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Could a brain lipid injection ease Parkinson's motor swings?

NCT ID NCT07585565

Disease control Sponsor: Qilu Pharmaceutical Co., Ltd. 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 phase 2 trial tests an injectable drug called GM1 in 276 people with Parkinson's disease who experience motor fluctuations (times when medication wears off). Participants are randomly assigned to receive GM1 or a placebo for about 12 weeks, while continuing their usual Parkinson's medications. The goal is to see if GM1 can increase the time they feel good movement control without troublesome involuntary movements.

What this could mean

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

Active substance
GM1 (monosialotetrahexosylganglioside sodium injection)
What this could lead to
If successful, this could provide a new option to help Parkinson's patients spend more time with good movement control and fewer side effects.
What could go wrong
This is an early-phase trial with a small number of participants, so results may not apply broadly. The drug may not work better than placebo, and side effects are still being studied.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 276 people

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

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Aug 2028

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.

Ages

30 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: 1. Age ≥ 30 years at screening. 2. Clinical diagnosis of clinically established or clinically probable Parkinson's disease. 3. Currently receiving levodopa therapy (stable regimen for ≥4 weeks prior to randomization, with a levodopa equivalent daily dose ≥400 mg) and experiencing motor fluctuations (including wearing-off, on-off phenomena, etc.). 4. Hoehn-Yahr stage ≥2 in the "OFF" state. Exclusion Criteria: 1. History or presence of other Parkinsonian syndromes or Parkinson-plus syndromes, or hereditary neurodegenerative disorders. 2. Diagnosis of Parkinson's disease dementia or severe cognitive impairment as judged by the investigator at screening. 3. Prior surgical treatment for Parkinson's disease or planned such surgery during the trial period. 4. History or presence of other neurological diseases. 5. History or presence of autoimmune diseases. 6. History or presence of any demyelinating diseases, including but not limited to acute inflammatory demyelinating polyneuropathy (Guillain-Barré syndrome). 7. History or presence of hereditary glycolipid metabolism disorders . 8. Known allergy to monosialotetrahexosylganglioside sodium or any excipient of the investigational product.

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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's disease

How to take part

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

  1. 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 ↗

  2. 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.

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