Clinical trial NCT00537485: A Placebo-controlled Study for SPM 962 in Early Parkinson's Disease Patients
Official title: A Placebo-controlled Study for SPM 962 in Early Parkinson's Disease Patients With Non-concomitant Treatment of L-dopa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Early Parkinson's Disease
Keywords: SPM 962
rotigotine
Parkinson's disease
monotherapy
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2007-10-01
Enrollment: 180
Sex: ALL
Minimum age (years): 30
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


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

Primary outcomes:
measure: Change From Baseline to the End of Maintenance Period in Total of Each Sum Score of UPDRS Part 2 and Part 3
timeFrame: baseline, end of maintenance period
Secondary outcomes:
measure: Efficacy Rate in Total of Each Sum Score of UPDRS Part 2 and Part 3
timeFrame: baseline, end of maintenance period
measure: Mean Change in UPDRS Part 2 Sum Score
timeFrame: Baseline, every two weeks
measure: Efficacy Rate in UPDRS Part 2 Sum Score
timeFrame: Baseline, every two weeks
measure: UPDRS Part 3 Sum Score
timeFrame: Baseline, every two weeks
measure: Efficacy Rate in UPDRS Part 3 Sum Score
timeFrame: Baseline, every two weeks
measure: UPDRS Part 1 Sum Score
timeFrame: Baseline, every two weeks
measure: UPDRS Part 4 Sum Score
timeFrame: Baseline, every two weeks
measure: Total of Each Sum Score of UPDRS Part 1, 2, 3, and 4
timeFrame: Baseline, every two weeks
measure: The Modified Hoehn and Yahr Stage
timeFrame: Baseline, end of maintenance period
Other outcomes:
Locations:
city: Chubu region
country: Japan
city: Hokkaido region
country: Japan
city: Kanto region
country: Japan
city: Kinki region
country: Japan
city: Kyushu region
country: Japan
city: Tohoku region
country: Japan
Study officials:
affiliation: New Product Evaluation and Development
name: Katsuhisa Saito
role: STUDY_DIRECTOR
References: