Safety of Intrathecal Riluzole in Patients With Amyotrophic Lateral Sclerosis

Sponsor
Brain Trust Bio
Study ID
NCT07093268
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Intrathecal Riluzole — DRUG
    Intrathecal infusion of riluzole for 6 weeks followed by 6 months treatment with safety committee approval.

Study Details

The purpose of this study is to investigate the safety and tolerability of intrathecal riluzole in adults with amyotrophic lateral sclerosis.

Key Dates

First listed
Jul 30, 2025
Start date
Aug 15, 2025
Status verified
Jul 2025
Primary completion
Jun 15, 2026
Completion
Jan 15, 2027

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single Arm
    Intrathecal riluzole continuous infusion up to 0.2 mg / hr.

Primary Outcome Measure

Safety and tolerability of 0.2mg/hr intrathecal infusion of intrathecal riluzole, Number of participants with abnormal vital signs [ Time Frame: 6 weeks ]

Central Contacts

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