Effect of Memantine versus Placebo on the Outcome and Functional Recovery of Patients with Intracranial hemorrhage: a double-blind randomized placebo-controlled pilot trial
The aim of this study is to evaluate the effect of memantine on the outcome of patients with Intracranial Hemorrhage (ICH). The present study is a double-blind randomized placebo-controlled pilot trial. Patients with ICH will be enrolled base on the inclusion criteria. Written informed consent will be obtained from all patients or patient’s family before enrollment in the study. Participates will randomly be divided into two groups, using random block. One group will receive a 10 mg memantine for the first month, starting during the first 24 hours following ICH, and then 20 mg for the next two months. The other group will receive a placebo in the same way as the active drug. Patient will be excluded if any adverse effect happens due to medication. Baseline neurological and functional status of patients will be evaluated using National Institute of Health Stroke Scale Criteria (NIHSS), Glasgow Outcome Scale (GCS), Modified Rankin Scale (MRS), Barthel Index (BI) and Fugl-Meyer (FM) at the time of admission. Brain CT scan will be performed on the day of admission, 72 hours after drugs administration and on 7th day to assess the size of hematoma and prihematoma edema. Mortality rate, neurological status and functional recovery will be evaluated over three months.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201305128490N2
Registration date:2013-05-19, 1392/02/29
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-05-19, 1392/02/29
Registrant information
Name
Seyed Mohammad Seyed Saadat
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
00983221572-00983223856
Email address
sm_seyedsaadat@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of research, Guilan University of Medical Sciences
Expected recruitment start date
2013-06-22, 1392/04/01
Expected recruitment end date
2014-06-22, 1393/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Memantine versus Placebo on the Outcome and Functional Recovery of Patients with Intracranial hemorrhage: a double-blind randomized placebo-controlled pilot trial
Public title
Effect of Memantine on the Outcome of Patients with Intracranial hemorrhage
Purpose
Treatment
Inclusion/Exclusion 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 <20
3. Patients whom diagnosis is made within less than 6 hours after onset of symptoms
4. Patients with a length of hospital stay of at least 7 days
5. Age <80
6. Admission GCS >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
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
Student Research Comittee, Deputy of research, Across Sepah bank, West shahid beheshti bolvard,Gas square
City
Rasht
Postal code
Approval date
2013-02-09, 1391/11/21
Ethics committee reference number
1910396403
Health conditions studied
1
Description of health condition studied
Intracerebral haemorrhage
ICD-10 code
I61.2
ICD-10 code description
Intracerebral haemorrhage in hemisphere, unspecified
Primary outcomes
1
Description
Mortality
Timepoint
During the three-month follow-up period
Method of measurement
Mortality rate
2
Description
Functional recovery
Timepoint
On admission, 7th day, and on discharge
Method of measurement
National Institute of Health Stroke Scale(NIHSS)
3
Description
Motor recovery
Timepoint
On admission, 7th day, on discharge, and 3 month later
Method of measurement
Fugl-Meyer (FM)
4
Description
disability
Timepoint
On admission, 7th day, on discharge, and 3 month later
Method of measurement
modified Rankin Scale(mRS)
5
Description
Performance in basic Activities of Daily Living
Timepoint
On admission, 7th day, on discharge, and 3 month later
Method of measurement
Barthel index (BI)
6
Description
Level of consciousness
Timepoint
On admission, 7th day, and on discharge
Method of measurement
Glosgow coma scale (GCS)
Secondary outcomes
1
Description
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
2
Description
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
Intervention groups
1
Description
Memantine , 10 mg oral pill daily for the first month and 20mg forthe next two months
Category
Treatment - Drugs
2
Description
Placebo, 10 mg oral pill daily for the first month and 20mg for the next 2 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Poursina Hospital, Guilan Trauma Research Center
Full name of responsible person
Dr Babak Bakhshayesh Eghbali
Street address
Poursina Hospital
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of research, Guilan University of Medical Sciences
Full name of responsible person
Dr Abdolrasool Sobhani
Street address
Student Research Comittee, Deputy of research, Across Sepah bank, West shahid beheshti bolvard,Gas square
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of research, Guilan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Guilan University of Medical Science
Full name of responsible person
Dr Mohadeseh Hajinoori
Position
Resident of Neurology
Other areas of specialty/work
Street address
Poursina Hospital
City
Rasht
Postal code
4193893345
Phone
+98 911 193 0396
Fax
Email
dr.hajinoori@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Research comittee, Guilan university of Medical Science
Full name of responsible person
Seyed Mohammad Seyed Saadat
Position
Medical Student
Other areas of specialty/work
Street address
Student Research Comittee, Deputy of research, Across Sepah bank, West shahid beheshti bolvard,Gas square
City
Rasht
Postal code
4193893345
Phone
+98 13 1322 8905
Fax
Email
sm_seyedsaadat@gums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Guilan University of Medical Science
Full name of responsible person
Seyedeh Nazanin Seyed Saadat
Position
Medical Student
Other areas of specialty/work
Street address
Student Research Comittee, Deputy of research, Across Sepah bank, West shahid beheshti bolvard,Gas square
City
Rasht
Postal code
4193893345
Phone
+98 13 1322 8905
Fax
Email
saadat.nazanin@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)