deltatrials
Completed PHASE2 INTERVENTIONAL 2-arm NCT01661855

A Pilot Study of Riluzole Versus Placebo in the Treatment of Children and Adolescents With ASD (RILISE)

A Pilot Study of Riluzole vs. Placebo in the Treatment of Children and Adolescents With Autism Spectrum Disorders

Sponsor: Holland Bloorview Kids Rehabilitation Hospital

Interventions Placebo Riluzole
Updated 7 times since 2017 Last updated: Jul 14, 2025 Started: Sep 30, 2013 Primary completion: Sep 30, 2015 Completion: Oct 31, 2015
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT01661855, this PHASE2 trial focuses on Autism Spectrum Disorders and remains completed. Sponsored by Holland Bloorview Kids Rehabilitation Hospital, it has been updated 7 times since 2013, reflecting limited change activity. Mental health research at this phase helps define safety and dosing parameters for future study.

Status Flow

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Oct 2021 · 9 months · monthly snapshotCompleted~Oct 2021 – ~Jul 2024 · 33 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Aug 2025 · 11 months · monthly snapshotCompleted~Aug 2025 – present · 11 months · monthly snapshotCompleted

Change History

7 versions recorded
  1. Aug 2025 — Present [monthly]

    Completed PHASE2

  2. Sep 2024 — Aug 2025 [monthly]

    Completed PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  4. Oct 2021 — Jul 2024 [monthly]

    Completed PHASE2

  5. Jan 2021 — Oct 2021 [monthly]

    Completed PHASE2

Show 2 earlier versions
  1. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE2

  2. Jan 2017 — Jun 2018 [monthly]

    Completed PHASE2

    First recorded

Sep 2013

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Holland Bloorview Kids Rehabilitation Hospital
  • McMaster University
  • The Hospital for Sick Children
  • The University of Western Ontario
  • Unity Health Toronto
  • University of Toronto
Data source: Holland Bloorview Kids Rehabilitation Hospital

For direct contact, visit the study record on ClinicalTrials.gov .