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Completed

NCT Number: NCT05819658

GV1001 Subcutaneous(SC) for the Treatment of Progressive Supranuclear Palsy (PSP)

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.

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Key information

Conditions

Progressive Supranuclear Palsy Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Cranial Nerve Diseases Eye Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Ocular Motility Disorders Ophthalmoplegia Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Supranuclear Palsy, Progressive Tauopathies

Age range

41 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Seoul National University Bundang Hospital, Seongnam-si, South Korea

Loading trial locations.

About this study

This is a 24-week, multicenter, randomized, double-blind, placebo-controlled, parallel design, prospective, Phase 2a exploratory clinical study. If the subject and/or the subject's representative provide a written consent to participate in this clinical study, the required examinations and tests will be performed at the screening visit, and the screening period will run for 4 weeks or shorter. Subjects who are ultimately determined as eligible by the inclusion/exclusion criteria after screening will be randomized at a 1:1:1 ratio to Study Group 1 (GV1001 0.56 mg/day), Study Group 2 (GV1001 1.12 mg/day), or the placebo group depending on the study site in which they are enrolled. Depending on the randomization results, subjects will be administered the investigational product (study drug or placebo) once weekly for the first 4 weeks (1 month), and then administered 10 times at 2-week intervals for 20 weeks (5 months) for a total of 14 doses over 24 weeks (6 months). All subjects will visit the institution according to the planned clinical study schedule to receive the investigational product and to be evaluated for efficacy and safety. To ensure the objectivity and accuracy of the study results, the individuals evaluating efficacy will be limited to neurologists who have been sufficiently educated and trained, and the collection of efficacy and safety evaluation data and biomarkers will be performed in a consistent order at each visit.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GV1001 Placebo

Drug

0.9% normal saline

Other names: Normal saline

GV1001 0.56mg

Drug

Lyophilized peptide from hTERT

Other names: Tertomotide 0.84mg

GV1001 1.12mg

Drug

Lyophilized peptide from hTERT

Other names: Tertomotide 1.68mg

Primary outcomes

  1. Change From the Baseline in the Total Score of PSP-rating Scale

    Time frame: 24 weeks(6 months)

    Change from the baseline in the total score of PSP-rating scale(Progressive Supranuclear Palsy Rating Scale) after 24 weeks (6 months) of investigational product administration. The possible total scores range from 0 to 100 with a higher score indicating severely impaired cognitive function.

Secondary outcomes

  1. Change From the Baseline in the Total Score of PSP-rating Scale

    Time frame: 12 Weeks(3 months)

    Change from the baseline in the total score of PSP-rating scale(Progressive Supranuclear Palsy Rating Scale) after 12 weeks (3 months) of investigational product administration. The possible total scores range from 0 to 100 with a higher score indicating severely impaired cognitive function.

  2. Change From the Baseline in the Montreal Cognitive Assessment - Korea (MoCAK)

    Time frame: 12 weeks (3 Months)

    Change from the baseline in the Montreal Cognitive Assessment - Korea (MoCAK) after 12 weeks (3 months) of investigational product administration. The possible total scores range from 0 to 30 with a higher score indicating greater cognitive function.

  3. Change From the Baseline in the Montreal Cognitive Assessment - Korea (MoCAK)

    Time frame: 24 weeks(6 months)

    Change from the baseline in the Montreal Cognitive Assessment - Korea (MoCAK) after 24 weeks (6 months) of investigational product administration. The possible total scores range from 0 to 30 with a higher score indicating greater cognitive function.

  4. Change From the Baseline in the Korean Frontal Assessment Battery (K-FAB)

    Time frame: 12 weeks(3 months)

    Change from the baseline in the Korean Frontal Assessment Battery (K-FAB) after 12 weeks (3 months) of investigational product administration. The possible total scores range from 0 to 18 with a higher score indicating greater cognitive function.

  5. Change From the Baseline in the Korean Frontal Assessment Battery (K-FAB)

    Time frame: 24 weeks(6 months)

    Change from the baseline in the Korean Frontal Assessment Battery (K-FAB) after 24 weeks (6 months) of investigational product administration. The possible total scores range from 0 to 18 with a higher score indicating greater cognitive function.

  6. Change From the Baseline in the England & Schwab Activity of Daily Living (ES ADL) Scale

    Time frame: 12 weeks(3 months)

    Change from the baseline in the England & Schwab Activity of Daily Living (ES ADL) scale after 12 weeks (3 months) of investigational product administration. The possible total scores range from 0 (complete dependence) to 100% (complete independence) based on the level of independence.

  7. Change From the Baseline in the England & Schwab Activity of Daily Living (ES ADL) Scale

    Time frame: 24 weeks(6 months)

    Change from the baseline in the England & Schwab Activity of Daily Living (ES ADL) scale after 24 weeks (6 months) of investigational product administration. The possible total scores range from 0 (complete dependence) to 100% (complete independence) based on the level of independence.

  8. Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (History)

    Time frame: 12 weeks(3 months)

    Change from the baseline in the score of [History] domain of the PSP-rating scale(Progressive Supranuclear Palsy Rating Scale) after 12 weeks (3 months) of investigational product administration. The possible total scores range from 0 to 24 with a higher score indicating severely impaired cognitive function.

  9. Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (History)

    Time frame: 24 weeks(6 months)

    Change from the baseline in the score of [History] domain of the PSP-rating scale(Progressive Supranuclear Palsy Rating Scale) after 24 weeks (6 months) of investigational product administration. The possible total scores range from 0 to 24 with a higher score indicating severely impaired cognitive function.

  10. Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Mentation)

    Time frame: 12 weeks(3 months)

    Change from the baseline in the score of [Mentation] domain of the PSP-rating scale(Progressive Supranuclear Palsy Rating Scale) after 12 weeks (3 months) of investigational product administration. The possible total scores range from 0 to 16 with a higher score indicating severely impaired cognitive function.

  11. Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Mentation)

    Time frame: 24 weeks(6 months)

    Change from the baseline in the score of [Mentation] domain of the PSP-rating scale(Progressive Supranuclear Palsy Rating Scale) after 24 weeks (6 months) of investigational product administration. The possible total scores range from 0 to 16 with a higher score indicating severely impaired cognitive function.

  12. Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Bulbar)

    Time frame: 12 weeks(3 months)

    Change from the baseline in the score of [Bulbar] domain of the PSP-rating scale(Progressive Supranuclear Palsy Rating Scale) after 12 weeks (3 months) of investigational product administration. The possible total scores range from 0 to 8 with a higher score indicating severely impaired cognitive function.

  13. Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Bulbar)

    Time frame: 24 weeks(6 months)

    Change from the baseline in the score of [Bulbar] domain of the PSP-rating scale(Progressive Supranuclear Palsy Rating Scale) after 24 weeks (6 months) of investigational product administration. The possible total scores range from 0 to 8 with a higher score indicating severely impaired cognitive function.

  14. Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Ocular Motor)

    Time frame: 12 weeks(3 months)

    Change from the baseline in the score of [Ocular Motor] domain of the PSP-rating scale(Progressive Supranuclear Palsy Rating Scale) after 12 weeks (3 months) of investigational product administration. The possible total scores range from 0 to 16 with a higher score indicating severely impaired cognitive function.

  15. Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Ocular Motor)

    Time frame: 24 weeks(6 months)

    Change from the baseline in the score of [Ocular Motor] domain of the PSP-rating scale(Progressive Supranuclear Palsy Rating Scale) after 24 weeks (6 months) of investigational product administration. The possible total scores range from 0 to 16 with a higher score indicating severely impaired cognitive function.

  16. Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Limb Motor)

    Time frame: 12 weeks(3 months)

    Change from the baseline in the score of [Limb Motor] domain of the PSP-rating scale(Progressive Supranuclear Palsy Rating Scale) after 12 weeks (3 months) of investigational product administration. The possible total scores range from 0 to 16 with a higher score indicating severely impaired cognitive function.

  17. Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Limb Motor)

    Time frame: 24 weeks(6 months)

    Change from the baseline in the score of [Limb Motor] domain of the PSP-rating scale(Progressive Supranuclear Palsy Rating Scale) after 24 weeks (6 months) of investigational product administration. The possible total scores range from 0 to 16 with a higher score indicating severely impaired cognitive function.

  18. Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Midline/Gait)

    Time frame: 12 weeks(3 months)

    Change from the baseline in the score of [Midline/Gait] domain of the PSP-rating scale(Progressive Supranuclear Palsy Rating Scale) after 12 weeks (3 months) of investigational product administration. The possible total scores range from 0 to 20 with a higher score indicating severely impaired cognitive function.

  19. Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Midline/Gait)

    Time frame: 24 weeks(6 months)

    Change from the baseline in the score of [Midline/Gait] domain of the PSP-rating scale(Progressive Supranuclear Palsy Rating Scale) after 24 weeks (6 months) of investigational product administration. The possible total scores range from 0 to 20 with a higher score indicating severely impaired cognitive function.

  20. Change From the Baseline in the Score of Each Item of the PSP-rating Scale(Item 12_Dysarthria)

    Time frame: 12 weeks(3 months)

    Change from the baseline in the score of each item [Item 12_Dysarthria] of the PSP-rating scale after 12 weeks (3 months) of investigational product administration. Only the analysis result for Item no.12 out of a total of 28 items is described. The possible total scores range from 0 to 4 with a higher score indicating severely impaired cognitive function.

  21. Change From the Baseline in the Score of Each Item of the PSP-rating Scale(Item 12_Dysarthria)

    Time frame: 24 weeks(6 months)

    Change from the baseline in the score of each item [Item 12_Dysarthria] of the PSP-rating scale after 24 weeks (6 months) of investigational product administration. Only the analysis result for Item no.12 out of a total of 28 items is described. The possible total scores range from 0 to 4 with a higher score indicating severely impaired cognitive function.

Sponsors and collaborators

Lead sponsor

GemVax & Kael

Industry

Registry information

Official study title

A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Design, Prospective, Phase IIa Exploratory Clinical Trial to Evaluate the Efficacy and Safety of SC Administration of GV1001 0.56 or 1.12 mg/Day in Patients With PSP

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 19, 2023
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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