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New treatment option for Spinal Cord Injury
Official title Pilot Study of Galantamine to Treat Metabolic Syndrome in People With Chronic Traumatic Spinal Cord Injury (SCI)
ClinicalTrials.gov ID: NCT07625332
What this study is testing
What is Galantamine Hydrobromide Extended Release?
Galantamine Hydrobromide Extended Release is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for spinal cord injury.
Also referred to as Razadyne ER.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 75
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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...
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- West Orange, New Jersey, United States
- Manhasset, New York, United States
- The Bronx, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include West Orange, New Jersey, United States; Manhasset, New York, United States; The Bronx, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.