Efficacy of Levodopa/Carbidopa/Entacapone vs Levodopa/Carbidopa in Parkinson's Disease Patients With Early Wearing-off
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: Levodopa/carbidopa/entacapone; Levodopa/carbidopa
Intervention description: Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa/entacapone was available in 2 oral dosage forms: 100/25/200 or 150/37.5/200 mg encapsulated tablets.; Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa was available in 2 oral dosage forms: One or one and one-half 100/25 mg encapsulated tablets.
Intervention MeSH terms: Levodopa; Carbidopa; Entacapone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 95.0
Sex: All
Minimum age: 30 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Parkinson's disease, adults, levodopa/carbidopa/entacapone, wearing-off, activities of daily living

Summary:

      The study evaluated the efficacy of levodopa/carbidopa/entacapone vs levodopa/carbidopa in
      patients with Parkinson's disease and early wearing-off with levodopa
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male and female patients ages ≥ 30 and ≤ 80 years old.

          2. A clinical diagnosis of idiopathic Parkinson's disease.

          3. Taking a stable dose of levodopa/carbidopa (≥ 300 and ≤ 600mg) for a period of at
             least 1 month prior to study entry.

          4. Must be using any of the following levodopa/carbidopa standard formulation
             levodopa/carbidopa 100/25mg dose in any intake of the day.

               -  1 full tablet, and/or

               -  1½ tablets The patient can also be using, for a period of at least 1 month prior
                  to study entry, 1 tablet of the controlled release formulation of
                  levodopa/carbidopa 100/25 mg (marketed in Spain as Sinemet Plus retard) or 1
                  tablet the controlled release formulation of levodopa/carbidopa 200/50 mg
                  (marketed in Spain as Sinemet retard) in each intake, at different doses.

          5. Must have early end-of-dose wearing-off defined by >= 2 or <=7 positive responses to
             the QUICK questionnaire.

          6. Must have a minimum UPDRS part II (ADL) score of 9.

          7. Patients without dyskinesia or with mild dyskinesia.

          8. Female patients must be either post-menopausal or using one or more acceptable methods
             of contraception.

          9. Must 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:

          1. Previous or current use of entacapone.

          2. History, signs, or symptoms suggesting the diagnosis of secondary or atypical
             parkinsonism.

          3. Unstable Parkinson's disease patients.

          4. Patients who experience severe dyskinesia.

          5. The following levodopa/carbidopa doses and strengths are not permitted:

               -  Patients taking ½ tablet of standard formulation levodopa/carbidopa 100/25

               -  Patients taking standard formulation levodopa/carbidopa 100/10 or 250/25

               -  Patients taking fewer than 3 or more than 6 daily intakes of standard formulation
                  levodopa/carbidopa 100/25 (fewer than 300mg or more than 600mg of levodopa)

          6. Patients with hallucinations or psychiatric diseases related to levodopa or dopamine
             agonists intake. Patients with major depression.

          7. Female patients who are pregnant, trying to become pregnant or nursing (lactating) an
             infant.

          8. Concomitant treatment with MAO-inhibitors (except selegiline up to 10mg/day),
             rotigotine or neuroleptics, within 60 days prior to the screening visit.

          9. Patients with a previous history of Neuroleptic Malignant Syndrome (NMS) and/or
             non-traumatic rhabdomyolysis.

         10. Participated in another trial of an investigational drug/device within the last 30
             days prior to study entry.

         11. Patients who have a history of poor compliance or are in the Investigator's judgment
             unlikely to comply with medical regimens or study requirements.