Autism Spectrum Disorders Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled, Cross-Over Pilot Study of Riluzole for Drug-Refractory Irritability in Autism Spectrum Disorders
Verified date | April 2017 |
Source | Children's Hospital Medical Center, Cincinnati |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Determine if riluzole shows evidence of efficacy, safety, and tolerability targeting drug-refractory irritability (DRI) in persons with autism spectrum disorders (ASD).
Status | Completed |
Enrollment | 8 |
Est. completion date | May 2015 |
Est. primary completion date | April 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 25 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital Medical Center, Cincinnati |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical Global Impression-Improvement | A clinician-rated global assessment of symptom change rated on a scale from 1 to 7 | Change from baseline to end of week 12 | |
Primary | Aberrant Behavior Checklist- Irritability | A parent questionnaire measuring five behavioral domains | Change between baseline and end of each phase |
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