The purpose of this study is to test the effects of carbidopa/levodopa/entacapone compared to
the effects of immediate-release carbidopa/levodopa on end-of-dose wearing off in persons who
have Parkinson's disease.
Inclusion Criteria:
- Be aged 30 to 85 years.
- Be male or female - female patients must be either not of childbearing potential
(defined as post menopausal for at least one year or surgically incapable of bearing
children), or must be practicing contraceptive methods as outlined in the protocol.
- Have a clinical diagnosis of idiopathic Parkinson's Disease, exhibiting at least 2 of
3 symptoms (rigidity, resting tremor, bradykinesia)
- Have non-motor symptoms of end of dose wearing off i. e., the presence of at least one
non-motor symptom of Parkinson's Disease which improves with the next immediate
release (IR) carbidopa/levodopa dose as determined by the Quantitative Wearing-Off
Questionnaire 9 and investigator's assessment. At least one non-motor item has to show
a severity of at least 2 points (of a maximum of 4) and show an improvement of at
least 1 one hour after immediate release (IR) carbidopa/levodopa administration.
(all criteria must be fulfilled)
- Be taking a stable dose of immediate release (IR) carbidopa/levodopa for at least 28
days prior to randomization at an equivalent total daily dose of immediate release
(IR) carbidopa/levodopa between 300 to 600 mg. Dosing should be either 3 or 4 times
per day.
- Be capable of satisfying the requirements of the protocol and must be willing and able
to give informed consent according to legal requirements.
Exclusion Criteria:
- Have a previous history of being non-responsive to entacapone or tolcapone treatment
or having experienced a serious or severe adverse event(s) which resulted in the
discontinuation of treatment from the previous use of entacapone or tolcapone; current
treatment with entacapone or tolcapone or discontinued treatment with either therapy
or discontinued less than 60 days before randomization;
- Have a history, signs, or symptoms suggesting a diagnosis of secondary or atypical
parkinsonism;
- Have unstable Parkinson's Disease requiring frequent booster doses;
- Disabling dyskinesias, indicated by a score of greater than 1 on Unified Parkinson
Disease Rating Scale question #32, or a score of greater than 1 on Unified Parkinson
Disease Rating Scale question #33;
- Have a history or current diagnosis of psychotic features according to the
investigator;
- Have a history or current diagnosis of symptoms of an impulse control disorder
according to a screening assessment with the modified Minnesota Impulsive Disorders
Interview and the investigator's judgment;
- Have a diagnosis of Bipolar Disorder I or II according to the Diagnostic Statistical
Manual, Fourth Edition;
- Demonstrate indications of marked suicidal tendencies as assessed by the
investigator;
- Have undergone psychotherapy or psychiatric pharmacotherapy, currently or within 28
days prior to randomization;
- If female, be pregnant, trying to become pregnant or nursing an infant;
- Diagnostic and Statistical Manual, Fourth Edition, Text Revision; [American
Psychiatric Association, 2000] diagnosis of 1. dementia (of any cause); 2. moderate or
severe major depression, present independent from the time of first diagnosis of
Parkinson's Disease, as defined by a Quick Inventory of Depressive Symptomatology
- Self Rating 16 score of > 15; or 3. generalized anxiety disorder or panic disorder if
made prior to the diagnosis of Parkinson's Disease;
- Have received treatment with MAO-inhibitors;
- Diagnostic and Statistical Manual, Fourth Edition, Text Revision diagnosis of alcohol
or substance abuse (excluding nicotine or caffeine) during the 3 months prior to
randomization) or alcohol or substance dependence (excluding nicotine or caffeine)
during the 6 months prior to randomization. Alcohol should be avoided within the 12
hours preceding the Screening, Baseline, Week 2 and Week 8 visits;
- Diagnostic and Statistical Manual, Fourth Edition, Text Revision diagnosis of
dysthymia within the last 12 months;
- Have a history or current diagnosis of malignancy of any organ system, treated or
untreated, within the past 5 years whether or not there is evidence of local
recurrence or metastases, with the exception of localized basal cell carcinoma of the
skin.
Other protocol-defined inclusion/exclusion criteria may apply
