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

Launched by GEMVAX & KAEL · Jan 23, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the long-term safety and effectiveness of a treatment called GV1001 for patients with Progressive Supranuclear Palsy (PSP), a rare brain disorder that affects movement, balance, and stability. The trial involves 75 patients who have previously participated in an earlier study and received the treatment for 24 weeks. If you or a loved one completed the earlier GV1001-PSP-CL2-011 trial and are interested in continuing with this study, you might be eligible to join.

To participate, patients must have completed the first study and have a guardian or caregiver who can help ensure they attend all scheduled visits. It's important to note that pregnant or breastfeeding individuals cannot participate, and the study has specific rules about contraception for male participants. During the trial, participants will receive the GV1001 treatment through injections under the skin for a period of 12 months, allowing researchers to monitor its effects over time.

Gender

ALL

Eligibility criteria

• 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