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Autism Spectrum DisordersPhase 2TIDENCT02586935

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

A Phase 2 study testing Tideglusib in people with Autism Spectrum Disorders, run by Holland Bloorview Kids Rehabilitation Hospital at 3 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages 12 to 17 years
Conditions the study is for
Autism Spectrum Disorders
What is being tested?
Tideglusib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
83 participants
Where
3 sitesCanada
Study dates
10 Feb 2016to 25 Feb 2018
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Outpatients 12-17 years of age inclusive with a mental age equivalent ≥ 18 months at Screening.
  • Weigh a minimum of 30 kg (the 3rd percentile for 12 years of age)
  • 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.
  • Have a Clinician's Global Impression-Severity (CGI-S) score ≥ 4 (moderately ill) at Screening.
  • 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
  • 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
  • Have normal physical examination and laboratory test results at Screening. If abnormal, the finding(s) must be deemed clinically insignificant by the Investigator.
  • 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.

Who cannot join

  • Patients with a primary psychiatric diagnosis other than ASD
  • Pregnant female patients; sexually active female patients on inadequate birth control.
  • Patients with known phosphatase and tensin homolog (PTEN) mutations as they are unlikely to respond to this medication
  • 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.).
  • 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).
  • Patients with hypersensitivity to tideglusib or any components of its formulation.
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  • Patients unable to tolerate venipuncture procedures for blood sampling.
  • Patients actively enrolled in another intervention study.
  • Patients who have elevated liver enzymes ≥ 3 times the normal amount before the study begins.
  • Patients who have serum creatinine of >150 μmol/L and creatinine clearance ≤60ml/m (according to Cockcroft-Gault formula) at Screening.
  • Patients taking strong CYP3A4 inhibitors (e.g. clarithromycin, telithromycin, ketoconazole, itraconazole, posaconazole, nefazodone, indinavir, ritonavir)
  • Inability to speak and understand English sufficiently enough to allow for the completion of all study assessments (parent; patient, if verbal).

Trial locations and contacts

3 sites in 1 country.

Canada3 sites

  • McMaster University, Offord Centre for Child Studies

    Hamilton, Ontario, L8S 4K1

  • University of Western Ontario, Lawson Health Research Institute

    London, Ontario, N6A 5W9

  • Holland Bloorview Kids Rehabilitation Hospital

    Toronto, Ontario, M4G 1R8

Other trials in Canada

About this study

Official title: A Randomized Placebo-controlled Trial of Tideglusib vs. Placebo in the Treatment of Adolescents With Autism Spectrum Disorders (ASD)

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

Read the 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.

Being tested
Tideglusib, Placebo
Keywords
ASD, Autism
Medical subject headings
Autism Spectrum Disorder, Autistic Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TideglusibDrug

    Administered orally after dispersion in approximately 100 ml of water at dose levels of 400 to 1000 mg

  • PlaceboOther

    Administered orally after dispersion in approximately 100 ml of water

Study groups in NCT02586935
Study groupRoleWhat they receive
TideglusibActive comparatorNot described
Receives: Drug: Tideglusib
PlaceboPlacebo comparatorNot described
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Effect of tideglusib vs. placebo on measures of social engagement/withdrawal

    This will be measured by the Aberrant Behavior Checklist (ABC) - Lethargy / Social Withdrawal Subscale

    Measured: 12 weeks

Secondary outcomes (8)

  1. Efficacy of tideglusib vs. placebo on measures of repetitive behaviours

    This will be measured by the Child Yale-Brown Obsessive Compulsive Scale (CY-BOCS)

    Measured: 12 weeks

  2. Efficacy of tideglusib vs. placebo on measures of repetitive behaviours

    This will be measured by the Repetitive Behavior Scale (RBS-R)

    Measured: 12 weeks

  3. Efficacy of tideglusib vs. placebo on measures of social function

    This will be measured by the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) - Socialization Domain

    Measured: 12 weeks

  4. Safety and tolerability of tideglusib in adolescents with ASD

    This will be measured by the Clinical Global Impressions - Improvement Scale - Global (CGI-I-Global)

    Measured: 12 weeks

  5. Safety and tolerability of tideglusib in adolescents with ASD

    This will be measured by the Safety Monitoring Uniform Report Form (SMURF)

    Measured: 12 weeks

  6. Pharmacokinetic (PK) parameters in this age group

    This will be completed by measuring / calculating Cmax (Peak Plasma Concentration)

    Measured: 12 weeks

  7. Pharmacokinetic (PK) parameters in this age group

    This will be completed by measuring / calculating C0-6 (Steady State Plasma Concentration)

    Measured: 12 weeks

  8. Pharmacokinetic (PK) parameters in this age group

    This will be completed by measuring / calculating Area Under the Curve (AUC)

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2015 (estimated)
  2. Study start10 Feb 2016
  3. Primary completion25 Feb 2018
  4. Study completion25 Feb 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
83 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02586935
Sponsor's protocol ID
TIDE-06-2015
Acronym
TIDE
Status last verified
May 2018
First submitted
16 Oct 2015
Last updated
16 Jul 2025
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tideglusib in people with Autism Spectrum Disorders, run by Holland Bloorview Kids Rehabilitation Hospital at 3 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effect of tideglusib vs. placebo on measures of social engagement/withdrawal (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02586935.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.

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