Minocycline for Stroke

Overseen By Ilya Levin, DO

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Maimonides Medical Center

Must not be taking: Antibiotics

Disqualifiers: Renal failure, Pregnancy, Allergies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 36

Duration: 5 days

1120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether Minocycline, an antibiotic, can improve recovery and survival rates for recent stroke patients. Participants will receive either standard stroke care or standard care plus Minocycline. The trial aims to determine if Minocycline's potential brain-protecting effects can enhance stroke recovery. Ideal candidates are those who have experienced a stroke with noticeable symptoms within the last 24 hours. As a Phase 2, Phase 3 trial, this research measures the treatment's effectiveness in an initial, smaller group and represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking advancements in stroke recovery.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that Minocycline is likely to be safe for humans?

Research has shown that Minocycline is safe for humans, even at higher doses. Studies found it to be well-tolerated up to doses of 10 mg per kg when administered intravenously, both alone and with the clot-busting drug tissue plasminogen activator (tPA). This indicates that Minocycline, when used for stroke treatment, usually does not cause severe side effects. The trial under consideration uses a lower oral dose, which is generally expected to be even safer. Therefore, based on past research, Minocycline appears to be a safe option for participants in clinical trials for stroke treatment. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for stroke?

Minocycline is unique because it offers a potential new approach to treating strokes. Most stroke treatments aim to restore blood flow or prevent further clotting, but Minocycline works differently by targeting inflammation and cell death in the brain, which are major contributors to stroke damage. Researchers are excited about Minocycline because it could be administered alongside standard care, potentially enhancing recovery without altering current treatment protocols. Additionally, Minocycline is already an established antibiotic, so its safety profile is well known, which may speed up its approval process for treating strokes.

What evidence suggests that Minocycline might be an effective treatment for stroke?

Studies have shown that Minocycline can aid recovery after a stroke. In some research, patients who received Minocycline within a day of their stroke experienced better outcomes than those who did not receive the treatment. The drug protects brain cells from damage following a stroke. Another study found that administering Minocycline soon after a stroke improved patients' ability to perform daily activities. In this trial, one group of participants will receive standard stroke care with Minocycline, while another group will receive standard stroke care without it. This suggests that Minocycline could be a valuable addition to standard stroke care. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with recent (less than 24 hours) stroke symptoms or imaging showing a stroke, who can take oral medication. It's not for those allergic to Tetracycline drugs, pregnant women, patients with severe illnesses affecting life expectancy within a year, renal failure cases, or existing infections needing antibiotics.

Inclusion Criteria

You have a measurable problem with your nervous system using a specific scale called NIHSS.

I recently had symptoms or imaging results that show a stroke due to lack of blood flow.

My symptoms started less than 24 hours ago.

Exclusion Criteria

I have no symptoms suggesting a stroke.

You had problems taking minocycline before.

Pregnancy or suspected pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive Minocycline 200 mg orally every 24 hours for five days in addition to standard care or standard care alone

5 days

Daily visits (in-person) for 5 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, with NIHSS and mRS scores collected at discharge, 30 days, and 90 days post-discharge

90 days

Visits at discharge, 30 days, and 90 days post-discharge

Interim Analysis

Interim analyses including safety monitoring conducted at 25%, 50%, and 75% enrollment intervals

Throughout the trial

What Are the Treatments Tested in This Trial?

Interventions

• Minocycline

Trial Overview The study tests if Minocycline taken orally (200mg daily for five days), starting within the first day of stroke symptoms along with standard care improves outcomes compared to standard care alone. Outcomes are measured using NIHSS and mRS scales at different times post-stroke.

How Is the Trial Designed?

Group I: Standard Stroke Care with Minocycline Experimental Treatment 1 Intervention

560 patients in the Minocycline arm will receive Minocycline 200 mg every 24 hours for five days with standard stroke care

Group II: Standard Stroke Care without Minocycline Active Control 1 Intervention

560 Patients will receive standard stroke care.

Minocycline is already approved in United States, European Union, Japan, India for the following indications:

Approved in United States as Minocin for:

• Acne
• Bacterial infections
• Periodontal disease
• Rosacea

Approved in European Union as Minostad for:

• Acne

Approved in Japan as Minopen for:

• Bacterial infections

Approved in India as Minoz for:

• Bacterial infections

Approved in United States as Amzeeq for:

• Acne

Approved in United States as Zilxi for:

• Rosacea

Who Is Running the Clinical Trial?

Maimonides Medical Center

Lead Sponsor

Trials

72

Recruited

15,400+

Published Research Related to This Trial

Minocycline, a commonly used antibiotic, has shown potential beyond its traditional use, demonstrating cytoprotective and neuroprotective effects that may benefit patients with cerebrovascular and neurodegenerative diseases.

Current literature suggests that minocycline's multi-faceted effects on cell functions make it a promising candidate for clinical trials targeting various conditions, including bacterial infections, cancer, and autoimmune disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minocycline mediated mitochondrial cytoprotection: premises for therapy of cerebrovascular and neurodegenerative diseases. Karachitos, A., García Del Pozo, JS., de Groot, PW., et al.[2019]

Minocycline, a tetracycline antibiotic, shows potential as a neuroprotective agent in acute ischemic stroke, demonstrating effects on reducing cell death, inflammation, and injury in both animal models and early human trials.

Current systemic thrombolytic therapies for stroke are limited by strict eligibility criteria and risks of bleeding, highlighting the need for alternative treatments like minocycline that may improve long-term outcomes without these risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minocycline repurposing in critical illness: focus on stroke. Liao, TV., Forehand, CC., Hess, DC., et al.[2021]

Minocycline, an antibiotic with neuroprotective properties, has shown promise in reducing brain damage and improving recovery in animal models of stroke, making it a strong candidate for treating acute ischemic stroke due to its ability to cross the blood-brain barrier and its good safety profile.

Early phase clinical trials indicate that minocycline is safe and may be effective in treating acute ischemic stroke, either alone or with other treatments, but further large-scale studies are necessary to confirm its efficacy and determine its role in stroke therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minocycline development for acute ischemic stroke. Fagan, SC., Cronic, LE., Hess, DC.[2021]

Minocycline, administered intravenously within 6 hours of stroke onset, was found to be safe and well tolerated at doses up to 10 mg/kg, with only one instance of dose-limiting toxicity reported.

The drug has a half-life of approximately 24 hours, suggesting it can be effectively dosed every 24 hours, making it a potentially ideal treatment option to use alongside tissue plasminogen activator in acute ischemic stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minocycline to improve neurologic outcome in stroke (MINOS): a dose-finding study. Fagan, SC., Waller, JL., Nichols, FT., et al.[2023]

Minocycline, traditionally an antibiotic, shows potential as a cardiovascular therapeutic due to its anti-inflammatory, antioxidant, and antiapoptotic properties, as supported by preclinical and clinical studies.

The review highlights ongoing clinical trials investigating minocycline's cardioprotective effects, emphasizing its promising role beyond its original use as an antibiotic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minocycline: a bacteriostatic antibiotic with pleiotropic cardioprotective effects. Brenes-Salazar, JA.[2015]

In a study involving 16 patients with intracerebral hemorrhage, intravenous minocycline was found to be safe and maintained neuroprotective serum concentrations, indicating its potential as a treatment option.

However, the oral form of minocycline showed delayed absorption, taking at least 6 hours to reach peak concentration, which may limit its effectiveness in acute situations where rapid action is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minocycline in Acute Cerebral Hemorrhage: An Early Phase Randomized Trial. Fouda, AY., Newsome, AS., Spellicy, S., et al.[2019]

In a study of 50 acute ischemic stroke patients, those treated with oral minocycline showed significant improvements in clinical outcomes, including NIHSS, mRS, and Barthel Index scores at 30 and 90 days compared to the control group receiving vitamin B.

No serious adverse effects, such as mortality or recurrent strokes, were reported in either group, indicating that minocycline is a safe option for improving recovery after an acute ischemic stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of minocycline in acute ischemic stroke: a single-blinded, placebo-controlled trial. Padma Srivastava, MV., Bhasin, A., Bhatia, R., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3916214/

Minocycline to Improve Neurologic Outcome in Stroke (MINOS) Even when the drug was administered orally for 5 days after acute ischemic stroke, significantly better stroke outcome was reported.An oral dose would achieve ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05367362?term=Minocycline&rank=9

Minocycline Efficacy in Improving Neurological Outcome of ... Pharmacokinetic studies have shown that minocycline has a half line approaching 24 hours permitting once daily dosing 2.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6306456/

Efficacy of Minocycline in Acute Ischemic Stroke: A Systematic ... Conclusions: Based on the results in our study, minocycline appears as an effective therapeutic option for acute ischemic stroke.

4. svn.bmj.com svn.bmj.com/content/early/2025/03/26/svn-2024-003577

Rationale and Study Design to Assess the Efficacy ... The EMPHASIS trial is the first phase III trial to investigate whether minocycline is effective and safe in improving functional outcome at 90 days in patients ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT00930020?term=AREA%5BInterventionSearch%5D(borymycin)%20AND%20AREA%5BStudyType%5D(INTERVENTIONAL)&rank=1

Neuroprotection With Minocycline Therapy for Acute Stroke ... Minocycline compared to placebo, when administered between 3 to 48 hours after onset of acute ischemic stroke improves functional outcome as assessed by the ...

6. ahajournals.org ahajournals.org/doi/10.1161/strokeaha.110.582601

Minocycline to Improve Neurologic Outcome in Stroke ... Conclusions—Minocycline is safe and well tolerated up to doses of 10 mg/kg intravenously alone and in combination with tissue plasminogen ...

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05487417/effects-of-minocycline-on-patients-with-ischemic-stroke-undergoing-intravenous-thrombectomy

Effects of Minocycline on Patients With Ischemic Stroke ... Animal model studies have shown that minocycline can reduce cerebral damage after ischemic stroke, and its mechanism involves multiple molecular ...