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

NCT ID: NCT00537485

Last Updated: 2014-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2009-12-31

Brief Summary

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)

Conditions

Early Parkinson's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

Group Type: EXPERIMENTAL

SPM 962

Intervention Type: DRUG

transdermal application, 1 time per day

2

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

transdermal application, 1 time per day

Interventions

SPM 962

transdermal application, 1 time per day

Intervention Type: DRUG

placebo

transdermal application, 1 time per day

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Katsuhisa Saito

Role: STUDY_DIRECTOR

New Product Evaluation and Development

Locations

Chubu Region, , Japan

Hokkaido Region, , Japan

Kanto Region, , Japan

Kinki Region, , Japan

Kyushu Region, , Japan

Tohoku Region, , Japan

Countries

Japan

Other Identifiers

243-07-001

Identifier Type: -

Identifier Source: org_study_id