1. A Randomized Placebo-Controlled Cross-Over Pilot Study of Riluzole for Drug-Refractory Irritability in Autism Spectrum Disorder.
- Author
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Wink LK, Adams R, Horn PS, Tessier CR, Bantel AP, Hong M, Shaffer RC, Pedapati EV, and Erickson CA
- Subjects
- Adolescent, Adult, Autism Spectrum Disorder diagnosis, Child, Cross-Over Studies, Double-Blind Method, Excitatory Amino Acid Antagonists pharmacology, Female, Humans, Irritable Mood physiology, Male, Pilot Projects, Riluzole pharmacology, Treatment Outcome, Young Adult, Autism Spectrum Disorder drug therapy, Autism Spectrum Disorder psychology, Excitatory Amino Acid Antagonists therapeutic use, Irritable Mood drug effects, Riluzole therapeutic use
- Abstract
Riluzole is a glutamatergic modulator of particular interest in autism spectrum disorder (ASD). In this 12-week randomized, double-blind, placebo-controlled, crossover pilot study we evaluated the safety and tolerability of 5-week of adjunctive riluzole treatment (vs. 5-week of placebo, with 2-week washout period) targeting ASD-associated drug-refractory irritability in eight individuals age 12-25 years. All participants tolerated riluzole 200 mg per day, however there were no statistically significant findings for the overall treatment effect, the treatment effect by week within period of the study, or a cross-over effect across the periods of the study on the Clinical Global Impression Improvement Scale or the Aberrant Behavior Checklist Irritability subscale. The results of this trial indicate that 5-week of riluzole treatment was well tolerated, but had no significant effect on the target symptoms. Trial Registration ClinicalTrials.gov Identifier NCT02081027, Registered 5 August 2013, First participant enrolled 19 September 2013.
- Published
- 2018
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