A Long-Term Extension Trial From Phase II/III of SPM 962 in Early Parkinson's Disease Patients

Phase 2

Completed

Conditions: Parkinson's Disease

Interventions: Drug: SPM 962

Registration Number: NCT01628965

Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.

Brief Summary: Safety of SPM 962 in a once-daily repeated long-term treatment in Parkinson's disease patients who are not concomitantly treated with L-dopa will be investigated with a doses.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 143

Inclusion Criteria

Subject completed the preceding trial 243-07-001 (NCT00537485)

Exclusion Criteria

Subject discontinued from the preceding trial 243-07-001.
Subject had a serious adverse event which association with the investigational drug was not ruled out during trial 243-07-001.
Subject has a persistent serious adverse event at the baseline, which was observed and association with the investigational drug was ruled out during trial 243-07-001.
Subject had persistent hallucination or delusion during trial 243-07-001.
Subject has psychiatric conditions such as confusion, excitation, delirium, abnormal behaviour at the baseline.
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 243-07-001.
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 243-07-001 and has a QTc-interval > 470 msec in female or > 450 msec in male at the baseline.
Subject has a serum potassium level < 3.5 mEq/L at the end of the taper period in trial 243-07-001.
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 243-07-001.
Subject has BUN >= 30 mg/dL or serum creatinine >= 2.0 mg/dl at the end of the taper period in trial 243-07-001.
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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SPM 962	SPM 962	SPM 962 transdermal patch

Primary Outcome Measures

Name	Time	Method
Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters	Up to 55 weeks after dosing	Incidence and severity of adverse events, vital signs, and laboratory parameters up to 54 weeks after dosing. \*decrease in difference between supine and standing systolic blood pressure
Skin Irritation Score of the Application Site	Up to 55 weeks after dosing	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

Name	Time	Method
Total of Unified Parkinson's Disease Rating Scale (UPDRS) Part 2 Sum Score and Part 3 Sum Score	Baseline, Up to 54 weeks after dosing	Mean change (LOCF) from baseline in Total of UPDRS Part 2 sum score and Part 3 sum up to 54 weeks after dosingUPDRS 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.