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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02081027
Other study ID # CIN001- Riluzole in Autism
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
Start date September 19, 2013
Est. completion date May 2015

Study information

Verified date April 2017
Source Children's Hospital Medical Center, Cincinnati
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Riluzole

Other:
placebo


Locations

Country Name City State
United States Cincinnati Children's Hospital Medical Center Cincinnati Ohio

Sponsors (1)

Lead Sponsor Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

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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