A Study To Evaluate The Safety And Efficacy Of IPX066 In Subjects With Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: Placebo; IPX066 95 mg LD; IPX066 145 mg LD; IPX066 195 mg LD; IPX066 245 mg LD
Intervention description: Placebo; IPX066 capsule containing 95 mg LD/23.75 mg CD; IPX066 capsule containing 145 mg LD/36.25 mg CD; IPX066 capsule containing 195 mg LD/48.75 mg CD; IPX066 capsule containing 245 mg LD/61.25 mg CD
Intervention MeSH terms: Carbidopa, levodopa drug combination; Carbidopa; Levodopa
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 381.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No
Keywords: Parkinson's disease

Summary:

      This study examines the efficacy of three doses of IPX066 as compared to placebo in
      Parkinson's disease.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Able to understand and willing to voluntarily sign an informed consent form (ICF) and
             Health Insurance Portability and Accountability Act (HIPAA) authorization or local
             equivalent if applicable.

          2. Diagnosed with idiopathic PD.

          3. LD-naïve: defined as subjects not exposed to LD or catechol-O-methyl transferase
             inhibitors for more than 30 days and the exposure is not within 4 weeks prior to study
             enrollment.

          4. If currently taking anticholinergic therapy, amantadine, or a monoamine oxidase type B
             (MAO-B) inhibitor, maintains a stable regimen for at least 4 weeks prior to Baseline,
             and agrees to maintain the stable regimen throughout study participation.

          5. Agrees to use a medically acceptable method of contraception throughout the study and
             for 1 month after completing the study.

          6. Able and willing to comply with the protocol, including availability for all scheduled
             clinic visits and telephone calls.

        Exclusion Criteria:

          1. Pregnant or breastfeeding.

          2. Diagnosed with atypical Parkinsonism or any known secondary parkinsonian syndrome.

          3. Prior functional neurosurgical treatment for PD or if such procedures are anticipated
             during study participation.

          4. Use of nonselective MAO inhibitors.

          5. Use of dopamine agonists within 30 days prior to Screening.

          6. Unable to tolerate a placebo regimen, in the Investigator's opinion.

          7. Treatment of psychosis with any antipsychotic.

          8. History of seizure or epilepsy.

          9. Active or prior medical condition or prior surgical procedure that would interfere
             with LD absorption.

         10. History of narrow-angle glaucoma.

         11. Subjects with a history of malignant melanoma.

         12. History of myocardial infarction with residual atrial, nodal, or ventricular
             arrhythmias, upper gastrointestinal hemorrhage, or neuroleptic malignant syndrome.

         13. Received any investigational medications during the 30 days prior to Screening.