Carbidopa-Levodopa (CD-LD) ER Alone or in Combination With CD-LD IR to IPX066 Followed by IPX066 Extension Safety Study
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: IPX066
Intervention description: Subjects were converted from their current treatment to IPX066 over a 6-week period.
Experimental Drug Product: IPX066 (carbidopa-levodopa) extended-release capsules
Intervention MeSH terms: Carbidopa, levodopa drug combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 43.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No

Summary:

      The study had three distinct parts and is described as follows:

      Part 1:

        -  To evaluate the dose conversion from CD-LD ER taken alone or in combination with CD-LD
           IR to IPX066 in subjects with advanced PD

        -  To evaluate the utility of the Objective Parkinson's Disease Measurement (OPDM), an
           exploratory computer-based system, in assessing dexterity and mobility in a subset of PD
           subjects.

      Part 2:

      • To evaluate the long-term safety and clinical utility of IPX066 under open-label conditions
      in eligible subjects who successfully completed Part 1 of the study.

      Part 3:

      • To further evaluate the long-term safety of IPX066 in eligible subjects who successfully
      completed Part 2.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosed with idiopathic PD without any known cause for Parkinsonism.

          2. At least 30 years old at the time of PD diagnosis.

          3. Currently being treated with:

               -  an LD dosing frequency of at least four times a day

               -  at least one dose of CD-LD ER daily

               -  requiring a total daily LD dose of at least 400 mg

               -  stable regimen for at least 4 weeks prior to Screening

          4. Concomitant therapy with amantadine, anticholinergics, selective monoamine oxidase
             (MAO) type B inhibitors (e.g., selegiline, rasagiline) or dopamine agonists is allowed
             as long as the doses and regimens have been stable for at least 4 weeks prior to
             Screening and the therapy is intended to be constant throughout the course of the
             study.

          5. Agrees to use a medically acceptable method of contraception throughout the study and
             for 1 month after completing the study.

        Exclusion Criteria:

          1. Pregnant or breastfeeding

          2. Diagnosed with atypical Parkinsonism or any known secondary Parkinsonian syndrome.

          3. Nonresponsive to LD therapy.

          4. Prior functional neurosurgical treatment for PD (e.g., ablation or deep brain
             stimulation) or if such procedures are anticipated during study participation.

          5. Planning to take during participation in the clinical study: any controlled-release LD
             product, additional CD or benserazide, entacapone or tolcapone, nonselective MAO
             inhibitors, or antipsychotics including neuroleptic agents for the purpose of treating
             psychosis or bipolar disorder.

          6. Any evidence of suicidal behavior within 6 months of entering the study.

          7. Allergic or hypersensitive to to CD, LD, entacapone, riboflavin, Yellow Dye #5
             (tartrazine), citrus fruit or grape juice.

          8. History of or currently active psychosis.

          9. Active or history of peptic ulcers or surgical procedure of the stomach, the small
             intestine or the large intestine.

         10. Active or history of narrow-angle glaucoma.

         11. History of malignant melanoma or a suspicious undiagnosed skin lesion.

         12. History of myocardial infarction with residual atrial, nodal, or ventricular
             arrhythmias, upper gastrointestinal hemorrhage, or neuroleptic malignant syndrome
             and/or nontraumatic rhabdomyolysis.

         13. Abnormal kidney function

         14. Severe hepatic impairment.

         15. Received any investigational medications during the 4 weeks prior to Screening.

         16. Previously enrolled in IPX066 studies.