Safety, Tolerability and Symptomatic Efficacy of the ROCK-Inhibitor Fasudil in Patients with Parkinson's Disease (ROCK-PD)

Idiopathic Parkinson's Disease

Combined occurrence of intolerance (termination of treatment because of treatment-related AE) and occurence of self-reported and pre-defined (laboratory, vital signs) treatment-related SAEs [time frame: from day 1 to day 22]

Occurrence of intolerance (termination of treatment because of treatment-related AE) [time frame: from day 1 to day 22]., Occurrence of self-reported and pre-defined (laboratory, vital signs) treatment-related SAEs [time frame: from day 1 to day 22, and day 1 to day 50]., the change of MDS-Unified PD Rating Scale (MDS-UPDRS) each part I to IV [time frame: part I and II from day 1 to day 22, and day 1 to day 50; time frame: part III and IV from day 1 to day 10, day 1 to day 22, and day 1 to day 50], the change of MDS-Unified PD Rating Scale (MDS-UPDRS) score part I to IV, the change of 8-item PD Quality of Life Scale (PDQ-8) [time frame: from day 1 to day 22, and day 1 to day 50], the change of PD Non-Motor Symptom Questionnaire (NMSQuest) [time frame: from day 1 to day 10, day 1 to day 22, and day 1 to day 50], the change of Montreal Cognitive Assessment (MoCA) [time frame: from day 1 to day 22, and day 1 to day 50], the change of Becks depression inventory-II (BDI-II) [time frame: from day 1 to day 22, and day 1 to day 50],, the Global Impression of Improvement score (CGI-I [clinician], PGI-I [patient]) [time point: at day 10, 22 and day 50].

No related papers found yet.

Germany