Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 12:05 AM
NCT ID:
NCT05819658
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
41 Years
Maximum Age:
85 Years
Study:
NCT05819658
Study Brief:
Protocol Section:
NCT05819658