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Trial record 5 of 11 for:    arbaclofen autism

Arbaclofen vs. Placebo in the Treatment of Children and Adolescents With ASD (ARBA) (ARBA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03887676
Recruitment Status : Active, not recruiting
First Posted : March 25, 2019
Last Update Posted : June 22, 2022
Sponsor:
Collaborators:
Holland Bloorview Kids Rehabilitation Hospital
McMaster University
University of Western Ontario, Canada
Queen's University
Unity Health Toronto
University of Toronto
Information provided by (Responsible Party):
Evdokia Anagnostou, Anagnostou, Evdokia, M.D.

Tracking Information
First Submitted Date  ICMJE March 21, 2019
First Posted Date  ICMJE March 25, 2019
Last Update Posted Date June 22, 2022
Actual Study Start Date  ICMJE March 18, 2019
Estimated Primary Completion Date August 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 22, 2019)
Vineland Adaptive Behavior Scales, Third Edition (Vineland-3) - Social Domain [ Time Frame: 16 weeks ]
To examine the effect of arbaclofen vs. placebo social function
Original Primary Outcome Measures  ICMJE
 (submitted: March 21, 2019)
Effect of arbaclofen vs. placebo on social function [ Time Frame: 16 weeks ]
This will be measured by the Vineland Adaptive Behavior Scales, Third Edition (Vineland-3) - Social Domain
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 22, 2019)
  • Clinical Global Impressions - Impression Scale - Improvement (CGI-I) [ Time Frame: 16 weeks ]
    To examine the effect of arbaclofen vs. placebo on measures of global function
  • Aberrant Behavior Checklist (ABC) - Social Withdrawal Subscale [ Time Frame: 16 weeks ]
    To examine the effect of arbaclofen vs. placebo on social withdrawal
  • Vineland Adaptive Behavior Scales, Third Edition (Vineland-3) - Communication Domain [ Time Frame: 16 weeks ]
    To examine the effect of arbaclofen vs. placebo on communication
  • Safety Monitoring Uniform Report Form (SMURF) [ Time Frame: 16 weeks ]
    To examine the safety and tolerability of arbaclofen in children and adolescents with ASD
  • Clinical Global Impressions - Impression Scale - Global (CGI-I-Global) [ Time Frame: 16 weeks ]
    To examine the safety and tolerability of arbaclofen in children and adolescents with ASD
  • Epworth Sleepiness Scale for Children and Adolescents (ESS-CHAD) [ Time Frame: 16 weeks ]
    To examine the safety and tolerability of arbaclofen in children and adolescents with ASD
  • Suicidality assessment using the Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 16 weeks ]
    To examine the safety and tolerability of arbaclofen in children and adolescents with ASD
Original Secondary Outcome Measures  ICMJE
 (submitted: March 21, 2019)
  • Effect of arbaclofen vs. placebo on measures of global function [ Time Frame: 16 weeks ]
    This will be measured by the Clinical Global Impressions - Impression Scale - Improvement (CGI-I)
  • Effect of arbaclofen vs. placebo on social withdrawal [ Time Frame: 16 weeks ]
    This will be measured by the Aberrant Behavior Checklist (ABC) - Social Withdrawl Subscale
  • Effect of arbaclofen vs. placebo on communication [ Time Frame: 16 weeks ]
    This will be measured by Vineland Adaptive Behavior Scales, Third Edition (Vineland-3) - Communication Domain
  • Safety and tolerability of arbaclofen in children and adolescents with ASD [ Time Frame: 16 weeks ]
    This will be measured by the Clinical Global Impressions - Impression Scale - Global (CGI-I-Global)
  • Safety and tolerability of arbaclofen in children and adolescents with ASD [ Time Frame: 16 weeks ]
    This will be measured by the Safety Monitoring Uniform Report Form (SMURF)
  • Safety and tolerability of arbaclofen in children and adolescents with ASD [ Time Frame: 16 weeks ]
    This will be measured by the Epworth Sleepiness Scale for Children and Adolescents (ESS-CHAD)
  • Safety and tolerability of arbaclofen in children and adolescents with ASD [ Time Frame: 16 weeks ]
    This will be measured by the Suicidality assessment using the Columbia-Suicide Severity Rating Scale (C-SSRS)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Arbaclofen vs. Placebo in the Treatment of Children and Adolescents With ASD (ARBA)
Official Title  ICMJE A Randomized Placebo-controlled Trial of ARBaclofen vs. Placebo in the Treatment of Children and Adolescents With ASD
Brief Summary This study will examine the safety and efficacy of arbaclofen vs. placebo on social function in children and adolescents with Autism Spectrum Disorder (ASD).
Detailed Description There are no pharmacologic treatments available for social function deficits in individuals with ASD. The data for pharmacologic treatment of repetitive behaviours in this disorder has also become difficult to interpret given that the last two large multisite trials of selective serotonin reuptake inhibitors (SSRIs) in autism are reported to be negative for the treatment of repetitive behaviours. Only the associated symptom of irritability has 2 drugs with Food and Drug Administration (FDA) indications, whereas no systematic data exists on the pharmacologic treatment of anxiety in ASD, and response to rates to stimulants for hyperactivity are lower than what is seen in Attention Deficit Hyperactivity Disorder (ADHD). In addition, there are no biological markers of treatment response identified in this population at this point. This study will examine the potential efficacy and safety of arbaclofen for social function, and will explore biological markers of safety and treatment response.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Autism Spectrum Disorder
Intervention  ICMJE
  • Drug: Arbaclofen
    Administered orally as disintegrating tabs, round, white and beveled edges, at the following strengths: 5mg, 10mg, 15mg and 20mg
  • Other: Placebo
    Administered orally as disintegrating tabs, round, white and beveled edges
Study Arms  ICMJE
  • Active Comparator: Arbaclofen
    Intervention: Drug: Arbaclofen
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: March 21, 2019)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 31, 2022
Estimated Primary Completion Date August 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Outpatients 5-17 years of age inclusive.
  2. Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). DSM-5 criteria will be established by a clinician with expertise with individuals with ASD. Diagnosis will be supported by the Autism Diagnostic Observation Schedule, Second Edition (ADOS-2).
  3. Complex language to qualify for ADOS-2 modules 3 or 4.
  4. If already receiving stable concomitant medications affecting behaviour, have stable regimens with no changes during the preceding 6 weeks prior to Screening, and will not electively initiate new or modify ongoing medications for the duration of the study.
  5. If already receiving stable non-pharmacological educational and behavioural interventions, have continuous participation during the preceding 3 months prior to Screening, and will not electively initiate new or modify ongoing interventions for the duration of the study.
  6. Have normal physical examination and laboratory test results at Screening. If abnormal, the finding(s) must be deemed clinically insignificant by the Investigator.
  7. Ability to obtain written informed consent from the participant, if developmentally appropriate. If a participant does not have the capacity to consent, ability to obtain assent (if developmentally appropriate), as well as written informed consent from their parent(s)/legal guardian(s).

Exclusion Criteria:

  1. Pregnant females; sexually active females on inadequate birth control.
  2. Have a serious medical condition that, based on Investigator judgment, might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being. Have evidence of any significant hematological, endocrine, cardiovascular (including uncorrected symptomatic congenital heart disease), respiratory, renal, hepatic, or gastrointestinal disease, not including mild common pediatric diseases in these areas that are stable (e.g. mild asthma, constipation, etc.).
  3. Have unstable epilepsy (i.e. seizures occurring within the last 6 months), or have epilepsy and not on stable doses of antiepileptic medications (i.e. dose changes within the last 3 months).
  4. Have a history of drug abuse.
  5. Have hypersensitivity to arbaclofen or any components of its formulation.
  6. Unable to tolerate venipuncture procedures for blood sampling.
  7. Actively enrolled in another intervention study.
  8. Taking racemic bacblofen, vigabatrin, tiagapine, riluzole, clobazam or regular benzodiazepine use (prn and hs use is allowed).
  9. Unable to take oral medications.
  10. Known hypersensitivity to racemic baclofen.
  11. Inability to speak and understand English sufficiently enough to allow for the completion of all study assessments (parent/legal guardian; participant).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03887676
Other Study ID Numbers  ICMJE ARB-05-2018
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Evdokia Anagnostou, Anagnostou, Evdokia, M.D.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Evdokia Anagnostou
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Holland Bloorview Kids Rehabilitation Hospital
  • McMaster University
  • University of Western Ontario, Canada
  • Queen's University
  • Unity Health Toronto
  • University of Toronto
Investigators  ICMJE
Principal Investigator: Evdokia Anagnostou, M.D Holland Bloorview Kids Rehabilitation Hospital
Principal Investigator: Robert Nicolson, M.D University of Western Ontario, Lawson Health Research Institute
Principal Investigator: Julia Frei, M.D McMaster University, Offord Centre for Child Studies
Principal Investigator: Muhammad Ayub, M.D Queen's University
PRS Account Anagnostou, Evdokia, M.D.
Verification Date June 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP