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Could a daily shot slow PSP? new study tests long-term safety

NCT ID NCT06235775

Disease control Sponsor: GemVax & Kael 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looked at the long-term safety of a daily injection called GV1001 in people with progressive supranuclear palsy (PSP), a rare brain disease that affects movement and balance. It included 67 patients who had already completed a previous GV1001 study. Researchers monitored side effects and lab results over 12 months to see if the drug remains safe for extended use.

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

67 people

The number who actually took part.

Started

Dec 2023

Finished

Sep 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

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: * A person who has been registered in the GV1001-PSP-CL2-011 clinical trial and has completed administration by Week 24 * A patient who accompanied all visits with the subject for the scheduled visit of this clinical trial, has a guardian who can supervise the subject's compliance with the examination and examination procedures conducted at the time of the visit, and provides information on the subject's indications, and whose guardian has agreed in writing to participate in the clinical trial (except where it is unnecessary to accompany the guardian at the discretion of the investigator) * Patient and/or representative of the patient who has voluntarily agreed in writing to participate in this clinical trial Exclusion Criteria: * Patients deemed unsuitable by the investigator to participate in this extension study * Pregnant or male subjects who do not consent to contraception by medically approved methods (surgical infertility, intrauterine contraceptive devices, fallopian tube ligature, double blocking (combined use of male condoms, female condoms, cervical caps, contraceptive diaphragm and sponges) and 90 days after clinical trial participation However, women who have undergone menopause or surgical infertility procedures (such as vasectomy and difficult conception on both sides) before participating in clinical trials can participate without consent to contraception. * Pregnant women or breastfeeding women

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Conditions

The condition(s) this trial relates to.

progressive supranuclear palsy

As listed by the trial registrant

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

Progressive supranuclear palsy

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

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