Maimonides Minocycline in Stroke Study
Megadott ok: The protocol is in the process to change due to challenges in recruiting participants (without a treatment arm) which is now reflected in 2024-04-01
Key facts
- Where
- Brooklyn, Egyesült ÁllamokSee the site
- Phase
- 2/3. fázis
Where in Egyesült Államok
- Maimonides Medical CenterBrooklyn, Egyesült ÁllamokNo longer taking part
Trial details
- Who runs it
- Maimonides Medical Center
- Trial code
- NCT06107725
- Record updated
- 2025. december 17.
- Original description
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.Read full original descriptionShow less
Effect of Oral Minocycline on Acute Stroke Outcome: A Randomized Open Label Prospective Study
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.
Inclusion: Age >/=18; Acute onset neurological deficit consistent with acute ischemic stroke or on imaging consistent with acute ischemia as defined by WHO (World Health Organization) guidelines; Acute onset of neurological deficits with intracerebral Hemorrhage on imaging consistent with intracerebral bleed; The onset of symptoms less than 24 hours; Measurable neurological deficit using NIHSS (National Institutes of Health Stroke Scale ).
Exclusion: Previous history of intolerance to minocycline; Inability to tolerate enteral medications/feeds; Clinically not suspect stroke; Allergic to the Tetracycline group of medications or Intolerance to Minocycline; Acute or chronic renal failure; Pre-existing infectious disease requiring antibiotics; Pregnancy or suspected pregnancy; Any patients with contraindications to undergo CT/ MRI; Life expectancy less than one year or severe co-morbidities or comfort measure only (CMO) on admission; Patient/ family refusal.