A Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy, Safety and Tolerability of ABBV-951 to Oral Carbidopa/Levodopa in Advanced Parkinson's Disease Patients

  • STATUS
    Recruiting
Updated on 23 November 2020
levodopa
carbidopa

Summary

The purpose of this study is to find out how well ABBV-951 works to control Parkinson's disease symptoms compared to oral Carbidopa (CD)/Levodopa (LD). The study is also seeking to test whether ABBV-951 is well tolerated in subjects with Parkinson's disease.

Description

After completing a Screening Period and Oral CD/LD Stabilization Period, participants will be randomly assigned to either receive a continuous subcutaneous infusion of ABBV-951 solution plus oral placebo capsules, or a continuous subcutaneous infusion of placebo solution plus oral CD/LD IR capsules.

Randomization into the two treatment regimens will be a 50:50 chance. Throughout study treatment visits, participants will continue to attend scheduled study visits, take part in study-related tests, assessments, and procedures to monitor health and well-being, and complete study diary entries.

Study participants and their caregivers, if applicable, will continue to receive information and training on how to properly operate the PM-PDSC pump delivery system.

Participants may be paid $125.00 for completing the Screening study visit, and $75.00 for each completed study visit 2 through 12 (Post Treatment).

Details
Condition Parkinson's disease
Clinical Study IdentifierTX249327
Last Modified on23 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female subjects, 30 years of age or older at the time of screening, with a diagnosis of idiopathic PD that is levodopa-responsive
Subjects must 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
Subject has not received deep brain stimulation, CD/LD enteral suspension, or any other PD medication as continuous daily infusion, whether commercially available or investigational
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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