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

NCT03775538 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2020-08-12

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Cerebral Dopamine Neurotrophic Factor

Repeated intracerebral infusions

DEVICE

Renishaw Drug Delivery System

Stereotactically implanted device

Sponsors & Collaborators

  • Renishaw plc.

    collaborator UNKNOWN

  • Herantis Pharma Plc.

    lead INDUSTRY

Principal Investigators

  • Per Svenningsson, MD, Prof. · Karolinska University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-05
Primary Completion
2020-07-08
Completion
2020-07-08

Countries

  • Finland
  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03775538 on ClinicalTrials.gov