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New gel treatment for Parkinson's aims to reduce 'Off' time

NCT ID NCT07313176

Disease control Sponsor: Britannia Pharmaceuticals Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study follows about 215 adults with advanced Parkinson's disease who are switching from a pump medication to a new intestinal gel called LECIGON®. Researchers want to see if the gel reduces daily 'off' time—when symptoms return—over 12 months. Participants continue their usual care while doctors track changes using a standard rating scale.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 215 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Jan 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

movement disorder neurodegenerative disease Parkinson disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced Parkinson disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Complejo Hospitalario Universitario de A Coruña (CHUAC)

    RECRUITING

    A Coruña, A Coruña, 15006, Spain

  • Hospital Universitario de Toledo

    RECRUITING

    Toledo, Castille-La Mancha, 45007, Spain

  • Hospital de Basurto

    RECRUITING

    Bilbao, Vizcaya, 48013, Spain

  • Hospital de Cruces

    RECRUITING

    Barakaldo, Vizcaya, 48903, Spain

  • Virgen del Rocío University Hospital

    RECRUITING

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

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