1120 Participants Needed

Minocycline for Stroke

QT
IL
Overseen ByIlya Levin, DO
Age: 18+
Sex: Any
Trial Phase: Phase 2 & 3
Sponsor: Maimonides Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 5 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

The goal of this study is to determine if oral Minocycline's proposed neuroprotective effects further improve the clinical outcomes, including mortality, of acute stroke patients beyond the current standard stroke care in a large scale randomized prospective open label (outcome assessor blinded) clinical trial. Participants will be randomly assigned (1:1) to take Minocycline 200mg orally every 24 hours for five days, starting within 24 hours from stroke symptoms onset, in addition to standard care or standard care alone. NIHSS (The National Institutes of Health Stroke Scale) and mRS (Modified Rankin Scale) will be collected at the time of presentation, discharge and again at 30- and 90-days post-discharge. All-cause mortality will also be obtained at 30 days and 90 days.

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.

What data supports the effectiveness of the drug Minocycline for stroke?

Minocycline has shown promise in animal models and early human trials for its ability to protect the brain by reducing inflammation and cell death after a stroke. It has been found to improve outcomes in animal studies and has a good safety profile in early human trials, suggesting it could be effective in treating stroke.12345

How is the drug minocycline unique for treating stroke?

Minocycline is unique for stroke treatment because it is an antibiotic that also has neuroprotective effects, helping to reduce brain damage by decreasing inflammation and cell death. Unlike standard treatments, it targets multiple pathways to protect brain cells, making it a promising option for improving outcomes in stroke patients.12367

Eligibility Criteria

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.
See 2 more

Exclusion Criteria

I have no symptoms suggesting a stroke.
You had problems taking minocycline before.
Pregnancy or suspected pregnancy
See 7 more

Timeline

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

Treatment Details

Interventions

  • Minocycline
Trial OverviewThe 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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Standard Stroke Care with MinocyclineExperimental Treatment1 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 MinocyclineActive Control1 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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Maimonides Medical Center

Lead Sponsor

Trials
72
Recruited
15,400+

Findings from Research

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.
Minocycline repurposing in critical illness: focus on stroke.Liao, TV., Forehand, CC., Hess, DC., et al.[2021]
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.
Efficacy of minocycline in acute ischemic stroke: a single-blinded, placebo-controlled trial.Padma Srivastava, MV., Bhasin, A., Bhatia, R., et al.[2019]
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.
Minocycline in Acute Cerebral Hemorrhage: An Early Phase Randomized Trial.Fouda, AY., Newsome, AS., Spellicy, S., et al.[2019]

References

1.United Arab Emiratespubmed.ncbi.nlm.nih.gov
Minocycline repurposing in critical illness: focus on stroke. [2021]
Efficacy of minocycline in acute ischemic stroke: a single-blinded, placebo-controlled trial. [2019]
Minocycline in Acute Cerebral Hemorrhage: An Early Phase Randomized Trial. [2019]
Minocycline development for acute ischemic stroke. [2021]
Minocycline to improve neurologic outcome in stroke (MINOS): a dose-finding study. [2023]
6.United Arab Emiratespubmed.ncbi.nlm.nih.gov
Minocycline mediated mitochondrial cytoprotection: premises for therapy of cerebrovascular and neurodegenerative diseases. [2019]
Minocycline: a bacteriostatic antibiotic with pleiotropic cardioprotective effects. [2015]