DDS Implantation With/Without CDNF Infusions

A Long-Term Follow-up Safety Study for Patients With Idiopathic Parkinson's Disease (PD) Implanted With the DDS and/or Who Received Treatment in the Main Study and/or Extension Study

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

Summary

This study is a follow up to the HP-CD-CL-2002 clinical study. It evaluates the long-term safety in patients with Parkinson's disease after implantation of an investigational drug delivery system (DDS) with or without infusions of CDNF. All patients will have at least the port explanted.

Detailed description

A patients participation in the study will last for up to 4 years and will include up to nine visits: * Screening (1 visit, same as HP-CD-CL-2003 End-of-Study visit) * Pre-surgery / explantation surgery / post-surgery (3 visits) * Safety (4 visits) * DAT-PET (Dopamine Transporter - Positron Emission Tomography) examination (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. * Magnetic resonance imaging (MRI) * Positron emission tomography scans (PET) * Skin condition over any remaining implanted subcutaneous portion of the device. * Skin healing after port / device removal. 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
DEVICE	Renishaw Drug Delivery System	Device that allows pharmaceuticals to be delivered into the brain is to be assessed over a period of time to inform of the long term safety of the implanted device.

Timeline

• Start date: 2019-03-20
• Primary completion: 2022-09-20
• Completion: 2023-03-20
• First posted: 2020-01-14
• Last updated: 2021-03-23

Locations

3 sites across 2 countries: Finland, Sweden