Clinical trial NCT01631812: A Long-Term Extension Trial From Late Phase II of SPM 962 in Advanced Parkinson's Disease Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson's Disease
Keywords: SPM 962
rotigotine
Parkinson's disease
concomitant use of L-dopa
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2012-06-29
Enrollment: 130
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


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.

Primary outcomes:
measure: Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters.
timeFrame: Up to 55 weeks after dosing
measure: Skin Irritation Score of the Application Site
timeFrame: Up to 55 weeks after dosing
Secondary outcomes:
measure: Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 Sum Score
timeFrame: Baseline, Up to 54 weeks after dosing
measure: UPDRS Part 2 Sum Score
timeFrame: Baseline, Up to 54 weeks after dosing
measure: Absolute Time Spent "Off"
timeFrame: Up to 54 weeks after dosing
Other outcomes:
Locations:
city: Chubu Region
country: Japan
city: Hokkaido Region
country: Japan
city: Kanto Region
country: Japan
city: Kinki Region
country: Japan
city: Kyushu Region
country: Japan
city: Shikoku Region
country: Japan
city: Tohoku Region
country: Japan
Study officials:
affiliation: Otsuka Pharmaceutical Co., Ltd.
name: Kyoji Imaoka, Mr
role: STUDY_DIRECTOR
References: