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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT02081027
First received: August 5, 2013
Last updated: April 17, 2017
Last verified: April 2017
  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: Participant, Care Provider, 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 ]
  • Aberrant Behavior Checklist- Irritability [ Time Frame: Change between baseline and end of each phase ]

Enrollment: 8
Actual Study Start Date: September 2013
Study Completion Date: May 2015
Primary Completion Date: April 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   (Child, Adult)
Sexes Eligible for Study:   All
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

Locations
United States, Ohio
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
  More Information

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: April 17, 2017

Additional relevant MeSH terms:
Disease
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders
Riluzole
Anticonvulsants
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 June 26, 2017