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Experimental Parkinson's drug talineuren put to early safety test

NCT ID NCT04976127

Disease control Sponsor: InnoMedica Schweiz AG Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial tested the safety of an intravenous drug called talineuren (liposomal GM1) in 22 people with Parkinson's disease. The study was open-label and designed to find a safe dose, but it was terminated before completion. No conclusions about effectiveness can be drawn from this small, preliminary study.

What this could mean

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

Active substance
talineuren (liposomal GM1)
What this could lead to
If successful, this could point toward a new add-on therapy to help manage Parkinson's symptoms alongside standard treatment.
What could go wrong
This was a very early Phase 1 safety trial with only 22 participants, and it was terminated early. It is too small and preliminary to draw any conclusions about effectiveness.

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.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

22 people

The number who actually took part.

Started

Dec 2021

Finished

Aug 2025

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.

Ages

30 to 85 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: * Informed consent as documented by signature. * Confirmed Parkinson's disease according to British brain bank criteria. * Hoehn and Yahr Stage 0 - 2.5 on medication. * Stable on PD treatment for a month at least. * Absence of dementia confirmed by cognitive testing (MoCA \>25). Exclusion Criteria: * Contraindications to the class of drugs under study, e.g., known hypersensitivity or allergy to class of drugs or the investigational product. * Women who are pregnant or breast feeding, or planning to become pregnant during the course of the trial or in the 3 months following the trial. * Lack of safe contraception in women with childbearing potential * Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc) that is not under stable control. * Subject has an atypical parkinsonian syndrome or secondary parkinsonism. * Patients with comorbidity that may interfere with the course of the trial.

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Conditions

The condition(s) this trial relates to.

Parkinson disease

As listed by the trial registrant

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

Parkinson disease

Contacts and locations

Locations

  • Neurologisches Institut Konolfingen

    Konolfingen, Canton of Bern, 3510, Switzerland

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