Phase 3
Completed N=143
A Long-Term Extension Trial From Phase II/III of SPM 962 in Early Parkinson's Disease Patients
Source: ClinicalTrials.gov NCT01628965 ↗Enrolled (actual)
143
Serious AEs
16.8%
Results posted
Mar 2014
Primary outcomePrimary: Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters — 140; 122; 18; 9 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters |
140; 122; 18; 9; 30; 14 | — |
| PRIMARY Skin Irritation Score of the Application Site |
20; 57; 46; 12; 6; 1 | — |
| SECONDARY Total of Unified Parkinson's Disease Rating Scale (UPDRS) Part 2 Sum Score and Part 3 Sum Score |
-9.9; -8.3; -6.5 | — |
Eligibility 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) = 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 = 3.0 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.
Data sourced from ClinicalTrials.gov (NCT01628965). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.