A Double-Blind, 3-Arm, Parallel Group, Placebo-and Ropinirole-Controlled Study of SPM 962 in Subjects with Parkinson's Disease Treated Concomitantly with L-dopa

Phase 3

• Conditions: Parkinson's Disease Treated Concomitantly with L-dopa

• Registration Number: JPRN-jRCT2080220857
• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-09-14
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 400

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 <80 years at the time of informed consent
3. Patients with a modified Hoehn & Yahr scale score of 2 to 4 (on time)
4. Patients with a UPDRS Part III total score of >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

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 <3.5 mEq/L at screening
9. Patients have a total bilirubin >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

Study & Design

• Study Type: Interventional
• Study Design: Not specified