Minocycline in Stroke Study at Maimonides

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorJoyce Chen

About this trial

The goal of this study is to determine if Minocycline, when added to standard care, can improve survival and functional outcomes in patients with moderate acute stroke (ischemic or hemorrhagic) aged 18 years and older.

The main questions it aims to answer are:

1. Does Minocycline improve \*National Institutes of Health Stroke Scale\* (NIHSS) scores at hospital discharge and 90 days post-stroke? 2. Does Minocycline reduce stroke-related disability, all-cause in hospital mortality (mRS -\*Modified Rankin Scale\* = 6) and at 90 days besides reducing brain bleeding complications compared to standard care?

Researchers will compare patients receiving oral Minocycline plus standard care to those receiving standard care only to see if Minocycline leads to better neurological outcomes and lower mortality.

Participants will:

1. Be randomly assigned by block to receive either:

Minocycline 200 mg orally once daily for five days within 24 hours from symptoms onset + Standard Care, or Standard Care only 2. Undergo neurological assessments using NIHSS \*National Institutes of Health Stroke Scale\* and Modified Rankin Scale (mRS) at admission, discharge, 30 days post-stroke, 90 days post-stroke 3. Be monitored for: a) hemorrhagic transformation of ischemic strokes; b) Adverse events and mortality outcomes; c) Safety and efficacy signals through interim analyses

NIHSS: \*National Institutes of Health Stroke Scale\*, which is stroke severity scale,

mRS: \*Modified Rankin Scale\*, which is stroke disability scale

Eligibility criteria

Qualifiers

Age >/=18

NIHSS 5-20 *National Institutes of Health Stroke Scale*

Acute onset neurological deficit consistent with acute ischemic stroke or on imaging consistent with acute ischemia as defined by WHO *(World Health Organization) * guidelines or acute onset of neurological deficits with intracerebral Hemorrhage on imaging consistent with intracerebral bleed

The onset of neurological symptoms less than 24 hours

Disqualifiers

Clinically stroke is not suspected

Allergic to the Tetracycline group of medications or Intolerance to Minocycline

Pregnancy or suspected pregnancy or breastfeeding

Previous history of intolerance to Minocycline

Trial design

Treatments tested in this trial

  • Minocycline 200mg

Treatment groups

1,164 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Joyce Chen

Lead sponsor

Maimonides Medical Center

Sponsor institution