Evaluation of prophylactic effect of memantine in comparison with placebo on post-traumatic headache in patients with head trauma 3 months and 6 months after starting the drug
Evaluation of prophylactic effect of memantine in comparison with placebo on post-traumatic headache in patients with head trauma 3 months and 6 months after starting the drug
Design
Clinical trial with control group, with single groups, double-blind, randomized, phase 3 on 90 patients.
Patients are assigned to the treatment and control groups in double random blocks in such a way that patients are identified in pairs and both people who are placed in a block are randomly assigned to one person in the treatment group and another person in the control group. Are placed until the sample size is complete.
Settings and conduct
A double-blind randomized clinical trial (patient and researcher) in Al-Zahra Hospital in Isfahan. Memantine is prescribed for the intervention group and placebo for the control group for up to three months.
Participants/Inclusion and exclusion criteria
Participants are people over the age of 18 who have head trauma and are fully satisfied to enter the study.
Conditions of non-entry include a history of severe neurological disease, a history of severe mental disease, and brain complications due to trauma such as infections.
Intervention groups
For patients in the intervention group, memantine tablets are prescribed for three months, and placebo is prescribed for patients in the control group. The pharmaceutical company of the patients' pills is the same.
Main outcome variables
Pain in patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201005048944N1
Registration date:2021-01-11, 1399/10/22
Registration timing:retrospective
Last update:2021-01-11, 1399/10/22
Update count:0
Registration date
2021-01-11, 1399/10/22
Registrant information
Name
Elham Bani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3620 2020
Email address
bani@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2020-09-05, 1399/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of prophylactic effect of memantine in comparison with placebo on post-traumatic headache in patients with head trauma 3 months and 6 months after starting the drug
Public title
Evaluation of the effect of memantine for the prevention of headaches caused by head trauma
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
People who have head trauma
Exclusion criteria:
Having a history of severe neurological disease
Having a history of severe mental illness
Having brain complications from trauma such as infections
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization, table of random numbers. In this study, reading the table of predefined random numbers (eg, up or down) and the researcher's second default is to consider even numbers for intervention group .
The researcher begins to read the numbers in a predetermined manner and the patients are divided.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to prepare placebo and memantine (main drug), we refer to the School of Pharmacy and they provide for us two similar drug packages with the same shape without informing the researcher and the patient. After conducting the research, during the data analysis, the type of drug (placebo or memantine ) is decoded by the pharmaceutical company (Hakim).
Placebo
Used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Esfahan university of Medical sciences
Street address
No. 18, Hezar Jarib Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
۸۱۳۷۸۶۶۵۱۵
Approval date
2020-05-08, 1399/02/19
Ethics committee reference number
IR.MUI.MED.REC.1399.124
Health conditions studied
1
Description of health condition studied
post traumatic headache
ICD-10 code
G44.3
ICD-10 code description
post traumatic headache
Primary outcomes
1
Description
Pain
Timepoint
3 months and 6 months after treatment
Method of measurement
Visual Analogue Scale questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Memantine tablets are an N-methyl-D-aspartate (NMDA) receptor-dependent inhibitor of the glutamate receptor subtype.For patients in the intervention group, 10 mg of memantine tablets are prescribed for half a tablet a day for two weeks and then one tablet a day for 5 months. The manufacturer is Hakim Pharmaceutical Company.
Category
Prevention
2
Description
Control group: A placebo is prescribed for patients in the control group.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospital, Isfahan
Full name of responsible person
elham bani
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3620 2020
Fax
+98 31 3669 1510
Email
alzahra@mui.ac.ir
Web page address
http://alzahra.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
No. 18, Hezar Jarib Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3620 1286
Fax
+98 31 3668 8597
Email
haghjoo.sh@med.mui.ac.ir
Web page address
http://med.mui.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
elham bani
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
School of Medicine, Isfahan University of Medical Sciences and Health Services, Hezar Jerib St
City
isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Fax
+98 31 3668 8597
Email
bani@resident.mui.ac.ir
Web page address
https://mui.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
fariborz khorvash
Position
full Profesor
Latest degree
Subspecialist
Other areas of specialty/work
Neurology
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Fax
+98 31 3669 1510
Email
fkhorvash@gmail.com
Web page address
https://mui.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Elham Bani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
Department of Neurology, Alzahra Hospital, Soffe Blvd
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Fax
+98 31 3668 8597
Email
bani@resident.mui.ac.ir
Web page address
https://mui.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available