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Tests treatment safety and results for Intracerebral Hemorrhage
Official title Efficacy and Safety of Minocycline in Acute Spontaneous Intracerebral Hemorrhage
ClinicalTrials.gov ID: NCT07338175
What this study is testing
What is Minocycline hydrochloride capsules?
Minocycline hydrochloride capsules is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for intracerebral hemorrhage.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a prospective, multicenter, randomized, double-blind, placebo-controlled clinical trial. It aims to evaluate the efficacy and safety of oral minocycline in patients with acute spontaneous intracerebral hemorrhage within 48 hours of onset.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- CT-confirmed spontaneous supratentorial intracerebral hemorrhage;
- Aged 18 to 80 years;
- Within 48 hours of symptom onset;
- Hematoma volume 15-40 ml;
- NIHSS score 8-24, with item 1a ≤ 2;
You likely can't join if
- Secondary intracerebral hemorrhage (traumatic, tumor-related, vascular malformation, aneurysm, coagulation disorder, etc.);
- Intraventricular hemorrhage filling one entire lateral ventricle, third ventricle, or fourth ventricle, or more than half of two lateral ventricles;
- Significant subarachnoid hemorrhage (Fisher grade ≥ 3) or subdural hemorrhage;
- Patients with uncontrollable hypertension ( systolic blood pressure persistently ≥ 180 mmHg despite intensive antihypertensive treatment);
- Progressive neurological or other severe systemic diseases;
- Planned surgical intervention for the intracerebral hemorrhage;
See the full eligibility criteria
- CT-confirmed spontaneous supratentorial intracerebral hemorrhage;
- Aged 18 to 80 years;
- Within 48 hours of symptom onset;
- Hematoma volume 15-40 ml;
- NIHSS score 8-24, with item 1a ≤ 2;
- Signed informed consent by the patient or legal representative.
- Secondary intracerebral hemorrhage (traumatic, tumor-related, vascular malformation, aneurysm, coagulation disorder, etc.);
- Intraventricular hemorrhage filling one entire lateral ventricle, third ventricle, or fourth ventricle, or more than half of two lateral ventricles;
- Significant subarachnoid hemorrhage (Fisher grade ≥ 3) or subdural hemorrhage;
- Patients with uncontrollable hypertension ( systolic blood pressure persistently ≥ 180 mmHg despite intensive antihypertensive treatment);
- Progressive neurological or other severe systemic diseases;
- Planned surgical intervention for the intracerebral hemorrhage;
- Pre-stroke disability (modified Rankin Scale score \> 1);
- Severe cardiac insufficiency (NYHA Class III-IV), severe liver disease (ALT or AST \> 3 times the normal upper limit value), severe renal insufficiency (serum creatinine \> 2 times the normal upper limit value, or...
- Moderate to severe anemia (hemoglobin \ 1.5);
- Allergy or intolerance to minocycline or other tetracycline antibiotics;
- History of pseudomembranous enteritis or antibiotic-associated enteritis;
- Use of tetracycline antibiotics within the past week;
- Intracranial or spinal surgery within the past 3 months;
- Any major surgery or severe physical trauma within the past month;
- Females who are pregnant, within 30 days postpartum, or in the lactation period.
- Participated in other treatment clinical trials within the past 3 months;
- Inability to obtain signed informed consent from the patient or representative;
- Other conditions that are not suitable for participating in this clinical trial, such as inability to understand and/or follow the research procedures due to mental, cognitive, emotional, or physical disorders, etc.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Chongqing, Chongqing Municipality, China
- Guangzhou, Guangdong, China
- Baoding, Hebei, China
- Zhangjiakou, Hebei, China
- Zunhua, Hebei, China
- Mengzhou, Henan, China
- Nanle, Henan, China
- Neixiang, Henan, China
- Pingdingshan, Henan, China
- Puyang, Henan, China
- Sanmenxia, Henan, China
- Shangqiu, Henan, China
- Taikang Chengguanzhen, Henan, China
- Zhengzhou, Henan, China
- Shiyan, Hubei, China
- Guankou, Hunan, China
- Shaodong, Hunan, China
- Baotou, Inner Mongolia, China
- Hohhot, Inner Mongolia, China
+ 19 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Chongqing, Chongqing Municipality, China; Guangzhou, Guangdong, China; Baoding, Hebei, China; Zhangjiakou, Hebei, China; Zunhua, Hebei, China and 33 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.