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Clinical Trial 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.


Clinical Trial Description

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/ ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03775538
Study type Interventional
Source Herantis Pharma Plc.
Contact
Status Completed
Phase Phase 1/Phase 2
Start date July 5, 2018
Completion date July 8, 2020

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