A Long-Term Extension Trial From Phase II/III of SPM 962 in Early Parkinson's Disease Patients

Otsuka

Status and phase

Completed

Phase 3

Phase 2

Conditions

Parkinson's Disease

Treatments

Drug: SPM 962

Study type

Interventional

Funder types

Industry

Identifiers

NCT01628965

243-07-002

Details and patient eligibility

About

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.

Enrollment

143 patients

Sex

All

Volunteers

No Healthy Volunteers

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.