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

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

Device-aided therapies (DATs) in Parkinson's disease (PD). The DATs-PD GETM Spanish Registry Protocol Study. (PubMed, PLoS One) - "The present study will help improve the care of PD patients treated with a DAT."

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

Real-world experience with continuous subcutaneous foslevodopa/foscarbidopa infusion: insights and recommendations. (PubMed, J Neural Transm (Vienna)) - "Traditional advanced therapies in Parkinson's disease (PD) with motor fluctuations and dyskinesias like continuous apomorphine infusion (CSAI), levodopa-carbidopa intestinal gel (LCIG), levodopa-carbidopa entacapone intestinal gel (LECIG), or deep brain stimulation (DBS) have played a central role in managing therapy-related complications. Recommendations are presented on how to prevent and manage these adverse effects to maximize patient compliance and therapeutic success. Additionally, the paper examines strategies for optimizing concurrent oral medications when combined with CSFLI, providing guidance on balancing pump infusion with necessary adjunctive oral treatments."

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

Two years' experience with levodopa-entacapone-carbidopa intestinal gel treatment in advanced Parkinson's disease (PubMed, Orv Hetil) - No abstract available

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

How well is the female population represented in clinical trials with infusion therapies for Parkinson's disease? A systematic review and metanalysis. (PubMed, Eur J Neurol) - "Female with advanced PD are underrepresented in infusion therapy trials. Most trials have overlooked sex-based biological differences that can impact clinical and functional outcomes, raising concerns about the generalizability of these findings to real-world contexts."

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

Long-term effect and reasons for switching and combining device-aided therapies in Parkinson's Disease. (PubMed, Neurol Neurochir Pol) - "Future studies are warranted to address the unresolved issues related to long-term efficacy, side effect profile and switching and combination of DATs in multicentric studies and using advanced analytical approaches such as machine learning."

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

Challenges of equitable access to device-aided therapies for advanced Parkinson's Disease in Poland - expert consensus and treatment recommendations. (PubMed, Neurol Neurochir Pol) - "Consensus expert opinion is that APD patients in Poland would benefit from additional reimbursement access to these treatment options to improve APD patient care."

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

Levodopa-entacapone-carbidopa intestinal gel: Data from the Swedish national registry for Parkinson's disease. (PubMed, Eur J Neurol) - "Data from ParkReg covering 150 patients over 3 years show LECIG to be an effective and safe device-aided therapy for advanced PD. However, the long-term efficacy and tolerability of LECIG need to be further investigated."

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

Effectiveness and safety of levodopa-entacapone-carbidopa infusion in Parkinson disease: A real-world data study. (PubMed, Eur J Neurol) - "LECIG was safe and effective in advanced PD patients."

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

A 4-Year Follow-Up of Levodopa-Entacapone-Carbidopa Intestinal Gel Treatment in Parkinson's Disease. (PubMed, Mov Disord Clin Pract) - "LECIG infusion is a viable treatment option for PD patients with motor fluctuations, for up to 4 years in our cohort."

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

ELEGANCE: Long-Term Observational Study on Effectiveness and Safety of Lecigon in Patients with Advanced Parkinson's Disease (clinicaltrials.gov) - P=N/A | N=300 | Active, not recruiting | Sponsor: Britannia Pharmaceuticals Ltd. | Recruiting ➔ Active, not recruiting

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

Levodopa-Entacapone-Carbidopa Intestinal Gel in the treatment of advanced Parkinson's disease: a two-year experience (MDS Congress 2024) - "Most patients (72%) were also being treated with dopamine agonists, namely pramipexole (3 patients; mean dose 2.4±0.6 mg), ropinirole (7 patients; mean dose 12 ± 6.5mg) or rotigotine patch (12 patients; mean dose 8.2 ± 2.0 mg). Therapeutic regimens also included rasagiline (18 patients, 62%) and entacapone (23 patients, 79%)... LECIG represents an effective DAT option for managing motor complications in APD. Further targeted studies are necessary to define the profile of APD patients who would benefit most from this new therapeutic solution, gather additional data on long-term safety and efficacy, and analyze the reduction of add-on medication over time."

Metastases • CNS Disorders • Parkinson's Disease

Levodopa-Entacapone-Carbidopa Intestinal Gel Treatment In Parkinson's Disease: A Single-Center Retrospective Chart Study (MDS Congress 2024) - "The infusion rate of LECIG gradually had to be increased over a period of 18 months or less, whereas day time infusion rates of LCIG remained relatively stable until LECIG was initiated. This may be the result of the onset of LECIG in a later stage of the disease and related to progression of symptoms in the course of the disease. Future research is warranted to compare LCIG and LECIG within similar stages of the disease, including the early stage."

Retrospective data • CNS Disorders • Parkinson's Disease

ELEGANCE: Long-Term Observational Study on Effectiveness and Safety of Lecigon in Patients With Advanced Parkinson's Disease (clinicaltrials.gov) - P=N/A | N=300 | Recruiting | Sponsor: Britannia Pharmaceuticals Ltd. | Trial completion date: Jul 2025 ➔ Sep 2026 | Trial primary completion date: Jul 2025 ➔ Sep 2026

Metastases • Trial completion date • Trial primary completion date • CNS Disorders • Movement Disorders • Parkinson's Disease

Monotherapy with infusion therapies - useful or not? (PubMed, J Neural Transm (Vienna)) - "This review presents the literature data on the efficacy, safety, and achievability of monotherapy with all available infusion-based therapies, including apomorphine, levodopa-carbidopa-intestinal gel (LCIG), levodopa-entacapone-carbidopa intestinal gel (LECIG), and foslevodopa-foscarbidopa (LDp/CDp). There is a need for further investigation of monotherapy compared to polytherapy, especially in new pump treatment options (LECIG and LDp/CDp). Future research should reveal which patients on infusion-based therapies could benefit from monotherapy, including identification of potential baseline predictors of achieving monotherapy in patients treated with specific infusion-based therapies."

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

Use of the MNCD classification/staging in advanced Parkinson´s disease patients treated with a device-aided therapy. (EAN 2024) - "Our aim was to apply the MNCD classification in patients treated with levodopa-entacapone-carbidopa intestinal gel (LECIG) infusion. The MNCD classification could be useful to classify advanced PD patients and to monitor the response to a device-aided therapy."

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

Effectiveness and safety of levodopa-entacapone-carbidopa infusion in Parkinson's disease. A real-world data study. (EAN 2024) - "Background and aims: Levodopa-entacapone-carbidopa intestinal gel (LECIG) infusion is a recently developed device-aided therapy for advanced Parkinson's disease (PD) patients. LECIG was safe and effective in advanced PD patients."

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

What was first and what is next in selecting device-aided therapy in Parkinson's disease? Balancing evidence and experience. (PubMed, J Neural Transm (Vienna)) - "Globally, various DATs options are available, including continuous subcutaneous apomorphine infusion, deep brain stimulation, levodopa-carbidopa intestinal gel, levodopa-entacapone-carbidopa intestinal gel, and subcutaneous foslevodopa/foscarbidopa infusion, each with its complexities. Follow-up care involves symptom monitoring and adjusting medications. Customized treatment plans are essential for optimizing PD management with DATs."

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

Levodopa-Entacapone-Carbidopa Intestinal Gel in the Treatment of Advanced Parkinson's Disease: A Single Center Real-World Experience. (PubMed, Pharmaceutics) - "The levodopa-entacapone-carbidopa intestinal gel therapy was well tolerated during the follow-up period immediately after initiation. Despite a relatively severe stage of the disease, all patients experienced a significant improvement in motor fluctuations, dyskinesias, and the freezing phenomenon."

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

Advanced therapies in Parkinson's disease: an individualized approach to their indication. (PubMed, J Neural Transm (Vienna)) - "Device aided therapies (DAT) comprising the intrajejunal administration of levodopa/carbidopa intestinal gel (LCIG) and levodopa/carbidopa/entacapone intestinal gel (LECIG), the continuous subcutaneous application of foslevodopa/foscarbidopa or apomorphine infusion (CSAI) and deep brain stimulation (DBS) are used to treat Parkinson's disease with insufficient symptom alleviation under intensified pharmacotherapy. This necessitates that, during each consultation, the current symptomatology should be analyzed, and the potential suitability for a DAT be assessed. This work represents a critical interdisciplinary appraisal of these therapies in terms of their individual profiles and compares these DAT regarding contraindications, periprocedural considerations as well as their efficacy regarding motor- and non-motor deficits, supporting a personalized approach."

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

Long-term follow-up of patients with advanced Parkinson's disease treated with levodopa–entacapone–carbidopa intestinal gel infusion (LECIG) in Sweden (CONy 2024) - "Of the patients still receiving treatment, the most recent PDQ-8 score taken had a median of 12. Conclusions Our study is the first to present long-term data on the use of LECIG for up to four years in patients with advanced PD and indicates that it is generally well-tolerated in long-term treatment."

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