Spinal Cord InjuryNCT00876889
Safety of Riluzole in Patients With Acute Spinal Cord Injury
An observational study of Spinal Cord Injury, run by The Methodist Hospital Research Institute at 8 sites in 2 countries.
Trial summary
The purpose of the study is to find out if the use of the drug Riluzole is both safe and improves outcome in patients with acute traumatic spinal cord injury (SCI). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Riluzole
- Type of treatment
- Pill or oral medicine
- How many people
- 36 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Apr 2010to Apr 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Admitted to a NACTN hospital
Who may be able to join
- Age equal to or greater than 18 years and less than or equal to 70 years;
- Willing to give written informed consent to participate in the study. The informed consent may require legally authorized representative to sign if arm/hand function is compromised.
- No other life-threatening injury
- Spinal cord injury at the neurologic level from C4 to T12
- ASIA Impairment Scale level A, B or C
- No cognitive impairment which would preclude an informed consent (including moderate or severe traumatic brain injury)
- Less than 12 hours since injury
Who cannot join
- Equal or more than 12 hours since injury
- Hypersensitivity to riluzole or any of its components
- Unable to receive riluzole orally or via nasogastric tube
- History of liver or kidney disease (e.g. Hepatitis A, B or C, Cirrhosis, etc.)
- Has a recent history of regular substance abuse (illicit drugs, alcohol)
- Unconscious
Show all 15Show fewer
- Penetrating spinal cord injury
- Pregnancy as established by urine pregnancy test
- Breastfeeding
- Life expectancy less than 12 months
- Is currently involved in another therapeutic SCI research study that precludes or complicates participation in this study (e.g. study of another therapeutic drug aiming for spinal cord injury recovery, any study that substantially interferes with the follow -up schedule (f/u) schedule, or any high risk study that complicates evaluation of safety outcomes. Types of studies that would not preclude participation are e.g. behavioral adaptation studies, mental health interventions)
- Has a mental disorder or other illness, which in the view of the site investigator, would preclude accurate evaluation (e.g. schizophrenia, severe cognitive disability, Parkinson disease)
- Unable to commit to the follow-up schedule
- Is a prisoner
- Unable to converse, read or write English at the elementary school level
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United States7 sites
University of Maryland Medical Center
Baltimore, Maryland, 21201
University of Virginia Health System
Charlottesville, Virginia, 22903
The Methodist Hospital
Houston, Texas, 77030
The University of Texas
Houston, Texas, 77030
University of Louisville Health Sciences Center
Louisville, Kentucky, 40205
University of Miami
Miami, Florida, 33136
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Canada1 site
University of Toronto/Toronto Western Hospital
Toronto, Ontario, M5T-2S8
About this study
Official title: Safety and Pharmacokinetics of Riluzole in Patients With Traumatic Acute Spinal Cord Injury
The purpose of the study is to find out if the use of the drug Riluzole is both safe and improves outcome in patients with acute traumatic spinal cord injury (SCI).
Read the detailed description
The primary aim of the study is to develop acute care safety and pharmacokinetic profiles of riluzole in patients who have sustained a acute traumatic spinal cord injury. Secondary objectives are to conduct exploratory analyses of functional outcomes for purposes of planning a subsequent Phase II randomized study of the efficiency of Riluzole for the treatment of acute traumatic spinal cord injury.
- Conditions
- Spinal Cord Injury
- Being tested
- Riluzole
- Keywords
- spinal cord injury, riluzole, pharmacokinetics, Acute Traumatic Spinal Cord Injury
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RiluzoleDrug
Also called Rilutek
50mg PO (by mouth) every 12 hours starting within 12 hours of injury and continuing for 14 days (28 doses).
What is being measured
The primary outcome is the main question the study is designed to answer.
American Spinal Injury Association Impairment Scale
Neurological assessment and classification of spinal cord injury
Measured: Baseline, days 3 and 14, 6 weeks, 3 and 6 months and unscheduled follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2009 (estimated)
- Study startApr 2010
- Primary completionJun 2011
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by The Methodist Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Methodist Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Christopher Reeve Paralysis Foundation, United States Department of Defense, AO Clinical Investigation and Publishing Documentation, Ontario Neurotrauma Foundation
- Responsible party
- Principal investigator, Robert G. Grossman, MD, The Methodist Hospital Research Institute
- Investigators
- Robert G Grossman, MD, Study chair, The Methodist Hospital Research InstituteMichael Fehlings, MD, PhD, Principal investigator, University of Toronto/Toronto Western Hospital, TorontoMichele M Johnson, MD, Principal investigator, the University of Houston/Memorial HermannHospital, HoustonChristopher Shaffery, MD, Principal investigator, University of Virginia Health System, CharlottesvilleSusan Harkema, PhD, Principal investigator, University of Louisville, LouisvilleBizhan Aarabi, MD, Principal investigator, University of Maryland Medical Center, BaltimoreJames Harrop, MD, Principal investigator, Thomas Jefferson University, PhiladelphiaJames Guest, MD, PhD, Principal investigator, University of Miami, Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00876889
- Sponsor's protocol ID
- Pro00002029
- Other IDs
- W81XWH-07-0042
- Status last verified
- Sep 2017
- First submitted
- 25 Mar 2009
- Last updated
- 12 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Carroll AH, Fakhre E, Quinonez A, Tannous O, Mesfin A. An Update on Spinal Cord Injury and Current Management. JBJS Rev. 2024 Oct 24;12(10). doi: 10.2106/JBJS.RVW.24.00124. eCollection 2024 Oct 1.
PubMed 39446982Chow DS, Nguyen A, Park J, Wu L, Toups EG, Harrop JS, Guest JD, Schmitt KM, Aarabi B, Fehlings MG, Boakye M, Grossman RG. Riluzole in Spinal Cord Injury Study (RISCIS)-Pharmacokinetic (PK) Sub-Study: An Analysis of Pharmacokinetics, Pharmacodynamics, and Impact on Axonal Degradation of Riluzole in Patients With Traumatic Cervical Spinal Cord Injury Enrolled in the RISCIS Phase III Randomized Controlled Trial. J Neurotrauma. 2023 Sep;40(17-18):1889-1906. doi: 10.1089/neu.2022.0499.
PubMed 37130044Nagoshi N, Nakashima H, Fehlings MG. Riluzole as a neuroprotective drug for spinal cord injury: from bench to bedside. Molecules. 2015 Apr 29;20(5):7775-89. doi: 10.3390/molecules20057775.
PubMed 25939067Fehlings MG, Wilson JR, Frankowski RF, Toups EG, Aarabi B, Harrop JS, Shaffrey CI, Harkema SJ, Guest JD, Tator CH, Burau KD, Johnson MW, Grossman RG. Riluzole for the treatment of acute traumatic spinal cord injury: rationale for and design of the NACTN Phase I clinical trial. J Neurosurg Spine. 2012 Sep;17(1 Suppl):151-6. doi: 10.3171/2012.4.AOSPINE1259.
PubMed 22985381Chow DS, Teng Y, Toups EG, Aarabi B, Harrop JS, Shaffrey CI, Johnson MM, Boakye M, Frankowski RF, Fehlings MG, Grossman RG. Pharmacology of riluzole in acute spinal cord injury. J Neurosurg Spine. 2012 Sep;17(1 Suppl):129-40. doi: 10.3171/2012.5.AOSPINE12112.
PubMed 22985379
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Pharmacokinetics of Riluzole in Patients With Traumatic Acute Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT00876889
- Acronym / sponsor ID
- Pro00002029
- Conditions
- Spinal Cord Injury
- Keywords
- spinal cord injury, riluzole, pharmacokinetics, Acute Traumatic Spinal Cord Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- The Methodist Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Christopher Reeve Paralysis Foundation, United States Department of Defense, AO Clinical Investigation and Publishing Documentation, Ontario Neurotrauma Foundation
- Study start
- Apr 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 7 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to find out if the use of the drug Riluzole is both safe and improves outcome in patients with acute traumatic spinal cord injury (SCI).
Detailed description
The primary aim of the study is to develop acute care safety and pharmacokinetic profiles of riluzole in patients who have sustained a acute traumatic spinal cord injury. Secondary objectives are to conduct exploratory analyses of functional outcomes for purposes of planning a subsequent Phase II randomized study of the efficiency of Riluzole for the treatment of acute traumatic spinal cord injury.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Admitted to a NACTN hospital
Key inclusion criteria (7 listed)
- Age equal to or greater than 18 years and less than or equal to 70 years;
- Willing to give written informed consent to participate in the study. The informed consent may require legally authorized representative to sign if arm/hand function is compromised.
- No other life-threatening injury
- Spinal cord injury at the neurologic level from C4 to T12
- ASIA Impairment Scale level A, B or C
Key exclusion criteria (15 listed)
- Equal or more than 12 hours since injury
- Hypersensitivity to riluzole or any of its components
- Unable to receive riluzole orally or via nasogastric tube
- History of liver or kidney disease (e.g. Hepatitis A, B or C, Cirrhosis, etc.)
- Has a recent history of regular substance abuse (illicit drugs, alcohol)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RiluzoleAlso: Rilutek50mg PO (by mouth) every 12 hours starting within 12 hours of injury and continuing for 14 days (28 doses). | Drug | – |
Primary outcome
American Spinal Injury Association Impairment Scale
Time frame: Baseline, days 3 and 14, 6 weeks, 3 and 6 months and unscheduled follow-up
Neurological assessment and classification of spinal cord injury
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2017.
- Derived from this study: PubMed 39446982Carroll AH, Fakhre E, Quinonez A, Tannous O, Mesfin A. An Update on Spinal Cord Injury and Current Management. JBJS Rev. 2024 Oct 24;12(10). doi: 10.2106/JBJS.RVW.24.00124. eCollection 2024 Oct 1.
- Derived from this study: PubMed 37130044Chow DS, Nguyen A, Park J, Wu L, Toups EG, Harrop JS, Guest JD, Schmitt KM, Aarabi B, Fehlings MG, Boakye M, Grossman RG. Riluzole in Spinal Cord Injury Study (RISCIS)-Pharmacokinetic (PK) Sub-Study: An Analysis of Pharmacokinetics, Pharmacodynamics, and Impact on Axonal Degradation of Riluzole in Patients With Traumatic Cervical Spinal Cord Injury Enrolled in the RISCIS Phase III Randomized Controlled Trial. J Neurotrauma. 2023 Sep;40(17-18):1889-1906. doi: 10.1089/neu.2022.0499.
- Derived from this study: PubMed 25939067Nagoshi N, Nakashima H, Fehlings MG. Riluzole as a neuroprotective drug for spinal cord injury: from bench to bedside. Molecules. 2015 Apr 29;20(5):7775-89. doi: 10.3390/molecules20057775.
- Derived from this study: PubMed 22985381Fehlings MG, Wilson JR, Frankowski RF, Toups EG, Aarabi B, Harrop JS, Shaffrey CI, Harkema SJ, Guest JD, Tator CH, Burau KD, Johnson MW, Grossman RG. Riluzole for the treatment of acute traumatic spinal cord injury: rationale for and design of the NACTN Phase I clinical trial. J Neurosurg Spine. 2012 Sep;17(1 Suppl):151-6. doi: 10.3171/2012.4.AOSPINE1259.
- Derived from this study: PubMed 22985379Chow DS, Teng Y, Toups EG, Aarabi B, Harrop JS, Shaffrey CI, Johnson MM, Boakye M, Frankowski RF, Fehlings MG, Grossman RG. Pharmacology of riluzole in acute spinal cord injury. J Neurosurg Spine. 2012 Sep;17(1 Suppl):129-40. doi: 10.3171/2012.5.AOSPINE12112.
- The Reeve Foundation is dedicated to curing spinal cord injury by funding innovative research, and improving the quality of life for people living with paralysis through grants, information and advocacy. Click here for more information about the network.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert G Grossman, MD study chair
The Methodist Hospital Research Institute
Michael Fehlings, MD, PhD principal investigator
University of Toronto/Toronto Western Hospital, Toronto
Michele M Johnson, MD principal investigator
the University of Houston/Memorial HermannHospital, Houston
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injury, run by The Methodist Hospital Research Institute at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
American Spinal Injury Association Impairment Scale (time frame: Baseline, days 3 and 14, 6 weeks, 3 and 6 months and unscheduled follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00876889, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2017.