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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.


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NEWS HIGHLIGHTS

Media Articles Related to Rilutek (Riluzole)

Amyotrophic Lateral Sclerosis May Involve A Form Of Sudden, Rapid Aging Of The Immune System
Source: Muscular Dystrophy / ALS News From Medical News Today [2009.10.09]
Premature aging of the immune system appears to play a role in the development of amyotrophic lateral sclerosis (ALS), or Lou Gehrig's disease, according to research scientists from the Maxine Dunitz Neurosurgical Institute at Cedars-Sinai Medical Center, the Weizmann Institute of Science in Israel, and Sheba Medical Center in Israel.

Amyotrophic Lateral Sclerosis (ALS)
Source: MedicineNet Peripheral Neuropathy Specialty [2009.04.22]
Title: Amyotrophic Lateral Sclerosis (ALS)
Category: Diseases and Conditions
Created: 12/31/1997
Last Editorial Review: 4/22/2009

Smoking May Now Be Considered An Established Risk Factor For ALS, Also Known As Lou Gehrig's Disease
Source: Genetics News From Medical News Today [2009.11.18]
While previous studies have indicated a "probable" connection between smoking and ALS, a new study published in the Nov. 17, 2009 issue of Neurology®, the medical journal of the American Academy of Neurology, states that smoking may now be considered an "established" risk factor for Amyotrophic Lateral Sclerosis (ALS), also known as Lou Gehrig's disease. The findings come from Baystate Medical Center neurologist Dr.

Smoking May Now Be Considered An Established Risk Factor For ALS
Source: Muscular Dystrophy / ALS News From Medical News Today [2009.11.17]
While previous studies have indicated a "probable" connection between smoking and ALS, a new study published in the Nov. 17, 2009 issue of Neurology®, the medical journal of the American Academy of Neurology, states that smoking may now be considered an "established" risk factor for Amyotrophic Lateral Sclerosis (ALS), also known as Lou Gehrig's disease. The findings come from Baystate Medical Center neurologist Dr.

PUrsuing Novel Stem-Cell Derived Therapy For Lou Gehrig's Disease With $10.8 Million Award
Source: Muscular Dystrophy / ALS News From Medical News Today [2009.10.30]
The Salk Institute has been awarded a $10.8 million grant by the California Institute for Regenerative Medicine (CIRM) for translational research focusing on developing a novel stem-cell based therapy for Amyotrophic Lateral Sclerosis (ALS) - or Lou Gehrig's Disease. Sam Pfaff, Ph.D.

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Published Studies Related to Rilutek (Riluzole)

Riluzole for relapse prevention following intravenous ketamine in treatment-resistant depression: a pilot randomized, placebo-controlled continuation trial. [2009.03.17]
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.

Riluzole treatment, survival and diagnostic criteria in Parkinson plus disorders: the NNIPPS study. [2009.01]
Parkinson plus diseases, comprising mainly progressive supranuclear palsy (PSP) and multiple system atrophy (MSA) are rare neurodegenerative conditions... They can be used to distinguish between PSP and MSA with high accuracy, and should facilitate research into these conditions relatively early in their evolution.

Riluzole in Huntington's disease: a 3-year, randomized controlled study. [2007.09]
OBJECTIVE: We conducted a randomized double-blind trial of riluzole in Huntington's disease to investigate the efficacy of this antiexcitotoxic drug in slowing disease progression... INTERPRETATION: No neuroprotective or beneficial symptomatic effects of riluzole in Huntington's disease were demonstrated. Ann Neurol 2007.

Placebo-controlled trial of riluzole in multiple system atrophy. [2006.10]
We performed a placebo-controlled cross-over trial of riluzole (100 mg b.i.d.) in 10 patients with probable multiple system atrophy (MSA) administering riluzole and placebo for 4 weeks each with a 4-week washout period... A trial assessing the disease-modifying potential of riluzole in MSA is underway.

Prognostic factors for survival in amyotrophic lateral sclerosis patients treated with riluzole. [2005.03]
The objective of this study was to identify prognostic factors for survival in amyotrophic lateral sclerosis from a large prospective observational study performed in France. The study included a cohort of 2069 patients fulfilling broad entry criteria treated with riluzole... The predictive powers of the two scores were similar.

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Clinical Trials Related to Rilutek (Riluzole)

CARE Canadian ALS Riluzole Evaluation [Completed]
Evaluate the efficacy of riluzole 50-mg bid defined by comparing the percentage of riluzole-treated subjects who experienced death, permanently assisted ventilation (PAV) or tracheostomy, to a group of recent historical controls for the treatment of amyotrophic lateral sclerosis (ALS).

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.

Neuroprotection With Riluzole Patients With Early Multiple Sclerosis [Recruiting]
This is a double blind, randomized, parallel group design placebo-controlled mono-center study. Patients will be evaluated within twelve months of CIS onset. Patients with at least 2 silent ovoid T2 bright areas in the deep white matter on their clinic brain MRI scan will be offered participation in the study. Patients will be randomized to oral riluzole or placebo (1: 1). Patient will take 50 mg of riluzole or placebo once a day for one month. If 50 mg once a day is well tolerated, patients will then go on 50 mg twice daily for the rest of the study. They will start Avonex therapy 30 mcg IM once weekly 3 months after study drug (riluzole or placebo) is initiated if their liver function has remained normal.

Forty patients within twelve months of onset CIS onset will be enrolled at UCSF MS Center. Patients will be evaluated every month for the first 12 months and every three months thereafter for a total study duration of 24-month. Enrollment period will last six months.

Riluzole to Treat Depression in Bipolar Disorder [Recruiting]
This study examines if Riluzole, (FDA approved for ALS), will improve symptoms of depression in Bipolar Disorder.

Pupose: This study will examine the safety and effectiveness of riluzole (Rilutek trademark) for short-term treatment of depression symptoms, such as depressed mood, psychomotor retardation, and excessive sleeping in patients with bipolar disease. Riluzole is approved by the Food and Drug Administration (FDA) to treat amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig's disease). Preliminary findings of a study using riluzole to treat acute depression in patients with unipolar depression indicate that it may have antidepressant properties in some patients.

Patients between 18 and 70 years of age with bipolar I or II disorder without psychosis may be eligible for this 8-week study. Candidates must be currently depressed, must have had at least one previous major depressive episode, and must have failed to improve with prior treatment with at least one antidepressant. They will be screened with a medical history, physical examination, electrocardiogram (EKG), blood and urine tests, and psychiatric evaluation. A blood or urine sample will be analyzed for illegal drugs. Women of childbearing potential will have a pregnancy test.

Participants will begin an 8-week course of treatment, starting with a placebo (a sugar pill formulated to look like the active drug) and, at some point, switching to riluzole. In addition to drug treatment, participants will undergo the following procedures:

Physical examination and electrocardiogram (EKG) at the beginning and end of the study;

Weekly check of vital signs (temperature, blood pressure and heart rate);

Weekly 1-hour interviews consisting of psychiatric and psychomotor rating scales to assess treatment response;

Weekly blood tests to measure blood levels of riluzole and evaluate drug side effects.

At the end of the study, participants' psychiatric status will be reassessed and appropriate long-term psychiatric treatment arranged.

Atendemos pacientes de habla hispana.

Safety of Riluzole in Patients With Acute Spinal Cord Injury [Not yet 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).

more trials >>

Page last updated: 2009-11-18

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