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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Children's Hospital Medical Center, Cincinnati
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT02081027
First received: August 5, 2013
Last updated: March 5, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention Phase
Autism Spectrum Disorders
Drug: Riluzole
Drug: placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Cross-Over Pilot Study of Riluzole for Drug-Refractory Irritability in Autism Spectrum Disorders

Resource links provided by NLM:


Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:
  • Clinical Global Impression-Improvement [ Time Frame: Change from baseline to end of week 14 ] [ Designated as safety issue: No ]
  • Aberrant Behavior Checklist- Irritability [ Time Frame: Change between baseline and end of each phase ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: June 2013
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Riluzole
The maximum dose of riluzole to be used in this study is 200 mg per day divided BID
Drug: Riluzole
Other Name: 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.
Drug: placebo

  Eligibility

Ages Eligible for Study:   12 Years to 26 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02081027

Contacts
Contact: Katie Friedmann, RN 513-636-0523 psychautism@cchmc.org

Locations
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Katie Friedmann, RN    513-636-0523    autism@cchmc.org   
Principal Investigator: Logan Wink, MD         
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
Principal Investigator: Logan Wink, MD Children's Hospital Medical Center, Cincinnati
  More Information

No publications provided

Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT02081027     History of Changes
Other Study ID Numbers: CIN001- Riluzole in Autism
Study First Received: August 5, 2013
Last Updated: March 5, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders
Riluzole
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on August 26, 2014