Phase 3
Completed N=180
A Placebo-controlled Study for SPM 962 in Early Parkinson's Disease Patients
Early Parkinson's Disease
Source: ClinicalTrials.gov NCT00537485 ↗
Enrolled (actual)
180
Serious AEs
1.1%
Results posted
Mar 2014
Primary outcomePrimary: Change From Baseline to the End of Maintenance Period in Total of Each Sum Score of UPDRS Part 2 and Part 3 — -8.4; -4.1 Scores on a scale — p=0.002
Summary
To investigate superiority of SPM 962 over placebo in early Parkinson's disease patients in a multi-center, placebo-controlled, double-blind study following once-daily multiple transdermal doses of SPM 962 within a range of 4.5 to 36.0 mg (12-week dose titration/maintenance period)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to the End of Maintenance Period in Total of Each Sum Score of UPDRS Part 2 and Part 3 |
-8.4; -4.1 | 0.002 sig |
| SECONDARY Efficacy Rate in Total of Each Sum Score of UPDRS Part 2 and Part 3 |
71.6; 40.9; 55.7; 29.5 | <0.001 sig |
| SECONDARY Mean Change in UPDRS Part 2 Sum Score |
-0.6; -0.5; -1.2; -1.0; -1.6; -1.4 | — |
| SECONDARY Efficacy Rate in UPDRS Part 2 Sum Score |
36.4; 13.6; 46.6; 34.1; 52.3; 40.9 | — |
| SECONDARY UPDRS Part 3 Sum Score |
-2.6; -1.7; -4.3; -2.7; -5.7; -3.3 | — |
| SECONDARY Efficacy Rate in UPDRS Part 3 Sum Score |
35.2; 19.3; 52.3; 28.4; 62.5; 35.2 | — |
| SECONDARY UPDRS Part 1 Sum Score |
-0.17; -0.01; -0.17; -0.11; -0.14; -0.13 | — |
| SECONDARY UPDRS Part 4 Sum Score |
0.19; 0.09; 0.28; 0.08; 0.18; 0.03 | — |
| SECONDARY Total of Each Sum Score of UPDRS Part 1, 2, 3, and 4 |
-3.3; -2.1; -5.4; -3.8; -7.2; -4.7 | — |
| SECONDARY The Modified Hoehn and Yahr Stage |
8.1; 9.1; 66.3; 71.6; 25.6; 19.3 | — |
Eligibility Criteria
Inclusion Criteria
- Subject diagnosed as having Parkinson's disease in accordance with "Diagnostic Criteria established by the Research Committee of MHLW-specified Intractable Neurodegenerative Diseases (1995)"
- Subject is 30 years 80 years at the time of informed consent
- Hoehn & Yahr stage 1- 3
- Total of each sum score of UPDRS Part 2 and 3 is over 10 at screening test
Exclusion Criteria
- Subject has previously participated in a trial with SPM 962
- Subject is on L-dopa treatment for total of over 6 months at the time of informed consent
- Subject has psychiatric symptoms, e.g. confusion, hallucination, delusion, excitation, delirium, abnormal behavior at screening test and baseline
- Subject has orthostatic hypotension
- Subject has a history of epilepsy, convulsion and other
- Subject has a complication of serious cardiac disorder/arrhythmia or has the history
- Subject has arrhythmia and treated with class 1a anti-arrhythmic drugs (e.g. quinidine, procainamide etc.) or class 3 anti-arrhythmic drugs (e.g. amiodarone, sotalol etc.)
- Subject has serious ECG abnormal at screening i.e.; 1) Subject has more than 450 msec of QTc values both in two measurements at screening test 2) Subject has more than 470 msec for females and more than 450 msec for males of mean QTc values of two measurements at baseline
- Subject has congenital long QT syndrome
- Subject has serum potassium of less than 3.5 mEq/L at screening test.
- Subject has total bilirubin of 3.0 mg/dL and above or AST(GOT), ALT(GPT) greater than 2.5 times (or 100 IU/L and above) of the clinical laboratory's upper limit of the reference range at screening test
- Subject has 30 mg/dL and above of BUN or 2.0 mg/dL and above of serum creatinine at screening test
- Subject has a history of allergy to topical medicine, e.g. transdermal patch
- Subject is pregnant, nursing, or is child bearing potential while the trial
- Subject is receiving therapy with prohibited drug specified in the study protocol
- Subject has a history of pallidotomy, thalamotomy, deep brain stimulation or fetal tissue transplant
- Subject has dementia
- Subject is unable to give consent
- Subject is participating in another trial of an investigational drug or done so within 12 weeks prior to the initial treatment
- Investigator judges that subject is inappropriate as a study subject with other reasons
Data sourced from ClinicalTrials.gov (NCT00537485). 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.