Could a common vitamin speed stroke recovery?
NCT ID NCT00796887
First seen Aug 28, 2026 ยท Last updated Aug 28, 2026
Summary
This phase 2 trial tests whether extended-release niacin, a form of vitamin B3, can safely help people recover after an ischemic stroke. Researchers will give participants either niacin or a placebo daily, starting within a week of their stroke. The study tracks safety and measures changes in neurological function to see if niacin offers any benefit.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Extended-release niacin (Niaspan), a vitamin B3 supplement, taken as a daily tablet
- What this could lead to
- If it works, this could point toward a simple, widely available way to boost recovery after a stroke, helping people regain more function.
- What could go wrong
- This is an early phase 2 trial with only 27 participants, so results may not apply broadly. Niacin can cause side effects like flushing, and the benefit is not yet proven.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
27 people
The number who actually took part.
- Start date
-
Apr 2009
- Finished
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Aug 2012
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 85 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients with clinical ischemic stroke able to enroll between 72 hours and 7 days after symptom onset. * Patients age 18-85, inclusive. * NIHSS score of 4-21, inclusive, prior to treatment. * Signed IRB-approved informed consent by patient or authorized representative. Exclusion Criteria: General * Participation in another study with an investigational drug or device. * Women known to be pregnant, lactating, or of childbearing potential with a positive urine beta-HCG. * Patients using niacin within the 7 days previous to their stroke. Safety Related * Unstable angina. * Acute Myocardial infarction. * Concurrent arterial bleeding. * Active peptic ulcer disease. * Platelet count less than 100,000 per microliter. * Internationally Normalized Ratio (INR) greater than 1.3 without use of warfarin. * Concurrent use of bile acid sequestrants (colestipol and cholestyramine) * Baseline systolic blood pressure less than 100 mmHg. * History of significant hepatic dysfunction. * Allergy or hypersensitivity to aspirin. * Concurrent use of amiodarone, gemfibrozil, fibrate or other bile acid resin, cyclosporine, itraconazole, ketaconazole, telithromycin, erythromycin, clarithromycin, HIV protease inhibitors, nefazodone, danazol. * Allergy or hypersensitivity to extended-release niacin. * Allergy or hypersensitivity to statin agents. Potentially Interfering with Outcomes Assessment * Prior history of dementia. * Patients without fixed address or those deemed unlikely to present for follow-up by the investigator. * Patients whose life expectancy is less than 24 weeks. * Pre-stroke modified Rankin score\>2. * Glucose less than 50 mg/dl. * Other serious illness (e.g., severe hepatic, cardiac, or renal failure; or a complex disease that may confound treatment assessment). Imaging Related * Evidence of primary intra-parenchymal hemorrhage on initial neuroimaging study. * Neuroimaging evidence of a nonvascular cause for the neurological symptoms.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Henry Ford Hospital
Detroit, Michigan, 48202, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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