Long-term LECIGON (levodopa-entacapone-carbidopa) intestinal gel for advanced Parkinson's disease
A Prospective, Non-Interventional Study on the Long-term Effectiveness of Levodopa-Entacapone-Carbidopa Intestinal Gel (LECIGON®) in Patients With Parkinson's Disease Previously Treated With Subcutaneous Foslevodopa in Routine Care
This study will test whether long-term LECIGON intestinal gel reduces daily OFF time in adults with advanced Parkinson's disease who have severe motor fluctuations and dyskinesia.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 215 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Britannia Pharmaceuticals Ltd. Industry-sponsored |
| Locations | 2 sites (Seville, Av. Manuel Siurot, S/n and 1 other locations) |
| Trial ID | NCT07313176 on ClinicalTrials.gov |
What this trial studies
This observational study follows adults with advanced Parkinson's disease who begin LECIGON treatment after prior use of subcutaneous foslevodopa. The main measurement is change in daily OFF time from baseline to 12 months using MDS-UPDRS Part IV. Participants are enrolled when the treating physician independently decides to start LECIGON and are followed with routine clinic visits and chart-based data collection. No investigational interventions are assigned by the protocol; device use and dosing are managed by the treating team.
Who should consider this trial
Good fit: Adults (18+) with advanced Parkinson's disease experiencing severe motor fluctuations and dyskinesia who are starting LECIGON per their treating physician and who have used subcutaneous foslevodopa for at least one month are ideal candidates.
Not a fit: Patients with contraindications to LECIGON, those unable to use pump therapy or comply with device management, or those not able to receive follow-up care at the investigator site are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, LECIGON could reduce daily OFF time and improve motor control and daily functioning for patients with advanced Parkinson's disease.
How similar studies have performed: Previous research on continuous intestinal levodopa formulations and subcutaneous levodopa preparations has reduced OFF time, but long-term real-world data specifically for LECIGON remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult participants (18 years old and over) with advanced Parkinson's disease with severe motor fluctuations and dyskinesia * Participants for whom the treating physician has made the decision to initiate treatment with LECIGON® in accordance with the Summary of Product Characteristics (SmPC) * Participants must have had previous treatment with subcutaneous foslevodopa (foslevodopa-foscarbidopa) for a minimum of 1 month * Participants or legal representative must have signed informed consent to participate in the study Exclusion Criteria: * Participants with contraindications as defined in the current version of the SmPC for LECIGON® * Participants who will not be seen again for their follow up care at the investigator's site after commencement of LECIGON® therapy * Participants with anticipated pump placement or pump use issues, e.g. participants with acute severe illness, participants unable to perform pump therapy, and in case of lacking compliance due to severe dementia, agitation or alcohol abuse * Participants taking part in a clinical (interventional) trial at the same time
Where this trial is running
Seville, Av. Manuel Siurot, S/n and 1 other locations
- Virgen del Rocío University Hospital — Seville, Av. Manuel Siurot, S/n, Spain (Recruiting)
- Complejo Hospitalario Universitario de A Coruña (CHUAC) — A Coruña, Spain (Recruiting)
Study contacts
- Study coordinator: Sukhdeep Singh, MSci
- Email: Sukhdeep.singh@britannia-pharm.com
- Phone: +44 07954751548
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.