deltatrials
Terminated PHASE2 INTERVENTIONAL 3-arm NCT01348607

Methylphenidate HCl or Modafinil in Treating Young Patients With Excessive Daytime Sleepiness After Cancer Therapy

A Randomized, Phase II Placebo-controlled Study of the Use of Extended-release Methylphenidate or Modafinil for the Treatment of Excessive Daytime Sleepiness in Children Following Cancer Therapy

Sponsor: National Cancer Institute (NCI)

Updated 9 times since 2017 Last updated: Jan 23, 2014 Started: Jul 31, 2010 Primary completion: Nov 30, 2012 Completion: Dec 31, 2012
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Study only randomized 1 subject and was determined not feasible by DSMB

Listed as NCT01348607, this PHASE2 trial focuses on Central Nervous System Tumor, Pediatric and Fatigue and remains terminated or withdrawn. Sponsored by National Cancer Institute (NCI), it has been updated 9 times since 2010, reflecting limited change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotTerminated~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshotTerminated~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotTerminated~Jan 2021 – ~Dec 2021 · 11 months · monthly snapshotTerminated~Dec 2021 – ~Dec 2022 · 12 months · monthly snapshotTerminated~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshotTerminated~Jan 2023 – ~Jul 2024 · 18 months · monthly snapshotTerminated~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotTerminated~Sep 2024 – present · 21 months · monthly snapshotTerminated

Change History

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

    Terminated PHASE2

  2. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE2

  3. Jan 2023 — Jul 2024 [monthly]

    Terminated PHASE2

  4. Dec 2022 — Jan 2023 [monthly]

    Terminated PHASE2

  5. Dec 2021 — Dec 2022 [monthly]

    Terminated PHASE2

Show 4 earlier versions
  1. Jan 2021 — Dec 2021 [monthly]

    Terminated PHASE2

  2. Jun 2018 — Jan 2021 [monthly]

    Terminated PHASE2

  3. Feb 2017 — Jun 2018 [monthly]

    Terminated PHASE2

  4. Jan 2017 — Feb 2017 [monthly]

    Terminated PHASE2

    First recorded

Jul 2010

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • National Cancer Institute (NCI)
  • University of South Florida
Data source: University of South Florida

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

Study Locations

No location information available.