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

Part of paid clinical trials in West Orange, New Jersey.

Sponsor
Northwell Health
Study ID
NCT07625332
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

  • Metabolic Syndrome
  • Paraplegia and Tetraplegia
  • Spinal Cord Injury
  • Traumatic Spinal Cord Injury

Eligibility Criteria

Sex
ALL
Age
21 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Galantamine Hydrobromide Extended Release — DRUG
    Galantamine hydrobromide extended release (ER) capsules, 8mg, administered orally once daily in the morning with a meal. Aim 1: Single 8mg dose in the laboratory with at least 5 hours of observation. Aim 2: 8mg once daily for Weeks 1-4; dose escalated to 16mg once daily (two 8mg capsules) for Weeks 5-12 based on tolerability. If the 16mg dose is not tolerated, the participant returns to 8mg daily. Total treatment duration: 12 weeks.

Study Details

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.

Key Dates

Start date
Jun 15, 2026
Status verified
May 2026
Primary completion
Jun 30, 2027
Completion
Dec 31, 2027

Study Design

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

Arms

  • Experimental: Galantamine ER
    All participants (tetraplegia and paraplegia cohorts) receive galantamine hydrobromide extended release (ER) capsules. Aim 1 (Day 1): single 8mg dose administered orally in the laboratory with at least 5 hours of monitored observation. Aim 2 (Weeks 1-12): 8mg once daily for Weeks 1-4, with dose escalation to 16mg (two 8mg capsules) once daily for Weeks 5-12 based on tolerability. Taken orally in the morning with a meal. The two cohorts (tetraplegia and paraplegia) are analyzed separately as pre-specified subgroups.

Primary Outcome Measure

Change in ISCI-BDS Neurogenic Bowel Symptoms Score (Aim 1 and Aim 2) [ Time Frame: Visit 0 (Screening) through Visit 5 (Week 12) ]

Central Contacts

Locations (3)

FacilityCityStateZIP
Kessler Institute for RehabilitationWest OrangeNew Jersey07052
Northwell HealthManhassetNew York11030
James J. Peters VA Medical CenterThe BronxNew York10468

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By research site
Kessler Institute for Rehabilitation· West Orange, NJNorthwell Health· Manhasset, NYJames J. Peters VA Medical Center· The Bronx, NY

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