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Rilutek (Riluzole) - Summary

 
 



RILUTEK SUMMARY

RILUTEK® (riluzole) is a member of the benzothiazole class.

RILUTEK is indicated for the treatment of patients with amyotrophic lateral sclerosis (ALS). Riluzole extends survival and/or time to tracheostomy.


See all Rilutek indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Rilutek (Riluzole)

The effectiveness of ALS drugs may be improved by blocking blood-brain barrier proteins
Source: Muscular Dystrophy / ALS News From Medical News Today [2014.12.04]
Through research in mice, scientists have found that proteins at the blood-brain barrier pump out riluzole, the only FDA-approved drug for ALS, or Lou Gehrig's disease, limiting the drug's...

Blocking molecules involved in ALS-drug resistance may improve how well ALS therapeutics work
Source: Muscular Dystrophy / ALS News From Medical News Today [2014.11.24]
Amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease, is a neurodegenerative disease that primarily kills motor neurons, leading to paralysis and death 2 to 5 years from diagnosis.

New Lou Gehrig's disease study shows that blocking ALS mutation in the brain slowed disease initiation and progression
Source: Muscular Dystrophy / ALS News From Medical News Today [2014.11.13]
Lou Gehrig's disease, also known as amyotrophic lateral sclerosis, or ALS, might damage muscle-controlling nerve cells in the brain earlier in the disease process than previously known, according to...

Small set of genes identified that are critical in aging and neurodegenerative disease
Source: Muscular Dystrophy / ALS News From Medical News Today [2014.11.05]
Aging is the most significant and universal risk factor for developing neurodegenerative diseases, such as amyotrophic lateral sclerosis (ALS) and Alzheimer's, Parkinson's and Huntington's diseases.

more news >>

Published Studies Related to Rilutek (Riluzole)

12-week, placebo-controlled trial of add-on riluzole in the treatment of childhood-onset obsessive-compulsive disorder. [2014]
Many children with childhood-onset obsessive-compulsive disorder (OCD) fail to respond adequately to standard therapies... However, future studies may show benefits for less treatment-refractory children with fewer concomitant medications.

Riluzole decreases flexion withdrawal reflex but not voluntary ankle torque in human chronic spinal cord injury. [2011.06]
The objectives of this study were to probe the contribution of spinal neuron persistent sodium conductances to reflex hyperexcitability in human chronic spinal cord injury... These results suggest that intrinsic spinal cellular excitability could be a target for managing chronic spinal cord injury hyperreflexia impairments without causing a significant loss in volitional strength.

Safety and efficacy of lithium in combination with riluzole for treatment of amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled trial. [2010.05]
BACKGROUND: In a pilot study, lithium treatment slowed progression of amyotrophic lateral sclerosis (ALS). We aimed to confirm or disprove these findings by assessing the safety and efficacy of lithium in combination with riluzole in patients with ALS... INTERPRETATION: We found no evidence that lithium in combination with riluzole slows progression of ALS more than riluzole alone. The time-to-event endpoint and use of prespecified interim analyses enabled a clear result to be obtained rapidly. This design should be considered for future trials testing the therapeutic efficacy of drugs that are easily accessible to people with ALS. FUNDING: National Institute of Neurological Disorders and Stroke, ALS Association, and ALS Society of Canada. Copyright 2010 Elsevier Ltd. All rights reserved.

Riluzole in cerebellar ataxia: a randomized, double-blind, placebo-controlled pilot trial. [2010.03.09]
BACKGROUND: The pleiotropic effects of riluzole may antagonize common mechanisms underlying chronic cerebellar ataxia, a debilitating and untreatable consequence of various diseases... CONCLUSIONS: These findings indicate the potential effectiveness of riluzole as symptomatic therapy in diverse forms of cerebellar ataxia. Classification of evidence: This study provides Class I evidence that riluzole reduces, by at least 5 points, the ICARS score in patients with a wide range of disorders that cause cerebellar ataxia (risk difference 63.2%, 95% CI 33.5%-79.9%).

Riluzole for relapse prevention following intravenous ketamine in treatment-resistant depression: a pilot randomized, placebo-controlled continuation trial. [2010.02]
The N-methyl-D-aspartate (NMDA) glutamate receptor antagonist ketamine may have rapid, albeit transient, antidepressant properties. This study in patients with treatment-resistant major depression (TRD) aimed to (1) replicate the acute efficacy of single-dose intravenous (i.v.) ketamine; (2) test the efficacy of the glutamate-modulating agent riluzole in preventing post-ketamine relapse; and (3) examine whether pretreatment with lamotrigine would attenuate ketamine's psychotomimetic effects and enhance its antidepressant activity.

more studies >>

Clinical Trials Related to Rilutek (Riluzole)

Riluzole Augmentation in Treatment-refractory Obsessive-compulsive Disorder [Recruiting]
Obsessive-compulsive disorder (OCD) affects 2-3% of the population and leads to a great deal of suffering. Many patients benefit from established treatments, the mainstay of which are cognitive behavioral therapy and a group of antidepressant medications known as serotonin reuptake inhibitors. However, 20-30% of patients get minimal benefit from these established therapeutic strategies. New avenues of treatment are urgently needed.

Existing medications for obsessive-compulsive disorder affect the neurotransmitters serotonin or dopamine; but increasing evidence suggests that functional disruptions of a different neurotransmitter, glutamate, may contribute to some cases of OCD. The investigators are therefore interested in using medications that target glutamate as novel treatment options for those OCD patients who do not benefit from established treatments.

One such medication is the drug riluzole, which is FDA approved for amyotrophic lateral sclerosis (ALS), or Lou Gehrig's disease, but may be of benefit to patients with psychiatric disorders due to its ability to moderate excessive glutamate. In preliminary studies, in which the investigators treated patients with riluzole (in addition to their established pharmacological regimen) in an open-label fashion (that is, without a placebo-treated control group), the investigators have found about 40-50% of patients to substantially improve over 2-3 months.

While immensely promising, these preliminary studies do not prove riluzole is truly a new beneficial medication for the treatment of OCD; a more rigorous placebo-controlled trial is needed for that purpose. The investigators are therefore now recruiting patients to participate in a double-blind, placebo-controlled trial of riluzole, added to whatever other OCD medications they are taking.

Riluzole and Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases [Recruiting]
RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. Drugs, such as riluzole, may make tumor cells more sensitive to radiation therapy. Giving riluzole together with whole-brain radiation therapy may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of riluzole when given together with whole-brain radiation therapy in treating patients with brain metastases.

Developing New Treatments for Tourette Syndrome: Therapeutic Trials With Modulators of Glutamatergic Neurotransmission [Recruiting]

A joint NIH - Tourette Syndrome Association Conference has emphasized the critical need for

the testing and development of new pharmacotherapy for tic suppression in Tourette syndrome (TS). This submission is a safety, tolerability and efficacy pilot study using two medications that modulate glutamate neurotransmission, riluzole, a glutamate antagonist, and D-serine, a glutamate agonist. Glutamate is the primary excitatory neurotransmitter in the central nervous system, an essential component of pathways implicated in TS and an extensive modulator of dopamine, the major neurotransmitter associated with tics.

This is a single site, short-term, proof of concept study of riluzole and D-serine for the treatment of tics. Each medication will be evaluated and compared to placebo as part of a double-blind, randomized, parallel, flexible dose, three-arm, 8-week, treatment protocol (D-serine, riluzole, or placebo). A total of sixty patients (age 8-17 years) with TS and moderate to moderately-severe tics will receive study medication according to a 2: 1 (dopamine modulating drug: placebo), randomized schedule, i. e., riluzole (n=24), D-serine (n=24), placebo (n=12). The primary outcome measure is tic suppression as determined by changes in the Total Tic Subscore of the Yale Global Tic Severity Scale (YGTSS). Secondary tic outcome measures include changes in the YGTSS Total Score and two Global Impression Scales. Further, since both riluzole and D-serine have been proposed as treatments for obsessive-compulsive behaviors, a TS comorbidity, these symptoms will be followed. Safety measures include serial physical examinations, vital signs, laboratory studies (comprehensive metabolic panel, complete blood count, plasma amino acids, and urine analyses), documentation of side effects and adverse events, and measurement of changes in ADHD, depression and anxiety.

This pilot investigation will provide important proof-of-concept data on glutamate therapies for TS and, in turn, evidence for large-scale, multicenter clinical trials.

Safety of Riluzole in Patients With Acute Spinal Cord Injury [Recruiting]
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).

Riluzole to Treat Child and Adolescent Obsessive-Compulsive Disorder With or Without Autism Spectrum Disorders [Recruiting]
This study will examine the effectiveness of riluzole for treating Obsessive-Compulsive Disorder in Youth, Including those with Autism Spectrum Disorders.

more trials >>

Reports of Suspected Rilutek (Riluzole) Side Effects

Death (4)Pyrexia (3)Agranulocytosis (3)Respiratory Failure (3)Confusional State (2)Pulse Abnormal (2)Pallor (2)Hypokalaemia (2)OFF Label USE (2)Weight Increased (2)more >>


Page last updated: 2014-12-04

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