Phase 2 Multiple Sclerosis Trial, Recruiting NCT06081348 Sponsor: Holland Bloorview Kids Rehabilitation Hospital Condition: Multiple Sclerosis
Back to Multiple Sclerosis

Phase 2 Multiple Sclerosis Trial, Recruiting

NCT06081348
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Children and teenagers between 8 and 17 years old who are not currently staying in a hospital
  • Girls who could become pregnant, are sexually active, and agree to use an approved form of birth control during the study and for at least one week after the last dose of study medication
  • Young people who have been diagnosed with Autism Spectrum Disorder (ASD), ADHD, Tic Disorders, Fragile X syndrome, tuberous sclerosis, or a 22q11 deletion
  • Young people who also have a diagnosed anxiety disorder, such as Separation Anxiety, Social Anxiety, Agoraphobia, Generalized Anxiety Disorder, or another anxiety condition identified through a clinical interview
  • Young people whose anxiety is rated as at least "moderately severe" by a clinician using a standard rating scale
  • Young people who can speak at least in short phrases — there is no minimum IQ requirement for this trial
  • Young people already taking behaviour-affecting medications, as long as the dose has been stable for at least one month before the study and will not be changed during the study
  • Young people already receiving non-medication behavioural support, as long as it has been stable for at least three months before the study and will not be changed during the study
  • Young people (or their caregivers) who are able to complete assessments in English or French

Who may not be able to join:

  • Young people who have taken another type of antidepressant medication called an SSRI within the past four weeks (or six weeks for fluoxetine specifically)
  • Young people who have previously tried sertraline (the study medication) at an adequate dose and either had no improvement or experienced significant side effects
  • Young people who have already tried more than two different SSRI medications without adequate benefit
  • Girls who are pregnant or sexually active without using adequate birth control
  • Young people with a serious medical condition that the study doctor believes could interfere with the study or put them at risk; this includes people with diabetes who take medication to control blood sugar levels
  • Young people who are allergic to sertraline or any of its ingredients
  • Young people currently taking certain other medications, including a type called MAO inhibitors or a medication called pimozide
  • Young people taking other medications known to significantly affect heart rhythm in a way the study doctor considers unsafe
  • Young people with a known inherited condition that causes a heart rhythm problem called long QT syndrome
  • Young people with certain health conditions including HIV, hepatitis B or C, hemophilia, abnormal blood pressure, substance misuse, immune system disorders, a current major depressive episode, or psychosis
  • Young people who are unable to tolerate having a blood sample taken by needle
  • Young people who are unable to swallow capsules
  • Young people who are currently enrolled in another intervention research study

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Dr. Evdokia Anagnostou, Holland Bloorview Kids Rehab Hospital

Phone: 4164256220

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Holland Bloorview Kids Rehabilitation Hospital
Registry
ClinicalTrials.gov
Start date
16 September 2024
Est. completion
1 September 2026

Where this trial is recruiting

🇨🇦 Canada

Primary endpoints

The Screen for Child Anxiety Related Emotional Disorders (SCARED) - parent version

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov