Pilot Study of Galantamine to Treat Metabolic Syndrome in People With Chronic Traumatic Spinal Cord Injury (SCI)
Recruiting
Phase 2Phase 3Interventional Study
Spinal Cord InjuryTraumatic Spinal Cord InjuryParaplegia and TetraplegiaMetabolic 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.
Ready to participate?
Review the details below, then apply to join this clinical trial.
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
Who this trial is looking for
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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…
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
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