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

Primary Purpose

Early Parkinson's Disease

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
SPM 962
placebo
Sponsored by
Otsuka Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Early Parkinson's Disease focused on measuring SPM 962, rotigotine, Parkinson's disease, monotherapy

Eligibility Criteria

30 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

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
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
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
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
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
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
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
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
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
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
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.

Full Information

First Posted
September 27, 2007
Last Updated
February 3, 2014
Sponsor
Otsuka Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00537485
Brief Title
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

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otsuka Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early Parkinson's Disease
Keywords
SPM 962, rotigotine, Parkinson's disease, monotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
SPM 962
Intervention Description
transdermal application, 1 time per day
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
transdermal application, 1 time per day
Primary Outcome Measure Information:
Title
Change From Baseline to the End of Maintenance Period in Total of Each Sum Score of UPDRS Part 2 and Part 3
Description
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.
Time Frame
baseline, end of maintenance period
Secondary Outcome Measure Information:
Title
Efficacy Rate in Total of Each Sum Score of UPDRS Part 2 and Part 3
Description
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
Time Frame
baseline, end of maintenance period
Title
Mean Change in UPDRS Part 2 Sum Score
Description
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.
Time Frame
Baseline, every two weeks
Title
Efficacy Rate in UPDRS Part 2 Sum Score
Description
Effective rate (percentage of subjects with 20% or 30% decrease) (LOCF) in UPDRS Part 2 sum score at every two weeks after dosing.
Time Frame
Baseline, every two weeks
Title
UPDRS Part 3 Sum Score
Description
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.
Time Frame
Baseline, every two weeks
Title
Efficacy Rate in UPDRS Part 3 Sum Score
Description
Effective rate (percentage of subjects with 20% or 30% decrease) (LOCF) in UPDRS Part 2 sum score at every two weeks after dosing.
Time Frame
Baseline, every two weeks
Title
UPDRS Part 1 Sum Score
Description
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.
Time Frame
Baseline, every two weeks
Title
UPDRS Part 4 Sum Score
Description
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.
Time Frame
Baseline, every two weeks
Title
Total of Each Sum Score of UPDRS Part 1, 2, 3, and 4
Description
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.
Time Frame
Baseline, every two weeks
Title
The Modified Hoehn and Yahr Stage
Description
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.
Time Frame
Baseline, end of maintenance period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katsuhisa Saito
Organizational Affiliation
New Product Evaluation and Development
Official's Role
Study Director
Facility Information:
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

12. IPD Sharing Statement

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

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