No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Treatment
Participants needed
1,164 (estimated)
Sponsor
Joyce Chen · Other
Who this trial is looking for
This trial is looking for adults aged 18 and older who have had a moderate stroke within the last 24 hours. Participants will either receive a medication called Minocycline along with standard care or just standard care and will be monitored for their recovery.
Are You a Good Fit for This Trial?
You may be able to join if
I am 18 years old or older
I have a moderate stroke severity score (NIHSS 5-20)
I have had sudden neurological symptoms consistent with a stroke
I have had symptoms for less than 24 hours
You may not be able to join if
I have not had a stroke
I am allergic to Minocycline or similar medications
I am pregnant, suspect I am pregnant, or breastfeeding
I have a history of not tolerating Minocycline
I have severe kidney problems
I cannot have a CT or MRI scan
My life expectancy is less than one year
I cannot take oral medications
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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?
…
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
Trial Locations
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Eligibility Criteria
\* Inclusion criteria
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
1. Age \>/=18
2. NIHSS 5-20 \*National Institutes of Health Stroke Scale\*
3. Acute onset neurological deficit consistent with acute ischemic stroke or on imaging cons…
\* Inclusion criteria
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
1. Age \>/=18
2. NIHSS 5-20 \*National Institutes of Health Stroke Scale\*
3. 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
4. The onset of neurological symptoms less than 24 hours
* Exclusion criteria
An individual who meets any of the following criteria is excluded from participation in this study:
1. Clinically stroke is not suspected
2. Allergic to the Tetracycline group of medications or Intolerance to Minocycline
3. Pregnancy or suspected pregnancy or breastfeeding
4. Previous history of intolerance to Minocycline
5. Acute or chronic renal failure (stage III with GFR \*(Glomerular Filtration Rate) \* or Creatinine threshold)
6. Any patients with contraindications to undergo CT (Computed Tomography) / MRI (Magnetic Resonance Imaging)
7. Life expectancy less than one year or severe co-morbidities or comfort measure only (CMO) on admission
8. Pre-existing infectious disease requiring antibiotics
9. Inability to tolerate enteral medications/feeds
10. Patient/ family refusal
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