Efficacy of Levodopa/Benserazide Dispersible Tablet on Response Fluctuations in PD Patients With Delayed ON
- Registration Number
- NCT02769793
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- Male or female patients between 31 and 80 years
- Parkinson disease (PD) was diagnosed by United Kingdom Parkinson disease brain bank criteria
- Patients receiving stable Levodopa treatment at least 2 weeks prior to baseline visit
- Delayed ON was confirmed by a specialized PD diary that records change in motor symptoms 90 minute after the first morning dose. Delayed ON is defined as delay of more than 40 minutes after the first morning dose for resolution of OFF state or experience of no ON state at least 1 per week.
- Existence of cognitive decline hard to participate in the clinical trial or K-Minimental Status Exam score 24 or less
- Any contraindication of blood sampling
- Subjects with clinically significant psychiatric illness
- Subjects with a cancer or severe medical illness
- Lactating, pregnant, or possible pregnant
- History of malignant melanoma
- Subjects with narrow-angle glaucoma
- Subjects with hypersensitivity to levodopa or benserazide
- Subjects treated with non-selective monoamine oxidase (MAO)-B inhibitors
- Subjects with peptic ulcer, colitis, or gastrointestinal disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Levodopa dispersible Levodopa dispersible Levodopa dispersible 100mg/tablet, PO, 1 tablet in the morning, once daily for 4 weeks (crossover) Levodopa Levodopa Levodopa 100mg/tablet, PO, 1 tablet in the morning, once daily for 4 weeks (crossover)
- Primary Outcome Measures
Name Time Method Change in the time to ON after first morning dose using 3-day PD diary 4 weeks 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.
- Secondary Outcome Measures
Name Time Method Change in the The Unified Dyskinesia Rating Scale (UDyskRS) 4 weeks a scale for assessment of levodopa-induced dyskinesia in PD patients
Change in the The Unified Parkinson Disease Rating Scale (UPDRS) 4 weeks a scale for assessment of parkinsonian symptom severity in PD patients
Change in the Total ON time, total OFF time using 3-day PD diary 4 weeks a severity assessment index for PD patients with motor fluctuation
Change in the The Schwab & England Activity of daily living scale (SEADL) 4 weeks a scale for activity of daily living assessment
Change in the The Parkinson Disease Questionnaire-39 (PDQ-39) 4 weeks a scale for health-related quality of life in PD patients
Change in the Clinician global improvement (CGI) 4 weeks clinician's assessment for global improvement
Change in the Patient global improvement (PGI) 4 weeks patient-centered assessment of global improvement
Change in the K-Minimental status examination (K-MMSE) 4 weeks global cognition assessment
Trial Locations
- Locations (2)
SMG-SNU Boramae Medical Center
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of