Autism Spectrum Disorders
Conditions
Brief summary
Determine if riluzole shows evidence of efficacy, safety, and tolerability targeting drug-refractory irritability (DRI) in persons with autism spectrum disorders (ASD).
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
DRUGRiluzole
OTHERplacebo
Sponsors
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to 25 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Global Impression-Improvement | 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 | Change between baseline and end of each phase | A parent questionnaire measuring five behavioral domains |
Countries
United States
Outcome results
None listed