The purpose of this study is to determine whether levodopa/benserazide dispersible is effective in the adjunctive treatment of Parkinson's disease (PD) patients with delayed ON.
Delayed ON is one of the motor complications of advanced PD patients that effect of anti-parkinsonian medication is delayed more than 40 minutes after intake. In the most severe cases, the effect does not appear even until next medication schedule, so called "No ON" status. It is important to manage delayed ON properly because it can interfere motor functions and quality of life of PD patients. Levodopa/benserazide dispersible can be absorbed rapidly in the intestine, so theoretically it can break the poor response to conventional treatment of PD patients with delayed ON. However, this has not been proven by clinical trials till now.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Levodopa dispersible 100mg/tablet, PO, 1 tablet in the morning, once daily for 4 weeks (crossover)
Levodopa 100mg/tablet, PO, 1 tablet in the morning, once daily for 4 weeks (crossover)
Samsung Medical Center
Seoul, South Korea
SMG-SNU Boramae Medical Center
Seoul, South Korea
Change in the time to ON after first morning dose using 3-day PD diary
A specialized 3-day PD diary will be distributed to the patients 3 days prior to each visit. This diary will evaluate the latency of ON after intake of the study medication.
Time frame: 4 weeks
Change in the The Unified Parkinson Disease Rating Scale (UPDRS)
a scale for assessment of parkinsonian symptom severity in PD patients
Time frame: 4 weeks
Change in the The Unified Dyskinesia Rating Scale (UDyskRS)
a scale for assessment of levodopa-induced dyskinesia in PD patients
Time frame: 4 weeks
Change in the The Schwab & England Activity of daily living scale (SEADL)
a scale for activity of daily living assessment
Time frame: 4 weeks
Change in the The Parkinson Disease Questionnaire-39 (PDQ-39)
a scale for health-related quality of life in PD patients
Time frame: 4 weeks
Change in the Patient global improvement (PGI)
patient-centered assessment of global improvement
Time frame: 4 weeks
Change in the Clinician global improvement (CGI)
clinician's assessment for global improvement
Time frame: 4 weeks
Change in the K-Minimental status examination (K-MMSE)
global cognition assessment
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Time frame: 4 weeks
Change in the Total ON time, total OFF time using 3-day PD diary
a severity assessment index for PD patients with motor fluctuation
Time frame: 4 weeks