A Long-Term Extension Trial From Late Phase II of SPM 962 in Advanced Parkinson's Disease Patients

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Drug: SPM 962


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SPM 962<br> | Drug: SPM 962<br>* SPM 962 transdermal patch once a daily up to 36.0 mg/day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 Outcome Measures

| Outcome Measure | 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. | Baseline, Up to 54 weeks after dosing | 
| UPDRS Part 2 Sum Score | 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. | Baseline, Up to 54 weeks after dosing | 
| Absolute Time Spent Off | Mean number of hours in off state during a 24-hour period. | Up to 54 weeks after dosing | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SPM 962, rotigotine, Parkinson's disease, concomitant use of L-dopa