Minocycline for Stroke
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether adding Minocycline, an antibiotic, to standard stroke care can enhance recovery and survival for individuals who have experienced a moderate stroke. The researchers aim to determine if Minocycline can improve neurological outcomes and reduce complications compared to standard care alone. Participants will either take Minocycline or receive standard care, with progress monitored several times over 90 days. The trial seeks individuals who have had a moderate stroke within the last 24 hours and can safely take Minocycline without any known allergies or conditions that prevent its use. As a Phase 2, Phase 3 trial, this study measures Minocycline's effectiveness in an initial group and represents the final step before FDA approval, offering participants a chance to contribute to significant stroke recovery research.
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.
Is there any evidence suggesting that Minocycline is likely to be safe for humans?
Research has shown that Minocycline is generally safe for individuals who have experienced a stroke. In studies where Minocycline was administered after an ischemic stroke, patients did not encounter more safety issues than those who did not receive it. One study found no additional safety risk when Minocycline was started within 72 hours of the stroke. Another study indicated that serious side effects were similar in both the Minocycline group and the non-Minocycline group, suggesting it is well-tolerated. Minocycline has also been safely used in doses up to 10 mg per kg of body weight daily in stroke patients. Overall, the evidence supports that Minocycline is safe for stroke patients, with no significant increase in serious side effects reported.12345
Why do researchers think this study treatment might be promising for stroke?
Unlike the standard stroke care that focuses on managing symptoms and preventing further complications, Minocycline offers a unique approach by potentially reducing inflammation and protecting brain cells after a stroke. Researchers are excited about Minocycline because it's an antibiotic with neuroprotective properties, which means it can help shield brain cells from damage during the critical early stages after a stroke. This could lead to better recovery outcomes and give patients a much-needed boost during the crucial recovery period.
What evidence suggests that Minocycline might be an effective treatment for stroke?
Research has shown that taking Minocycline within 72 hours after an ischemic stroke can greatly improve recovery after 90 days. One study found that people who took Minocycline were more likely to have little or no disability. Another study showed that Minocycline aided recovery without causing additional safety concerns. In this trial, participants in the Minocycline group will receive Minocycline alongside standard stroke care, while another group will receive standard stroke care without Minocycline. These findings suggest that Minocycline might help reduce disability from strokes and improve survival when used with standard treatments. While most research focuses on ischemic strokes, the potential benefits for overall stroke recovery are encouraging.12367
Who Is on the Research Team?
Qingliang T. Wang, MD, PhD
Principal Investigator
Maimonides Medical Center
Are You a Good Fit for This Trial?
This trial is for adults aged 18 or older with moderate acute stroke, either ischemic or hemorrhagic, who experienced symptoms less than 24 hours ago. They should have an NIHSS score between 5 and 20, indicating a certain level of stroke severity.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Minocycline 200 mg orally once daily for five days within 24 hours from symptoms onset, or standard care only
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments at discharge, 30 days, and 90 days post-stroke
Monitoring
Participants are monitored for hemorrhagic transformation, adverse events, and mortality outcomes during hospitalization
What Are the Treatments Tested in This Trial?
Interventions
- Minocycline
Trial Overview
The study tests if Minocycline (200mg daily for five days) plus standard care improves survival and recovery compared to standard care alone in stroke patients. Outcomes are measured using the NIH Stroke Scale and Modified Rankin Scale at various points post-stroke.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
582 patients in the Minocycline arm will receive Minocycline 200 mg every 24 hours for five days with standard stroke care
582 Patients in this arm will receive standard stroke care, No Minocycline will be given
Find a Clinic Near You
Who Is Running the Clinical Trial?
Joyce Chen
Lead Sponsor
Citations
Efficacy and safety of minocycline in patients with acute ...
The primary outcome was an excellent functional outcome at 90 days (with a modified Rankin Scale [mRS] score of 0-1) and was analysed in all ...
Efficacy and safety of minocycline in patients with acute ...
Minocycline therapy initiated within 72 h of acute ischaemic stroke provided a significant functional outcome benefit compared with placebo at ...
EMPHASIS: Minocycline Initiation Effective, Safe Within 72 ...
Minocycline started within 72 hours of ischemic stroke improved 90‑day outcomes with no added safety risk.
Efficacy of Minocycline in Acute Ischemic Stroke
Conclusions: Based on the results in our study, minocycline appears as an effective therapeutic option for acute ischemic stroke.
TITLE: Effect of Oral Minocycline in Patients with Acute Stroke
The results of this study may help us better understand the efficacy and safety profile of Minocycline in acute stroke treatment in both.
Study Details | NCT05367362 | Minocycline Efficacy in ...
Justification of Dose The trial performed by Fagan et al showed minocycline to be safe in patients with acute ischemic stroke at doses as high as 10 mg/kg daily ...
Rationale and Study Design to Assess the Efficacy ...
Minocycline was shown to exert anti-inflammatory effects by attenuating microglial activation and protecting blood-brain barrier in preclinical ...
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