Progressive Supranuclear Palsy Clinical Trial
Official title:
Twelve-months Extension Study to Explore the Long-Term Safety and Efficacy of Subcutaneous Administration of GV1001 1.12 mg/Day in Patients With Progressive Supranuclear Palsy Who Completed Study GV1001-PSP-CL2-011
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.
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04096651 -
Pathophysiology of Gait and Posture in Progressive Supranuclear Palsy
|
N/A | |
| Recruiting |
NCT02194816 -
Modifiable Variables in Parkinsonism (MVP)
|
||
| Completed |
NCT00703677 -
A Pilot Trial of Lithium in Subjects With Progressive Supranuclear Palsy or Corticobasal Degeneration
|
Phase 1/Phase 2 | |
| Completed |
NCT00382824 -
Effects of Coenzyme Q10 in Progressive Supranuclear Palsy (PSP)
|
N/A | |
| Completed |
NCT04184063 -
Study of NBMI Treatment in Patients With Atypical Parkinsons (PSP or MSA)
|
Phase 2 | |
| Recruiting |
NCT04706234 -
Systematic Assessment of Laryngopharyngeal Function in Patients With MSA, PD, and 4repeat Tauopathies
|
||
| Recruiting |
NCT04472130 -
Neurodegenerative Diseases Registry
|
||
| Recruiting |
NCT04139551 -
Oxford Study of Quantification in Parkinsonism
|
||
| Completed |
NCT02734485 -
Deep TMS for the Treatment of Patients With Parkinson's Disease and Progressive Supranuclear Palsy
|
N/A | |
| Completed |
NCT01110720 -
Study to Evaluate the Safety and Efficacy of Davunetide for the Treatment of Progressive Supranuclear Palsy
|
Phase 2/Phase 3 | |
| Completed |
NCT01174771 -
Repetitive Transcranial Magnetic Stimulation (TMS) for Progressive Supranuclear Palsy and Corticobasal Degeneration
|
N/A | |
| Completed |
NCT00465790 -
Research of Biomarkers in Parkinson Disease
|
Phase 0 | |
| Completed |
NCT02460094 -
Multiple Ascending Dose Study of Intravenously Administered BMS-986168 (BIIB092) in Patients With Progressive Supranuclear Palsy
|
Phase 1 | |
| Active, not recruiting |
NCT04993768 -
A Phase 2a Study of TPN-101 in Patients With Progressive Supranuclear Palsy (PSP)
|
Phase 2 | |
| Recruiting |
NCT03225144 -
Investigating Complex Neurodegenerative Disorders Related to Amyotrophic Lateral Sclerosis and Frontotemporal Dementia
|
||
| Completed |
NCT03058965 -
Phase 0 Evaluation of [18F]MNI-958 as a Potential PET Radioligand for Imaging Tau Protein in the Brain
|
Early Phase 1 | |
| Recruiting |
NCT02605785 -
A Molecular Anatomic Imaging Analysis of Tau in Progressive Supranuclear Palsy
|
N/A | |
| Completed |
NCT01353183 -
Analysis of the Enteric Nervous System Using Colonic Biopsies
|
N/A | |
| Completed |
NCT00385710 -
Trial of Valproic Acid in Patients With Progressive Supranuclear Palsy (Depakine)
|
Phase 2 | |
| Recruiting |
NCT05260151 -
Tau Protein and SV2a Imaging in Patients With Tau Protein-related Diseases
|