Phase 2
Completed N=130
A Long-Term Extension Trial From Late Phase II of SPM 962 in Advanced Parkinson's Disease Patients
Source: ClinicalTrials.gov NCT01631812 ↗Enrolled (actual)
130
Serious AEs
13.1%
Results posted
Mar 2014
Primary outcomePrimary: Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters. — 126; 112; 17; 12 participants
Summary
The primary objective of this study is to investigate safety of SPM 962 in advanced PD patients in a multi-center, open-label, non-controlled study following once-daily multiple transdermal doses of SPM962 within a range of 4.5 to 36.0 mg (maximum treatment period: 54 weeks). Efficacy is also to be exploratory investigated.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters. |
126; 112; 17; 12; 26; 10 | — |
| PRIMARY Skin Irritation Score of the Application Site |
18; 53; 42; 9; 7; 1 | — |
| SECONDARY Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 Sum Score |
-9.6; -9.1; -8.3 | — |
| SECONDARY UPDRS Part 2 Sum Score |
-2.7; -2.4; -1.9 | — |
| SECONDARY Absolute Time Spent "Off" |
-3.0; -2.6; -1.9 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01631812). 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.