A Study To Evaluate The Safety And Efficacy Of IPX066 In Advanced Parkinson's Disease (ADVANCE-PD).
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: IPX066; IR CD-LD
Intervention description: extended-release carbidopa-levodopa capsules; immediate-release carbidopa-levodopa tablets
Intervention MeSH terms: Levodopa; Carbidopa; Carbidopa, levodopa drug combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 471.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No
Keywords: Parkinson's Disease

Summary:

      This is a study to evaluate the safety and efficacy of IPX066 in advanced Parkinson's
      disease.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosed with idiopathic PD.

          2. At least 30 years old at the time of PD diagnosis.

          3. Currently being treated with IR LD (CD-LD or benserazide-LD) and on a stable regimen
             of IR LD for at least 4 weeks and:

               -  Requiring a total daily IR LD dose of at least 400 mg

               -  Having a minimum dosing frequency of four times per day.

          4. Able to differentiate "on" state from "off" state.

          5. Have predictable "off" periods.

          6. Amantadine, anticholinergics, selective monoamine oxidase (MAO) type B inhibitors
             (e.g., selegiline, rasagiline) or dopamine agonists are 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.

          7. Agrees to use a medically acceptable method of contraception throughout the study and
             for 1 month afterward.

        Exclusion Criteria:

          1. Diagnosed with atypical Parkinsonism or any known secondary Parkinsonian syndrome.

          2. Nonresponsive to LD therapy.

          3. Prior functional neurosurgical treatment for PD (e.g., ablation or deep brain
             stimulation) or if such procedures are anticipated during study participation.

          4. Received within 4 weeks or planning to take during participation in the clinical
             study: any controlled-release LD product, additional CD (e.g., Lodosyn®) or
             benserazide (e.g. Serazide®), catechol-O-methyl transferase inhibitors (e.g.,
             entacapone and tolcapone), nonselective MAO inhibitors, apomorphine, and
             antipsychotics including neuroleptic agents for the purpose of treating psychosis or
             bipolar disorder.

          5. Allergic to Yellow Dye #5 (tartrazine).

          6. History of or currently active psychosis.

          7. Active or prior medical conditions such as peptic ulcers or prior surgical (e.g.,
             bowel) procedures that would interfere with LD absorption.

          8. Active or history of narrow-angle glaucoma.

          9. A history of malignant melanoma or a suspicious undiagnosed skin lesion.

         10. History of myocardial infarction with residual atrial, nodal, or ventricular
             arrhythmias, upper gastrointestinal hemorrhage, or neuroleptic malignant syndrome
             and/or nontraumatic rhabdomyolysis.

         11. Received any investigational medications during the 4 weeks prior to Screening.

         12. Unable to swallow large pills (e.g., large vitamin pills).

         13. Pregnant or breastfeeding.

         14. Subjects who are unable to complete a symptom diary.