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

Last updated: October 21, 2024
Sponsor: GemVax & Kael
Overall Status: Active - Not Recruiting

Phase

2

Condition

Progressive Supranuclear Palsy

Cataplexy

Treatment

GV1001 Placebo

GV1001 1.12mg

Clinical Study ID

NCT06235775
GV1001-PSP-CL2-011-E
  • Ages 41-85
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • A person who has been registered in the GV1001-PSP-CL2-011 clinical trial and hascompleted administration by Week 24

  • A patient who accompanied all visits with the subject for the scheduled visit ofthis clinical trial, has a guardian who can supervise the subject's compliance withthe examination and examination procedures conducted at the time of the visit, andprovides information on the subject's indications, and whose guardian has agreed inwriting to participate in the clinical trial (except where it is unnecessary toaccompany the guardian at the discretion of the investigator)

  • Patient and/or representative of the patient who has voluntarily agreed in writingto participate in this clinical trial

Exclusion

Exclusion Criteria:

  • Patients deemed unsuitable by the investigator to participate in this extensionstudy

  • Pregnant or male subjects who do not consent to contraception by medically approvedmethods (surgical infertility, intrauterine contraceptive devices, fallopian tubeligature, double blocking (combined use of male condoms, female condoms, cervicalcaps, contraceptive diaphragm and sponges) and 90 days after clinical trialparticipation However, women who have undergone menopause or surgical infertilityprocedures (such as vasectomy and difficult conception on both sides) beforeparticipating in clinical trials can participate without consent to contraception.

  • Pregnant women or breastfeeding women

Study Design

Total Participants: 67
Treatment Group(s): 2
Primary Treatment: GV1001 Placebo
Phase: 2
Study Start date:
December 12, 2023
Estimated Completion Date:
December 31, 2025

Study Description

In GV1001-PSP-CL2-011 study, subjects who were in the trial group (Study Group 1(GV1001 0.56 mg/day), Study Group 2(GV1001 1.12 mg/day) is alternately administered High-dose test drug(GV1001 1.12 mg/day) and placebo once a week from Ex-Visit 1(Visit 16, Week 26) to Ex-Visit 5(Visit 20, Week 30) and High-dose test drugs(GV1001 1.12 mg/day) are administered from Ex-Visit 6 (Visit 21, Week 32) to Ex-Visit 26(Visit 41, Week 72) every two weeks.

In the GV1001-PSP-CL2-011 study, subjects who were in the placebo group are administered placebo at Ex-Visit 1 (Visit16, Week26), the first visit of the extension study, and Ex-Visit 2 (Visit17, Week27) to Ex-Visit 5 (Visit 20, Week 30), High-dose test drugs(GV1001 1.12 mg/day) are administered once a week and High-dose test drugs (GV1001 1.12 mg/day) are administered from Ex-Visit 6 (Visit 21, Week 32) to Ex-Visit 26(Visit 41, Week 72) every two weeks.

Connect with a study center

  • Seoul National University Bundang Hospital

    Seongnam-si,
    Korea, Republic of

    Site Not Available

  • Kyung Hee University Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    Seoul,
    Korea, Republic of

    Site Not Available

  • Seoul Metropolitan Government Seoul National University Boramae Medical Center

    Seoul,
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

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