Advanced Parkinson DiseaseSWITCH-ONNCT07313176
Long Term Effectiveness of Levodopa-Entacapone-Carbidopa Intestinal Gel in Participants With Advanced Parkinson's Disease
An observational study of Advanced Parkinson Disease, run by Britannia Pharmaceuticals Ltd. at 4 sites in 3 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Parkinson Disease
- Type of treatment
- Injection or infusion
- How many people
- 1 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 8 May 2026to 31 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
United Kingdom2 sites
National Hospital for Neurology and Neurosurgery
London, WC1N3BG
Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, NE46BE
Spain1 site
Complejo Hospitalario Universitario de A Coruña (CHUAC)
A Coruña, A Coruña, 15006
About this study
Official title: 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).
- Conditions
- Advanced Parkinson Disease
- Being tested
- No Intervention
- Keywords
- Parkinson´s Disease, Movement Disorders, Portable Pump, Neurodegenerative Disorder, Subcutaneous Foslevodopa, Quality of Life, Dopamine Agonists
- Medical subject headings
- Parkinson Disease, Movement Disorders, Neurodegenerative Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
This is a non-interventional study.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Baseline, Month 6
Change from Baseline in the Reduction in OFF time (h/day) as Measured by Hauser Patient Diaries
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.
Measured: 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
Total daily levodopa dose will be measured using the multi-rate programming of pump.
Measured: Baseline, Months 6 and 12
Change from Baseline in Clinical Global Impression of Improvement as Measured by Clinical Global Impression of Change (CGI-C)
Measured: 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
Measured: Baseline, Months 6 and 12
Change from Baseline in Non-motor Experiences of Daily Living as Measured by MDS-UPDRS-I
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.
Measured: Baseline, Months 6 and 12
Change from Baseline in Motor Complications as Measured by MDS-UPDRS-IV
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.
Measured: Baseline, Months 6 and 12
Change from Baseline in Quality of Life as Measured by Parkinson's Disease Questionnaire Total Score (PDQ-8)
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.
Measured: Baseline, Months 6 and 12
Change from Baseline in Sleep as Measured by Parkinson's Disease Sleep Scale - 2 (PDSS-2)
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.
Measured: Baseline, Months 6 and 12
Treatment Satisfaction Questionnaire at Months 6 and 12
Participants will be asked questions to assess their satisfaction with LECIGON® treatment.
Measured: At Months 6 and 12
Change from Baseline in Body Mass Index (BMI)
Measured: 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)
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study start8 May 2026
- Primary completion31 Aug 2026
- Study completion31 Aug 2026
Why it stopped: Following a reassessment, it was concluded that continuation of the study would no longer achieve its scientific objectives originally set out for the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Britannia Pharmaceuticals Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Watt, Study director, Britannia Pharmacetuicals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07313176
- Sponsor's protocol ID
- NIS-MA-2025-01
- Acronym
- SWITCH-ON
- Status last verified
- Sep 2026
- First submitted
- 17 Dec 2025
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07313176
- Acronym / sponsor ID
- SWITCH-ON / NIS-MA-2025-01
- Conditions
- Advanced Parkinson Disease
- Keywords
- Parkinson´s Disease, Movement Disorders, Portable Pump, Neurodegenerative Disorder, Subcutaneous Foslevodopa, Quality of Life, Dopamine Agonists
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Following a reassessment, it was concluded that continuation of the study would no longer achieve its scientific objectives originally set out for the study.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Britannia Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 May 2026 (actual)
- Primary completion
- 31 Aug 2026 (actual)
- Study completion
- 31 Aug 2026 (actual)
- First posted
- 31 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants Receiving LECIGON® Treatment | – | Other: No InterventionAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionThis is a non-interventional study. | Other | Participants Receiving LECIGON® Treatment |
Primary outcome
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.
12 secondary outcomes
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
Change from Baseline in the Reduction in OFF time (h/day) as Measured by Hauser Patient Diaries
Time frame: 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
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
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
Change from Baseline in Non-motor Experiences of Daily Living as Measured by MDS-UPDRS-I
Time frame: Baseline, Months 6 and 12
Change from Baseline in Motor Complications as Measured by MDS-UPDRS-IV
Time frame: 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
Change from Baseline in Sleep as Measured by Parkinson's Disease Sleep Scale - 2 (PDSS-2)
Time frame: Baseline, Months 6 and 12
Treatment Satisfaction Questionnaire at Months 6 and 12
Time frame: At Months 6 and 12
Change from Baseline in Body Mass Index (BMI)
Time frame: 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
Results and safety
The study was stopped early (reason given: Following a reassessment, it was concluded that continuation of the study would no longer achieve its scientific objectives originally set out for the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Watt study director
Britannia Pharmacetuicals
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Parkinson Disease, run by Britannia Pharmaceuticals Ltd. at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom, Germany, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Following a reassessment, it was concluded that continuation of the study would no longer achieve its scientific objectives originally set out for the study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.