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Efficacia a lungo termine del gel intestinale Levodopa-Entacapone-Carbidopa nei partecipanti con Malattia di Parkinson avanzata (SWITCH-ON)

29 settembre 2026 aggiornato da: Britannia Pharmaceuticals Ltd.

Studio prospettico, non interventistico sull'efficacia a lungo termine del gel intestinale Levodopa-Entacapone-Carbidopa (LECIGON®) in pazienti con malattia di Parkinson precedentemente trattati con foslevodopa sottocutanea nell'assistenza di routine

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).

Panoramica dello studio

Stato

Terminato

Intervento / Trattamento

Tipo di studio

Osservativo

Iscrizione (Effettivo)

1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

      • Stadtroda, Germania, 07646
        • Asklepios Fachklinikum Stadtroda GmbH
      • London, Regno Unito, WC1N3BG
        • National Hospital for Neurology and Neurosurgery
      • Newcastle upon Tyne, Regno Unito, NE46BE
        • Newcastle upon Tyne Hospitals NHS Foundation Trust
    • A Coruña
      • A Coruña, A Coruña, Spagna, 15006
        • Complejo Hospitalario Universitario de A Coruña (CHUAC)

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione di probabilità

Popolazione di studio

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.

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Modelli osservazionali: COHORT
  • Prospettive temporali: PROSPECTIVE

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
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.

This is a non-interventional study.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Variazione rispetto al basale nella Impressione Clinica Globale di Miglioramento misurata mediante Impressione Clinica Globale di Cambiamento (CGI-C)
Lasso di tempo: Baseline, mesi 6 e 12
Baseline, mesi 6 e 12
Variazione rispetto al basale nell'Impressione Clinica Globale di miglioramento misurata dall'Impressione Globale del Paziente di cambiamento (PGI-C) a 12 mesi
Lasso di tempo: Baseline, mesi 6 e 12
Baseline, mesi 6 e 12
Variazione rispetto al basale dell'Indice di Massa Corporea (BMI)
Lasso di tempo: Baseline, Mese 6 e Mese 12
Baseline, Mese 6 e Mese 12
Change from Baseline in the Reduction in OFF time (h/day) as Measured by MDS-UPDRS IV at 6 months
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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 Non-motor Experiences of Daily Living as Measured by MDS-UPDRS-I
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: At Months 6 and 12

Participants will be asked questions to assess their satisfaction with LECIGON® treatment.

At 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)
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Direttore dello studio: Mark Watt, Britannia Pharmacetuicals

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

8 maggio 2026

Completamento primario (Effettivo)

31 agosto 2026

Completamento dello studio (Effettivo)

31 agosto 2026

Date di iscrizione allo studio

Primo inviato

17 dicembre 2025

Primo inviato che soddisfa i criteri di controllo qualità

17 dicembre 2025

Primo Inserito (Effettivo)

31 dicembre 2025

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

2 ottobre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

29 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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