Phase 2
N=174
A Dose-finding Study for SPM 962 in Advanced Parkinson's Disease Patients
Parkinson's Disease
Bottom Line
View on ClinicalTrials.gov: NCT01628848 ↗Enrolled (actual)
174
Serious AEs
3.5%
Results posted
Mar 2014
Primary outcome: Primary: Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 Sum Score — -10.1; -4.4 Scores on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- SPM 962 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Primary completion
- Apr 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 Sum Score |
-10.1; -4.4 | — |
| SECONDARY UPDRS Part 2 Sum Score (Average Score of on State and Off State) |
-3.8; -1.6 | — |
| SECONDARY Off Time |
-2.1; -0.7 | — |
| SECONDARY Effective Rate in UPDRS Part 3 Sum Score |
73.3; 43.0; 64.0; 29.1 | — |
| SECONDARY UPDRS Part 1 Sum Score |
-0.15; -0.12 | — |
| SECONDARY Effective Rate in Off Time |
63.0; 46.4; 51.9; 37.5 | — |
| SECONDARY UPDRS Part 2 Sum Score (on State) |
-3.0; -1.2 | — |
| SECONDARY UPDRS Part 2 Sum Score (Off State) |
-4.6; -1.9 | — |
| SECONDARY UPDRS Part 4 Sum Score |
-0.40; -0.22 | — |
| SECONDARY Total of UPDRS Part 2 Sum Score (Average Score of on State and Off State) and UPDRS Part 3 Sum Score |
-14.0; -6.0 | — |
| SECONDARY Total of UPDRS Part 1 Sum Score, UPDRS Part 2 Sum Score (Average Score of on State and Off State), UPDRS Part 3 Sum Score, and UPDRS Part 4 Sum Score. |
-14.6; -6.4 | — |
| SECONDARY The Modified Hoehn & Yahr Severity of Illness |
1.2; 4.7; 61.6; 80.0; 37.2; 15.3 | — |
Summary
The primary objective of this study is to investigate efficacy and safety of SPM 962 in advanced Parkinson's Disease (PD) patients in a multi-center, placebo-controlled study following once-daily multiple transdermal doses of SPM 962 within a range of 4.5 to 36.0 mg (12 weeks of dose titration/maintenance period). Recommended maintenance dose range is also to be investigated with distribution of the maintenance dose and accumulated response rate of efficacy.
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 and more and less than 80 years of age at the time of informed consent.
- Hoehn & Yahr stage 2-4 (on time).
- Total UPDRS Part 3 score is over 10 at screening test (on time).
- Subject is on a stable dose of L-dopa with no change in daily dose or dosing regimen for at least 28 days prior to the initial treatment of SPM 962.
- Subject has any of the following problematic symptoms; 1) Wearing off phenomenon 2) On and off phenomenon 3) Delayed-on and/or No-on phenomenon 4) Not well controlled with L-dopa due to adverse effect 5) Weakening of L-dopa efficacy.
Exclusion Criteria
- Subject has previously participated in a trial with SPM 962.
- Subject is on other dopamine agonist treatment within 28 days prior to the initial treatment.
- Subject has psychiatric symptoms, e.g. confusion, hallucination, delusion, excitation, delirium, abnormal behavior at screening test or baseline.
- Subject has orthostatic hypotension.
- Subject has a history of epilepsy, convulsion and other.
- Subject has a complication of serious cardiac disorder or has the history.
- Subject has arrhythmia and treated with class 1a antiarrhythmic drugs (e.g. quinidine, procainamide etc.) or class 3 antiarrhythmic drugs (e.g. amiodarone, sotalol etc.).
- At screening and baseline, subject develops serious ECG abnormality. Subjects has QTc-interval >450 msec twice at screening. Subject has a the average QTc-interval from two ECGs >450 msec in males and >470 msec in females at baseline.
- Subject has congenital long QT syndrome.
- Subject has hypokalaemia.
- 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 screening test.
- Subject has BUN >= 25 mg/dL or serum creatinine >= 2.0 mg/dl at screening test.
- Subject has a history of allergic reaction to topical agents such as transdermal patch.
- Subject is pregnant or nursing or woman who plans pregnancy during 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 24 weeks prior to the initial treatment.
- Investigator judges that subject is inappropriate as a study subject with other reasons.
Data sourced from ClinicalTrials.gov (NCT01628848). 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.