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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01631825
First received: June 25, 2012
Last updated: February 3, 2014
Last verified: February 2014
  Purpose
  • 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.

Condition Intervention Phase
Parkinson's Disease
Drug: SPM 962
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters [ Time Frame: Up to 55 weeks after dosing ] [ Designated as safety issue: Yes ]

    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:

    1. sudden onset of sleep
    2. obsessive-compulsive disorder or impulse-control disorder
    3. 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 [ Time Frame: Baseline, Up to 54 weeks after dosing ] [ Designated as safety issue: No ]

    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) [ Time Frame: Baseline, up to 54 weeks after dosing ] [ Designated as safety issue: No ]

    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" [ Time Frame: Baseline, up to 54 weeks after dosing ] [ Designated as safety issue: No ]
    Mean number of hours in "off state" during a 24-hour period.

  • UPDRS Part 1 Sum Score [ Time Frame: Baseline, up to 54 weeks after dosing ] [ Designated as safety issue: No ]

    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) [ Time Frame: Baseline, up to 54 weeks after dosing ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline, up to 54 weeks after dosing ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, up to 54 weeks after dosing ] [ Designated as safety issue: No ]

    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 [ Time Frame: Baseline, up to 54 weeks after dosing ] [ Designated as safety issue: No ]

    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 [ Time Frame: Baseline, up to 54 weeks after dosing. ] [ Designated as safety issue: No ]

    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 [ Time Frame: Baseline, up to 54 weeks after dosing. ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline, up to 54 weeks after dosing. ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline, up to 54 weeks after dosing. ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline, up to 54 weeks after dosing. ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline, up to 54 weeks after dosing ] [ Designated as safety issue: No ]

    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) [ Time Frame: Baseline, up to 54 weeks after dosing. ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, up to 54 weeks after dosing. ] [ Designated as safety issue: No ]
    The percentage of subjects with elevated scores for each item of UPDRS Part 4. The data at week 52 is shown.


Enrollment: 321
Study Start Date: October 2009
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SPM 962
SPM 962 transdermal patch
Drug: SPM 962
SPM 962 transdermal patch once a daily up to 36.0 mg/day
Other Name: rotigotine

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  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: NCT01631825

Locations
Japan
Chubu Region, Japan
Chugoku Region, Japan
Hokkaido Region, Japan
Kanto Region, Japan
Kinki Region, Japan
Kyushu Region, Japan
Shikoku Region, Japan
Tohoku Region, Japan
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.
Investigators
Study Director: Kyoji Imaoka, Mr Otsuka Pharmaceutical Co., Ltd.
  More Information

No publications provided

Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01631825     History of Changes
Other Study ID Numbers: 243-08-002
Study First Received: June 25, 2012
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
concomitant use of L-dopa

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
N 0437
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 23, 2014