NCT04734379

Rho Kinase (ROCK) Inhibitor in Tauopathies - 1

A Phase 2a Open-Label Preliminary Safety, Tolerability, and Biomarker Study of Oral Fasudil in Patients With the 4-Repeat Tauopathies of Progressive Supranuclear Palsy-Richardson Syndrome or Corticobasal Syndrome.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Woolsey Pharmaceuticals · Industry
• Sex: All
• Age: 35 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

A Phase 2a Open-Label Preliminary Safety, Tolerability, and Biomarker Study of Oral Fasudil in Patients with the 4-Repeat Tauopathies of Progressive Supranuclear Palsy-Richardson Syndrome or Corticobasal Syndrome

Detailed description

After consent, participants will undergo screening evaluations, which may occur over the course of up to 6 weeks. Subjects who meet inclusion/exclusion criteria will be enrolled into the study and complete baseline evaluations. Dosing with study drug will begin on Day 1 and continue for 48 weeks. Participants will return to the clinic at Week 1 (7 ± 2 days after the first study drug administration) and at Weeks 12, 24, 36, and 48 for study evaluations, and at Week 52 for post-treatment follow-up evaluations. Plasma biomarker collection will occur at baseline, and Weeks 12, 24, 36, and 48. Cerebrospinal fluid (CSF) Biomarker collection will occur at screening, Week 24 and Week 48. Brain magnetic resonance imaging (MRI) will occur at screening, and Weeks 24 and 48. Safety labs will be collected at each study visit as well as during Week 4. Adverse events (AEs) will be assessed at all visits and subjects will be contacted one day after the start of treatment (that is, one day after Visit 1), and monthly thereafter including at each visit. Subject will also be contacted one day after Visit 6/last day of dosing with study drug for subjects who discontinue early. Subjects/caregivers will be queried for study drug compliance one day after the start of treatment (that is, one day after Visit 1), and monthly thereafter. After completion of the 48-week primary portion of the study, subjects will be given the option to continue open-label treatment for up to an additional 12 months.

Conditions

• Progressive Supranuclear Palsy
• Corticobasal Syndrome

Interventions

Type	Name	Description
DRUG	Fasudil	Oral fasudil 180 mg/day

Timeline

• Start date: 2021-01-22
• Primary completion: 2022-11-30
• Completion: 2023-11-30
• First posted: 2021-02-02
• Last updated: 2022-06-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study