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Clemastine Fumarate Improves Cognitive Function and Prognosis in Patients with Ruptured Intracranial Aneurysms

Clemastine Fumarate Improves Cognitive Function and Prognosis in Patients with Ruptured Intracranial Aneurysms

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500109656
Enrollment
Unknown
Registered
2025-09-23
Start date
2025-10-01
Completion date
Unknown
Last updated
2025-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subarachnoid hemorrhage

Interventions

Placebo group :Administer a placebo (starch).
drug intervention group:Administration of Clemastine Fumarate.

Sponsors

The Wuxi No.2 People Hospital (Jiangnan University Affiliated Central Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Demographic characteristics: 18 = 60 ml/min; II. Normal coagulation: platelet count >= 100×10?/L, INR <= 1.2.

Exclusion criteria

Exclusion criteria: Disease-related exclusions: 1. Combined with other intracranial lesions: uncontrolled intracranial tumors (except benign tumors requiring treatment), arteriovenous malformations, moyamoya disease, etc.; 2. History of recent bleeding or surgery: intracranial hemorrhage (such as parenchymal hemorrhage, subdural hematoma) or major surgery related to non-target aneurysms within 30 days prior to surgery; 3. Severe vascular stenosis: symptomatic intracranial artery stenosis =50%, or internal carotid artery stenosis =70%. Drug-related exclusions: 1. History of allergies: known allergy to clomasten fumarate or its excipients; 2. Concomitant medications: strong CYP3A4 inhibitors (e.g., ketoconazole) and monoamine oxidase inhibitors (MAOIs), or there is a risk of drug interactions. Systemic disease exclusion: 1. Severe organ dysfunction: hepatic insufficiency (ALT>3 times the upper limit of normal), renal insufficiency (GFR 180 mmHg), severe arrhythmias (such as persistent atrial fibrillation); 3. Neurological diseases: comorbid with epilepsy, Parkinson's disease, myasthenia gravis and other diseases that may interfere with cognitive assessment. Other exclusions: 1. Pregnant or lactating females, or those who plan to become pregnant (negative urine pregnancy test before enrollment); 2. Patients with malignant tumors (requiring active treatment) or expected survival of < 1 year; 3. Psychiatric illness or cognitive impairment (e.g., dementia, schizophrenia) that makes it impossible to cooperate with the study; 4. Participation in other clinical trials has not been completed, or participation in similar intervention studies in the past 3 months; 5. Other factors (e.g., alcoholism, drug abuse) that affect the safety of the study or the reliability of the results as judged by the investigator

Design outcomes

Primary

MeasureTime frame
GOS-E;Disability Rating Scale(DRS);

Secondary

MeasureTime frame
Rankin(mRS);

Countries

China

Contacts

Public ContactZhao Xudong

the Wuxi No.2 People Hospital (Jiangnan University Affiliated Central Hospital)

9862022148@jiangnan.edu.cn+86 151 9029 8665

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026