Study Comparing Continuous Subcutaneous Infusion Of ABBV-951 With Oral Carbidopa/Levodopa Tablets For Treatment Of Motor Fluctuations In Adult Participants With Advanced Parkinson's Disease
Condition: Parkinson's Disease (PD)
MeSH terms: Parkinson Disease
Intervention: ABBV-951; Placebo for Levodopa/Carbidopa (LD/CD); Levodopa/Carbidopa (LD/CD); Placebo for ABBV-951
Intervention description: Solution for continuous subcutaneous infusion (CSCI); Oral capsule; Oral encapsulated tablet; Solution for continuous subcutaneous infusion (CSCI)
Intervention MeSH terms: Levodopa; Carbidopa
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 174.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No
Keywords: Parkinson's Disease (PD); ABBV-951; Levodopa/Carbidopa (LD/CD); Levodopa Phosphate/Carbidopa Phosphate (LDP/CDP)

Summary:

      Parkinson's disease (PD) is a neurological condition, which affects the brain. PD gets worse
      over time, but how quickly it progresses varies a lot from person to person. Some symptoms of
      PD are tremors, stiffness, and slowness of movement. This study measures the efficacy,
      safety, and tolerability of ABBV-951 versus oral Levodopa (LD)/Carbidopa (CD) [LD/CD] in
      advanced PD participants to achieve reduction in motor fluctuations.

      ABBV-951 is an investigational (unapproved) drug containing Levodopa Phosphate/Carbidopa
      Phosphate (LDP/CDP) given subcutaneously (under the skin) for the treatment of Parkinson's
      Disease. Adult participants with advanced PD will be enrolled. Approximately 130 participants
      will be enrolled in the study in approximately 80 sites across the world.

      In one arm, participants will receive ABBV-951 solution as a continuous infusion under the
      skin plus oral placebo capsules for LD/CD. In the second arm, participants will receive
      placebo solution for ABBV-951 as a continuous infusion under the skin plus oral capsules
      containing LD/CD tablets. The treatment duration is 12 weeks.

      There may be higher treatment burden for participants in this trial compared to their
      standard of care. Participants will attend regular visits during the course of the study at a
      hospital or clinic. The effect of the treatment will be checked by medical assessments, blood
      tests, checking for side effects, and completing questionnaires.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of idiopathic Parkinson's Disease (PD) that is levodopa-responsive.

          -  Participant must be taking a minimum of 400 milligrams/day (mg/day) of Levodopa (LD)
             equivalents and be judged by the investigator to have motor symptoms inadequately
             controlled by current therapy, have a recognizable/identifiable "Off" and "On" states
             (motor fluctuations), and have an average "Off" time of at least 2.5 hours/day over 3
             consecutive PD Diary days with a minimum of 2 hours each day.

          -  Participant or caregiver, if applicable, demonstrates the understanding and correct
             use of the delivery system, including the insertion of the cannula into the
             participant's abdomen, as assessed by the investigator or designee during the
             Screening period.

        Exclusion Criteria:

          -  Clinically significant, unstable medical conditions or any other reason that the
             investigator determines would interfere with the participant's participation in this
             study or would make the participant an unsuitable candidate to receive study drug.

          -  History of allergic reaction or significant sensitivity to LD or constituents of the
             study drug (and its excipients) and/or other products in the same class.

          -  Participant has not received deep brain stimulation, CD/LD enteral suspension, or any
             other PD medication as continuous daily infusion, whether commercially available or
             investigational. Previous exposure to ABBV-951 is not allowed.