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Tideglusib vs. Placebo in the Treatment of Adolescents With Autism Spectrum Disorders (TIDE)

This study is currently recruiting participants.
See Contacts and Locations
Verified March 2017 by Evdokia Anagnostou, Anagnostou, Evdokia, M.D.
Sponsor:
Collaborators:
Holland Bloorview Kids Rehabilitation Hospital
McMaster University
University of Western Ontario, Canada
St. Michael's Hospital, Toronto
University of Toronto
Information provided by (Responsible Party):
Evdokia Anagnostou, Anagnostou, Evdokia, M.D.
ClinicalTrials.gov Identifier:
NCT02586935
First received: October 16, 2015
Last updated: March 17, 2017
Last verified: March 2017
  Purpose
This study will examine the safety and efficacy of tideglusib vs. placebo for the treatment of core symptom domains in adolescents with Autism Spectrum Disorders

Condition Intervention Phase
Autism Spectrum Disorders Drug: Tideglusib Other: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Placebo-controlled Trial of Tideglusib vs. Placebo in the Treatment of Adolescents With Autism Spectrum Disorders (ASD)

Resource links provided by NLM:


Further study details as provided by Evdokia Anagnostou, Anagnostou, Evdokia, M.D.:

Primary Outcome Measures:
  • Effect of tideglusib vs. placebo on measures of social engagement/withdrawal [ Time Frame: 12 weeks ]
    This will be measured by the Aberrant Behavior Checklist (ABC) - Lethargy / Social Withdrawal Subscale


Secondary Outcome Measures:
  • Efficacy of tideglusib vs. placebo on measures of repetitive behaviours [ Time Frame: 12 weeks ]
    This will be measured by the Child Yale-Brown Obsessive Compulsive Scale (CY-BOCS)

  • Efficacy of tideglusib vs. placebo on measures of repetitive behaviours [ Time Frame: 12 weeks ]
    This will be measured by the Repetitive Behavior Scale (RBS-R)

  • Efficacy of tideglusib vs. placebo on measures of social function [ Time Frame: 12 weeks ]
    This will be measured by the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) - Socialization Domain

  • Safety and tolerability of tideglusib in adolescents with ASD [ Time Frame: 12 weeks ]
    This will be measured by the Clinical Global Impressions - Improvement Scale - Global (CGI-I-Global)

  • Safety and tolerability of tideglusib in adolescents with ASD [ Time Frame: 12 weeks ]
    This will be measured by the Safety Monitoring Uniform Report Form (SMURF)

  • Pharmacokinetic (PK) parameters in this age group [ Time Frame: 12 weeks ]
    This will be completed by measuring / calculating Cmax (Peak Plasma Concentration)

  • Pharmacokinetic (PK) parameters in this age group [ Time Frame: 12 weeks ]
    This will be completed by measuring / calculating C0-6 (Steady State Plasma Concentration)

  • Pharmacokinetic (PK) parameters in this age group [ Time Frame: 12 weeks ]
    This will be completed by measuring / calculating Area Under the Curve (AUC)


Estimated Enrollment: 90
Study Start Date: December 2015
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Tideglusib Drug: Tideglusib
Administered orally after dispersion in approximately 100 ml of water at dose levels of 400 to 1000 mg
Placebo Comparator: Placebo Other: Placebo
Administered orally after dispersion in approximately 100 ml of water

Detailed Description:
There are no pharmacologic treatments available for social function deficits in individuals with Autism Spectrum Disorders (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 re-uptake 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 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 tideglusib for core and associated symptom domains of autism, and will explore biological markers of safety and treatment response. As there is no juvenile toxicity published in the animal model, we will limit the age range to 12 years of age and older.
  Eligibility

Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Outpatients 12-17 years of age inclusive with a mental age equivalent ≥ 18 months at Screening.
  2. Weigh a minimum of 30 kg (the 3rd percentile for 12 years of age)
  3. Meet Diagnostic and Statistical Manual of Mental Disorders. Diagnostic and Statistical Manual (DSM-5) criteria will be established by a clinician with expertise with individuals with ASD.
  4. Have a Clinician's Global Impression-Severity (CGI-S) score ≥ 4 (moderately ill) at Screening.
  5. If already receiving stable concomitant medications affecting behaviour, have stable regimens with no changes during the preceding 1 month prior to Screening (with the exception of fluoxetine, where a period of 6 weeks is needed), and will not electively initiate new or modify ongoing medications for the duration of the study
  6. If already receiving stable non-pharmacological educational and behavioural interventions, have continuous participation during the preceding 3 months prior to Screening, and not electively initiate new or modify ongoing interventions for the duration of the study
  7. Have normal physical examination and laboratory test results at Screening. If abnormal, the finding(s) must be deemed clinically insignificant by the Investigator.
  8. 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.

Exclusion Criteria:

  1. Patients with a primary psychiatric diagnosis other than ASD
  2. Pregnant female patients; sexually active female patients on inadequate birth control.
  3. Patients with known phosphatase and tensin homolog (PTEN) mutations as they are unlikely to respond to this medication
  4. Patients with 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. Patients with 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.).
  5. Patients with unstable epilepsy (i.e. seizures occurring within the last 6 months), or patients with epilepsy who are not on stable doses of antiepileptic medications (i.e. dose changes within the last 3 months).
  6. Patients with hypersensitivity to tideglusib or any components of its formulation.
  7. Patients unable to tolerate venipuncture procedures for blood sampling.
  8. Patients actively enrolled in another intervention study.
  9. Patients who have elevated liver enzymes ≥ 3 times the normal amount before the study begins.
  10. Patients who have serum creatinine of >150 μmol/L and creatinine clearance ≤60ml/m (according to Cockcroft-Gault formula) at Screening.
  11. Patients taking strong CYP3A4 inhibitors (e.g. clarithromycin, telithromycin, ketoconazole, itraconazole, posaconazole, nefazodone, indinavir, ritonavir)
  12. Inability to speak and understand English sufficiently enough to allow for the completion of all study assessments (parent; patient, if verbal).
  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: NCT02586935

Contacts
Contact: Evdokia Anagnostou, M.D. eanagnostou@hollandbloorview.ca
Contact: Vanessa Ballin, M.Sc. 416-425-6220 ext 6602 vballin@hollandbloorview.ca

Locations
Canada, Ontario
McMaster University, Offord Centre for Child Studies Recruiting
Hamilton, Ontario, Canada, L8S 4K1
Contact: Nancy Selman, M.D.    905-521-2100 ext 21261    selmann@mcmaster.ca   
Principal Investigator: Terry Bennett, M.D.         
University of Western Ontario, Lawson Health Research Institute Recruiting
London, Ontario, Canada, N6A 5W9
Contact: Ahsan Ahmad, M.D.    (519) 685-8500 ext 74906    ahsan.ahmad@lhsc.on.ca   
Principal Investigator: Robert Nicolson, M.D.         
Holland Bloorview Kids Rehabilitation Hospital Recruiting
Toronto, Ontario, Canada, M4G 1R8
Contact: Naomi Peleg, M.Sc    416-425-6220 ext 3456    npeleg@hollandbloorview.ca   
Principal Investigator: Evdokia Anagnostou, M.D.         
Sponsors and Collaborators
Evdokia Anagnostou
Holland Bloorview Kids Rehabilitation Hospital
McMaster University
University of Western Ontario, Canada
St. Michael's Hospital, Toronto
University of Toronto
Investigators
Principal Investigator: Evdokia Anagnostou, M.D. Holland Bloorview Kids Rehabilitation Hospital
Principal Investigator: Terry Bennett, M.D. MacMaster University, Offord Centre for Child Studies
Principal Investigator: Robert Nicolson, M.D. University of Western Ontario, Lawson Health Research Institute
  More Information

Responsible Party: Evdokia Anagnostou, Principal Investigator, Anagnostou, Evdokia, M.D.
ClinicalTrials.gov Identifier: NCT02586935     History of Changes
Other Study ID Numbers: TIDE-06-2015
Study First Received: October 16, 2015
Last Updated: March 17, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Evdokia Anagnostou, Anagnostou, Evdokia, M.D.:
ASD
Autism

Additional relevant MeSH terms:
Disease
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 20, 2017