Parkinson's Disease
Conditions
Keywords
SPM 962, rotigotine, Parkinson's disease, monotherapy
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.
Interventions
DRUGSPM 962
SPM 962 transdermal patch once a daily up to 36.0 mg/day
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SPM 962 SPM 962 transdermal patch | 143 |
| Total | 143 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 30 |
| Overall Study | Discontinuation criteria | 8 |
| Overall Study | Lack of Efficacy | 7 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | SPM 962 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 85 Participants |
| Age, Categorical Between 18 and 65 years | 58 Participants |
| Age, Continuous | 65.3 years STANDARD_DEVIATION 8.4 |
| Region of Enrollment Japan | 143 participants |
| Sex: Female, Male Female | 83 Participants |
| Sex: Female, Male Male | 60 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 138 / 143 |
| serious Total, serious adverse events | 24 / 143 |
Outcome results
Primary
Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters
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
Time frame: Up to 55 weeks after dosing
Population: Safety set (SS)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SPM 962 | Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters | Any AEs | 140 participants |
| SPM 962 | Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters | Treatment-related AEs | 122 participants |
| SPM 962 | Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters | SAEs | 18 participants |
| SPM 962 | Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters | Severe AEs | 9 participants |
| SPM 962 | Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters | Discontinuation due to AEs | 30 participants |
| SPM 962 | Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters | Severe laboratory abnormality | 14 participants |
| SPM 962 | Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters | ≥30 mmHg decrease* | 1 participants |
| SPM 962 | Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters | Treatment-related AE of orthostatic hypotension | 2 participants |
| SPM 962 | Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters | QTcB ≥500 ms | 1 participants |
| SPM 962 | Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters | Weight decrease of 5% or more | 53 participants |
| SPM 962 | Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters | Weight increase of 5% or more | 22 participants |
Primary
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
Time frame: Up to 55 weeks after dosing
Population: SS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SPM 962 | Skin Irritation Score of the Application Site | - | 20 participants |
| SPM 962 | Skin Irritation Score of the Application Site | ± | 57 participants |
| SPM 962 | Skin Irritation Score of the Application Site | + | 46 participants |
| SPM 962 | Skin Irritation Score of the Application Site | ++ | 12 participants |
| SPM 962 | Skin Irritation Score of the Application Site | +++ | 6 participants |
| SPM 962 | Skin Irritation Score of the Application Site | ++++ | 1 participants |
| SPM 962 | Skin Irritation Score of the Application Site | +++> | 7 participants |
Secondary
Total of Unified Parkinson's Disease Rating Scale (UPDRS) Part 2 Sum Score and Part 3 Sum Score
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.
Time frame: Baseline, Up to 54 weeks after dosing
Population: Full analysis set (FAS), last observation carried forward (LOCF)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SPM 962 | Total of Unified Parkinson's Disease Rating Scale (UPDRS) Part 2 Sum Score and Part 3 Sum Score | Week 12 | -9.9 Scores on a scale | Standard Deviation 8.7 |
| SPM 962 | Total of Unified Parkinson's Disease Rating Scale (UPDRS) Part 2 Sum Score and Part 3 Sum Score | Week 24 | -8.3 Scores on a scale | Standard Deviation 9.5 |
| SPM 962 | Total of Unified Parkinson's Disease Rating Scale (UPDRS) Part 2 Sum Score and Part 3 Sum Score | Week 52 | -6.5 Scores on a scale | Standard Deviation 10.1 |