Parkinson's Disease Treated Concomitantly with L-dopa
Conditions
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed as having PD in accordance with the "Diagnostic Criteria established by the Research Committee of MHLW-specified Intractable Neurodegenerative Diseases (1995)" 2. Patients aged >30 years and 10 at screening ("on" time) 5. Patients who have received a fixed dose of L-dopa (ie, no change in daily dose or dosing regimen) for at least 28 days prior to the baseline (including a day for initial treatment) 6. Patients with any of the following problematic symptoms : a. Wearing off phenomena (including frozen gait at "off" time and dystonia at "off" time) b. On-off phenomenon c. Delayed on and/or no-on phenomena d. Dyskinesia e. Insufficient efficacy of L-dopa
Exclusion criteria
Exclusion criteria: 1. Patients who have participated in a study of SPM 962 and received administration of study drug 2. Patients with psychiatric symptoms, eg, confusion, hallucination, delusion, excitation, delirium, or abnormal behavior at screening or baseline 3. Patients who show a decrease of SBP from spine to standing position > 30 mmHg at screening or have orthostatic hypotension at baseline 4. Patients have a history of epilepsy, convulsion or the like 5. Patients with a complication or history of serious cardiac disorder or arrhythmia (eg, NYHA Class III or IV congestive heart failure, second- or third-degree AV block, complete left bundle branch block, sick-sinus-syndrome, history or complication of ventricular fibrillation, myocardial infarction within 12 months prior to screening or complication of angina pectoris) 6. Patients demonstrating QTc interval of >450 msec twice at screening Patients whose average QTc interval for two baseline measurement is >470 msec (females) or>450 msec (males) 7. Patients with congenital long QT syndrome 8. Patients with serum potassium 3.0 mg/dL or AST(GOT) and/or ALT(GPT) 2.5 times greater than the upper limit of the reference range (or >100 IU/L) during screening, or patients suffer complications of active phase of chronic hepatitis or liver cirrhosis 10. Patients with BUN >30 mg/dL or serum creatinine >2.0 mg/dL at screening 11. Patients with a history of allergy to topical medicine such as transdermal patches 12. Patients have a history of known intolerance/hypersensitivity to ropinirole and/or adverse drug reactions that prevent patients from receiving treatment 13. Female patients who are pregnant or nursing or who plan on becoming pregnant during the study period 14. Patients undergoing therapy with a drug prohibited by the specifications in Section 6.6.1, "Prohibited Concomitant Therapy", in the study protocol 15. Patients with a history of pallidotomy, thalamotomy, deep brain stimulation or fetal tissue transplant 16. Patients suffering dementia, including DLB and PDD (MMSE score :24 at screening) 17. Patients with a history or the complications of a malignant neoplastic disease within 12 months prior to screening or have been treated for the disease 18. Patients incapable of giving consent 19. Patients incapable of keeping an appropriate patient diary 20. Patients are participating in another study of an investigational drug or have received another investigational drug within the last 12 weeks prior to the baseline 21. Patients otherwise judged by the investigator or sub-investigator to be ineligible for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from the baseline to the end of the dose-titration/maintenance period inUPDRS Part III total score ( "on" time) Screening test, week 0, 2, 4, 6, 8, 10, 12, 14, 16, end of de-titration (or discontinuation) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Change from the baseline to Week 8 (LOCF) and Week 10 (LOCF) in dose titration/maintenance period in UPDRS Part III ("on" time) sum score 2) UPDRS Part II (average "on" and "off" time) sum score 3) Off time 4) On time 5) On time when troublesome dyskinesia is absent 6) On time with troublesome dyskinesia is present 7) Responder rate of UPDRS Part III ("on" time) sum score 8) Responder rate of UPDRS Part II (average of "on" and "off" time) 9) Responder rate of "off" time 10) CGI (Severity of disease) 11) Early morning dystonia 12) Daytime dystonia ), 2), 7), 8): Screening test, week 0, 2, 4, 6, 8, 10, 12, 14, 16, end of de-titration (or discontinuation) 3)-6), 9): every week 10)-12): screening test, week 0, 8, 12, 16(or discontinuation) | — |
Outcome results
None listed