An observational study in Advanced Parkinson Disease, sponsored by Britannia Pharmaceuticals Ltd.. Terminated at 4 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-02.
Sponsored by Britannia Pharmaceuticals Ltd. · Observational
Following a reassessment, it was concluded that continuation of the study would no longer achieve its scientific objectives originally set out for the study.
Among 246 studies in Parkinson Disease with a site in United Kingdom — 55 open to participants now, 66 under way, 5 of them phase 3. Parkinson Disease · United Kingdom.
Among the 246 studies in Parkinson Disease with a site in United Kingdom, this one is the 60th largest by enrollment of the 62 observational ones, is one of 11 that started in 2026, is one of 62 observational ones, and was the 232nd registered.
4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.
This study's enrollment of 1 is below the median of 96 across 1,085 observational studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →55 of the 246 studies in Parkinson Disease with a site in United Kingdom are open now, in 12 countries. Each count lists the studies.
Of the 748 Parkinson Disease studies recruiting now, 311 (42%) set no upper age limit and 127 (17%) stop at 75 or younger; 63 take children under 18; 189 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →246 studies; the count open now beside each. This study's row is marked.
First in 1999; this study’s year is marked. 11 started in 2026.
Median enrollment 80 across the 183 interventional studies, 100 across the 62 observational. Of the 152 that completed or were terminated, 45 (30%) have results posted.
122 of 246 have an industry lead sponsor. The 10 most frequent:
Britannia Pharmaceuticals Ltd. is the lead sponsor of 4 studies on the registry; none are open to participants now.
Britannia Pharmaceuticals Ltd. has 4 studies filed under Parkinson Disease — fewer than ten, so there is no comparison to draw.
16 of the studies in Parkinson Disease with a site in United Kingdom that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07821151University of ExeterThe Effect of Beechband on Parkinson's Symptoms | 2026-11-10 |
| NCT05986643University of LeicesterBrain Training to Improve Balance in Parkinson's Disease | 2026-12 |
| NCT05635409Region SkaneA Trial to Determine the Safety and Tolerability of Transplanted Stem Cell Derived Dopamine Neurons to the Brains of Individuals With Parkinson's Disease | 2027-01 |
| NCT02760108University College, LondonParkinson's Families Project | 2027-01 |
| NCT07882108Cambridge University Hospitals NHS Foundation TrustGinger-PD: Ginger as a Modifier of Ghrelin Levels and Gut Function in Parkinson's Disease | 2027-03-01 |
Among the 246 studies in Parkinson Disease with a site in United Kingdom, from their registry updates:
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).
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Time frame: Baseline, Month 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.
Time frame: 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.
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
Total daily levodopa dose will be measured using the 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
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.
Time frame: 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.
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)
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.
Time frame: 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.
Time frame: 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.
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)
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.
Time frame: 12 months
Plan to share: No
No publications or documents are linked to this record.
Ran from May 2026 to primary completion in Aug 2026, 3 months.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 2, 2026: primary completion Oct 2028 → Aug 2026 and completion Jan 2029 → Aug 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
Following a reassessment, it was concluded that continuation of the study would no longer achieve its scientific objectives originally set out for the study.
Following a reassessment, it was concluded that continuation of the study would no longer achieve its scientific objectives originally set out for the study.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is terminated, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Britannia Pharmaceuticals Ltd.