GV1001 Subcutaneous(SC) for the Treatment of Progressive Supranuclear Palsy (PSP) (NCT05819658) | Clinical Trial Compass
CompletedPhase 2
GV1001 Subcutaneous(SC) for the Treatment of Progressive Supranuclear Palsy (PSP)
South Korea78 participantsStarted 2023-06-14
Plain-language summary
The study will be conducted by the Sponsor to evaluate the efficacy and safety of GV1001 (0.56 mg and 1.12 mg) administered subcutaneously as a treatment for Progressive Supranuclear Palsy, (PSP). In 75 patients diagnosed with PSPR Richardson(PSP-RS) or PSP-Parkinsonism (PSP-P) at five hospitals in Korea, subcutaneous administration of GV1001 0.56 or 1.12 mg/day will be conducted with multicenter, randomized, double-blind, placebo-controlled, parallel design, prospective phase 2a.
Who can participate
Age range
41 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
* …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change From the Baseline in the Total Score of PSP-rating Scale