The Reeve Foundation’s North American Clinical Trials Network (NACTN) enrolled its first paralysis patient into the Riluzole Phase I safety study on Monday evening. The purpose of the NACTN study is to determine whether or not Riluzole is safe for patients with acute spinal cord injuries, meaning only recent spinal cord injuries.
If you’re a consistent reader of our blog then you know that our San Diego personal injury firm’s spinal cord injury attorneys love news of new spinal cord injury studies. Studies like these give hope to thousands of people with paraplegia and quadriplegia — even though these are just stage one trials — and hope can be very powerful.
Riluzole could limit damage to severely injured spinal cords.
This tiny molecule forms Riluzole and might one day help prevent paralysis in some acute spinal cord injuries. (Source: sanofi-aventis)
Riluzole is currently used for treatment of amyotrophic lateral sclerosis — known as ALS or Lou Gehrig’s disease — to prolong the life spans of patients. This neuroprotective drug blocks sodium and calcium ions from entering and damaging nerve cells. When lab studies showed that Riluzole effectively limits severe damage to the spinal cord, this paralysis treatment study came to life.
The Riluzole Phase I study will involve 36 spinal cord injury patients and will take place in five to eight different NACTN clinical sites. Here are the requirements to take place in this paralysis study:
- Spinal cord injury patients must be 18-70 years of age.
- Patients with spinal cord injuries must be willing to give written informed consent.
- Patients cannot have any other life-threatening injuries.
- Spinal cord injuries must be at the neurological level from C4 to T12.
- The ASIA Impairment Scale level needs to be A, B or C.
- Patients must be able to receive Riluzole within 12 hours post-spinal cord injury.
- Spinal cord injury patients cannot be pregnant or breast-feeding.
- Patients cannot have substance-abuse problems.
- Penetrating spinal cord injuries are excluded.
According to the Reeve Foundation, this spinal cord injury study will blaze new trails by measuring blood and cerebrospinal fluid levels to see if effective levels of the drug reach the spinal cord and brain as well as check toxicity levels. The Phase I study will also investigate the biochemical and physiological effects of Riluzole on the body as well as what the body does to it.
If the rate of adverse side effects Phase I is not greater than expected, a Phase II study with a larger number of patients with spinal cord injuries will take place. Our spinal cord injury attorneys are rooting for its success.
If you or a loved one have suffered a spinal cord injury or paralysis, please contact our bilingual offices as soon as possible at 1-858-551-2090 for a FREE consultation with an experienced spinal cord injury attorney in San Diego or click here to submit your case for a FREE online review. We handle all cases on a contingency fee basis, which means that you owe nothing until we recover money on your behalf.