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

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Phase 2
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 243-05-001.

Exclusion Criteria:

  • Subject discontinued from the preceding trial 243-05-001.
  • Subject had a serious adverse event which association with the investigational drug was not ruled out during trial 243-05-001.
  • Subject has a persistent serious adverse event at the baseline, which was observed and association with the investigational drug was ruled out during trial 243-05-001.
  • Subject had persistent hallucination or delusion during trial 243-05-001.
  • Subject has psychiatric conditions such as confusion, excitation, delirium, abnormal behaviour at the baseline.
  • Subject has orthostatic hypotension at baseline.
  • Subject has a history of epilepsy, convulsion etc. during trial 243-05-001.
  • Subject has a complication of serious cardiac disorder.
  • Subject has arrhythmia and need to be treated with class 1a antiarrhythmic drugs (e.g. quinidine, procainamide etc.) or class 3 antiarrhythmic drugs (e.g. amiodarone, sotalol etc.).
  • 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 243-05-001 and has a QTc-interval > 470 msec in female or > 450 msec in male at the baseline.
  • Subject had hypokalaemia in 243-05-001 study and not yet recovered.
  • 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 243-05-001.
  • Subject has BUN >= 25 mg/dL or serum creatinine >= 2.0 mg/dl at the end of the taper period in trial 243-05-001.
  • Subject has a history of allergic reaction to topical agents such as transdermal patch. Subject showed serious or extensive application site reactions beyond the application site in the 243-05-001 study.
  • Subject who plans pregnancy during the trial.
  • Subject has dementia.
  • 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

Outcomes

Primary Outcome Measures

Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters.
Incidence and severity of adverse events, vital signs, and laboratory parameters after dosing. *decrease in difference between supine and standing systolic blood pressure
Skin Irritation Score of the Application Site
Skin irritation score of the application site were evaluated according to the criteria below. The worst score throughout the treatment period was used in the analysis. -: no reaction, ±: mild erythema, +: erythema, ++: erythema and Oedema, +++: erythema and oedema and rash papular, or serous papule, or vesicles, ++++: bullosum

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) up to 54 weeks after dosing 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
Mean change (LOCF) from baseline in UPDRS Part 2 sum score (average scores of on state and off state) up to 54 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.
Absolute Time Spent "Off"
Mean number of hours in "off state" during a 24-hour period.

Full Information

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

Unique Protocol Identification Number
NCT01631812
Brief Title
A Long-Term Extension Trial From Late Phase II of SPM 962 in Advanced Parkinson's Disease Patients
Official Title
An Open-label Long-term Extension Trial From Late Phase II of SPM962 (243-05-001) 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
December 2006 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (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
The primary objective of this study is to investigate safety of SPM 962 in advanced PD patients in a multi-center, open-label, non-controlled study following once-daily multiple transdermal doses of SPM962 within a range of 4.5 to 36.0 mg (maximum treatment period: 54 weeks). Efficacy is also to be exploratory investigated.

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 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SPM 962
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
SPM 962
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, Vital Signs, and Laboratory Parameters.
Description
Incidence and severity of adverse events, vital signs, and laboratory parameters after dosing. *decrease in difference between supine and standing systolic blood pressure
Time Frame
Up to 55 weeks after dosing
Title
Skin Irritation Score of the Application Site
Description
Skin irritation score of the application site were evaluated according to the criteria below. The worst score throughout the treatment period was used in the analysis. -: no reaction, ±: mild erythema, +: erythema, ++: erythema and Oedema, +++: erythema and oedema and rash papular, or serous papule, or vesicles, ++++: bullosum
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) up to 54 weeks after dosing 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
Description
Mean change (LOCF) from baseline in UPDRS Part 2 sum score (average scores of on state and off state) up to 54 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, 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
Up to 54 weeks after dosing

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject completed the preceding trial 243-05-001. Exclusion Criteria: Subject discontinued from the preceding trial 243-05-001. Subject had a serious adverse event which association with the investigational drug was not ruled out during trial 243-05-001. Subject has a persistent serious adverse event at the baseline, which was observed and association with the investigational drug was ruled out during trial 243-05-001. Subject had persistent hallucination or delusion during trial 243-05-001. Subject has psychiatric conditions such as confusion, excitation, delirium, abnormal behaviour at the baseline. Subject has orthostatic hypotension at baseline. Subject has a history of epilepsy, convulsion etc. during trial 243-05-001. Subject has a complication of serious cardiac disorder. Subject has arrhythmia and need to be treated with class 1a antiarrhythmic drugs (e.g. quinidine, procainamide etc.) or class 3 antiarrhythmic drugs (e.g. amiodarone, sotalol etc.). 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 243-05-001 and has a QTc-interval > 470 msec in female or > 450 msec in male at the baseline. Subject had hypokalaemia in 243-05-001 study and not yet recovered. 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 243-05-001. Subject has BUN >= 25 mg/dL or serum creatinine >= 2.0 mg/dl at the end of the taper period in trial 243-05-001. Subject has a history of allergic reaction to topical agents such as transdermal patch. Subject showed serious or extensive application site reactions beyond the application site in the 243-05-001 study. Subject who plans pregnancy during the trial. Subject has dementia. 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
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

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

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