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New hope for Parkinson's: drug infusion studied in earlier advanced patients

NCT ID NCT07227896

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Sep 02, 2026 · Updated 4 times

Summary

This study looks at how well the drug Foslevodopa/Foscarbidopa works for people with advanced Parkinson's disease who are still in the earlier phases of that stage. About 100 adults will receive the drug as a continuous infusion under the skin for up to 6 months. Researchers will track changes in 'off' time (when symptoms return) and quality of life through questionnaires.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Foslevodopa/Foscarbidopa (a drug combination given as a continuous infusion under the skin)
What this could lead to
If successful, this could show that starting this treatment earlier in advanced Parkinson's helps reduce 'off' time and improve daily function.
What could go wrong
This is an observational study, not a controlled trial, so results may be less reliable. It's also small (100 people) and short (6 months), so benefits may not be clear or lasting.

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 100 people

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

Started

Aug 2026

Expected to finish

Oct 2027

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

Participants with earlier within advanced Parkinson disease receiving Foslevodopa/Foscarbidopa treatment in accordance with the local label requirements in the participating country.

Ages

18 to 80 years

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: * Eligibility for Foslevodopa/Foscarbidopa (LDp/CDp) therapy in accordance with approved local label in the participating country and local reimbursement regulations, if applicable * A diagnosis of levodopa-responsive idiopathic Parkinson's Disease (PD) * Adult male or female between 18 and 80 years of age * Disease duration (time since diagnosis) \<10 years * Time since motor fluctuations ≤3 years * H\&Y Stage \<3 in best "on" * "off" time of 2.5-6 hours per day * Naïve to LDp/CDp * Treatment has been optimized with oral/transdermal PD medication in the opinion of the Investigator * Decision to treat with LDp/CDp made by the clinician prior to any decision to approach the participant to participate in the study * Willing and able to comply with procedures required during this study, specifically with entering data and filling questionnaires in an electronic device (tablet). * Prior to any study-related procedures being performed, the participant or Legal Authorized Representative (LAR) must voluntarily sign an Authorization for Use/Disclosure of Data (AUDD)/Informed Consent Form (ICF) according to national regulations once the study has been explained and the participant has the opportunity to have any questions answered Exclusion Criteria: * History of any condition included in the contraindications section of the approved local Foslevodopa/Foscarbidopa (LDp/CDp) label in the participating country * History of treatment with any Device-Aided Therapy (DAT), such as Deep Brain Stimulation (DBS), Continuous Subcutaneous Apomorphine Infusion (CSAI), Levodopa/Carbidopa Intestinal Gel (LCIG)/ Carbidopa/Levodopa Enteral Suspension (CLES), Levodopa/Entacapone/Carbidopa Intestinal Gel (LECIG) * Mini-Mental State Examination (MMSE) score \<24 * Participation in a concurrent investigational or observational clinical trial * Lack of motivation/insufficient language skills to complete the study questionnaires * History of significant skin conditions or disorders (e.g., psoriasis, atopic dermatitis). In case of temporary affections like recent sunburn or open wounds, or in case of permanent affections like acne, scar tissue, tattoo, branding, or colorations, the participant should not be included if the Investigator considers these as interfering with infusion of study drug or study assessments.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    10 sites in 4 countries. 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

  • Arcadia Spitale Si Centre Medicale /Id# 277525

    RECRUITING

    Iași, Iaşi, 700620, Romania

  • Fundeni Clinical Institute /ID# 277490

    RECRUITING

    Bucharest, Bucharest, 022328, Romania

  • Hadassah Medical Center-Hebrew University /ID# 276211

    RECRUITING

    Jerusalem, 91120, Israel

  • Neurotim Med /ID# 277500

    RECRUITING

    Timișoara, Timiș County, 300724, Romania

  • Shaare Zedek Medical Center /ID# 276209

    RECRUITING

    Jerusalem, Jerusalem, 91031, Israel

  • Spitalul Clinic Judetean De Urgenta Brasov /ID# 277499

    NOT_YET_RECRUITING

    Brasov, 500326, Romania

  • Tel Aviv Sourasky Medical Center /ID# 276212

    RECRUITING

    Tel Aviv, Tel Aviv, 6423906, Israel

  • Texas Movement Disorder Specialists /ID# 278565

    RECRUITING

    Georgetown, Texas, 78628, United States

  • The Chaim Sheba Medical Center /ID# 276210

    RECRUITING

    Ramat Gan, Tel Aviv, 5265601, Israel

  • University Hospitals Plymouth NHS Trust /ID# 284977

    RECRUITING

    Plymouth, Devon, PL6 8DH, United Kingdom

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