This is a triple blind randomized clinical trial and the aim of this study was evaluation of Gabapentin in improvement of consciousness level of traumatic brain injury patients.
60 patients with these criteria were enrolled:
The patients who suffered from moderate (9 <=GSC>12) and severe (GCS<9) traumatic brain injury and diffuse axonal injury were included.
The exclusion criteria were: the patient death during the study and the patients who did not tolerate gabepentin or present its severe side effects.
The Patients were randomized to receive 300 mg Gabapentin or placebo twice a day for two weeks.
Before treatment and twice during this period and at the first outpatient referral the patients were followed and be examined for probable problems or drug side effects. and GCS (Glasgow Coma Scale) and GOS (Glasgow outcome scale) were determined and EEG (Electroencephalogram) recording is done.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201009204786N1
Registration date:2010-11-12, 1389/08/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-11-12, 1389/08/21
Registrant information
Name
Seyed Ali Sonbolestan
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1233 1401
Email address
sonbolestan@edc.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan university of medical sciences
Expected recruitment start date
2008-03-20, 1387/01/01
Expected recruitment end date
2009-08-23, 1388/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Gabapentin (vs. placebo) in improvement of consciousness level of traumatic brain injury patients
Public title
The effect of Gabapentin in traumatic brain injury
Purpose
Treatment
Inclusion/Exclusion criteria
The patients who suffered from moderate (9 <=GSC>12) and severe (GCS<9) traumatic brain injury and diffuse axonal injury were included.
The exclusion criteria were: the patient death during the study and the patients who did not tolerate gabepentin or present its severe side effects.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan university of medical sciences - Isfahan neuroscience research center
Street address
Hezar jerib St.
City
Isfahan
Postal code
Approval date
2010-10-30, 1389/08/08
Ethics committee reference number
051/24/1034
Health conditions studied
1
Description of health condition studied
Diffuse brain injury
ICD-10 code
S06.2
ICD-10 code description
Diffuse brain injury
Primary outcomes
1
Description
Glasgow Coma Scale
Timepoint
before intervention, 1 and 2 weeks after intervention onset, at the first outpatient referral
Method of measurement
Physical examination
2
Description
Glasgow outcome scale
Timepoint
before intervention, 1 and 2 weeks after intervention onset, at the first outpatient referral
Method of measurement
Physical examination
Secondary outcomes
1
Description
Electroencephalography
Timepoint
before intervention, 1 and 2 weeks after intervention onset, at the first outpatient referral
Method of measurement
Electroencephalography
Intervention groups
1
Description
The intervention group is treated by 300 mg Gabapentin twice daily
Category
Treatment - Drugs
2
Description
The control group is treated by placebo twice daily
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani hospital
Full name of responsible person
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellery for research, Isfahan university of medical sciences
Full name of responsible person
Dr. Peiman Adibi
Street address
Hezar jerib St.
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellery for research, Isfahan 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
Isfahan university of medical sciences
Full name of responsible person
Seyed Ali Sonbolestan
Position
Student
Other areas of specialty/work
Street address
hezar jerib st.
City
Isfahan
Postal code
Phone
+93 3117922295
Fax
Email
sonbolestan@edc.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan university of medical sciences
Full name of responsible person
Dr. Mohammad reza Najafi
Position
Associated professor of Neurology
Other areas of specialty/work
Street address
Sofeh St., Alzahra hospital
City
Isfahan
Postal code
Phone
+98 31 1629 1050
Fax
Email
najafi@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan university of medical sciences
Full name of responsible person
Seyed Ali Sonbolestan
Position
Other areas of specialty/work
Street address
City
Isfahan
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)