Pilot Study of Galantamine to Treat Metabolic Syndrome in People With Chronic Traumatic Spinal Cord Injury (SCI)

Recruiting Phase 2 Phase 3 Interventional Study
Spinal Cord Injury Traumatic Spinal Cord Injury Paraplegia and Tetraplegia Metabolic Syndrome
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
21 – 75
Sex
Any
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
Northwell Health · Other
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About This Trial

The purpose of this research study is to measure the tolerability and preliminary efficacy of a drug, galantamine, to treat metabolic syndrome (MetS) by reducing circulating inflammation in people with spinal cord injury (SCI). Galantamine is FDA-approved for the treatment of Alzheimer's disease. Here, the drug is considered experimental for the purposes of this study.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Adults aged 21-75 years (male or female) * Chronic (≥1 year post injury) traumatic non-progressive spinal cord injury (SCI) * Wheelchair user for community mobility * Injury level of tetraplegia (cervical level) or paraplegia (all levels) * SCI-specific obesity indicated by wa…
Contacts

Ona Bloom, PhD

516-562-1309

obloom@northwell.edu

CONTACT