Session Information
Date: Thursday, June 8, 2017
Session Title: Parkinson’s Disease: Clinical Trials, Pharmacology And Treatment
Session Time: 1:15pm-2:45pm
Location: Exhibit Hall C
Objective: To evaluate whether continuous 24 hours delivery of subcutaneous ND0612 offers practical and clinical benefits over continuous delivery over the waking day (14 hours).
Background: Continuous levodopa/carbidopa (LD/CD) infusion is considered a preferred method of delivering levodopa for patients with advanced PD because it avoids the LD peaks and troughs and decreases the risk of motor complications. ND0612 is a proprietary liquid solution of LD/CD that can be continuously delivered via the subcutaneous route and avoids surgical risks associated with intra-intestinal infusion.
Methods: ND0612-006 is an ongoing open-label, rater-blind, multicenter, parallel-group, randomized clinical study in PD patients who have motor fluctuations. After completing 1 day of standard oral LD/CD treatment, subjects were randomized to 28 days of treatment with ND0612 subcutaneous infusion administered for 24 hours (total LD/CD dose of 720/90 mg) or infusion during the waking day (total LD/CD dose of 538/67mg) infused over 14 hours + supplemental dose of oral LD/CD as needed.
Results: As of December 2016, recruitment was completed with 38 subjects from USA, Israel, Italy and Austria enrolled. Mean (±SD) age was 63 (±9.2) years, 68% were male, and mean MMSE score was 29 (±1.0). Mean time since diagnosis of PD was 11.5 (±5.25) years, and patients had motor fluctuations and dyskinesia for 5.6 (±5.87) and 3.7 (±3.07) years, respectively. Mean OFF time/day was 5.3 (±2.22) hours. Baseline oral LD dose was 1100 (±703.6) mg, 37% of patients were treated with 4-5 doses of LD per day, 26% were treated with 6-7 daily LD doses, and 34% with 8 or more daily doses. Almost a third (32%) of subjects were treated with a concomitant COMT inhibitor.
Conclusions: Baseline characteristics of the patients enrolled to ND0612 confirm that the study population is a typical representation of patients with advanced PD who suffer from motor fluctuations despite optimized oral treatment. Final results from this trial are expected in 2017 and will better inform the optimal dosing regimen for ND0612 in PD patients with motor fluctuations
To cite this abstract in AMA style:
W. Olanow, A. Ellenbogen, R. Djaldetti, T. Rachmilewitz Minei, Y. Cohen, S. Oren, K. Kieburtz. Baseline characteristics of the population enrolled to a randomized clinical study of subcutaneous levodopa/carbidopa (ND0612) infusion in patients with advanced PD [abstract]. Mov Disord. 2017; 32 (suppl 2). https://www.mdsabstracts.org/abstract/baseline-characteristics-of-the-population-enrolled-to-a-randomized-clinical-study-of-subcutaneous-levodopacarbidopa-nd0612-infusion-in-patients-with-advanced-pd/. Accessed November 21, 2024.« Back to 2017 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/baseline-characteristics-of-the-population-enrolled-to-a-randomized-clinical-study-of-subcutaneous-levodopacarbidopa-nd0612-infusion-in-patients-with-advanced-pd/