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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02081027
• Other study ID #: CIN001- Riluzole in Autism
• Status: Completed
• Phase: Early Phase 1
• 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
• 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.

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autism Spectrum Disorders
• Autistic Disorder
• Child Development Disorders, Pervasive

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

External Links

•   Journal of Autism and Developmental Disorders (2018) 48:3051-3060