A Long-Term Extension Trial From Late Phase II 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:
NCT01631812
First received: June 25, 2012
Last updated: February 3, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Parkinson's Disease
Drug: SPM 962
Phase 2

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 Late Phase II of SPM962 (243-05-001) 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, Vital Signs, and Laboratory Parameters. [ Time Frame: Up to 55 weeks after dosing ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: Up to 55 weeks after dosing ] [ Designated as safety issue: Yes ]

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


Enrollment: 130
Study Start Date: December 2006
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SPM 962 Drug: SPM 962
SPM 962 transdermal patch once a daily up to 36.0 mg/day

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01631812

Locations
Japan
Chubu 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: NCT01631812     History of Changes
Other Study ID Numbers: 243-06-001
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

ClinicalTrials.gov processed this record on September 22, 2014