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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo SC injection will be administered once weekly for 4 weeks then every 2 weeks through Week 24 for double blind phase. |
|
| GV1001 0.56 mg | Experimental | GV1001 0.56 mg SC injection will be administered once weekly for 4 weeks then every 2 weeks through Week 24 for double blind phase. |
|
| GV1001 1.12 mg | Experimental | GV1001 1.12 mg SC injection administered once weekly for 4 weeks then every 2 weeks through Week 24 for double blind phase. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GV1001 Placebo | Drug | 0.9% normal saline |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From the Baseline in the Total Score of PSP-rating Scale | 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. | 24 weeks(6 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From the Baseline in the Total Score of PSP-rating Scale | 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. | 12 Weeks(3 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sang Jae Kim | GemVax & Kael | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam-si | South Korea | ||||
| Kyung Hee University Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo SC injection will be administered once weekly for 4 weeks then every 2 weeks through Week 24 for double blind phase. |
| FG001 | GV1001 0.56 mg | GV1001 0.56 mg SC injection will be administered once weekly for 4 weeks then every 2 weeks through Week 24 for double blind phase. |
| FG002 | GV1001 1.12 mg | GV1001 1.12 mg SC injection administered once weekly for 4 weeks then every 2 weeks through Week 24 for double blind phase. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo SC injection will be administered once weekly for 4 weeks then every 2 weeks through Week 24 for double blind phase. |
| BG001 | GV1001 0.56 mg | GV1001 0.56 mg SC injection will be administered once weekly for 4 weeks then every 2 weeks through Week 24 for double blind phase. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Sex: Female, Male | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From the Baseline in the Total Score of PSP-rating Scale | 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. | Participants who completed 24 weeks (6 months) were included. | Posted | Mean | Standard Deviation | scores on a scale | 24 weeks(6 months) |
|
From enrollment until end of follow-up, up to 28 weeks
Participants who were not treated were excluded.(0.56mg/day group: 1. Placebo group: 1)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo SC injection will be administered once weekly for 4 weeks then every 2 weeks through Week 24 for double blind phase. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia aspiration | Infections and infestations | MedDRA version: 27.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin laceration | Injury, poisoning and procedural complications | MedDRA version: 27.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hyuck Lee, Clinical Research Manager | GemVax & Kael | +82 070 8633 6925 | leehyuck@gemvax.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: Study Protocol | Mar 15, 2024 | Dec 1, 2025 | Prot_SAP_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Statistical Analysis Plan | Oct 10, 2024 | Dec 1, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D013494 | Supranuclear Palsy, Progressive |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| GV1001 0.56mg | Drug | Lyophilized peptide from hTERT |
|
|
| GV1001 1.12mg | Drug | Lyophilized peptide from hTERT |
|
|
| Change From the Baseline in the Montreal Cognitive Assessment - Korea (MoCAK) | 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. | 12 weeks (3 Months) |
| Change From the Baseline in the Montreal Cognitive Assessment - Korea (MoCAK) | 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. | 24 weeks(6 months) |
| Change From the Baseline in the Korean Frontal Assessment Battery (K-FAB) | 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. | 12 weeks(3 months) |
| Change From the Baseline in the Korean Frontal Assessment Battery (K-FAB) | 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. | 24 weeks(6 months) |
| Change From the Baseline in the England & Schwab Activity of Daily Living (ES ADL) Scale | 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. | 12 weeks(3 months) |
| Change From the Baseline in the England & Schwab Activity of Daily Living (ES ADL) Scale | 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. | 24 weeks(6 months) |
| Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (History) | 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. | 12 weeks(3 months) |
| Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (History) | 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. | 24 weeks(6 months) |
| Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Mentation) | 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. | 12 weeks(3 months) |
| Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Mentation) | 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. | 24 weeks(6 months) |
| Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Bulbar) | 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. | 12 weeks(3 months) |
| Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Bulbar) | 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. | 24 weeks(6 months) |
| Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Ocular Motor) | 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. | 12 weeks(3 months) |
| Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Ocular Motor) | 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. | 24 weeks(6 months) |
| Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Limb Motor) | 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. | 12 weeks(3 months) |
| Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Limb Motor) | 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. | 24 weeks(6 months) |
| Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Midline/Gait) | 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. | 12 weeks(3 months) |
| Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Midline/Gait) | 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. | 24 weeks(6 months) |
| Change From the Baseline in the Score of Each Item of the PSP-rating Scale(Item 12_Dysarthria) | 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. | 12 weeks(3 months) |
| Change From the Baseline in the Score of Each Item of the PSP-rating Scale(Item 12_Dysarthria) | 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. | 24 weeks(6 months) |
| Seoul |
| South Korea |
| Samsung Medical Center | Seoul | South Korea |
| Seoul Metropolitan Government Seoul National University Boramae Medical Center | Seoul | South Korea |
| Seoul National University Hospital | Seoul | South Korea |
| BG002 | GV1001 1.12 mg | GV1001 1.12 mg SC injection administered once weekly for 4 weeks then every 2 weeks through Week 24 for double blind phase. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| PSP type | PSP-RS type: patients with clearly identified supranuclear ophthalmoplegia (SOP) according to the judgment of the investigator. PSP-p type: patients identified as having shown little or no response to previous administration of levodopa according to the judgment of the investigator. | Count of Participants | Participants |
|
| Age, Categorical | Participants aged 41 to 85 years old | Count of Participants | Participants |
|
GV1001 0.56 mg SC injection will be administered once weekly for 4 weeks then every 2 weeks through Week 24 for double blind phase.
| OG002 | GV1001 1.12 mg | GV1001 1.12 mg SC injection administered once weekly for 4 weeks then every 2 weeks through Week 24 for double blind phase. |
|
|
| Secondary | Change From the Baseline in the Total Score of PSP-rating Scale | 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. | Participants who completed 12 weeks (3 months) were included. | Posted | Mean | Standard Deviation | scores on a scale | 12 Weeks(3 months) |
|
|
|
| Secondary | Change From the Baseline in the Montreal Cognitive Assessment - Korea (MoCAK) | 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. | Participants who completed 12 weeks (3 months) were included. | Posted | Mean | Standard Deviation | scores on a scale | 12 weeks (3 Months) |
|
|
|
| Secondary | Change From the Baseline in the Montreal Cognitive Assessment - Korea (MoCAK) | 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. | Participants who completed 24 weeks (6 months) were included. | Posted | Mean | Standard Deviation | scores on a scale | 24 weeks(6 months) |
|
|
|
| Secondary | Change From the Baseline in the Korean Frontal Assessment Battery (K-FAB) | 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. | Participants who completed 12 weeks (3 months) were included. | Posted | Mean | Standard Deviation | scores on a scale | 12 weeks(3 months) |
|
|
|
| Secondary | Change From the Baseline in the Korean Frontal Assessment Battery (K-FAB) | 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. | Participants who completed 24 weeks (6 months) were included. | Posted | Mean | Standard Deviation | scores on a scale | 24 weeks(6 months) |
|
|
|
| Secondary | Change From the Baseline in the England & Schwab Activity of Daily Living (ES ADL) Scale | 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. | Participants who completed 12 weeks (3 months) were included. | Posted | Mean | Standard Deviation | scores on a scale | 12 weeks(3 months) |
|
|
|
| Secondary | Change From the Baseline in the England & Schwab Activity of Daily Living (ES ADL) Scale | 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. | Participants who completed 24 weeks (6 months) were included. | Posted | Mean | Standard Deviation | scores on a scale | 24 weeks(6 months) |
|
|
|
| Secondary | Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (History) | 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. | Participants who completed 12 weeks (3 months) were included. | Posted | Mean | Standard Deviation | scores on a scale | 12 weeks(3 months) |
|
|
|
| Secondary | Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (History) | 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. | Participants who completed 24 weeks (6 months) were included. | Posted | Mean | Standard Deviation | scores on a scale | 24 weeks(6 months) |
|
|
|
| Secondary | Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Mentation) | 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. | Participants who completed 12 weeks (3 months) were included. | Posted | Mean | Standard Deviation | scores on a scale | 12 weeks(3 months) |
|
|
|
| Secondary | Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Mentation) | 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. | Participants who completed 24 weeks (6 months) were included. | Posted | Mean | Standard Deviation | scores on a scale | 24 weeks(6 months) |
|
|
|
| Secondary | Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Bulbar) | 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. | Participants who completed 12 weeks (3 months) were included. | Posted | Mean | Standard Deviation | scores on a scale | 12 weeks(3 months) |
|
|
|
| Secondary | Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Bulbar) | 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. | Participants who completed 24 weeks (6 months) were included. | Posted | Mean | Standard Deviation | scores on a scale | 24 weeks(6 months) |
|
|
|
| Secondary | Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Ocular Motor) | 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. | Participants who completed 12 weeks (3 months) were included. | Posted | Mean | Standard Deviation | scores on a scale | 12 weeks(3 months) |
|
|
|
| Secondary | Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Ocular Motor) | 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. | Participants who completed 24 weeks (6 months) were included. | Posted | Mean | Standard Deviation | scores on a scale | 24 weeks(6 months) |
|
|
|
| Secondary | Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Limb Motor) | 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. | Participants who completed 12 weeks (3 months) were included. | Posted | Mean | Standard Deviation | scores on a scale | 12 weeks(3 months) |
|
|
|
| Secondary | Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Limb Motor) | 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. | Participants who completed 24 weeks (6 months) were included. | Posted | Mean | Standard Deviation | scores on a scale | 24 weeks(6 months) |
|
|
|
| Secondary | Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Midline/Gait) | 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. | Participants who completed 12 weeks (3 months) were included. | Posted | Mean | Standard Deviation | scores on a scale | 12 weeks(3 months) |
|
|
|
| Secondary | Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Midline/Gait) | 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. | Participants who completed 24 weeks (6 months) were included. | Posted | Mean | Standard Deviation | scores on a scale | 24 weeks(6 months) |
|
|
|
| Secondary | Change From the Baseline in the Score of Each Item of the PSP-rating Scale(Item 12_Dysarthria) | 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. | Participants who completed 12 weeks (3 months) were included. | Posted | Mean | Standard Deviation | scores on a scale | 12 weeks(3 months) |
|
|
|
| Secondary | Change From the Baseline in the Score of Each Item of the PSP-rating Scale(Item 12_Dysarthria) | 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. | Participants who completed 24 weeks (6 months) were included. | Posted | Mean | Standard Deviation | scores on a scale | 24 weeks(6 months) |
|
|
|
| 0 |
| 24 |
| 3 |
| 24 |
| 15 |
| 24 |
| EG001 | GV1001 0.56 mg | GV1001 0.56 mg SC injection will be administered once weekly for 4 weeks then every 2 weeks through Week 24 for double blind phase. | 0 | 24 | 2 | 24 | 12 | 24 |
| EG002 | GV1001 1.12 mg | GV1001 1.12 mg SC injection administered once weekly for 4 weeks then every 2 weeks through Week 24 for double blind phase. | 0 | 28 | 5 | 28 | 9 | 28 |
| Infective spondylitis | Infections and infestations | MedDRA version: 27.1 | Non-systematic Assessment |
|
| Tuberculous pleurisy | Infections and infestations | MedDRA version: 27.1 | Non-systematic Assessment |
|
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA version: 27.1 | Non-systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA version: 27.1 | Non-systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA version: 27.1 | Non-systematic Assessment |
|
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA version: 27.1 | Non-systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA version: 27.1 | Non-systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA version: 27.1 | Non-systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version: 27.1 | Non-systematic Assessment |
|
| Suicide attempt | Psychiatric disorders | MedDRA version: 27.1 | Non-systematic Assessment |
|
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA version: 27.1 | Non-systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA version: 27.1 | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA version: 27.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA version: 27.1 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA version: 27.1 | Non-systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA version: 27.1 | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA version: 27.1 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA version: 27.1 | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA version: 27.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA version: 27.1 | Non-systematic Assessment |
|
Not provided
Not provided
| D009069 | Movement Disorders |
| D009886 | Ophthalmoplegia |
| D015835 | Ocular Motility Disorders |
| D003389 | Cranial Nerve Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Male |
|
| Title | Measurements |
|---|---|
|
| Between 18 and 65 years |
|
| >=65 years |
|