A Long-Term Extension Trial From Late Phase II of SPM 962... | NCT01631812

NCT01631812

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Label	Type	Description	Intervention Names
SPM 962	Experimental		Drug: SPM 962

Name	Type	Description	Arm Group Labels	Other Names
SPM 962	Drug	SPM 962 transdermal patch once a daily up to 36.0 mg/day	SPM 962

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 Sum Score	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.

Eligibility Module

Eligibility 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.

Name	Affiliation	Role
Kyoji Imaoka, Mr	Otsuka Pharmaceutical Co., Ltd.	Study Director

ID	Title	Description
FG000	SPM 962	SPM 962 : SPM 962 transdermal patch once a daily up to 36.0 mg/day

Baseline Characteristics Module

ID	Title	Description
BG000	SPM 962	SPM 962 : SPM 962 transdermal patch once a daily up to 36.0 mg/day

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters.

Incidence and severity of adverse events, vital signs, and laboratory parameters after dosing.

*decrease in difference between supine and standing systolic blood pressure

Safety set (SS)

Posted

Number

participants

Up to 55 weeks after dosing

ID	Title	Description
OG000	SPM 962	SPM 962 transdermal patch once a daily up to 36.0 mg/day

Units	Counts
Participants

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	SPM 962	SPM 962 : SPM 962 transdermal patch once a daily up to 36.0 mg/day

Facility	Status	City	State	ZIP	Country	Contacts
		Chubu Region			Japan

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases