A Dose-ranging Study for SPM 962 in Parkinson's Disease Patients

• Status: Completed
• Trial end date: 2006-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this trial is to establish the maximum maintenance dose of SPM 962 in patients with Parkinson's disease in a multi-center, uncontrolled, open-label study by conducting safety evaluation of each patient following once-daily transdermal doses of SPM 962 within a range of 4.5 to 36.0 mg. (The administration period will consist of a standard 8-week dose-titration period, 4-week dose-maintenance period, and a dose de-escalation period) Exploratory evaluation of each patient's maintenance dose will also be conducted with attention to patient safety. The relationship of pharmacokinetics, safety, and efficacy will also be examined.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.
• Treatments: N 0437; Rotigotine

Criteria

Inclusion Criteria:

• For subject with early and advanced Parkinson's disease

• 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.

• Gender and inpatient-outpatient status are not specified.

• For subject with early Parkinson's disease

• Hoehn & Yahr stage 3 or less.

• Subject who has not taken L-dopa within 28 days prior to initial administration of SPM 962.

• For subject with dvanced Parkinson's disease

• Hoehn & Yahr stage 2-4.

• Subject is on a stable dose of L-dopa with no change in daily dose or dosing regimen for at least 7 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) Not well controlled with L-dopa due to adverse effect 4) Weakening of L-dopa efficacy.

Exclusion Criteria:

• Subject is on other dopamine agonist treatment within 7 days prior to the initial treatment. Subject is on cabergoline treatment within 14 days prior to the initial treatment.

• Subject has psychiatric symptoms, e.g. confusion, hallucination, delusion, excitation, delirium, abnormal behavior.

• 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 at screening. Subject has QTc-interval >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).

• Subject has BUN >= 25 mg/dL or serum creatinine >= 2.0 mg/dl.

• 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 6 months prior to the initial treatment.

• Investigator judges that subject is inappropriate as a study subject with other reasons.