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Recruiting NCT07625332

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

Phase II / Phase III Interventional Spinal Cord Injury Traumatic Spinal Cord Injury Paraplegia and Tetraplegia Metabolic Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Galantamine Hydrobromide Extended Release.
Who it may be relevant to
Registry conditions: Spinal Cord Injury, Traumatic Spinal Cord Injury, Paraplegia and Tetraplegia, Metabolic Syndrome. Basic parameters: 21 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Galantamine Hydrobromide Extended Release
    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.

Primary outcome measures

  • Change in ISCI-BDS Neurogenic Bowel Symptoms Score (Aim 1 and Aim 2) [Time frame: Visit 0 (Screening) through Visit 5 (Week 12)]
  • Change in Heart Rate (Avg) During In-Lab Observation (Aim 1) [Time frame: Visit 1 (Day 1; pre-dose through 5 hours post-dose)]
  • Change in Blood Pressure During In-Lab Observation (Aim 1) [Time frame: Visit 1 (Day 1; pre-dose through 5 hours post-dose)]
  • Occurrence of Adverse Events During In-Lab Observation (Aim 1) [Time frame: Visit 1 (Day 1; pre-dose through 5 hours post-dose)]
  • Change in Heart Rate (Avg) During Outpatient Treatment (Aim 2) [Time frame: Visit 2 (Day 2) through Visit 5 (Week 12)]
  • Change in Blood Pressure During Outpatient Treatment (Aim 2) [Time frame: Visit 2 (Day 2) through Visit 5 (Week 12)]
  • Occurrence of Adverse Events During Outpatient Treatment (Aim 2) [Time frame: Visit 2 (Day 2) through Visit 5 (Week 12)]
Secondary outcome measures (12)
  • Change in Inflammatory Cytokines During Outpatient Treatment (Aim 2) [Time frame: Visit 2 (Day 2) and Visit 5 (Week 12)]
  • Change in Plasma Leptin During Outpatient Treatment (Aim 2) [Time frame: Visit 2 (Day 2) and Visit 5 (Week 12)]
  • Change in Plasma Adiponectin During Outpatient Treatment (Aim 2) [Time frame: Visit 2 (Day 2) and Visit 5 (Week 12)]
  • Change in Lipids (HDL, LDL, and Triglycerides) [Time frame: Visit 0 (Screening) and Visit 5 (Week 12)]
  • Change in Fasting Plasma Insulin [Time frame: Visit 0 (Screening) and Visit 5 (Week 12)]
  • Change in Fasting Blood Glucose [Time frame: Visit 0 (Screening) and Visit 5 (Week 12)]
  • Change in HOMA-IR From Screening (Aim 2) [Time frame: Visit 0 (Screening) and Visit 5 (Week 12)]
  • Change in HbA1c From Screening [Time frame: Visit 0 (Screening) and Visit 5 (Week 12)]
  • Change in C-Reactive Protein (CRP) [Time frame: Visit 0 (Screening) and Visit 5 (Week 12)]
  • Change in Body Composition by DXA During Outpatient Treatment (Aim 2) [Time frame: Visit 2 (Day 2) and Visit 5 (Week 12)]
  • Change in Waist and Hip Circumference During Outpatient Treatment (Aim 2) [Time frame: Visit 2 (Day 2) and Visit 5 (Week 12)]
  • Change in High Frequency Heart Rate Variability (HF-HRV) During Outpatient Treatment (Aim 2) [Time frame: Visit 2 (Day 2), Visit 3 (Week 4), Visit 4 (Week 8), and Visit 5 (Week 12)]

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 waist circumference ≥94 cm
  • Resting heart rate >45 bpm based on 10 measurements over 10 minutes
  • Without clinically significant cardiovascular abnormalities as indicated by 12-lead ECG
  • Tolerable bowel routine indicated by a score of <10 on the International SCI Bowel Function Data Set (ISCI-BDS)
  • Metabolic Syndrome (MetS) defined by the presence of at least three of the following: (1) obesity indicated by SCI-specific waist circumference ≥94 cm, (2) elevated fasting glucose ≥100 mg/dL, (3) dyslipidemia: high triglycerides ≥150 mg/dL or low HDL cholesterol <40 mg/dL for men and <50 mg/dL for women, (4) C-reactive protein (CRP) levels >1 mg/dL
  • Able to understand and communicate in English at the level of describing adverse event frequency and severity and completing validated outcome measures
  • Willingness to comply with all study procedures and availability for the duration of the study
  • Provision of signed and dated informed consent form

Exclusion criteria

  • Diagnosis of neurological injury or condition other than SCI
  • Progressive condition that would be expected to change neurological status
  • Signs and symptoms of cardiovascular disease or cardiac arrhythmias
  • Resting heart rate <45 bpm
  • Score of 10 or greater on the ISCI-BDS v2.1 indicating moderate to severe neurogenic bowel dysfunction
  • Severe concurrent medical disease, condition, or illness judged to be contraindicated by the site physician
  • Psychopathology documented in the medical record or history that may conflict with study objectives
  • Pregnancy (participant reported or determined by clinical lab test), women who plan to become pregnant, or women who are nursing during the study
  • Active cancer or currently in treatment for cancer
  • Triglyceride levels ≥400 mg/dL
  • Chronic use of medications with known or probable interactions with galantamine
  • Enrolled in another research study that is likely to interfere with conduct or results of the current study
  • Any other reason the site physician feels that participation is contraindicated

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 3 centers
  • Kessler Institute for Rehabilitation — West Orange
  • Northwell Health — Manhasset
  • James J. Peters VA Medical Center — The Bronx

Identifiers

NCT: NCT07625332 · 25-0846 · C41213GM · 1349754

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗