Clinical Study to Test the Safety of CDNF by Brain Infusion in Patients With Parkinson's Disease
Condition: Parkinson Disease; Movement Disorders; Neurodegenerative Diseases; Nervous System Diseases; Brain Diseases
MeSH terms: Parkinson Disease; Nervous System Diseases; Movement Disorders; Neurodegenerative Diseases; Brain Diseases
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study evaluates the 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). Safety and accuracy of the DDS is also being evaluated. One-third of the
      patients will receive monthly infusions with placebo and two-third of the patients will
      receive monthly infusions with either mid- or high-doses of CDNF for a period of 6 months.
    

Detailed description: 
      A patient's participation in the study will last for ten months and will include sixteen to
      seventeen visits:

        -  Screening (2 visits)

        -  Planning of surgery - Surgery: implantation of drug delivery system - Post-surgery
           follow-up (3 visits)

        -  Test infusions with vehicle (1-2 visits)

        -  Positron emission tomography (PET) examinations before the first and after the last dose
           (2 visits)

        -  Baseline and randomisation to CDNF or placebo group (1 visit)

        -  Dosing visits: CDNF or placebo (6 visits)

        -  End-of-study visit (1 visit)

      Study examinations and assessments

      - Physical examination: pulse rate, blood pressure, temperature, body weight and height

        -  ECG (electrocardiography) and blood and urine tests

        -  HIV, hepatitis B and C blood tests (on first visit)

        -  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 device worn on the wrist for
           certain periods during the study to record movements

        -  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)

        -  Computed tomography (CT)

      For more information: https://treater.eu/clinical-study/
    

Intervention name(s): Cerebral Dopamine Neurotrophic Factor; Renishaw Drug Delivery System
Intervention type(s): Drug; Device
Intervention description(s): Repeated intracerebral infusions; Stereotactically implanted device
Other intervention name(s): CDNF; DDS
Intervention MeSH terms: Dopamine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomised, Double-Blind, Placebo Controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Parkinson; CDNF; Drug Delivery System; Intracerebral