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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 October 2017
Main ID:  NCT01631825
Date of registration: 25/06/2012
Prospective Registration: No
Primary sponsor: Otsuka Pharmaceutical Co., Ltd.
Public title: A Long-Term Extension Trial From of SPM 962 in Advanced Parkinson's Disease Patients
Scientific 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
Date of first enrolment: October 2009
Target sample size: 321
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT01631825
Study type:  Interventional
Study design:   
Phase:  Phase 3
Countries of recruitment
Japan
Contacts
Name:     Kyoji Imaoka, Mr
Address: 
Telephone:
Email:
Affiliation:  Otsuka Pharmaceutical Co., Ltd.
Key inclusion & exclusion 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.



Age minimum: N/A
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Parkinson's Disease
Intervention(s)
Drug: SPM 962
Primary Outcome(s)
Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters [Time Frame: Up to 55 weeks after dosing]
Secondary Outcome(s)
Each Item of UPDRS Part 3 (on State) [Time Frame: Baseline, up to 54 weeks after dosing.]
The Modified Hoehn & Yahr Severity of Illness [Time Frame: Baseline, up to 54 weeks after dosing.]
Total of UPDRS Part 2 Sum Score (Average of on State and Off State) and UPDRS Part 3 Sum Score (on State) [Time Frame: Baseline, up to 54 weeks after dosing]
UPDRS Part 1 Sum Score [Time Frame: Baseline, up to 54 weeks after dosing]
Each Item of UPDRS Part 2 (on State) [Time Frame: Baseline, up to 54 weeks after dosing.]
UPDRS Part 2 Sum Score (Off State) [Time Frame: Baseline, up to 54 weeks after dosing]
Absolute Time Spent "Off" [Time Frame: Baseline, up to 54 weeks after dosing]
Each Item of UPDRS Part 2 (Off State) [Time Frame: Baseline, up to 54 weeks after dosing.]
UPDRS Part 2 Sum Score (On State) [Time Frame: Baseline, up to 54 weeks after dosing]
Each Item of UPDRS Part 1 [Time Frame: Baseline, up to 54 weeks after dosing.]
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 [Time Frame: Baseline, up to 54 weeks after dosing]
UPDRS Part 2 Sum Score (Average of on State and Off State) [Time Frame: Baseline, up to 54 weeks after dosing]
UPDRS Part 4 Sum Score [Time Frame: Baseline, up to 54 weeks after dosing]
Each Item of UPDRS Part 2 (Average of on State and Off State) [Time Frame: Baseline, up to 54 weeks after dosing.]
Each Item of UPDRS Part 4 [Time Frame: Baseline, up to 54 weeks after dosing.]
Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 Sum Score [Time Frame: Baseline, Up to 54 weeks after dosing]
Secondary ID(s)
243-08-002
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 19/03/2014
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT01631825
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