A Placebo-Controlled Study for SPM 962 in Early Parkinson's Disease Patients - Full Text View

Sponsored by:	Otsuka Pharmaceutical Co., Ltd.
Information provided by:	Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:	NCT00537485

Purpose

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)

Condition	Intervention	Phase
Early Parkinson's Disease	Drug: SPM 962 Drug: placebo	Phase II Phase III

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Parkinson's Disease

Drug Information available for: Levodopa Rotigotine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Placebo-Controlled Study for SPM 962 in Early Parkinson's Disease Patients With Non-Concomitant Treatment of L-Dopa

Further study details as provided by Otsuka Pharmaceutical Co., Ltd.:

Primary Outcome Measures:

Change from baseline to the end of maintenance period in total of each sum score of UPDRS Part 2 and Part 3 [ Time Frame: end of maintenance period ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

1.UPDRS Part 2 sum score 2.UPDRS Part 3 sum score 3.UPDRS Part 1 sum score 4.UPDRS Part 4 sum score 5.Total of each sum score of UPDRS Part 1, 2, 3, and 4 6.Hoehn and Yahr stage [ Time Frame: every two weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	200
Study Start Date:	September 2007
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: SPM 962 transdermal application, 1 time per day
2: Placebo Comparator	Drug: placebo transdermal application, 1 time per day

Eligibility

Ages Eligible for Study:	30 Years to 79 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Subject has previously participated in a trial with SPM 962
Subject is on L-dopa treatment for total of over 6 months at the time of informed consent
Subject has psychiatric symptoms, e.g. confusion, hallucination, delusion, excitation, delirium, abnormal behavior at screening test and baseline
Subject has orthostatic hypotension
Subject has a history of epilepsy, convulsion and other
Subject has a complication of serious cardiac disorder/arrhythmia or has the history
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.)
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
Subject has congenital long QT syndrome
Subject has serum potassium of less than 3.5 mEq/L at screening test.
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
Subject has 30 mg/dL and above of BUN or 2.0 mg/dL and above of serum creatinine at screening test
Subject has a history of allergy to topical medicine, e.g. transdermal patch
Subject is pregnant, nursing, or is child bearing potential while the trial
Subject is receiving therapy with prohibited drug specified in the study protocol
Subject has a history of pallidotomy, thalamotomy, deep brain stimulation or fetal tissue transplant
Subject has dementia
Subject is unable to give consent
Subject is participating in another trial of an investigational drug or done so within 12 weeks prior to the initial treatment
Investigator judges that subject is inappropriate as a study subject with other reasons

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00537485

Contacts

Contact: Drug Information Center

opc_ctr@otsuka.jp

Locations

Japan
	Recruiting
Tohoku region, Japan
	Recruiting
Kanto region, Japan
	Recruiting
Chubu region, Japan
	Recruiting
Hokkaido region, Japan
	Recruiting
Kinki region, Japan
	Recruiting
Kyushu region, Japan

Sponsors and Collaborators

Otsuka Pharmaceutical Co., Ltd.

Investigators

Study Director:

Katsuhisa Saito

New Product Evaluation and Development

More Information

Responsible Party:	OPCJ ( Katsuhisa Saito )
Study ID Numbers:	243-07-001
Study First Received:	September 27, 2007
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00537485
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Otsuka Pharmaceutical Co., Ltd.:

SPM 962
rotigotine
Parkinson's disease
monotherapy

Study placed in the following topic categories:

Levodopa
Ganglion Cysts
Movement Disorders
Parkinson Disease
Basal Ganglia Diseases

Dihydroxyphenylalanine
Central Nervous System Diseases
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 15, 2009