A Dose-ranging Study for SPM 962 in Parkinson's Disease Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01634243
First received: June 27, 2012
Last updated: February 3, 2014
Last verified: February 2014
  Purpose

The primary objective of this trial is to establish the maximum maintenance dose of SPM 962 in patients with Parkinson's disease in a multi-center, uncontrolled, open-label study by conducting safety evaluation of each patient following once-daily transdermal doses of SPM 962 within a range of 4.5 to 36.0 mg. (The administration period will consist of a standard 8-week dose-titration period, 4-week dose-maintenance period, and a dose de-escalation period) Exploratory evaluation of each patient's maintenance dose will also be conducted with attention to patient safety. The relationship of pharmacokinetics, safety, and efficacy will also be examined.


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

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Open-label Dose-ranging Study for SPM 962 in Parkinson's Disease Patients

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Maintenance Dose of the SPM962 [ Time Frame: Up to 12 weeks after dosing ] [ Designated as safety issue: Yes ]
    The maintenance dose of the SPM 962 was examined based on the safety and efficacy.


Secondary Outcome Measures:
  • Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters [ Time Frame: Up to 12 weeks after dosing ] [ Designated as safety issue: Yes ]
    Incidence and severity of adverse events, vital signs, and laboratory parameters following the initiation of study treatment.

  • Total of Unified Parkinson's Disease Rating Scale (UPDRS) Part 2 Sum Score and Part 3 Sum Score for Early Parkinson's Disease Without Concomitant L-dopa Therapy [ Time Frame: baseline, 12 weeks after dosing ] [ Designated as safety issue: No ]

    Mean change (LOCF) from baseline in Total of UPDRS Part 2 sum score and Part 3 sum at 12 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 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.


  • UPDRS Part 3 Sum Score for Advanced Parkinson's Disease With Concomitant L-dopa Therapy [ Time Frame: baseline, 12 weeks after dosing ] [ Designated as safety issue: No ]

    Mean change (LOCF) from baseline in UPDRS Part 3 sum score at 12 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.


  • UPDRS Part 2 Sum Score for Early Parkinson's Disease Without Concomitant L-dopa Therapy [ Time Frame: Baseline, 12 weeks after dosing ] [ Designated as safety issue: No ]

    Mean change (LOCF) from baseline in UPDRS Part 2 sum score at 12 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.


  • UPDRS Part 3 Sum Score for Early Parkinson's Disease Without Concomitant L-dopa Therapy [ Time Frame: Baseline, 12 weeks after dosing ] [ Designated as safety issue: No ]

    Mean change (LOCF) from baseline in UPDRS Part 3 sum score at 12 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.


  • UPDRS Part 2 Sum Score (on State) for Advanced Parkinson's Disease With Concomitant L-dopa Therapy. [ Time Frame: Baseline, 12 weeks after dosing ] [ Designated as safety issue: No ]

    Mean change (LOCF) from baseline in UPDRS Part 2 sum score (on state) at 12 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.


  • UPDRS Part 2 Sum Score (Off State) for Advanced Parkinson's Disease With Concomitant L-dopa Therapy. [ Time Frame: Baseline, 12 weeks after dosing ] [ Designated as safety issue: No ]

    Mean change (LOCF) from baseline in UPDRS Part 2 sum score (off state) at 12 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.


  • UPDRS Part 2 Sum Score (Average Score of on State and Off State) for Advanced Parkinson's Disease With Concomitant L-dopa Therapy [ Time Frame: Baseline, 12 weeks after dosing ] [ Designated as safety issue: No ]

    Mean change (LOCF) from baseline in UPDRS Part 2 sum score (average score of on state and off state) at 12 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.


  • Total of UPDRS Part 2 Sum Score (Average Score of on State and Off State) and Part 3 Sum Score for Advanced Parkinson's Disease With Concomitant L-dopa Therapy [ Time Frame: Baseline, 12 weeks after dosing ] [ Designated as safety issue: No ]

    Mean change (LOCF) from baseline in Total of UPDRS Part 2 sum score (average score of on state and off state) and Part 3 sum score at 12 weeks after dosing.

    UPDRS sub-scale 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.


  • Off Time for Advanced Parkinson's Disease With Concomitant L-dopa Therapy [ Time Frame: Baseline, 12 weeks after dosing ] [ Designated as safety issue: No ]
    Mean change (LOCF) from baseline in off time at 12 weeks after dosing.


Enrollment: 64
Study Start Date: January 2005
Study Completion Date: May 2006
Primary Completion Date: May 2006 (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

Ages Eligible for Study:   30 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • For subject with early and advanced Parkinson's disease

    • 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 and more and less than 80 years of age at the time of informed consent.
    • Gender and inpatient-outpatient status are not specified.
  • For subject with early Parkinson's disease

    • Hoehn & Yahr stage 3 or less.
    • Subject who has not taken L-dopa within 28 days prior to initial administration of SPM 962.
  • For subject with dvanced Parkinson's disease

    • Hoehn & Yahr stage 2-4.
    • Subject is on a stable dose of L-dopa with no change in daily dose or dosing regimen for at least 7 days prior to the initial treatment of SPM 962.
    • Subject has any of the following problematic symptoms; 1) Wearing off phenomenon 2) On and off phenomenon 3) Not well controlled with L-dopa due to adverse effect 4) Weakening of L-dopa efficacy.

Exclusion Criteria:

  • Subject is on other dopamine agonist treatment within 7 days prior to the initial treatment. Subject is on cabergoline treatment within 14 days prior to the initial treatment.
  • Subject has psychiatric symptoms, e.g. confusion, hallucination, delusion, excitation, delirium, abnormal behavior.
  • Subject has orthostatic hypotension.
  • Subject has a history of epilepsy, convulsion and other.
  • Subject has a complication of serious cardiac disorder or has the history.
  • Subject has arrhythmia and treated with class 1a antiarrhythmic drugs (e.g. quinidine, procainamide etc.) or class 3 antiarrhythmic drugs (e.g. amiodarone, sotalol etc.).
  • At screening and baseline, subject develops serious ECG abnormality. Subjects has QTc-interval >450 msec at screening. Subject has QTc-interval >450 msec in males and >470 msec in females at baseline.
  • Subject has congenital long QT syndrome.
  • Subject has hypokalaemia.
  • 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).
  • Subject has BUN >= 25 mg/dL or serum creatinine >= 2.0 mg/dl.
  • Subject has a history of allergic reaction to topical agents such as transdermal patch.
  • Subject is pregnant or nursing or woman who plans pregnancy during 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 6 months prior to the initial treatment.
  • Investigator judges that subject is inappropriate as a study subject with other reasons.
  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: NCT01634243

Locations
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: NCT01634243     History of Changes
Other Study ID Numbers: 243-03-001
Study First Received: June 27, 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

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 August 26, 2014