Dogs Who Received Riluzole Two Ways Fared Well in ALS Study

Dogs Who Received Riluzole Two Ways Fared Well in ALS Study

In a study using dogs, the combination of infusing riluzole directly into the spinal cord and also taking it orally increased the concentration of the medication in the spinal cord significantly, compared to oral administration alone.

The results of the study suggest that this combination therapy may increase its benefits in the treatment of amyotrophic lateral sclerosis (ALS) without increasing the risk of adverse side effects.

The study, “Intrathecal Riluzole for the Treatment of Patients With Amyotrophic Lateral Sclerosis,” was published recently in the journal Neurosurgery. It also is scheduled to be presented in October at the 2019 Congress of Neurological Surgeons Annual Meeting in San Francisco.

Riluzole (brand name Rilutek when dispensed in tablets, and Tiglutik when dispensed as oral liquid) is the first treatment approved by the U.S. Food and Drug Administration (FDA) that is known to help improve the survival of ALS patients.

Studies have demonstrated that oral riluzole has modest effectiveness and the dose at which it is administered is limited by hepatic (liver) toxicity and asthenia (abnormal physical weakness or lack of energy).

When administered orally, the amount of riluzole that actually reaches the nerve cells for which it is intended is decreased.

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So, researchers sought to determine if continuous intrathecal (IT) delivery (infused directly into the spinal fluid) of low daily doses of riluzole could increase concentration of the drug in the spinal cord well above those that are achievable with oral treatment alone, without increasing the side effects.

Researchers used purpose-bred hound dogs that were administered oral riluzole in combination with one of three IT doses that were given through continuous infusion.

Then, the concentration of riluzole in the blood, spinal cord and brain were measured, along with an assessment of safety and tolerability.

Researchers conducted the assessments at two time points, six weeks and 24 weeks post-treatment.

Results from the six-week study showed that when oral and IT delivery methods were combined, there was a significant increase in the concentration of the drug in the spinal cord, compared to what would have been achieved through oral riluzole alone.

Additionally, researchers found that all three IT doses in combination with oral riluzole were well-tolerated by the animals.

Results from the six-month study, in which the lowest dose from the six-week study was dropped and a higher dose was added, showed that the highest dose of IT riluzole was not well-tolerated by the dogs.

The authors concluded that continuous IT administration of riluzole — when combined with oral administration — increases the concentration of the drug in the spinal cord significantly more than is achievable by oral therapy alone.

Importantly, this increase in drug concentration occurs without increasing the risk for adverse side effects that are associated with constant drug exposure or off-target side effects in the brain.

The researchers added that the combined riluzole therapy may safely enhance neuroprotection and boost the drug’s benefits through improved delivery into the spinal cord. “With a careful selection of IT doses, it could be implemented in patients with ALS,” they wrote.

Iqra holds a MSc in Cellular and Molecular Medicine from the University of Ottawa in Ottawa, Canada. She also holds a BSc in Life Sciences from Queen’s University in Kingston, Canada. Currently, she is completing a PhD in Laboratory Medicine and Pathobiology from the University of Toronto in Toronto, Canada. Her research has ranged from across various disease areas including Alzheimer’s disease, myelodysplastic syndrome, bleeding disorders and rare pediatric brain tumors.
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Margarida graduated with a BS in Health Sciences from the University of Lisbon and a MSc in Biotechnology from Instituto Superior Técnico (IST-UL). She worked as a molecular biologist research associate at a Cambridge UK-based biotech company that discovers and develops therapeutic, fully human monoclonal antibodies.
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Iqra holds a MSc in Cellular and Molecular Medicine from the University of Ottawa in Ottawa, Canada. She also holds a BSc in Life Sciences from Queen’s University in Kingston, Canada. Currently, she is completing a PhD in Laboratory Medicine and Pathobiology from the University of Toronto in Toronto, Canada. Her research has ranged from across various disease areas including Alzheimer’s disease, myelodysplastic syndrome, bleeding disorders and rare pediatric brain tumors.
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8 comments

  1. Roxanne Kusske says:

    So what I’m getting from this report is that the drug helps you live longer, but in what stage? My husband is in the beginning stages of ALS, and told me he doesn’t want to live longer if he’s in the late stages of the disease. Is there any studies or medicine that can help him live longer in the beginning or middle stages of ALS?

  2. Márcia Valeria Araújo says:

    Hi! Good afternoon! Great news, thanks! My diagnosis of 6 years, draws attention in medicine, because it comes from the gen VAPB (mutation of traditional E.L.A) and the way of evolution little slower than known or studied cases. So I have been available to participate in research. I am Brazilian and I am currently in Florida, USA. In case of interest, my email will be below. When would it be ready for use, the one presented in the survey? How can we, E.L.A carriers, have access without wasting time? Thank you! Sorry about the English I use translator to leave this message. Marcia Valeria [email protected]

  3. Clare Crawley says:

    What this does not say is if it helps slow or halt disease progression – just that the dogs tolerated the increased dose and that it was administered differently . Makes one wonder about some of this research and who funds it .

  4. Raj says:

    Also… what about the side effects previously mentioned about liver and/or kidney. does taking oral and through IV .. still have those ?

  5. Can increasing this medication intrathecally improve quality of life? Are ALS patients to live with an intrathecal catheter or receive regular infusions (outside of a cushy research setting sponsored by a well-to-do Sponsor)? What kind of life is intrathecal catheter when the insurance industry is in-charge of physicians and hospitals who are willing to dump paralyzed patients, leaving them alone in the dark unsupervised after being escorted via hospital paratransit services? what happens when they need follow-up care from complications such as dehydration, infection and leakage of spinal fluid? is this just driving up the cost of care? How can this pass feasibility testing in this population?

    Did the dogs let researchers know how their mood, memory and attention span responded to increasing this medication in the CNS? Is combined creatine and trimethlyglycine a safer, equally effective intervention for maintaining the intracellular hydration of muscle cells deteriorating from damaged motor neurons? Is merely extending the cruelest months of a patient’s life ethical? Is this real research for the patient or is it research for research-sake?
    Would the intranasal delivery of riluzole have been a better use of research funds? All this and more…chat with me through my website

  6. J Sprague says:

    If they implant a device for delivery into the spinal canal it might work. This would be like they do heart pacer or the new setup they use for diabetes.

    Questions already asked are good, how does this work on late stage? If this were begun in early stages, how long could it be expected to prolong survival?

    Good questions, will anyone reply?

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