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Experimental PSP drug shows promise in early trial

NCT ID NCT05819658

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested a drug called GV1001 in 78 people with Progressive Supranuclear Palsy (PSP), a rare brain disease that affects movement and thinking. Participants received daily injections of either a low dose, a higher dose, or a placebo for 6 months. The goal was to see if the drug could slow down the worsening of symptoms like balance and eye movement.

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

78 people

The number who actually took part.

Started

Jun 2023

Finished

Oct 2024

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

41 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: * Patients aged ≥41 years to ≤ 85 years. * Clinical diagnosis of probable progressive supranuclear palsy (PSP). * Patient is on a stable therapy for a neurological drug for at least 1 month prior to screening visit. * Patients who are able to walk 3 meters or more independently or with assistive devices. * Score 15 points ≥ on the Korean Mini-Mental Status Exam (K-MMSE) at the screening visit. * Have reliable caregiver to accompany participant to all study visits. * Patients and/or their representatives who have voluntarily provided a written consent for participation in this clinical study. Exclusion Criteria: * Patients who have Presence of structural lesions or Suspected concurrent onset of central nervous system diseases based on the CT/MRI scan results and neurological examinations performed within 12 months of screening or at screening. * Patients with a history of known or suspected seizures. * Patients with a recent unexplained loss of consciousness within 3 months prior to screening or a history of significant head trauma with loss of consciousness. * Patients with acute or unstable cardiovascular disease, uncontrolled hypertension, uncontrolled diabetes, or any other medical condition that can interfere with completing the clinical study. * Patients with hypersensitivity reactions to the ingredients of the investigational product. * Patients with a history of cancer within 5 years prior to screening. * Patients with abnormal renal function. * Patients with severe liver function abnormalities. * Patients weighing ≤35 kg. * Among the female subjects who does not agree to use proper contraception. * Pregnant or breastfeeding women. * Patients who participated in another clinical study within 4 weeks prior to screening and were administered investigational products or were applied investigational medical devices. * Patients who were administered the study drug (GV1001) of this clinical study within 12 months prior to screening. * Patients who participated in a clinical study for progressive supranuclear palsy within 6 months prior to screening. * Other patients judged by the investigator as ineligible to participate in this clinical study.

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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.

Contacts and locations

Locations

  • Kyung Hee University Hospital

    Seoul, South Korea

  • Samsung Medical Center

    Seoul, South Korea

  • Seoul Metropolitan Government Seoul National University Boramae Medical Center

    Seoul, South Korea

  • Seoul National University Bundang Hospital

    Seongnam-si, South Korea

  • Seoul National University Hospital

    Seoul, South Korea

More trials for these conditions

Other studies related to the condition(s) this trial covers.