New hope for Parkinson's: drug infusion studied in earlier advanced patients
NCT ID NCT07227896
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
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2026
- Expected to finish
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Oct 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
10 sites in 4 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Arcadia Spitale Si Centre Medicale /Id# 277525
RECRUITINGIași, Iaşi, 700620, Romania
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Fundeni Clinical Institute /ID# 277490
RECRUITINGBucharest, Bucharest, 022328, Romania
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Hadassah Medical Center-Hebrew University /ID# 276211
RECRUITINGJerusalem, 91120, Israel
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Neurotim Med /ID# 277500
RECRUITINGTimișoara, Timiș County, 300724, Romania
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Shaare Zedek Medical Center /ID# 276209
RECRUITINGJerusalem, Jerusalem, 91031, Israel
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Spitalul Clinic Judetean De Urgenta Brasov /ID# 277499
NOT_YET_RECRUITINGBrasov, 500326, Romania
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Tel Aviv Sourasky Medical Center /ID# 276212
RECRUITINGTel Aviv, Tel Aviv, 6423906, Israel
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Texas Movement Disorder Specialists /ID# 278565
RECRUITINGGeorgetown, Texas, 78628, United States
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The Chaim Sheba Medical Center /ID# 276210
RECRUITINGRamat Gan, Tel Aviv, 5265601, Israel
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University Hospitals Plymouth NHS Trust /ID# 284977
RECRUITINGPlymouth, Devon, PL6 8DH, United Kingdom
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Walking memory tests may reveal early Parkinson's clues
- Colon tissue may hold clues to telling Parkinson's apart from Look-Alike diseases
- A genetic roadmap for Parkinson's: testing thousands to unlock clues
- Can gentle touch therapy calm Parkinson's tremors?
- Stem cell infusions aim to slow Parkinson's progression
- Can an inhaled levodopa ease Parkinson's OFF episodes? a study asks patients.