Parkinson Disease Clinical Trial
Official title:
A Randomised, Double-Blind, Multi-centre, Active Treatment, Extension and Safety Study for Patients With Idiopathic Parkinson's Disease (PD) Who Previously Completed the CDNF/DDS Main Study HP-CD-CL-2002
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.
A patient's participation in the study will last for six months and will include nine visits:
Screening (1 visit, same as HP-CD-CL-2002 End-of-Study visit) Dosing visits: CDNF (6 visits)
DAT-PET (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
- 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)
For more information: https://treater.eu/clinical-study/
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