Safety of Intrathecal Riluzole in Patients With Amyotrophic Lateral Sclerosis
NCT07093268 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2025-07-30
Summary
The purpose of this study is to investigate the safety and tolerability of intrathecal riluzole in adults with amyotrophic lateral sclerosis.
Conditions
- Amyotrophic Lateral Sclerosis
- Motor Neuron Disease
Interventions
- DRUG
-
Intrathecal Riluzole
Intrathecal infusion of riluzole for 6 weeks followed by 6 months treatment with safety committee approval.
Sponsors & Collaborators
-
Brain Trust Bio
lead INDUSTRY
Principal Investigators
-
David Schultz, Dr · Flinders Medical Centre
-
Antony Winkel, Dr · Sunshine Coast University Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-08-15
- Primary Completion
- 2026-06-15
- Completion
- 2027-01-15
Countries
- Australia
Study Locations
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