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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-19

Study Completion Date

2015-05-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Autism Spectrum Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Riluzole

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

Group Type EXPERIMENTAL

Riluzole

Intervention Type DRUG

Placebo

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

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

Interventions

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Riluzole

Intervention Type DRUG

placebo

Intervention Type OTHER

Other Intervention Names

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Other name: Rilutek

Eligibility Criteria

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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.

Minimum Eligible Age

12 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No