Effect of Oral Minocycline in Patients With Acute Stroke - a Randomized, Open Label, Prospective Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ In order to be eligible to participate in this study, an individual must meet all of the following criteria:

• 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

Locations
United States
New York
Maimonides Medical Center
RECRUITING
Brooklyn
Contact Information
Primary
Qingliang T. Wang, MD, PhD
qwang@maimo.org
718.283.7670
Backup
Ilya Levin, DO
718.283.8681
Time Frame
Start Date: 2026-02-02
Estimated Completion Date: 2028-12
Participants
Target number of participants: 1164
Treatments
No_intervention: Standard Stroke Care without Minocycline
582 Patients in this arm will receive standard stroke care, No Minocycline will be given
Experimental: Standard Stroke Care with Minocycline
582 patients in the Minocycline arm will receive Minocycline 200 mg every 24 hours for five days with standard stroke care
Related Therapeutic Areas
Sponsors
Leads: Joyce Chen

This content was sourced from clinicaltrials.gov