Could a common vitamin speed stroke recovery?

NCT ID NCT00796887

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

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

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

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