Session Information
Date: Monday, September 23, 2019
Session Title: Clinical Trials, Pharmacology and Treatment
Session Time: 1:45pm-3:15pm
Location: Agora 3 West, Level 3
Objective: To evaluate the effectiveness of levodopa-carbidopa intestinal gel, LCIG (known as carbidopa-levodopa enteral suspension in the US), on non-motor symptoms (NMS) compared with optimized medical treatment (OMT) in advanced Parkinson’s disease (aPD).
Background: With conventional therapies, many aPD patients experience inadequate motor control and develop motor complications such as motor fluctuations and dyskinesia. Additionally, many aPD patients suffer from a constellation of NMS that can cause significant disability and impair quality of life. LCIG has been shown to be effective in treating motor fluctuations in aPD and has the potential to be effective for the management of NMS; however, comparative data on NMS are limited.
Method: INSIGHTS is a phase 3b, randomized, open-label, multicenter, 26-week study comparing the effect of LCIG versus OMT on NMS in aPD (NCT02549092). The study population includes levodopa-responsive aPD patients with motor fluctuations no longer controlled by oral PD medications and who experience sleep disturbances as confirmed by a score >18 on the modified Parkinson’s Disease Sleep Scale (PDSS-2). Approximately 88 patients will be enrolled and randomized in a 1:1 ratio to either LCIG or OMT. Primary endpoints include changes from baseline in the Non-Motor Symptoms Scale (NMSS) and the PDSS-2 total scores. Key secondary endpoints measure activities of daily living, quality of life, and safety assessments.
Results: As of January 2019, 67 patients have been randomized in the study. Baseline patient demographics and disease characteristics are presented in Table 1. The majority of patients are white and ≥60 years of age. [table 1]
Conclusion: This is the first study comparing the effectiveness of LCIG versus OMT on NMS and sleep. These data will provide important information for physicians, patients, and caregivers when assessing the benefits of aPD treatment.
To cite this abstract in AMA style:
S. Chung, M. Garriga, M. Ceravolo, N. Tambasco, W. Robieson, M. Facheris, O. Sánchez-Soliño, L. Barbato. Design and Baseline Characteristics of an Open-Label, Randomized, 26-Week Study Comparing Levodopa-Carbidopa Intestinal Gel to Optimized Medical Treatment on Non-Motor Symptoms in Patients with Advanced Parkinson’s Disease – INSIGHTS Study [abstract]. Mov Disord. 2019; 34 (suppl 2). https://www.mdsabstracts.org/abstract/design-and-baseline-characteristics-of-an-open-label-randomized-26-week-study-comparing-levodopa-carbidopa-intestinal-gel-to-optimized-medical-treatment-on-non-motor-symptoms-in-patients-with-advanc/. Accessed June 15, 2025.« Back to 2019 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/design-and-baseline-characteristics-of-an-open-label-randomized-26-week-study-comparing-levodopa-carbidopa-intestinal-gel-to-optimized-medical-treatment-on-non-motor-symptoms-in-patients-with-advanc/