Safety of Intrathecal Riluzole in Patients With Amyotrophic Lateral Sclerosis
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorBrain Trust Bio
About this trial
The purpose of this study is to investigate the safety and tolerability of intrathecal riluzole in adults with amyotrophic lateral sclerosis.
Eligibility criteria
Qualifiers
Men and women aged 18 years or older.
Participants are ambulatory with or without an assistive device.
Sporadic or familial ALS diagnosis with possible, laboratory-supported probable, probable, or definite as defined by revised El Escorial criteria.
Slow vital capacity (SVC) measure ≥70% of predicted for gender, height, and age.
Disqualifiers
Participants with bulbar-onset ALS
Anatomical factors at or near the site of implantation;
Underlying disorders of the coagulation cascade or platelet function (eg, hemophilia, Von Willebrand's disease, liver disease);
Administration of antiplatelet or anticoagulant medication within 7 days before or after pump implantation (eg, aspirin, clopidogrel bisulfate, rivaroxaban, nonsteroidal anti-inflammatory agents [NSAIDs]), or
Trial design
Treatments tested in this trial
- Intrathecal Riluzole
Treatment groups
10 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov