Experimental PSP drug shows promise in early trial
NCT ID NCT05819658
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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78 people
The number who actually took part.
- Started
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Jun 2023
- Finished
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Oct 2024
- 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.
- Ages
-
41 to 85 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.
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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
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Kyung Hee University Hospital
Seoul, South Korea
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Samsung Medical Center
Seoul, South Korea
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Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul, South Korea
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Seoul National University Bundang Hospital
Seongnam-si, South Korea
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Seoul National University Hospital
Seoul, South Korea
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