Lecigon (carbidopa/levodopa/entacapone) / LobSor - LARVOL DELTA

INITIATE-LECIG: Intestinal Levodopa + Entacapone Therapy (Lecigon®) to Counteract Dopaminergic Desensitization and Neuropsychiatric Complications in Parkinson's Disease (clinicaltrials.gov) - P3 | N=150 | Recruiting | Sponsor: University Hospital Tuebingen | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Movement Disorders • Parkinson's Disease • Psychiatry

Continuous Subcutaneous Versus Intestinal Levodopa Infusion for Parkinson's Disease: A Real-World, Monocentric, Observational Study and Critical Review. (PubMed, Mov Disord Clin Pract) - "Conclusively, our data suggest real-world efficacy for SCFF in controlling motor fluctuations. However, there are significant dropout rates, side effects and patient-clinician disagreement in global efficacy estimation. Comparison with intestinal infusion and literature revealed that pump-based therapies lack structured management. We recommend the establishment of systematic guidelines for pump-based therapies in advanced PD and provide a first troubleshooting algorithm for treating clinicians."

Journal • Observational data • Real-world evidence • CNS Disorders • Movement Disorders • Parkinson's Disease

SWITCH-ON: Long Term Effectiveness of Levodopa-Entacapone-Carbidopa Intestinal Gel in Participants With Advanced Parkinson's Disease (clinicaltrials.gov) - P=N/A | N=215 | Recruiting | Sponsor: Britannia Pharmaceuticals Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Movement Disorders • Parkinson's Disease

SWITCH-ON: Long Term Effectiveness of Levodopa-Entacapone-Carbidopa Intestinal Gel in Participants With Advanced Parkinson's Disease (clinicaltrials.gov) - P=N/A | N=215 | Not yet recruiting | Sponsor: Britannia Pharmaceuticals Ltd.

New trial • CNS Disorders • Movement Disorders • Parkinson's Disease

Infusion therapies for Parkinson's disease: where are we in 2025? (PubMed, Expert Opin Drug Deliv) - No abstract available

Journal • CNS Disorders • Movement Disorders • Parkinson's Disease

Treatment Of Advanced Parkinson's With Levodopa–Entacapone–Carbidopa Intestinal Gel – Impact On Dyskinesia (MDS Congress 2025) - P | "Data from ELEGANCE suggest that long-term treatment with LECIG can improve the daily duration of dyskinesia. In the small number of patients who switched from LCIG to LECIG, there was a trend for a slight reduction in daily hours of dyskinesia. Figure 1 Figure 2"

Metastases • CNS Disorders • Movement Disorders • Parkinson's Disease

Sustained Motor Symptom Efficacy With Long-Term Levodopa–Entacapone–Carbidopa Intestinal Gel (LECIG) Treatment – Data From The ELEGANCE Interim Analysis (MDS Congress 2025) - P | "LECIG showed sustained clinical efficacy in reducing PD motor symptoms, both during the day and at night, following treatment for up to two years. Figure 1 Figure 2 Figure 3"

Clinical • CNS Disorders • Movement Disorders • Parkinson's Disease

Timing And Type Of Adverse Events Following Long-Term Treatment With Levodopa–Entacapone–Carbidopa Intestinal Gel (LECIG) Infusion – Data From The ELEGANCE Interim Analysis (MDS Congress 2025) - P | "These data suggest that LECIG treatment for up to one year is generally well tolerated by patients with advanced PD. As has been observed with levodopa–carbidopa intestinal gel infusion, the most frequent AEs are associated with the procedure or the device. Table 1"

Adverse events • CNS Disorders • Movement Disorders • Parkinson's Disease

Three-Year Single-Center Experience with Levodopa–Entacapone–Carbidopa Intestinal Gel in Advanced Parkinson's Disease (MDS Congress 2025) - "The therapeutic efficacy of LECIG in mitigating motor complications is comparable to that of levodopa–carbidopa intestinal gel (LCIG), with the added benefits of a reduced daily levodopa requirement and a more compact administration device. However, further longitudinal studies and extended clinical experience are required to determine the relative advantages of these two enteral levodopa formulations within the framework of personalized treatment strategies for advanced Parkinson's disease."

Clinical • Metastases • CNS Disorders • Movement Disorders • Parkinson's Disease

Patient And Clinician Perceptions Of Disease Improvement With Levodopa–Entacapone–Carbidopa Intestinal Gel (LECIG) In Advanced Parkinson's – Data From The ELEGANCE Interim Analysis (MDS Congress 2025) - P | "Both clinicians and PD patients report sustained favourable improvements in their disease following treatment with LECIG for up to two years compared with their baseline condition. Figure 1 Figure 2"

Clinical • Metastases • CNS Disorders • Cognitive Disorders • Movement Disorders • Parkinson's Disease

Multidimensional Assessment of Levodopa/Carbidopa/Entacapone Gel (LECIG) Therapy in Parkinson's Disease: Perspectives of Patients, Clinicians, and Caregivers (MDS Congress 2025) - "LECIG therapy significantly reduces caregiver burden and improves patient-reported quality of life in PD. Clinician assessments corroborate these benefits, with no reported worsening. These findings highlight the importance of continuous dopaminergic stimulation in managing advanced PD."

Clinical • CNS Disorders • Movement Disorders • Parkinson's Disease

Comparative Analysis of miR-29a Expression in Optimized Medical Therapy and Intestinal Infusion Therapies in Advanced Parkinson's Disease (MDS Congress 2025) - "Objective: To compare the relative expression of miR-29a in patients with advanced Parkinson's disease (PD) receiving optimized medical therapy (OMT) versus intestinal infusion therapies—levodopa/carbidopa intestinal gel (LCIG) and levodopa/entacapone/carbidopa intestinal gel (LECIG). In our study, we observed that there was a significant decrease in the relative expression of miR-29a in patients on OMT. This decrease may be associated with greater dopamine level fluctuations, potentially contributing to increased oxidative stress. The stable miR-29a expression in the intestinal infusion groups (LCIG and LECIG) could suggest a neuroprotective effect of continuous levodopa administration, potentially mitigating neuronal stress and inflammation."

Metastases • CNS Disorders • Movement Disorders • Parkinson's Disease • MIR29A

Effects of levodopa-entacapone-carbidopa intrajejunal infusion on non-motor symptoms of advanced Parkinson's disease-interim analysis of the ELEGANCE study. (PubMed, J Neural Transm (Vienna)) - P | "The ELEGANCE study (NCT05043103) is an ongoing, non-interventional registry study collecting real-world data on long-term efficacy, safety and patient-reported outcomes following treatment with levodopa-entacapone-carbidopa intestinal gel (LECIG) infusion. The significant reductions in the scores for two domains, 'sleep/fatigue' and 'gastrointestinal (GI) tract', were sustained at V3. Routine use of LECIG for up to 12 months was found to reduce the overall NMS burden, a factor that is known to impact the quality of life of people with Parkinson's, with particular impact on sleep- and GI-related symptoms."

Journal • CNS Disorders • Fatigue • Movement Disorders • Parkinson's Disease

Living Alone Is Associated With Discontinuation of Levodopa-Entacapone-Carbidopa Intestinal Gel Treatment in Advanced Parkinson's Disease. (PubMed, Eur Neurol) - "Yet, no direct comparison to LCIG was made in this study. Similar to LCIG, the discontinuation rate is particularly high among patients living alone."

Journal • CNS Disorders • Movement Disorders • Parkinson's Disease

Levodopa-Carbidopa-Entacapone Intestinal Gel for Advanced Parkinson's Disease-Results from a Monocentric Study Evaluating Both Motor and Non-Motor Manifestations. (PubMed, Biomedicines) - "Among the non-motor symptoms, depression and sleep disorders improved, with no changes in cognitive status and psychotic disorders. Adding new data for the use of device-assisted therapy in advanced PD, our study also highlights the need to further research this challenging patient profile."

Journal • CNS Disorders • Depression • Geriatric Disorders • Movement Disorders • Parkinson's Disease • Psychiatry • Sleep Disorder

Intrajejunal levodopa infusion therapy – comparison of real-world data from the ELEGANCE, GLORIA and DUOGLOBE registries (EAN 2025) - P | "Background and aims: The therapeutic options for patients with advanced Parkinson's disease (PD) who choose intrajejunal levodopa infusion treatment are levodopa–carbidopa intestinal gel (LCIG) or levodopa–entacapone–carbidopa intestinal gel (LECIG). At an early stage of treatment with LECIG (up to 12 months) patients in ELEGANCE showed significant improvements in PD motor symptoms, sleep and QoL. These findings are directly comparable to observations after 12 months of treatment with LCIG in the GLORIA and DUOGLOBE studies."

Clinical • Real-world • Real-world evidence • CNS Disorders • Movement Disorders • Parkinson's Disease

COMT inhibition with entacapone for patients with Parkinson's disease and motor complications: the novelty of continuous infusion. (PubMed, J Neural Transm (Vienna)) - "In this review, we describe the pharmacologic rationale for combining COMT inhibition with entacapone and continuous dopaminergic delivery that led to the development of levodopa/entacapone/carbidopa intestinal gel (LECIG). Accumulating real-world evidence with LECIG supports its use in managing motor fluctuations in patients whose control is becoming suboptimal with oral approaches. We provide an overview of the growing evidence base for its risk-benefit profile in patients with motor fluctuations."

Journal • Review • CNS Disorders • Movement Disorders • Parkinson's Disease • COMT

INITIATE-LECIG: Intestinal Levodopa + Entacapone Therapy (Lecigon®) to Counteract Dopaminergic Desensitization and Neuropsychiatric Complications in Parkinson's Disease (clinicaltrials.gov) - P3 | N=150 | Not yet recruiting | Sponsor: University Hospital Tuebingen

New P3 trial • CNS Disorders • Movement Disorders • Parkinson's Disease • Psychiatry

Cost of Quality of Life in Advanced Parkinson's Disease: Efficient Strategies for Disease Assessment. (PubMed, Rev Neurol) - "These results provide additional information on the efficiency of treatments that should inform decision-making in the management of advanced Parkinson's disease, thus enabling better resource management."

HEOR • Journal • CNS Disorders • Movement Disorders • Parkinson's Disease

Cognitive outcomes of infusion therapies in Parkinson's disease: A comprehensive systematic review. (PubMed, Parkinsonism Relat Disord) - "The cognitive effects of device-aided treatments in PD show substantial variability, and their impact on cognitive function, processing speed, attention, and memory is inconsistent, with some studies reporting impairments and others indicating stability or slight improvements. The heterogeneity in study designs, neuropsychological assessments and coexisting vascular and amyloid pathology further complicates interpretation, underscoring the need for more controlled investigations."

Journal • Review • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Movement Disorders • Parkinson's Disease

Levodopa Intestinal Gel Infusion Therapies in Advanced Parkinson's Disease: A Swedish Study on Real-World Use and Costs. (PubMed, Neurol Ther) - "Real-world data show that the number of dispensed cassettes and overall treatment costs are higher for LECIG than LCIG treatment among patients with advanced PD in Sweden."

Journal • Real-world evidence • CNS Disorders • Movement Disorders • Parkinson's Disease

Complications associated with intestinal infusion therapies in patients with Parkinson's disease: a single-center retrospective study and 15-year experience. (PubMed, Front Neurol) - "Advanced therapies, such as levodopa/carbidopa intestinal gel or carbidopa/levodopa enteral suspension (LCIG/CLES) and levodopa/entacapone/carbidopa intestinal gel (LECIG), offer continuous levodopa administration to reduce fluctuations and improve QoL. Gastrojejunostomy-related AEs in LCIG/CLES and LECIG therapies are common but generally manageable with proper intervention. Serious complications are rare, with less than 10% discontinuing treatment due to dissatisfaction."

Journal • Retrospective data • CNS Disorders • Gastrointestinal Disorder • Movement Disorders • Parkinson's Disease

The device-aided intrajejunal delivery of levodopa-entacapone-carbidopa intestinal gel the treatment of Parkinson's disease: overview of efficacy and safety. (PubMed, Expert Rev Med Devices) - "Clinical and real-world data reporting its efficacy, safety and tolerability of LECIG in advanced PD patients from a range of European centers are reviewed, with a focus on the practical benefits that a smaller, lighter and quieter device can provide for patients who wish to start treatment with intrajejunal levodopa infusion. LECIG infusion delivered via the LECIG infusion pump offers another valuable DAT option to consider for suitable people with advanced PD providing both good long-term clinical benefits and a favorable treatment experience for patients."

Journal • Review • CNS Disorders • Movement Disorders • Parkinson's Disease

Target-Controlled Sedation with Propofol Infusion for PEG-J Placement in Advanced Parkinson's Disease: A Prospective Observational Study on Safety and Feasibility. (PubMed, Life (Basel)) - "This study highlights the feasibility and clinical applicability of a TCI propofol protocol for PEG-J placement in patients with advanced PD (stages 4 and 5). While no deaths were recorded within the 30-day follow-up, the sample size is insufficient to draw definitive conclusions regarding long-term safety."

Journal • Observational data • Anesthesia • CNS Disorders • Movement Disorders • Parkinson's Disease

Levodopa-Entacapone-Carbidopa Intrajejunal Infusion in Advanced Parkinson's Disease - Interim Analysis of the ELEGANCE Study. (PubMed, Mov Disord Clin Pract) - P | "Routine use of LECIG for up to 12 months provided sustained control of motor symptoms, and was well tolerated with a positive impact on QoL and high patient satisfaction."

Journal • CNS Disorders • Movement Disorders • Parkinson's Disease