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

NCT ID: NCT04228653

Last Updated: 2021-03-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-20
• Study Completion Date: 2023-03-20

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

No Arm

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

Group Type: EXPERIMENTAL

Renishaw Drug Delivery System

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Herantis Pharma Plc.

INDUSTRY

Sponsor Role: collaborator

Renishaw

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Helsinki University Hospital

Helsinki, , Finland

Skåne University Hospital

Lund, , Sweden

Karolinksa University Hospital

Stockholm, , Sweden

Countries

Finland; Sweden

Other Identifiers

HP-CD-CL-2004

Identifier Type: -

Identifier Source: org_study_id