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

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

Japan

Study Type

Interventional

Intervention

SPM 962

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring SPM 962, rotigotine, Parkinson's disease

Eligibility Criteria

30 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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

Maintenance Dose of the SPM962

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

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

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

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

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

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.

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.

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

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

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

Mean change (LOCF) from baseline in off time at 12 weeks after dosing.

Full Information

NCT ID

NCT01634243

First Posted

June 27, 2012

Last Updated

February 3, 2014

Sponsor

Otsuka Pharmaceutical Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01634243

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2014

Overall Recruitment Status

Completed

Study Start Date

January 2005 (undefined)

Primary Completion Date

May 2006 (Actual)

Study Completion Date

May 2006 (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 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.

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

64 (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

Maintenance Dose of the SPM962

Description

The maintenance dose of the SPM 962 was examined based on the safety and efficacy.

Time Frame

Up to 12 weeks after dosing

Secondary 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 following the initiation of study treatment.

Time Frame

Up to 12 weeks after dosing

Title

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

Description

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.

Time Frame

baseline, 12 weeks after dosing

Title

UPDRS Part 3 Sum Score for Advanced Parkinson's Disease With Concomitant L-dopa Therapy

Description

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.

Time Frame

baseline, 12 weeks after dosing

Title

UPDRS Part 2 Sum Score for Early Parkinson's Disease Without Concomitant L-dopa Therapy

Description

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.

Time Frame