A Placebo-controlled Study for SPM 962 in Early Parkinson's Disease Patients

Otsuka

Status and phase: Completed; Phase 3; Phase 2

Conditions: Early Parkinson's Disease

Treatments: Drug: SPM 962; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00537485

243-07-001

Details and patient eligibility

About

To investigate superiority of SPM 962 over placebo in early Parkinson's disease patients in a multi-center, placebo-controlled, double-blind study following once-daily multiple transdermal doses of SPM 962 within a range of 4.5 to 36.0 mg (12-week dose titration/maintenance period)

Enrollment: 180 patients

Sex: All

Ages: 30 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subject diagnosed as having Parkinson's disease in accordance with "Diagnostic Criteria established by the Research Committee of MHLW-specified Intractable Neurodegenerative Diseases (1995)"
2. Subject is 30 years < > 80 years at the time of informed consent
3. Hoehn & Yahr stage 1- 3
4. Total of each sum score of UPDRS Part 2 and 3 is over 10 at screening test

Exclusion criteria

1. Subject has previously participated in a trial with SPM 962
2. Subject is on L-dopa treatment for total of over 6 months at the time of informed consent
3. Subject has psychiatric symptoms, e.g. confusion, hallucination, delusion, excitation, delirium, abnormal behavior at screening test and baseline
4. Subject has orthostatic hypotension
5. Subject has a history of epilepsy, convulsion and other
6. Subject has a complication of serious cardiac disorder/arrhythmia or has the history
7. Subject has arrhythmia and treated with class 1a anti-arrhythmic drugs (e.g. quinidine, procainamide etc.) or class 3 anti-arrhythmic drugs (e.g. amiodarone, sotalol etc.)
8. Subject has serious ECG abnormal at screening i.e.; 1) Subject has more than 450 msec of QTc values both in two measurements at screening test 2) Subject has more than 470 msec for females and more than 450 msec for males of mean QTc values of two measurements at baseline
9. Subject has congenital long QT syndrome
10. Subject has serum potassium of less than 3.5 mEq/L at screening test.
11. Subject has total bilirubin of 3.0 mg/dL and above or AST(GOT), ALT(GPT) greater than 2.5 times (or 100 IU/L and above) of the clinical laboratory's upper limit of the reference range at screening test
12. Subject has 30 mg/dL and above of BUN or 2.0 mg/dL and above of serum creatinine at screening test
13. Subject has a history of allergy to topical medicine, e.g. transdermal patch
14. Subject is pregnant, nursing, or is child bearing potential while the trial
15. Subject is receiving therapy with prohibited drug specified in the study protocol
16. Subject has a history of pallidotomy, thalamotomy, deep brain stimulation or fetal tissue transplant
17. Subject has dementia
18. Subject is unable to give consent
19. Subject is participating in another trial of an investigational drug or done so within 12 weeks prior to the initial treatment
20. Investigator judges that subject is inappropriate as a study subject with other reasons

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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180 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: SPM 962

2

Placebo Comparator group

Treatment:

Drug: placebo