The objectives of this study is to evaluation the effect of riluzole on motor and sensory function of patients with post- traumatic acute spinal cord injury. Inclusion criteria are:
1. acute spinal cord injury with Frankel Impairment Scale level A to C
2. 18 to 70 years old
3. Informed consent
4. C4 to L2 vertebral fractures.
Exclusion criteria are:
1. Hepatic or renal disorders
2. Penetrating brain trauma
3. Traumatic brain injury
4. Pregnancy or Breastfeeding
5. Recent alcohol consumption
6. Neurological or psychiatric disorders
7. Life threatening injuries
8. Unable to receive riluzole orally.
60 patients with acute spinal cord injury and Frankel Impairment Scale level A, B or C will be selected and matched based on age, sex and Frankel Impairment Scale level in two equal groups of A and B. Rilozul therapy will be performed in group A and after 6 months, sensory and motor examinations will be done in all of patients. This study will be done in a randomized, double bind, with use of placebo, in one center and trial phase of 2. Evaluation will be done in three post-interventional phases: early, after 6 weeks and after 6 months with 50mg PO (by mouth) every 12 hours continuing for 4 weeks.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014031813947N3
Registration date:2014-07-16, 1393/04/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-07-16, 1393/04/25
Registrant information
Name
Atta Mahdkhah
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1332 6196
Email address
mshimia@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2014-03-20, 1392/12/29
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of riluzole on motor and sensory function of patients with post- traumatic acute spinal cord injury
Public title
The effect of riluzole on spinal cord injury
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. acute spinal cord injury with Frankel Impairment Scale level A to C;
2. 18 to 70 years old;
3. Informed consent;
4. C4 to L2 vertebral fractures
Exclusion criteria:
1. Hepatic or renal disorders;
2. Penetrating brain trauma;
3. Traumatic brain injury;
4. Pregnancy or Breastfeeding;
5. Recent alcohol consumption;
6. Neurological or psychiatric disorders;
7. Life threatening injuries;
8. Unable to receive riluzole orally
Age
From 18 years old to 70 years old
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 Tabriz University of Medical Sciences
Street address
Ethics committee of Tabriz University of Medical Sciences, Golgash St, Tabriz, Iran
City
Tabriz
Postal code
5165687386
Approval date
2014-01-21, 1392/11/01
Ethics committee reference number
92219
Health conditions studied
1
Description of health condition studied
Spinal injury
ICD-10 code
S34.1
ICD-10 code description
Injury of nerves and lumbar spinal cord at abdomen, lower back and pelvis level
Primary outcomes
1
Description
Sensory injury
Timepoint
Primary, 6 weeks and 6 months following end of treatment
Method of measurement
Frankel classification
2
Description
Motor injury
Timepoint
Primary, 6 weeks and 6 months following end of treatment
Method of measurement
Frankel classification
3
Description
Pain
Timepoint
Primary, 6 weeks and 6 months following end of treatment
Method of measurement
Visual Analog Scale
Secondary outcomes
1
Description
Side effects
Timepoint
Primary, 6 weeks and 6 months following end of treatment
Method of measurement
Physical examination
Intervention groups
1
Description
Rilozul therapy will be performed in group A and after 6 months, sensory, motor and pain examinations will be done in all of patients. Rilozul will be administrated 50mg PO (by mouth) every 12 hours continuing for 4 weeks.
Category
Treatment - Drugs
2
Description
Placebo will be administrated to control group and after 6 months, sensory and motor examinations will be done.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital,Tabriz University of Medical Sciences,
Full name of responsible person
Atta Mahdkhah
Street address
Golgasht St, Azadi Ave, Tabriz, Iran
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Tabriz University of Medical Sciences
Full name of responsible person
Ali Meshkini
Street address
Vice chancellor for research, Tabriz University of Medical Sciences, Golgasht St, Azadi Ave, Tabriz, Iran
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Tabriz 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Atta Mahdkhah
Position
Neurosurgery Resident
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences, Golgash St, Azadi Ave, Tabriz, Iran
City
Tabriz
Postal code
5165687386
Phone
+98 41 1332 6196
Fax
Email
mahdkhah@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Atta Mahdkhah
Position
Neurosurgery Resident
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences, Golgasht St, Azadi Ave, Tabriz, Iran
City
Tabriz
Postal code
5165687386
Phone
+98 41 1332 6196
Fax
Email
mahdkhah@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)