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

Autism Spectrum Disorders research study

What is the primary objective of this study?

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

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Autism Spectrum Disorders

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Riluzole

Drug:placebo

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

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

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

Study Status

Completed

Start Date: September 2013

Completed Date: May 2015

Phase: Phase 2/Phase 3

Type: Interventional

Design:

Primary Outcome: Clinical Global Impression-Improvement

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Logan Wink, MD

Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02081027

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