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The effect of levodopa-carbidopa intestinal gel on activities of daily living: Results from the observational MONOTREAT study in advanced Parkinson’s disease patients

R. Krüger, P. Lingor, T. Doskas, J. Henselmans, E.H. Danielsen, O. de Fabregues, A. Stefani, S.C. Sensken, J.C. Parra Riaza, K. Onuk, A. Yegin (Tübingen, Germany)

Meeting: 2016 International Congress

Abstract Number: 2010

Keywords: Levodopa(L-dopa), Motor control, Parkinsonism

Session Information

Date: Thursday, June 23, 2016

Session Title: Parkinson's disease: Clinical trials, pharmacology and treatment

Session Time: 12:00pm-1:30pm

Location: Exhibit Hall located in Hall B, Level 2

Objective: To assess the tolerability and effect of levodopa-carbidopa intestinal gel (LCIG, designated in the United States as carbidopa-levodopa enteral suspension) on activities of daily living (ADL) in advanced Parkinson’s disease (PD) patients with troublesome motor fluctuations.

Background: LCIG is continuously delivered via percutaneous gastrojejunostomy (PEG-J) in advanced PD patients with motor fluctuations and dyskinesia not adequately reduced by available oral anti-Parkinsonian medications.

Methods: This multinational (7 countries, 35 centres) post-marketing observational study included advanced PD patients characterised by either 2-4 hours “off” time or 2 hours of dyskinesia daily, supported by a Unified Parkinson’s disease Rating Scale (UPDRS) Total Score of ≥40 at baseline. LCIG was titrated via a nasojejunal (NJ) tube, then administered via PEG-J for 12 months. ADL and quality of life were assessed by the UPDRS Part II total score and 8-item Parkinson’s disease Questionnaire (PDQ-8) summary index, respectively. Adverse events (AEs) were collected.

Results: Sixty-five patients were enrolled, 58 out of 64 patients (91%) who were treated with LCIG via NJ continued treatment via PEG-J (1 discontinued before titration), and 41 completed the study. At baseline, patients had PD for a mean of 13.9 years (Table 1). Patients had improvements in activities of daily living in the first 6 months and at final (Figure 1), and in quality of life (PDQ-8 summary index) at every time point. One-third of patients had an AE (Table 2), of which, 8 (12.5%) had an AE with a reasonable possibility of being related to LCIG, as rated by the study investigator.

Table 1: Baseline Demographics and Disease Characteristics
Demographic or Characteristic n (% of N=64) Mean (SD)
Gender Male 39 (61)  
  Female 25 (39)  
Age, years     70.4 (7.8)
Race Caucasian 64 (100)  
Parkinson’s disease duration, years     13.9 (5.4)
Previous PD therapy Oral levodopa 64 (100)  
  Dopamine agonist 60 (94)  
  COMT inhibitor 45 (70)  
  MAO-B inhibitor 38 (59)  
  Amantadine 31 (48)  
  Rotigotine 25 (39)  
  Apomorphine s.c. 12 (19)  
UPDRS Part II, total score during “on” time     18.1 (8.0)
UPDRS = Unified Parkinson’s disease Rating Scale; COMT = catechol-O-methyltransferase; MAO-B = Monoamine Oxidase-B; s.c. = subcutaneous”

Table 2: Summary of Safety
Patients with: n (% of N=64)
Any adverse event (AE) 21 (33)
Any serious AE 14 (22)
Any AE leading to discontinuation of LCIG 7 (11)
Death 2 (3.1)a
AEs occurring in ≥2 patients by preferred term:  
Stoma site infection [ensp] [ensp] 3 (4.7)
Therapy cessationb 3 (4.7)
Psychotic disorder 2 (3.1)
MedDRA version 18.0

a. Both patients had AEs that had no reasonable possibility of being related to the treatment, as rated by the investigator.

b. This preferred term was under the surgical and medical procedures system organ class.“

Conclusions: LCIG led to significant improvements in activities of daily living in the first 6 months of infusion in advanced PD patients. The safety results were consistent with the established safety profile of LCIG. (ref 1). References: 1. Fernandez et al. Mov Disord. 2015; 30(4):500-9.

To cite this abstract in AMA style:

R. Krüger, P. Lingor, T. Doskas, J. Henselmans, E.H. Danielsen, O. de Fabregues, A. Stefani, S.C. Sensken, J.C. Parra Riaza, K. Onuk, A. Yegin. The effect of levodopa-carbidopa intestinal gel on activities of daily living: Results from the observational MONOTREAT study in advanced Parkinson’s disease patients [abstract]. Mov Disord. 2016; 31 (suppl 2). https://www.mdsabstracts.org/abstract/the-effect-of-levodopa-carbidopa-intestinal-gel-on-activities-of-daily-living-results-from-the-observational-monotreat-study-in-advanced-parkinsons-disease-patients/. Accessed May 16, 2025.
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