Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| SMG-SNU Boramae Medical Center | OTHER |
| Samsung Medical Center | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levodopa dispersible | Experimental | Levodopa dispersible 100mg/tablet, PO, 1 tablet in the morning, once daily for 4 weeks (crossover) |
|
| Levodopa | Active Comparator | Levodopa 100mg/tablet, PO, 1 tablet in the morning, once daily for 4 weeks (crossover) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levodopa dispersible | Drug | Levodopa dispersible 100mg/tablet, PO, 1 tablet in the morning, once daily for 4 weeks (crossover) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the The Unified Parkinson Disease Rating Scale (UPDRS) | a scale for assessment of parkinsonian symptom severity in PD patients | 4 weeks |
| Change in the The Unified Dyskinesia Rating Scale (UDyskRS) |
| Measure | Description | Time Frame |
|---|---|---|
| relationship between delayed ON and response to investigational drugs and the Helicobactor pylori serology and index for atrophic gastritis | whether delayed ON and treatment response are affected by H.pylori status | at baseline and after 4 weeks of each treatment arm |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jee-Young Lee, MD, PhD | SMG-SNU Boramae Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | South Korea | ||||
| SMG-SNU Boramae Medical Center |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D007980 | Levodopa |
| C005177 | benserazide, levodopa drug combination |
| ID | Term |
|---|---|
| D004295 | Dihydroxyphenylalanine |
| D002395 | Catecholamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Levodopa | Drug | Levodopa 100mg/tablet, PO, 1 tablet in the morning, once daily for 4 weeks (crossover) |
|
|
a scale for assessment of levodopa-induced dyskinesia in PD patients
| 4 weeks |
| Change in the The Schwab & England Activity of daily living scale (SEADL) | a scale for activity of daily living assessment | 4 weeks |
| Change in the The Parkinson Disease Questionnaire-39 (PDQ-39) | a scale for health-related quality of life in PD patients | 4 weeks |
| Change in the Patient global improvement (PGI) | patient-centered assessment of global improvement | 4 weeks |
| Change in the Clinician global improvement (CGI) | clinician's assessment for global improvement | 4 weeks |
| Change in the K-Minimental status examination (K-MMSE) | global cognition assessment | 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 | 4 weeks |
| Seoul |
| South Korea |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D002396 |
| Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014443 | Tyrosine |