Study Design
In a single-center, open-label, single-dose, randomized, 5-period, crossover, comparative bioavailability study, healthy participants (n=32), under fasting conditions, were randomized to receive
In fact, 7 out of 10 patients newly diagnosed with ALS are prescribed riluzole each year.7,a
aAs based on IQVIA/NBRX data 01/20-12/20.
Two pivotal clinical trials found that riluzole, compared with placebo, increased the time to death or tracheostomy in patients with ALS.3
Original RILUTEK study design 13
Study 1 was a randomized, double-blind, placebo-controlled clinical study that enrolled 155 patients with either familial or sporadic ALS, a disease duration of less than 5 years, and a baseline forced vital capacity ≥ 60% of normal. Patients were randomized to receive riluzole 50 mg tablets twice daily (n=77) or placebo (n=78) and were followed for at least 13 months (up to a maximum duration of 18 months). The clinical outcome measure was time to tracheostomy or death.
Original RILUTEK study design 23
Study 2 was a randomized, double-blind, placebo-controlled clinical study that enrolled 959 patients with either familial or sporadic ALS, a disease duration of less than 5 years, and a baseline forced vital capacity ≥ 60% of normal. Patients were randomized to riluzole 50 mg tablets twice daily (n=236) or placebo (n=242) and were followed for at least 12 months (up to a maximum duration of 18 months). The clinical outcome measure was time to tracheostomy or death.
Adverse reactions in pooled placebo-controlled trials (studies 1 and 2) in patients with ALS1
Riluzole Tablets (RILUTEK) 50 mg Twice daily (N=313) |
Placebo (N=320) | |
---|---|---|
Asthenia | 19 | 12 |
Nausea | 16 | 11 |
Decreased lung function | 10 | 9 |
Hypertension | 5 | 4 |
Abdominal pain | 5 | 4 |
Vomiting | 4 | 2 |
Arthralgia | 4 | 3 |
Dizziness | 4 | 3 |
Dry mouth | 4 | 3 |
Insomnia | 4 | 3 |
Pruitus | 4 | 3 |
Tachycardia | 3 | 1 |
Flatulence | 3 | 2 |
Increased cough | 3 | 2 |
Peripheral edema | 3 | 2 |
Urinary tract infection | 3 | 2 |
Circumoral paresthesia | 2 | 0 |
Somnolence | 2 | 1 |
Vertigo | 2 | 1 |
Eczema | 2 | 1 |
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Learn MoreImportant Safety Information
Contraindication
Warnings and Precautions
Hepatic Injury
The use of
Neutropenia
Interstitial Lung Disease
Adverse Reactions
The most common adverse reactions (incidence greater than or equal to 5% and greater than placebo) of
Drug Interactions
Coadministration of
Coadministration of
Use in Specific Populations
Based on animal data, riluzole may cause fetal harm. Women should be advised of a possible risk to the fetus associated with use of
Japanese patients are more likely to have higher riluzole concentrations, and thus may be at a greater risk of adverse reactions.
To report suspected adverse reactions or product complaints, contact Mitsubishi Tanabe Pharma America, Inc. at 1-888-292-0058. You may also report suspected adverse reactions to the FDA at 1-800-FDA-1088 or
Indication
Please see the full
Prescribing Information for