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Effect of Memantine on the Outcome of Patients with Intracranial hemorrhage

Effect of Memantine versus Placebo on the Outcome and Functional Recovery of Patients with Intracranial hemorrhage: a double-blind randomized placebo-controlled pilot trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT201305128490N2
Enrollment
60
Registered
2013-05-19
Start date
2013-06-22
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Intracerebral haemorrhage. Intracerebral haemorrhage in hemisphere, unspecified

Interventions

Intervention 1: Memantine , 10 mg oral pill daily for the first month and 20mg forthe next two months. Intervention 2: Placebo, 10 mg oral pill daily for the first month and 20mg for the next 2 mont
Treatment - Drugs
Placebo
Memantine , 10 mg oral pill daily for the first month and 20mg forthe next two months
Placebo, 10 mg oral pill daily for the first month and 20mg for the next 2 months

Sponsors

Deputy of research, Guilan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: The inclusion criteria: 1. Patients with the diagnosis of first ever, spontaneous, non-traumatic supratentorial ICH confirmed by a clinical examination and radiological findings 2. Admission NIHSS 5 7. Admission hematoma volume <30 cc Patients who will not include: 1.Those with previous or concomitant ischemic stroke 2.Those with other systemic disease including liver or kidney failure 3. Those who have pace maker, or suffer from severe neuropathy, systemic vascular disease or major affective disorders. 4. Those with a positive history of severe disability due to neurological or non-neurological causes 5.Those with a previous history of ICH, myocardial infarction or ischemic stroke 6. Those who abuse alcohol 7. Those with confirmed diagnosis of cognitive disorders based on DSM-IV criteria for dementia or IQCODE questionnaire 8. Those with ICH secondary to brain trauma or rupture of brain aneurysm 9. Those with a history of using anticoagulant drugs, antiplatelet drugs and NSAIDs. 10. Pregnant patients 11. Those with concomitant Intraventricular hemorrhage (IVH) 12.Deep coma Exclusion criteria: 1. Refusal to continue with the study 2. The occurrence of serious adverse drug affects at any time during the study. 3. Alcohol abuse during the study period

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Mortality. Timepoint: During the three-month follow-up period. Method of measurement: Mortality rate.;Functional recovery. Timepoint: On admission, 7th day, and on discharge. Method of measurement: National Institute of Health Stroke Scale(NIHSS).;Motor recovery. Timepoint: On admission, 7th day, on discharge, and 3 month later. Method of measurement: Fugl-Meyer (FM).;Disability. Timepoint: On admission, 7th day, on discharge, and 3 month later. Method of measurement: modified Rankin Scale(mRS).;Performance in basic Activities of Daily Living. Timepoint: On admission, 7th day, on discharge, and 3 month later. Method of measurement: Barthel index (BI).;Level of consciousness. Timepoint: On admission, 7th day, and on discharge. Method of measurement: Glosgow coma scale (GCS).

Secondary

MeasureTime frame
Changes in the size of hematoma. Timepoint: On admission, 72 hours later, and 7th day. Method of measurement: Based on the findings of CT scan.;Changes in the size of perihematomal edema. Timepoint: On admission, 72 hours later, and 7th day. Method of measurement: Based on the findings of CT scan.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Mohadeseh Hajinoori

Guilan University of Medical Science

dr.hajinoori@gmail.com+98 911 193 0396

Outcome results

None listed

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