deltatrials
Completed PHASE2/PHASE3 INTERVENTIONAL 2-arm NCT02231008

Evaluating the Effects of Tasimelteon vs Placebo on Sleep Disturbances in SMS

A Double-blind, Randomized, Two-period Crossover Study Evaluating the Effects of Tasimelteon vs. Placebo on Sleep Disturbances of Individuals With Smith-Magenis Syndrome (SMS)

Sponsor: Vanda Pharmaceuticals

Updated 7 times since 2017 Last updated: Nov 15, 2022 Started: Sep 30, 2015 Primary completion: Nov 19, 2018 Completion: Jan 31, 2022
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE2/PHASE3 clinical study on Circadian and Smith-Magenis Syndrome, this trial is completed. The trial is conducted by Vanda Pharmaceuticals and has accumulated 7 data snapshots since 2015. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotRecruiting~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshotRecruiting~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotUnknown Status~Jan 2021 – ~Dec 2022 · 23 months · monthly snapshotUnknown Status~Dec 2022 – ~Jul 2024 · 19 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 23 months · monthly snapshotCompleted

Change History

7 versions recorded
  1. Sep 2024 — Present [monthly]

    Completed PHASE2/PHASE3

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2/PHASE3

    Phase: PHASE2_PHASE3PHASE2/PHASE3

  3. Dec 2022 — Jul 2024 [monthly]

    Completed PHASE2_PHASE3

    Status: Unknown StatusCompleted

  4. Jan 2021 — Dec 2022 [monthly]

    Unknown Status PHASE2_PHASE3

  5. Jun 2018 — Jan 2021 [monthly]

    Unknown Status PHASE2_PHASE3

    Status: RecruitingUnknown Status

Show 2 earlier versions
  1. Feb 2017 — Jun 2018 [monthly]

    Recruiting PHASE2_PHASE3

  2. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE2_PHASE3

    First recorded

Sep 2015

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Vanda Pharmaceuticals
Data source: Vanda Pharmaceuticals

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