search
Back to results

A Long-Term Extension Trial From of SPM 962 in Advanced Parkinson's Disease Patients

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
SPM 962
Sponsored by
Otsuka Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring SPM 962, rotigotine, Parkinson's disease, concomitant use of L-dopa

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subject completed the preceding trial 243-08-001.

Exclusion Criteria:

  • Subject discontinued from the preceding trial 243-08-001.
  • Subject had a serious adverse event which association with the investigational drug was not ruled out during trial 243-08-001.
  • Subject has a persistent serious adverse event at the baseline, which was observed and association with the investigational drug was ruled out during trial 243-08-001.
  • Subject had persistent confusion, hallucination, delusion or excitation during trial 243-08-001.
  • Subject has abnormal behavior such as obsessive-compulsive disorder and delusion in 243-08-001 study.
  • Subject showed serious or extensive application site reactions beyond the application site in the 243-08-001 study.
  • Subject has orthostatic hypotension or a systolic blood pressure (SBP) <= 100 mmHg and has a decrease of SBP from spine to standing position >= 30 mmHg at baseline.
  • Subject has a history of epilepsy, convulsion etc. during trial 243-08-001.
  • Subject develops serious ECG abnormality at the baseline.
  • Subject has QTc-interval >= 500 msec at the baseline or subject has an increase of QTc-interval >= 60 msec from the baseline in the trial 243-08-001 and has a QTc-interval > 470 msec in female or > 450 msec in male at the baseline.
  • Subject had a serum potassium level < 3.5 mEq/L at the end of the taper period in trial 243-08-001.
  • Subject has a total bilirubin >= 3.0 mg/dL or AST(GOT) or ALT(GPT) greater than 2.5 times of the upper limit of the reference range (or ? 100 IU/L) at the end of the period in trial 243-08-001.
  • Subject had BUN >= 30 mg/dL or serum creatinine >= 2.0 mg/dl at the end of the taper period in trial 243-08-001.
  • Subject who plans pregnancy during the trial.
  • Subject is unable to give consent.
  • Subject is judged to be inappropriate for this trial by the investigator for the reasons other than above.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SPM 962

Arm Description

SPM 962 transdermal patch

Outcomes

Primary Outcome Measures

Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters
The safety of the long-term SPM 962 treatment was examined based on the incidence and severity of AEs, vital signs, and laboratory parameters. AEs of special interest (1-3) are defined as below: sudden onset of sleep obsessive-compulsive disorder or impulse-control disorder hallucination, delusion Application site reaction is scored as -, ±, +, ++, +++, or ++++. More + indicates a greater severity of symptoms. The worst score obtained throughout the evaluation period was to be assessed.

Secondary Outcome Measures

Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 Sum Score
Mean change (LOCF) from baseline in UPDRS Part 3 sum score (on state). 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 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.
UPDRS Part 2 Sum Score (Average of on State and Off State)
Mean change (LOCF) from baseline in UPDRS Part 2 sum score (average of on state and off state). 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.
Absolute Time Spent "Off"
Mean number of hours in "off state" during a 24-hour period.
UPDRS Part 1 Sum Score
Mean change (LOCF) from baseline in UPDRS Part 1 sum score. 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 2 Sum Score (On State)
Mean change (LOCF) from baseline in UPDRS Part 2 sum score (on state). A decrease in the scores means improvement.
UPDRS Part 2 Sum Score (Off State)
Mean change (LOCF) from baseline in UPDRS Part 2 sum score (off state). A decrease in the scores means improvement.
UPDRS Part 4 Sum Score
Mean change (LOCF) from baseline in UPDRS Part 4 sum score. 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 UPDRS Part 1 Sum Score, UPDRS Part 2 Sum Score (Average of on State and Off State), UPDRS Part 3 Sum Score (on State), and UPDRS Part 4 Sum Score
Mean change (LOCF) from baseline in total of UPDRS Part 1 sum score, UPDRS Part 2 sum score (average of on state and off state), UPDRS Part 3 sum score (on state), and UPDRS Part 4 sum score. A decrease in the scores means improvement.
The Modified Hoehn & Yahr Severity of Illness
Change (LOCF) from baseline in the Modified Hoehn & Yahr Severity of Illness. The Modified Hoehn & 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. The data at week 52 is shown.
Each Item of UPDRS Part 1
The percentage of subjects with elevated scores for each item of UPDRS Part 1. The data at week 52 is shown.
Each Item of UPDRS Part 2 (on State)
The percentage of subjects with elevated scores for each item of UPDRS Part 2 (on state). The data at week 52 is shown.
Each Item of UPDRS Part 2 (Off State)
The percentage of subjects with elevated scores for each item of UPDRS Part 2 (off state). The data at week 52 is shown.
Each Item of UPDRS Part 2 (Average of on State and Off State)
The percentage of subjects with elevated scores for each item of UPDRS Part 2 (average of on state and off state). The data at week 52 is shown.
Total of UPDRS Part 2 Sum Score (Average of on State and Off State) and UPDRS Part 3 Sum Score (on State)
Mean change (LOCF) from baseline in total of UPDRS Part 2 sum score (average of on state and off state) and UPDRS Part 3 sum score (on state). A decrease in the scores means improvement.
Each Item of UPDRS Part 3 (on State)
The percentage of subjects with elevated scores for each item of UPDRS Part 3 (on state). The data at week 52 is shown.
Each Item of UPDRS Part 4
The percentage of subjects with elevated scores for each item of UPDRS Part 4. The data at week 52 is shown.

Full Information

First Posted
June 25, 2012
Last Updated
February 3, 2014
Sponsor
Otsuka Pharmaceutical Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT01631825
Brief Title
A Long-Term Extension Trial From of SPM 962 in Advanced Parkinson's Disease Patients
Official Title
An Open-label Long-term Extension Trial From Phase III of SPM962 (243-08-002) in Advanced Parkinson's Disease Patients With Concomitant Treatment of L-dopa
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (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 the safety of once-daily repeated transdermal administration of SPM 962 within a dose range of 4.5 to 36.0 mg/day (54-week treatment period) in Parkinson's disease (PD) patients treated concomitantly with L-dopa in a multi-center, open-label uncontrolled study. To investigate efficacy of SPM 962 in an exploratory manner.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
SPM 962, rotigotine, Parkinson's disease, concomitant use of L-dopa

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
321 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SPM 962
Arm Type
Experimental
Arm Description
SPM 962 transdermal patch
Intervention Type
Drug
Intervention Name(s)
SPM 962
Other Intervention Name(s)
rotigotine
Intervention Description
SPM 962 transdermal patch once a daily up to 36.0 mg/day
Primary Outcome Measure Information:
Title
Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters
Description
The safety of the long-term SPM 962 treatment was examined based on the incidence and severity of AEs, vital signs, and laboratory parameters. AEs of special interest (1-3) are defined as below: sudden onset of sleep obsessive-compulsive disorder or impulse-control disorder hallucination, delusion Application site reaction is scored as -, ±, +, ++, +++, or ++++. More + indicates a greater severity of symptoms. The worst score obtained throughout the evaluation period was to be assessed.
Time Frame
Up to 55 weeks after dosing
Secondary Outcome Measure Information:
Title
Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 Sum Score
Description
Mean change (LOCF) from baseline in UPDRS Part 3 sum score (on state). 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 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, Up to 54 weeks after dosing
Title
UPDRS Part 2 Sum Score (Average of on State and Off State)
Description
Mean change (LOCF) from baseline in UPDRS Part 2 sum score (average of on state and off state). 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, up to 54 weeks after dosing
Title
Absolute Time Spent "Off"
Description
Mean number of hours in "off state" during a 24-hour period.
Time Frame
Baseline, up to 54 weeks after dosing
Title
UPDRS Part 1 Sum Score
Description
Mean change (LOCF) from baseline in UPDRS Part 1 sum score. 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, up to 54 weeks after dosing
Title
UPDRS Part 2 Sum Score (On State)
Description
Mean change (LOCF) from baseline in UPDRS Part 2 sum score (on state). A decrease in the scores means improvement.
Time Frame
Baseline, up to 54 weeks after dosing
Title
UPDRS Part 2 Sum Score (Off State)
Description
Mean change (LOCF) from baseline in UPDRS Part 2 sum score (off state). A decrease in the scores means improvement.
Time Frame
Baseline, up to 54 weeks after dosing
Title
UPDRS Part 4 Sum Score
Description
Mean change (LOCF) from baseline in UPDRS Part 4 sum score. 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, up to 54 weeks after dosing
Title
Total of UPDRS Part 1 Sum Score, UPDRS Part 2 Sum Score (Average of on State and Off State), UPDRS Part 3 Sum Score (on State), and UPDRS Part 4 Sum Score
Description
Mean change (LOCF) from baseline in total of UPDRS Part 1 sum score, UPDRS Part 2 sum score (average of on state and off state), UPDRS Part 3 sum score (on state), and UPDRS Part 4 sum score. A decrease in the scores means improvement.
Time Frame
Baseline, up to 54 weeks after dosing
Title
The Modified Hoehn & Yahr Severity of Illness
Description
Change (LOCF) from baseline in the Modified Hoehn & Yahr Severity of Illness. The Modified Hoehn & 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. The data at week 52 is shown.
Time Frame
Baseline, up to 54 weeks after dosing.
Title
Each Item of UPDRS Part 1
Description
The percentage of subjects with elevated scores for each item of UPDRS Part 1. The data at week 52 is shown.
Time Frame
Baseline, up to 54 weeks after dosing.
Title
Each Item of UPDRS Part 2 (on State)
Description
The percentage of subjects with elevated scores for each item of UPDRS Part 2 (on state). The data at week 52 is shown.
Time Frame
Baseline, up to 54 weeks after dosing.
Title
Each Item of UPDRS Part 2 (Off State)
Description
The percentage of subjects with elevated scores for each item of UPDRS Part 2 (off state). The data at week 52 is shown.
Time Frame
Baseline, up to 54 weeks after dosing.
Title
Each Item of UPDRS Part 2 (Average of on State and Off State)
Description
The percentage of subjects with elevated scores for each item of UPDRS Part 2 (average of on state and off state). The data at week 52 is shown.
Time Frame
Baseline, up to 54 weeks after dosing.
Title
Total of UPDRS Part 2 Sum Score (Average of on State and Off State) and UPDRS Part 3 Sum Score (on State)
Description
Mean change (LOCF) from baseline in total of UPDRS Part 2 sum score (average of on state and off state) and UPDRS Part 3 sum score (on state). A decrease in the scores means improvement.
Time Frame
Baseline, up to 54 weeks after dosing
Title
Each Item of UPDRS Part 3 (on State)
Description
The percentage of subjects with elevated scores for each item of UPDRS Part 3 (on state). The data at week 52 is shown.
Time Frame
Baseline, up to 54 weeks after dosing.
Title
Each Item of UPDRS Part 4
Description
The percentage of subjects with elevated scores for each item of UPDRS Part 4. The data at week 52 is shown.
Time Frame
Baseline, up to 54 weeks after dosing.

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject completed the preceding trial 243-08-001. Exclusion Criteria: Subject discontinued from the preceding trial 243-08-001. Subject had a serious adverse event which association with the investigational drug was not ruled out during trial 243-08-001. Subject has a persistent serious adverse event at the baseline, which was observed and association with the investigational drug was ruled out during trial 243-08-001. Subject had persistent confusion, hallucination, delusion or excitation during trial 243-08-001. Subject has abnormal behavior such as obsessive-compulsive disorder and delusion in 243-08-001 study. Subject showed serious or extensive application site reactions beyond the application site in the 243-08-001 study. Subject has orthostatic hypotension or a systolic blood pressure (SBP) <= 100 mmHg and has a decrease of SBP from spine to standing position >= 30 mmHg at baseline. Subject has a history of epilepsy, convulsion etc. during trial 243-08-001. Subject develops serious ECG abnormality at the baseline. Subject has QTc-interval >= 500 msec at the baseline or subject has an increase of QTc-interval >= 60 msec from the baseline in the trial 243-08-001 and has a QTc-interval > 470 msec in female or > 450 msec in male at the baseline. Subject had a serum potassium level < 3.5 mEq/L at the end of the taper period in trial 243-08-001. Subject has a total bilirubin >= 3.0 mg/dL or AST(GOT) or ALT(GPT) greater than 2.5 times of the upper limit of the reference range (or ? 100 IU/L) at the end of the period in trial 243-08-001. Subject had BUN >= 30 mg/dL or serum creatinine >= 2.0 mg/dl at the end of the taper period in trial 243-08-001. Subject who plans pregnancy during the trial. Subject is unable to give consent. Subject is judged to be inappropriate for this trial by the investigator for the reasons other than above.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyoji Imaoka, Mr
Organizational Affiliation
Otsuka Pharmaceutical Co., Ltd.
Official's Role
Study Director
Facility Information:
City
Chubu Region
Country
Japan
City
Chugoku Region
Country
Japan
City
Hokkaido Region
Country
Japan
City
Kanto Region
Country
Japan
City
Kinki Region
Country
Japan
City
Kyushu Region
Country
Japan
City
Shikoku Region
Country
Japan
City
Tohoku Region
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

A Long-Term Extension Trial From of SPM 962 in Advanced Parkinson's Disease Patients

We'll reach out to this number within 24 hrs