NCT04935762

A Study of CST-103 Co-administered With CST-107 in Subjects With Parkinson's Disease Having Freezing of Gait (CLIN-012)

A Phase II, Randomized, Placebo-Controlled, Double-Blind, Crossover Study to Evaluate the Use of CST-103 Co-administered With CST-107 on Freezing of Gait in Subjects With Parkinson's Disease

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: CuraSen Therapeutics, Inc. · Industry
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase II, randomized, placebo-controlled, double-blind, crossover study to evaluate the effect of multiple oral doses of CST-103 in the presence of CST-107 on Freezing of Gait (FOG) symptoms in subjects with Parkinson's Disease (PD).

Detailed description

Approximately 25 PD subjects with FOG symptoms will be enrolled in a 2 period, 2-way crossover design following study eligibility confirmation during the screening period. During each treatment period, subjects will receive daily doses of CST-103 co-administered with CST-107 or matching placebo for 14 days. Each treatment period will be separated by a washout period of at least 14 days. All subjects will complete clinical and pharmacodynamic assessments during each treatment period. Pharmacokinetic blood samples will be collected prior to and after study medication administration. Pharmacodynamic blood samples will also be collected to investigate the effects of CST-103 co-administered with CST-107 on inflammatory and neurodegenerative biomarkers.

Conditions

• Freezing of Gait Symptoms in Parkinson's Disease

Interventions

Type	Name	Description
DRUG	CST-103, CST-107, matching placebo	CST-103 and matching placebo orange capsules; CST-107 and matching placebo white capsules

Timeline

• Start date: 2024-06-01
• Primary completion: 2024-12-01
• Completion: 2025-03-01
• First posted: 2021-06-23
• Last updated: 2024-07-03

Locations

1 site across 1 country: Australia