Minocycline Efficacy in Improving Neurological Outcome of Patients Who Undergo Endovascular Revascularization for Acute Ischemic Stroke

NCT05367362 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: STUDY00006145
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study will be a prospective, randomized, double- blinded placebo, single center pilot clinical trial. Patients with acute ischemic stroke due to large vessel occlusion undergoing endovascular thrombectomy will be included. The treatment group will receive 200 mg intravenous/oral minocycline hydrochloride in addition to endovascular thrombectomy for a total of 21 days. The control group will receive standard medical and endovascular care along with a similar looking placebo. Patients will be randomized to the treatment or control group by the Pharmacy eliminating the selection bias. The patient and evaluator will be blind to the allocation of patients further minimizing the bias. Through randomization we expect to achieve two groups that are comparable in their baseline clinical characteristics.

Conditions

Acute Ischemic Stroke

Keywords

Neuroprotection; Acute Ischemic Stroke; Mechanical Thrombectomy; Neuroprotective Drug; Minocycline

Outcome Measures

Primary Outcomes (1)

• mRS at 90-days

  The primary study end-point is the degree of disability or dependence at 90 days as assessed by the mRS shift. A global measure of disability, the mRS comprises of seven grades ranging from 0 (no symptoms) to 6 (death). The mRS will be assessed in a formally operationalized manner by use of the Rankin Focused Assessment - Ambulation (RFA-A). The 90-day mRS will be assessed by study personnel certified in the scoring of the mRS using the RFA-A and will be blinded to treatment assignment.

  90 days post op

Secondary Outcomes (5)

• National Institute of Health Stroke Scale (NIHSS) at 24 hours

  90 days post op

• mRS at discharge

  24 hours post procedure

• Barthel Index at 7,30, and 90 days

  7 days, 30 days, and 90 days post procedure

• Volume of cerebral infarction

  72 hours

• Change in Infarct Volume

  90 days

Study Arms (2)

Intervention

EXPERIMENTAL

Patients randomized to minocycline will receive 200mg administered once a day for 21 days. The first dose will be administered in the emergency room or the angiography suite prior to endovascular intervention or within the first two hours of endovascular stroke intervention. If the patient is considered able to swallow as per the routine swallow test, the study drug will be administered orally as intact capsules. If the patient is considered to be at any risk for aspiration or is unable to swallow based on swallowing evaluation, study drug may be started using intravenous route and later switched to oral or via feeding tube as it becomes available.

Drug: Minocyclin

Control

NO INTERVENTION

Patients randomized to control arm will receive look-alike placebo administered once a day for 21 days. The first dose will be administered in the emergency room or the angiography suite prior to endovascular intervention or within the first two hours of endovascular stroke intervention. If the patient is considered able to swallow as per the routine swallow test, the placebo will be administered orally as intact capsules. If the patient is considered to be at any risk for aspiration or is unable to swallow based on swallowing evaluation, placebo may be started using intravenous route and later switched to oral or via feeding tube as it becomes available.

Interventions

Minocyclin DRUG

200 mg intravenous/oral minocycline hydrochloride for a total of 21 days

Also known as: Minocycline HCL 200mg Daily (Oral or Intravenous)

Intervention

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• provision of consent, either by self or authorized representative, willingness and ability to participate in study procedures
• Acute onset focal neurologic deficit consistent with acute ischemic stroke, or computed tomographic scan consistent with acute cerebral ischemia
• Age more than 18 years
• Premorbid Rankin score ≤ 3
• Treatment with intra-arterial endovascular revascularization methods.
• Patients should be given first dose of minocycline as soon as possible, latest by 24 hours after the endovascular stroke intervention

You may not qualify if:

• Allergy/ Intolerance to tetracycline antibiotics
• Pregnant women - positive pregnancy test on admission or known to be pregnant
• ALT or AST \> 3 times the upper limit of normal
• Serum creatinine \> 2 mg/dL
• Patient is participating in another clinical trial at any time during the duration of the study that could confound the treatment or outcomes of this investigation; and/or
• Has a severe health condition that may potentially result in death within 6 months.

Sponsors & Collaborators

• State University of New York at Buffalo: lead

MeSH Terms

Conditions

Ischemic Stroke; cyclopia sequence

Interventions

Minocycline

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Adnan H Siddiqui, MD PhD

  University at Buffalo Neurosurgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chairman University at Buffalo Neurosurgery

Model Details: The study will be a prospective, randomized, double- blinded placebo, single center pilot clinical trial.

Study Record Dates

• First Submitted: February 10, 2022
• First Posted: May 10, 2022
• Study Start: December 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share