Long Term Effectiveness of Levodopa-Entacapone-Carbidopa Intestinal Gel in Participants With Advanced Parkinson's Disease

NCT07313176 | Recruiting

• 1 other identifier: NIS-MA-2025-01
• Study Type: observational
• Target: 215
• Locations: 1 country
• Sites: 2

Brief Summary

The primary objective of the study is to assess the effectiveness of LECIGON® treatment on the reduction in OFF time (h/day) from baseline at 12 months as measured by Movement Disorder Society-Unified Parkinson's Disease Rating Scale, Part IV (MDS-UPDRS IV).

Conditions

Advanced Parkinson Disease

Keywords

Parkinson´s Disease; Movement Disorders; Portable Pump; Neurodegenerative Disorder; Subcutaneous Foslevodopa; Quality of Life; Dopamine Agonists

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in the Reduction in OFF time (h/day) as Measured by Movement Disorder Society-unified Parkinson's Disease Rating Scale, Part IV (MDS-UPDRS IV) at 12 months

  The MDS-UPDRS is a revision of the Unified Parkinson's disease rating scale (UPDRS) developed to evaluate various aspects of Parkinson's disease including non-motor and motor experiences of daily living and motor complications. Part IV concerns motor complication and all questions in Part IV that deal with motor fluctuations and dyskinesias, the investigator is required to conduct the interview of participants.

  Baseline, Month 12

Secondary Outcomes (12)

• Change from Baseline in the Reduction in OFF time (h/day) as Measured by MDS-UPDRS IV at 6 months

  Baseline, Month 6

• Change from Baseline in the Reduction in OFF time (h/day) as Measured by Hauser Patient Diaries

  Baseline, Months 6 and 12

• Change from Baseline in LECIGON® Treatment Patterns due to Change in Daily Levodopa Dose (mg/day) as Measured by Total Daily Dose Using Multi-rate Programming of Pump

  Baseline, Months 6 and 12

• Change from Baseline in Clinical Global Impression of Improvement as Measured by Clinical Global Impression of Change (CGI-C)

  Baseline, Months 6 and 12

• Change from Baseline in Clinical Global Impression of Improvement as Measured by Patient Global Impression of Change (PGI-C) at 12 months

  Baseline, Months 6 and 12

Study Arms (1)

Participants Receiving LECIGON® Treatment

All participants with advanced Parkinson's disease who switched from subcutaneous foslevodopa (foslevodopa-foscarbidopa) to LECIGON®, will be observed in the study. Participants real-world data on the long-term effectiveness of LECIGON® in routine clinical practice will be observed.

Other: No Intervention

Interventions

No Intervention OTHER

This is a non-interventional study.

Participants Receiving LECIGON® Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult participants with advanced Parkinson's disease have discontinued treatment with foslevodopa-foscarbidopa and are receiving LECIGON® as part of their routine care will be included in this observational study.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Britannia Pharmaceuticals Ltd.: lead

Study Sites (2)

Virgen del Rocío University Hospital

Seville, Av. Manuel Siurot, S/n, 41013, Spain

RECRUITING

Complejo Hospitalario Universitario de A Coruña (CHUAC)

A Coruña, 15006, Spain

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Movement Disorders; Neurodegenerative Diseases

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Synucleinopathies

Study Officials

• Bharat Amlani, MPharm

  Britannia Pharmacetuicals

  STUDY DIRECTOR

Central Study Contacts

Sukhdeep Singh, MSci

CONTACT

+44 07954751548; Sukhdeep.singh@britannia-pharm.com

Niall Smith, MBA

CONTACT

Niall.smith@britannia-pharm.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: December 31, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)