Carbidopa/Levodopa/Entacapone Versus Immediate Release (IR) Carbidopa/Levodopa on Non-motor Symptoms in Patients With Idiopathic Parkinson's Disease and Demonstrating Non-motor Symptoms of Wearing Off
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: Carbidopa/levodopa/entacapone; Immediate release carbidopa/levodopa
Intervention description: Carbidopa/levodopa/entacapone 25/100/200 mg tablets plus placebo immediate release carbidopa/levodopa capsules, administered orally for 8 weeks. Total daily dosage and frequency of dosing for each patient was determined by the investigator and stabilized upon entry into the study.; Immediate release carbidopa/levodopa 25/100 mg capsules plus placebo carbidopa/levodopa/entacapone tablets, administered orally for 8 weeks. The maximum daily dose is 800 mg. Total daily dosage and frequency of dosing for each patient was determined by the investigator.
Intervention MeSH terms: Levodopa; Carbidopa; Entacapone; Carbidopa, levodopa drug combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 14.0
Sex: All
Minimum age: 30 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Idiopathic Parkinson's disease; carbidopa/levodopa/entacapone; non-motor symptoms; motor-symptoms

Summary:

      The purpose of this study is to test the effects of carbidopa/levodopa/entacapone compared to
      the effects of immediate-release carbidopa/levodopa on non-motor symptoms of end-of-dose
      wearing off in persons who have Parkinson's disease.
    

Eligibility criteria:

        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. Also
             there should not have been a deterioration of 1 point or more in another non-motor
             item.(all criteria must be fulfilled)

          -  Be taking a stable dose of immediate release (IR) carbidopa/levodopa for at least 21
             days prior to randomization at an equivalent total daily dose of immediate release
             (IR) carbidopa/levodopa between 300 to 800 mg. Dosing should be either 3 to 6 times
             per day.

        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;

        Other protocol-defined inclusion/exclusion criteria applied to the study.