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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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IRCT |
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Last refreshed on:
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22 February 2018 |
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Main ID: |
IRCT2014031813947N3 |
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Date of registration:
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2014-07-16 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The effect of riluzole on spinal cord injury
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Scientific title:
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The effect of riluzole on motor and sensory function of patients with post- traumatic acute spinal cord injury |
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Date of first enrolment:
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2014-03-20 |
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Target sample size:
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60 |
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Recruitment status: |
Complete |
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URL:
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http://en.irct.ir/trial/13663 |
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Study type:
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interventional |
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Study design:
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Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.
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Phase:
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2
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Countries of recruitment
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Iran (Islamic Republic of)
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Atta Mahdkhah
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Address:
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Tabriz University of Medical Sciences, Golgash St, Azadi Ave, Tabriz, Iran
5165687386
Tabriz
Iran (Islamic Republic of) |
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Telephone:
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+98 41 1332 6196 |
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Email:
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mahdkhah@yahoo.com |
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Affiliation:
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Tabriz University of Medical Sciences |
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Key inclusion & exclusion criteria
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Inclusion 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
Exclusion criteria:
Age minimum:
18 years
Age maximum:
70 years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Injury of nerves and lumbar spinal cord at abdomen, lower back and pelvis level
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Spinal injury.
Injury of nerves and lumbar spinal cord at abdomen, lower back and pelvis level
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Intervention(s)
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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.
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Intervention 1: 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. Intervention 2: Placebo will be administrated to control group and after 6 months, sensory and motor examinations will be done.
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Treatment - Drugs
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Placebo
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Placebo will be administrated to control group and after 6 months, sensory and motor examinations will be done.
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Primary Outcome(s)
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Pain. Timepoint: Primary, 6 weeks and 6 months following end of treatment. Method of measurement: Visual Analog Scale.
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Sensory injury. Timepoint: Primary, 6 weeks and 6 months following end of treatment. Method of measurement: Frankel classification.
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Motor injury. Timepoint: Primary, 6 weeks and 6 months following end of treatment. Method of measurement: Frankel classification.
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Secondary Outcome(s)
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Side effects. Timepoint: Primary, 6 weeks and 6 months following end of treatment. Method of measurement: Physical examination.
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Source(s) of Monetary Support
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Vice Chancellor for research of Tabriz University of Medical Sciences
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Ethics review
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Status: Approved
Approval date:
Contact:
Ethics committee of Tabriz University of Medical Sciences
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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