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.
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Incidence of treatment-emergent adverse events (AEs)[safety-tolerability]
Timeframe: Until study completion, up to month 58
Change in Electrocardiogram (ECG): Ventricular rate (bpm), [safety-tolerability]
Timeframe: Week 71 and Month 25
Change in Electrocardiogram (ECG): PR (pulse rate) interval, qRS duration, QT, QTc (msec) [safety-tolerability]
Timeframe: Week 71 and Month 25
Change in Beck Depression Inventory (BDI) score [safety-tolerability]
Timeframe: Week 71 and Month 25
Change in Questionnaire for impulsive-compulsive disorder in Parkinson's disease rating scale (QUIP_RS) [safety-tolerability]
Timeframe: Week 71 and Month 25
Change in Montreal cognitive assessment (MoCA) [safety-tolerability]
Timeframe: Week 71 and Month 25
Changes in physical examination: anatomic findings [safety-tolerability]
Timeframe: Week 71, and Months 25, 34, 58
Changes in physical examination: clinical standard neurological examination
Timeframe: Week 71, and Months 25, 34, 58
Changes in vital signs: blood pressure [safety-tolerability]
Timeframe: Weeks 55, 57, 58, 75
Changes in vital signs: pulse rate [safety-tolerability]
Timeframe: Weeks 55, 57, 58, 75
Changes in vital signs: body temperature [safety-tolerability]
Timeframe: Weeks 55, 57, 58, 75
Changes in vital signs: body weight [safety-tolerability]
Timeframe: Weeks 55, 57, 58, 75
Changes in vital signs: body mass index (BMI) [safety-tolerability]
Timeframe: Weeks 55, 57, 58, 75
Changes in clinical laboratory safety screen: clinical chemistry [safety-tolerability]
Timeframe: Weeks 53, 55, 57, 58, 71 and Months 25, 34, 58
Changes in clinical laboratory safety screen: haematology - haemoglobin [safety-tolerability]
Timeframe: Weeks 53, 55, 57, 58, 71 and Months 25, 34, 58
Changes in clinical laboratory safety screen: haematology - haematocrit [safety-tolerability]
Timeframe: Weeks 53, 55, 57, 58, 71 and Months 25, 34, 58
Changes in clinical laboratory safety screen: haematology - red blood cell (RBC) count [safety-tolerability]
Timeframe: Weeks 53, 55, 57, 58, 71 and Months 25, 34, 58
Changes in clinical laboratory safety screen: mean cell volume (MCV) of red blood cells [safety-tolerability]
Timeframe: Weeks 53, 55, 57, 58, 71 and Months 25, 34, 58
Changes in clinical laboratory safety screen: mean cell haemoglobin of RBC (MHC) [safety-tolerability]
Timeframe: Weeks 53, 55, 57, 58, 71 and Months 25, 34, 58
Changes in clinical laboratory safety screen: Platelet count [safety-tolerability]
Timeframe: Weeks 53, 55, 57, 58, 71 and Months 25, 34, 58
Changes in clinical laboratory safety screen: white blood call (WBC) count [safety-tolerability]
Timeframe: Weeks 53, 55, 57, 58, 71 and Months 25, 34, 58
Changes in clinical laboratory safety screen: activated partial thromboplastin time (aPTT) [safety-tolerability]
Timeframe: Weeks 53, 55, 57, 58, 71 and Months 25, 34, 58
Changes in clinical laboratory safety screen: International Normalised Ratio (INR) [safety-tolerability]
Timeframe: Weeks 53, 55, 57, 58, 71 and Months 25, 34, 58
Changes in clinical laboratory safety screen: urinanalysis [safety-tolerability]
Timeframe: Weeks 53, 55, 57, 58, 71 and Month 25
Formation of anti-CDNF antibodies [safety-tolerability]
Timeframe: Weeks 58, 78 and Month 25
Device related occurrence of adverse device effects [safety-tolerability]
Timeframe: Week 49 and Month 58