Objective: Primary analyses of this Phase 2 study have demonstrated significant efficacy of ND0612 in reducing OFF time and improving motor status. This secondary analysis evaluated the efficacy of two ND0612 dosing regimens (R1: 24 hours infusion & R2: 14 hours daytime infusion) on patient rated activities of daily living (ADL), and quality of life (QoL).

Background: The presence of motor fluctuations and dyskinesia are well-established contributors to disability and poor quality of life in people living with Parkinson’s disease (PD). ND0612 is a drug-device combination that continuously delivers liquid Carbidopa/Levodopa Subcutaneous Solution (CLSS).

Method: After one day of standard oral CD/LDtreatment, 38 subjects with fluctuating PD (mean age: 63.5 years; OFF-time 5.3 hours/day) were randomized to two ND0612 dosing regimens for 28 days: R1 (subcutaneous dailyCD/LDdose: 720/90 mg) or R2 (subcutaneous daily CD/LDdose: 538/68mg + morning oral dose CD/LD[150/15 mg]). Patient reported outcomes included the UPDRS Part II (ADL) at Day 28 and PD Questionnaire (PDQ-39) at Day 27.In addition, patients self-rated their impression of improvement at Days 3 and 28.

Results: After 28 days of treatment, UPDRS ADL scores significantly improved for patients in R1 (LS mean [95%CI] reduction from baseline: -2.9 [-5.4, -0.5] points, p=0.02) and trended towards improvement for R2 (reduction of -1.9 [-4.2, 0.4] points, p=0.11). PDQ-39 scores also significantly improved for R1 (LS mean reduction: -7.51 [-12.93, -2.08] points, p=0.008) and trended towards improvement for R2 (reduction of -3.66 [-8.86, 1.54] points; p=0.16). Improvements in R1 were driven by 7 out of 8 PDQ-39 scales (mobility, ADL, emotional well-being, stigma, social support, communication and bodily discomfort); the cognition scale remained unchanged. Overall, 74% of R1 patients and 53% of R2 patients self-reported improvements in their clinical status already at Day 3. At Day 28, 78% of R1 and 79% of R2 patients reported improvement.

Conclusion: 24-hour levodopa infusion with ND0612 significantly improved patient ratings of ADL, QoL and overall clinical status.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/impact-of-nd0612-on-patient-reported-outcomes-a-blinded-rater-study-of-2-dosing-regimens/