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

Renishaw

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Neuro-Degenerative Disease; Movement Disorders; Parkinson Disease; Nervous System Diseases; Brain Diseases

Treatments: Device: Renishaw Drug Delivery System

Study type: Interventional

Funder types: Industry

Identifiers

NCT04228653

HP-CD-CL-2004

Details and patient eligibility

About

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.

Full 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/

Enrollment: 15 patients

Sex: All

Ages: 35 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Completion of visit 4 (implantation of DDS) within main study HP-CD-CL-2002.

2. Patients who:

   • Discontinued main study after visit 4 of main study or discontinued extension study.
   • Received 6 doses in main study but didn't participate in extension study.
   • Received 12 doses including extension study.

3. Provision of informed consent.

Exclusion criteria

• None

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

15 participants in 1 patient group

No Arm

Experimental group

Description:

As this is the follow up study, there are no arms

Treatment:

Device: Renishaw Drug Delivery System