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 range41 Years – 85 Years
SexALL
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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.
* …
What they're measuring
1
Change From the Baseline in the Total Score of PSP-rating Scale