Clinical trial NCT01628848: A Dose-finding Study for SPM 962 in Advanced Parkinson's Disease Patients
Official title: A Placebo-controlled Dose-finding Study for SPM 962 in Advanced Parkinson's Disease Patients With Concomitant Treatment of L-dopa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson's Disease
Keywords: SPM 962
rotigotine
Parkinson's disease
concomitant use of L-dopa
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2012-06-27
Enrollment: 174
Sex: ALL
Minimum age (years): 30
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 Sum Score
timeFrame: baseline, 12 weeks after dosing
Secondary outcomes:
measure: UPDRS Part 2 Sum Score (Average Score of on State and Off State)
timeFrame: baseline, 12 weeks after dosing
measure: Off Time
timeFrame: baseline, 12 weeks after dosing
measure: Effective Rate in UPDRS Part 3 Sum Score
timeFrame: Baseline, 12 weeks after dosing
measure: UPDRS Part 1 Sum Score
timeFrame: Baseline, 12 weeks after dosing
measure: Effective Rate in Off Time
timeFrame: Baseline, 12 weeks after dosing.
measure: UPDRS Part 2 Sum Score (on State)
timeFrame: Baseline, 12 weeks after dosing
measure: UPDRS Part 2 Sum Score (Off State)
timeFrame: Baseline, 12 weeks after dosing
measure: UPDRS Part 4 Sum Score
timeFrame: Baseline, 12 weeks after dosing
measure: Total of UPDRS Part 2 Sum Score (Average Score of on State and Off State) and UPDRS Part 3 Sum Score
timeFrame: Baseline, 12 weeks after dosing
measure: 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.
timeFrame: Baseline, 12 weeks after dosing
measure: The Modified Hoehn & Yahr Severity of Illness
timeFrame: Baseline, 12 weeks after dosing
Other outcomes:
Locations:
city: Chubu Region
country: Japan
city: Hokkaido Region
country: Japan
city: Kanto Region
country: Japan
city: Kinki Region
country: Japan
city: Kyushu Region
country: Japan
city: Shikoku Region
country: Japan
city: Tohoku Region
country: Japan
Study officials:
affiliation: Otsuka Pharmaceutical Co., Ltd.
name: Kyoji Imaoka, Mr
role: STUDY_DIRECTOR
References: