CompletedPhase 2

Administration of GV1001 for the Treatment of Progressive Supranuclear Palsy Who Completed Study GV1001-PSP-CL2-011

South Korea67 participantsStarted 2023-12-12

Plain-language summary

The study will be conducted by the Sponsor to evaluate Twelve-months Long-Term Safety and Efficacy of GV1001 (1.12 mg) administered subcutaneously as a treatment for Progressive Supranuclear Palsy(PSP). In 75 patients diagnosed with PSP Richardson(PSP-RS) or PSP-Parkinsonism (PSP-P) who Completed Study GV1001-PSP-CL2-011.

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: * A person who has been registered in the GV1001-PSP-CL2-011 clinical trial and has completed administration by Week 24 * A patient who accompanied all visits with the subject for the scheduled visit of this clinical trial, has a guardian who can supervise the subject's compliance with the examination and examination procedures conducted at the time of the visit, and provides information on the subject's indications, and whose guardian has agreed in writing to participate in the clinical trial (except where it is unnecessary to accompany the guardian at the discretion of the investigator) * Patient and/or representative of the patient who has voluntarily agreed in writing to participate in this clinical trial Exclusion Criteria: * Patients deemed unsuitable by the investigator to participate in this extension study * Pregnant or male subjects who do not consent to contraception by medically approved methods (surgical infertility, intrauterine contraceptive devices, fallopian tube ligature, double blocking (combined use of male condoms, female condoms, cervical caps, contraceptive diaphragm and sponges) and 90 days after clinical trial participation However, women who have undergone menopause or surgical infertility procedures (such as vasectomy and difficult conception on both sides) before participating in clinical trials can participate without consent to contraception. * Pregnant women or breastfeeding women

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

Adverse Event

Timeframe: 12 months

Change in Hematological tests WBC(10^3/µl)

Timeframe: 12 months

Change in Hematological tests RBC(10^6/µl)

Timeframe: 12 months

Change in Hematological tests Hemoglobin(g/dL)

Timeframe: 12 months

Change in Hematological tests Hematocrit(%)

Timeframe: 12 months

Change in Hematological tests Platelets count(10^3/µl)

Timeframe: 12 months

Change in Hematological tests WBC differential count (Neutrophils(%))

Timeframe: 12 months

Change in Hematological tests WBC differential count( Lymphocytes(%))

Trial details

NCT IDNCT06235775

SponsorGemVax & Kael

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-09-01

View on ClinicalTrials.gov More Progressive Supranuclear Palsy trials

Plain-language summary

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.

What they're measuring

Adverse Event

Timeframe: 12 months

Change in Hematological tests WBC(10^3/µl)

Timeframe: 12 months

Change in Hematological tests RBC(10^6/µl)

Timeframe: 12 months

Change in Hematological tests Hemoglobin(g/dL)

Timeframe: 12 months

Change in Hematological tests Hematocrit(%)

Timeframe: 12 months

Change in Hematological tests Platelets count(10^3/µl)

Timeframe: 12 months

Change in Hematological tests WBC differential count (Neutrophils(%))

Timeframe: 12 months

Change in Hematological tests WBC differential count( Lymphocytes(%))