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

Completed · Early Phase 1 · Has a placebo group

Conditions studied: Autism Spectrum Disorders

In brief

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

Key facts

Study ID

NCT02081027

Run by

Children's Hospital Medical Center, Cincinnati

People needed

8

Starts

2013-09-19

Expected to finish

2015-05-01

Last updated by the study team

2021-01-14

Who can join

Age: 12 and older, up to 25. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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