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

June 5, 2026 updated by: Britannia Pharmaceuticals Ltd.

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
215

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Spain
    • A Coruña
      • A Coruña, A Coruña, Spain, 15006
        • Recruiting
        • Complejo Hospitalario Universitario de A Coruña (CHUAC)
        • Contact:
    • Av. Manuel Siurot, S/n
      • Seville, Av. Manuel Siurot, S/n, Spain, 41013
        • Recruiting
        • Virgen del Rocio University Hospital
        • Contact:
          • Sukhdeep Singh, MSci
    • Castille-La Mancha
      • Toledo, Castille-La Mancha, Spain, 45007
        • Recruiting
        • Hospital Universitario de Toledo
    • Vizcaya
      • Barakaldo, Vizcaya, Spain, 48903
        • Recruiting
        • Hospital de Cruces
      • Bilbao, Vizcaya, Spain, 48013
        • Recruiting
        • Hospital de Basurto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
This is a non-interventional study.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Time Frame: Baseline, Month 12
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from Baseline in the Reduction in OFF time (h/day) as Measured by MDS-UPDRS IV at 6 months
Time Frame: Baseline, Month 6
The MDS-UPDRS is a revision of the 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 6
Change from Baseline in the Reduction in OFF time (h/day) as Measured by Hauser Patient Diaries
Time Frame: Baseline, Months 6 and 12
The Hauser Diary is a home diary, completed by the participant, that assesses functional status in participants with Parkinson's disease with motor fluctuations and dyskinesia. Participants will complete the Hauser Diary for a 72-hour period occurring after informed consent has been obtained and prior to LECIGON® treatment start and for 48 hours prior to each of the two follow-up visits.
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
Time Frame: Baseline, Months 6 and 12
Total daily levodopa dose will be measured using the 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)
Time Frame: Baseline, Months 6 and 12
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
Time Frame: Baseline, Months 6 and 12
Baseline, Months 6 and 12
Change from Baseline in Non-motor Experiences of Daily Living as Measured by MDS-UPDRS-I
Time Frame: Baseline, Months 6 and 12
The MDS-UPDRS is a revision of the UPDRS developed to evaluate various aspects of Parkinson's disease including non-motor and motor experiences of daily living and motor complications. Part I concerns non-motor experiences of daily living. Several questions from Part I are designed to be amenable to a patient/caregiver questionnaire format and therefore can be completed without the investigator's input. For the remaining Part I questions that deal with complex behaviors, the investigator is required to conduct the interview of participants.
Baseline, Months 6 and 12
Change from Baseline in Motor Complications as Measured by MDS-UPDRS-IV
Time Frame: Baseline, Months 6 and 12
The MDS-UPDRS is a revision of the 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, Months 6 and 12
Change from Baseline in Quality of Life as Measured by Parkinson's Disease Questionnaire Total Score (PDQ-8)
Time Frame: Baseline, Months 6 and 12
The PDQ-8 is an eight-question instrument, completed by the participants, that measures the quality of life among Parkinson's disease participants. It is a shortened version of the 39-item Parkinson's disease questionnaire to reduce participant burden and increase convenience for use among Parkinson's disease participants. It includes one question from each of the dimensions including include mobility, activities of daily of living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort.
Baseline, Months 6 and 12
Change from Baseline in Sleep as Measured by Parkinson's Disease Sleep Scale - 2 (PDSS-2)
Time Frame: Baseline, Months 6 and 12
The PDSS is a visual analogue scale, completed by the Parkinson's disease participant, addressing 15 commonly reported symptoms associated with sleep disturbances, including overall quality of night's sleep, sleep onset and maintenance insomnia, nocturnal restlessness, nocturnal psychosis, nocturia, nocturnal motor symptoms, sleep refreshment, and daytime dozing. The PDSS-2 uses a 5-point frequency scale (0-4) for each item, with a total score ranging from 0 to 60. Higher scores indicate more severe sleep problems.
Baseline, Months 6 and 12
Treatment Satisfaction Questionnaire at Months 6 and 12
Time Frame: At Months 6 and 12
Participants will be asked questions to assess their satisfaction with LECIGON® treatment.
At Months 6 and 12
Change from Baseline in Body Mass Index (BMI)
Time Frame: Baseline, Months 6 and 12
Baseline, Months 6 and 12
Number of Participants With Adverse Drug Reactions (ADRs), Serious ADRs, Reportable Events (REs), Serious REs and REs of Special Interest (RESIs)
Time Frame: 12 months
An ADR is any untoward and unintended response to a medicinal product, related to any dose administered and which implies a RE with at least a reasonable possibility of a causal relationship with the use of the product. A RE is any unfavorable or unintended sign, symptom or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. RESIs include drug interaction, drug exposure during pregnancy, drug exposure during breastfeeding, lack of drug efficacy, overdose, misuse/abuse, medication errors (incl. prescription and application errors), off-label use, adverse reaction which occurred during occupational exposure, falsified medicinal product, suspected transmission of infectious agents via a medicinal product.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Britannia Pharmaceuticals Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Bharat Amlani, MPharm, Britannia Pharmacetuicals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 8, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 17, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 17, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 31, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NIS-MA-2025-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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