Overview
A Long-Term Extension Trial From Phase II/III of SPM 962 in Early Parkinson's Disease Patients
Status:
Completed
Completed
Trial end date:
2010-10-01
2010-10-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 2/Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Otsuka Pharmaceutical Co., Ltd.Treatments:
N 0437
Rotigotine
Criteria
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.