Interim data from an ongoing phase 3b trial, presented in a poster by Jordan Dubow, MD, AbbVie, Inc., North Chicago, Illinois, USA, indicated that treatment with levodopa-carbidopa intestinal gel (LCIG) significantly improved nonmotor symptoms (NMSs) in patients with advanced Parkinson disease (PD).

NMSs play an important role, clearly affecting health-related quality of life (HRQOL) of patients with PD. LCIG (carbidopa-levodopa enteral suspension) is an effective treatment option for motor fluctuations in advanced refractory PD [Olanow CW et al. Lancet Neurol. 2014]. Open-label studies have shown that LCIG is associated with significant improvements in NMSs and HRQOL in patients with advanced PD [Fasano A et al. Eur Rev Med Pharmacol Sci. 2012; Reddy P et al. Clin Neuropharmacol. 2012].

This phase 3b, open-label, multicenter study [NCT01736176] included patients aged ≥ 30 years with levodopa-responsive idiopathic PD and severe motor fluctuations with ≥ 3 hours of “off” time/day (despite individually optimized therapy). After conversion to oral levodopa-carbidopa, all patients underwent a percutaneous endoscopic gastrostomy-jejunostomy placement procedure. The study included an initial 12-week LCIG treatment period and a 48-week long-term treatment period. The primary end point was the change in NMSs from baseline to week 12 as measured by the Non-Motor Symptoms Scale (NMSS) total score. Secondary end points included the change from baseline to week 12 in the 9 NMSS domains. Adverse events (AEs) were recorded. Interim analysis was completed for the first 17 of 36 participants.

Patients had a mean age of 64 years (range, 45-76), 65% were men, and 94% were white. Mean exposure to LCIG was 180 days (range, 5-368 days). Fourteen of 17 patients had a reduction in NMSS total score between baseline and final evaluation; the mean reduction was 38.3% (–20.7; P = .001).

Significant decreases were noted in 3 of the 9 NMSS domains: sleep/fatigue (–6.7; P = .008), sexual function (–2.5; P = .011), and miscellaneous (–4.9; P = .002).

At least 1 treatment-emergent AE was reported for 16 patients, and 2 patients discontinued due to AEs. The most frequently reported AEs were procedural pain (65%) and anxiety (24%). Serious AEs were reported for 2 patients; neither was considered related to LCIG.

This study provides additional evidence that LCIG can be a safe and effective treatment for NMSs in patients with advanced PD.