Clinical trial NCT01631825: A Long-Term Extension Trial From of SPM 962 in Advanced Parkinson's Disease Patients
Official title: An Open-label Long-term Extension Trial From Phase III of SPM962 (243-08-002) in Advanced Parkinson's Disease Patients With Concomitant Treatment of L-dopa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
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: 321
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: * To investigate the safety of once-daily repeated transdermal administration of SPM 962 within a dose range of 4.5 to 36.0 mg/day (54-week treatment period) in Parkinson's disease (PD) patients treated concomitantly with L-dopa in a multi-center, open-label uncontrolled study.
* To investigate efficacy of SPM 962 in an exploratory manner.


Eligibility criteria: Inclusion Criteria:

* Subject completed the preceding trial 243-08-001.

Exclusion Criteria:

* Subject discontinued from the preceding trial 243-08-001.
* Subject had a serious adverse event which association with the investigational drug was not ruled out during trial 243-08-001.
* Subject has a persistent serious adverse event at the baseline, which was observed and association with the investigational drug was ruled out during trial 243-08-001.
* Subject had persistent confusion, hallucination, delusion or excitation during trial 243-08-001.
* Subject has abnormal behavior such as obsessive-compulsive disorder and delusion in 243-08-001 study.
* Subject showed serious or extensive application site reactions beyond the application site in the 243-08-001 study.
* 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 243-08-001.
* 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 243-08-001 and has a QTc-interval \> 470 msec in female or \> 450 msec in male at the baseline.
* Subject had a serum potassium level \< 3.5 mEq/L at the end of the taper period in trial 243-08-001.
* 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 243-08-001.
* Subject had BUN \>= 30 mg/dL or serum creatinine \>= 2.0 mg/dl at the end of the taper period in trial 243-08-001.
* Subject who plans pregnancy during the trial.
* 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 (AEs), Vital Signs, and Laboratory Parameters
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 (Average of on State and Off State)
timeFrame: Baseline, up to 54 weeks after dosing
measure: Absolute Time Spent "Off"
timeFrame: Baseline, up to 54 weeks after dosing
measure: UPDRS Part 1 Sum Score
timeFrame: Baseline, up to 54 weeks after dosing
measure: UPDRS Part 2 Sum Score (On State)
timeFrame: Baseline, up to 54 weeks after dosing
measure: UPDRS Part 2 Sum Score (Off State)
timeFrame: Baseline, up to 54 weeks after dosing
measure: UPDRS Part 4 Sum Score
timeFrame: Baseline, up to 54 weeks after dosing
measure: Total of UPDRS Part 1 Sum Score, UPDRS Part 2 Sum Score (Average of on State and Off State), UPDRS Part 3 Sum Score (on State), and UPDRS Part 4 Sum Score
timeFrame: Baseline, up to 54 weeks after dosing
measure: The Modified Hoehn & Yahr Severity of Illness
timeFrame: Baseline, up to 54 weeks after dosing.
measure: Each Item of UPDRS Part 1
timeFrame: Baseline, up to 54 weeks after dosing.
measure: Each Item of UPDRS Part 2 (on State)
timeFrame: Baseline, up to 54 weeks after dosing.
measure: Each Item of UPDRS Part 2 (Off State)
timeFrame: Baseline, up to 54 weeks after dosing.
measure: Each Item of UPDRS Part 2 (Average of on State and Off State)
timeFrame: Baseline, up to 54 weeks after dosing.
measure: Total of UPDRS Part 2 Sum Score (Average of on State and Off State) and UPDRS Part 3 Sum Score (on State)
timeFrame: Baseline, up to 54 weeks after dosing
measure: Each Item of UPDRS Part 3 (on State)
timeFrame: Baseline, up to 54 weeks after dosing.
measure: Each Item of UPDRS Part 4
timeFrame: Baseline, up to 54 weeks after dosing.
Other outcomes:
Locations:
city: Chubu Region
country: Japan
city: Chugoku 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: