Objective: To provide baseline and clinical characteristics for participants in the phase 3 Accordance study of the Accordion Pill™ (AP)—a gastric-retentive formulation of carbidopa/levodopa (CD/LD)—versus immediate-release (IR)-CD/LD (Sinemet®) in patients with PD experiencing motor fluctuations.

Background: Many PD patients experience dose-by-dose motor fluctuations with substantial daily OFF time within a few years of starting LD treatment. AP-CD/LD is a novel gastric-retention pill with multilayer films containing IR-CD and both IR and controlled-release LD to provide more consistent drug delivery.

Method: The Accordance study (NCT02605434) is a randomized, double-blind, active-controlled study of AP-CD/LD vs IR-CD/LD in PD patients experiencing motor fluctuations. Key inclusion criteria were daily LD intake of 400 mg – 1300 mg and ≥2.5 hours home diary OFF time daily. Two unique, 6-week, open-label, dose-titration phases were included: dose stabilization and optimization of IR-CD/LD (active comparator, first 6 weeks), and conversion to AP-CD/LD (second 6 weeks). Participants were then randomized 1:1 to double-blind 13-week treatment with either IR-CD/LD or AP-CD/LD, with a 2-week follow-up. Primary endpoint was change from baseline in total daily OFF time (percent of waking hours). Key secondary endpoints included: daily OFF time (h); ON time without troublesome dyskinesia (h); Clinician and Patient Global Impression (CGI-I); and Unified Parkinson’s Disease Rating Scale (UPDRS) parts 2 and 3. Safety was assessed via adverse events and standard clinical and laboratory procedures.

Results: A total of 320 participants were randomized; as of February 26, 2019, all but 11 had finished their participation. Most enrolled participants were men (65.6%); mean (SD) age was 63.4 (8.9) y. Mean (SD) PD duration was 8.7 (4.2) y and reported mean (SD) daily OFF time was 6.2 (2.3) h

Conclusion: This phase 3 randomized, double-blind study of AP-CD/LD vs IR-CD/LD has randomized 320 fluctuating PD patients and seeks to determine if the improved PK profile of LD delivery offered by the AP yields improvements in OFF time as compared with IR-CD/LD.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/patients-experiencing-motor-fluctuations-with-parkinsons-disease-pd-participant-characteristics-in-the-accordance-phase-3-efficacy-and-safety-trial-of-accordion-pill-carbidopa-lev/