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

Sponsor
Children's Hospital Medical Center, Cincinnati (Other)
Overall Status
Completed
CT.gov ID
NCT02081027
Collaborator
(none)
8
Enrollment
1
Location
2
Arms
19.4
Actual Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Early Phase 1

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
8 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Basic Science
Official Title:
A Randomized, Double-Blind, Placebo-Controlled, Cross-Over Pilot Study of Riluzole for Drug-Refractory Irritability in Autism Spectrum Disorders
Actual Study Start Date :
Sep 19, 2013
Actual Primary Completion Date :
Apr 1, 2015
Actual Study Completion Date :
May 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Riluzole

The maximum dose of riluzole to be used in this study is 200 mg per day divided BID

Drug: Riluzole
Other Names:
  • Other name: Rilutek

    		•
    Placebo Comparator: Placebo

    Placebo will be administered in the same manner as the riluzole group, in order to maintain subject assignment throughout the study.

    Other: placebo

    Outcome Measures

    Primary Outcome Measures

    1. 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

    2. Aberrant Behavior Checklist- Irritability [Change between baseline and end of each phase]

      A parent questionnaire measuring five behavioral domains

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years to 25 Years
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cincinnati Children's Hospital Medical Center Cincinnati Ohio United States 45229

    Sponsors and Collaborators

    • Children's Hospital Medical Center, Cincinnati

    Investigators

    • Principal Investigator: Logan Wink, MD, Children's Hospital Medical Center, Cincinnati

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Children's Hospital Medical Center, Cincinnati
    ClinicalTrials.gov Identifier:
    NCT02081027
    Other Study ID Numbers:
    • CIN001- Riluzole in Autism
    First Posted:
    Mar 7, 2014
    Last Update Posted:
    Jan 14, 2021
    Last Verified:
    Apr 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Autistic Disorder
    Autism Spectrum Disorder
    Child Development Disorders, Pervasive
    Riluzole

    Study Results

    No Results Posted as of Jan 14, 2021