Pilot Study of Riluzole for Drug-Refractory Irritability in Autism Spectrum Disorders

Overview

Determine if riluzole shows evidence of efficacy, safety, and tolerability targeting drug-refractory irritability (DRI) in persons with autism spectrum disorders (ASD).

Full Title of Study: “A Randomized, Double-Blind, Placebo-Controlled, Cross-Over Pilot Study of Riluzole for Drug-Refractory Irritability in Autism Spectrum Disorders”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Basic Science
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: April 2015

Detailed Description

A randomized, double blind, placebo-controlled, 12-week cross-over study (5-week treatment periods with 2-week washout) of adjunctive riluzole in 12 persons with ASD and DRI between the ages of 12 and 25 years.

Interventions

  • Drug: Riluzole
  • Other: placebo

Arms, Groups and Cohorts

  • Experimental: Riluzole
    • The maximum dose of riluzole to be used in this study is 200 mg per day divided BID
  • Placebo Comparator: Placebo
    • Placebo will be administered in the same manner as the riluzole group, in order to maintain subject assignment throughout the study.

Clinical Trial Outcome Measures

Primary Measures

  • Clinical Global Impression-Improvement
    • Time Frame: Change from baseline to end of week 12
    • A clinician-rated global assessment of symptom change rated on a scale from 1 to 7
  • Aberrant Behavior Checklist- Irritability
    • Time Frame: Change between baseline and end of each phase
    • A parent questionnaire measuring five behavioral domains

Participating in This Clinical Trial

Inclusion Criteria

  • Age ≥ 12 and < 26 years. – Weight greater than 50 kg. – Diagnosis of ASD – Drug-refractory irritability, as defined as screening ABC Irritability subscale (ABC-I) score of ≥18 AND 1) failure of clinically adequate treatment trials of both aripiprazole and risperidone or 2) failure of at least three previous clinically adequate drug trials targeting irritability (one trial must include aripiprazole or risperidone), as confirmed by caregiver reports and medical record review when available. – Stable dosing of all concomitant psychotropic medications (including those targeting irritability) for four weeks prior to screening visit and during the study. – Presence of parent/guardian willing to serve as informant for behavioral outcome measures and shipping control sample for Extracellular Signal-Related Kinase biomarker (ERK) assay. Exclusion Criteria:

  • Current use of more than two concomitant psychotropic drugs targeting irritability. – Current use of valproic acid. – Current use of drugs with known interaction with riluzole – Current use of drugs with concomitant glutamatergic or glutamatergic- modulating action medications. – For female subjects of child bearing potential, a positive serum pregnancy test. – History of pancreatitis. – Hemoglobin less than or equal to 8.0 gm/dL. – Neutropenia with absolute neutrophil count less than or equal to 1.0 K/mcL. – Problems with kidney functioning, as assessed by lab work – Any major chronic medical or chronic respiratory illness considered to be uncontrolled by the Principal Investigator.

Gender Eligibility: All

Minimum Age: 12 Years

Maximum Age: 25 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Children’s Hospital Medical Center, Cincinnati
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Logan Wink, MD, Principal Investigator, Children’s Hospital Medical Center, Cincinnati

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