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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00537485
First received: September 27, 2007
Last updated: February 3, 2014
Last verified: February 2014
  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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Placebo-controlled Study for SPM 962 in Early Parkinson's Disease Patients With Non-concomitant Treatment of L-dopa

Resource links provided by NLM:


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: baseline, end of maintenance period ] [ Designated as safety issue: No ]

    Mean change (LOCF) from baseline to the end of maintenance period in total of each sum score of UPDRS Part 2 and Part 3.

    UPDRS is a scale for monitoring Parkinson's Disease-related disability and impairment. The UPDRS consists of the following four sub-scales. Part 1: Mentation, Part 2: Activities of Daily Living, Part 3: Motor, Part 4: Complications. Part 2 assesses 13 items and Part 3 assesses 14 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement.



Secondary Outcome Measures:
  • Efficacy Rate in Total of Each Sum Score of UPDRS Part 2 and Part 3 [ Time Frame: baseline, end of maintenance period ] [ Designated as safety issue: No ]
    Effective rate (percentage of subjects with 20% or 30% decrease) (LOCF) in total of each sum score of UPDRS Part 2 and Part 3 at the end of maintenance period

  • Mean Change in UPDRS Part 2 Sum Score [ Time Frame: Baseline, every two weeks ] [ Designated as safety issue: No ]

    Mean change (LOCF) from baseline in UPDRS Part 2 sum score at every two weeks after dosing.

    UPDRS sub-scale Part 2 assesses 13 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement.


  • Efficacy Rate in UPDRS Part 2 Sum Score [ Time Frame: Baseline, every two weeks ] [ Designated as safety issue: No ]
    Effective rate (percentage of subjects with 20% or 30% decrease) (LOCF) in UPDRS Part 2 sum score at every two weeks after dosing.

  • UPDRS Part 3 Sum Score [ Time Frame: Baseline, every two weeks ] [ Designated as safety issue: No ]

    Mean change (LOCF) from baseline in UPDRS Part 3 sum score at every two weeks after dosing.

    UPDRS sub-scale Part 3 assesses 14 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement.


  • Efficacy Rate in UPDRS Part 3 Sum Score [ Time Frame: Baseline, every two weeks ] [ Designated as safety issue: No ]
    Effective rate (percentage of subjects with 20% or 30% decrease) (LOCF) in UPDRS Part 2 sum score at every two weeks after dosing.

  • UPDRS Part 1 Sum Score [ Time Frame: Baseline, every two weeks ] [ Designated as safety issue: No ]

    MMean change (LOCF) from baseline in UPDRS Part 1 sum score at every two weeks after dosing.

    UPDRS sub-scale Part 1 assesses 4 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement.


  • UPDRS Part 4 Sum Score [ Time Frame: Baseline, every two weeks ] [ Designated as safety issue: No ]

    Mean change (LOCF) from baseline in UPDRS Part 4 sum score at every two weeks after dosing.

    UPDRS sub-scale Part 4 assesses 11 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement.


  • Total of Each Sum Score of UPDRS Part 1, 2, 3, and 4 [ Time Frame: Baseline, every two weeks ] [ Designated as safety issue: No ]

    Mean change (LOCF) from baseline to the end of maintenance period in total of each sum score of UPDRS Part 1, 2, 3 and 4.

    UPDRS sub-scale Part 1, 2, 3, and 4 assess 4, 13, 14, and 11 items respectively. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement.


  • The Modified Hoehn and Yahr Stage [ Time Frame: Baseline, end of maintenance period ] [ Designated as safety issue: No ]
    Mean change (LOCF) from baseline in the Modified Hoehn and Yahr Severity of Illness at the end of maintenance period. The Modified Hoehn and Yahr criteria are measured on the following 8-point scale for staging: 0, No signs of disease; 1, Unilateral disease; 1.5, Unilateral plus axial involvement; 2, Bilateral disease without impairment of balance; 2.5, Mild bilateral disease with recovery on pull test; 3, Mild to moderate bilateral disease, some postural instability, physically independent 4, Severe disability, still able to walk or stand unassisted; and 5, Wheelchair bound or bedridden unless aided.


Enrollment: 180
Study Start Date: September 2007
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: SPM 962
transdermal application, 1 time per day
Placebo Comparator: 2 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:

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Japan
Chubu region, Japan
Hokkaido region, Japan
Kanto region, Japan
Kinki region, Japan
Kyushu region, Japan
Tohoku region, Japan
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.
Investigators
Study Director: Katsuhisa Saito New Product Evaluation and Development
  More Information

No publications provided

Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00537485     History of Changes
Other Study ID Numbers: 243-07-001
Study First Received: September 27, 2007
Results First Received: February 3, 2014
Last Updated: February 3, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Otsuka Pharmaceutical Co., Ltd.:
SPM 962
rotigotine
Parkinson's disease
monotherapy

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on August 19, 2014