- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01631812
A Long-Term Extension Trial From Late Phase II of SPM 962 in Advanced Parkinson's Disease Patients
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 Overview
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
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Chubu Region, Japan
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Hokkaido Region, Japan
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Kanto Region, Japan
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Kinki Region, Japan
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Kyushu Region, Japan
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Shikoku Region, Japan
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Tohoku Region, Japan
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: SPM 962
|
SPM 962 transdermal patch once a daily up to 36.0 mg/day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Skin Irritation Score of the Application Site
Time Frame: 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 |
Up to 55 weeks after dosing
|
Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters.
Time Frame: Up to 55 weeks after dosing
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 Sum Score
Time Frame: Baseline, Up to 54 weeks after dosing
|
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
Time Frame: Baseline, Up to 54 weeks after dosing
|
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"
Time Frame: Up to 54 weeks after dosing
|
Mean number of hours in "off state" during a 24-hour period.
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Up to 54 weeks after dosing
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 243-06-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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