Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT04419272 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Methylphenidate for the Treatment of Epilepsy-related Cognitive Deficits

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary and study completion dates: Sep 30, 2027 to May 31, 2028 Eligibility criteria expanded, about 38 wordsv8 Show 1 more changeShow less
    • Eligibility criteria expanded, about 38 words

    See this version in full on ClinicalTrials.gov ↗

  2. Eligibility criteria expanded, about 6 words Study sites revised (4)v7 Show 1 more changeShow less
    • Study sites revised (4)

    See this version in full on ClinicalTrials.gov ↗

  3. Primary completion date: Jun 30, 2027 to Sep 30, 2027 Completion date: Mar 31, 2028 to Sep 30, 2027 · Secondary endpoints: 9 to 12 · Eligibility criteria expanded, about 3 wordsv6 Show 3 more changesShow less
    • Completion date: Mar 31, 2028 to Sep 30, 2027
    • Secondary endpoints: 9 to 12
    • Eligibility criteria expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  4. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jul 1, 2023 to Aug 14, 2023 · Site details revised at 4 of 4 sitesv5 Show 2 more changesShow less
    • Start date changed from estimate of Jul 1, 2023 to Aug 14, 2023
    • Site details revised at 4 of 4 sites
  5. Primary completion date: Dec 31, 2026 to Jun 30, 2027 Start date: Jan 1, 2023 to Jul 1, 2023 · Completion date: Dec 31, 2027 to Mar 31, 2028 · Eligibility criteria shortened, about 14 words · 1 morev4 Show 4 more changesShow less
    • Start date: Jan 1, 2023 to Jul 1, 2023
    • Completion date: Dec 31, 2027 to Mar 31, 2028
    • Eligibility criteria shortened, about 14 words
    • Site details revised at 1 of 4 sites

    See this version in full on ClinicalTrials.gov ↗

Show 2 earlier versionsHide 2 earlier versions
  1. Lead sponsor: VA New York Harbor Healthcare System to VA Office of Research and Development Enrollment target: 77 to 226 · Primary completion date: Mar 2026 to Dec 31, 2026 · Start date: Apr 2022 to Jan 1, 2023 · 9 morev3 Show 12 more changesShow less
    • Enrollment target: 77 to 226
    • Primary completion date: Mar 2026 to Dec 31, 2026
    • Start date: Apr 2022 to Jan 1, 2023
    • Primary endpoint revised
    • Study sites: 3 to 4
    • Completion date: Mar 2027 to Dec 31, 2027
    • Interventions: Methylphenidate (Drug), Placebo (Other) to Methylphenidate (Drug), Methylphenidate (Drug), Placebo (Other)
    • Eligibility criteria shortened, about 287 words
    • Secondary endpoints revised (9)
    • Study description expanded, about 10 words
    • Collaborators: 2 to 4
    • Study arms: 2 to 3

    See this version in full on ClinicalTrials.gov ↗

  2. Study description expanded, about 3 wordsv2 See this version in full on ClinicalTrials.gov ↗
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Methylphenidate (MPH) is a stimulant, FDA-approved for the treatment of attention deficit hyperactivity disorder (ADHD). It is unknown, however, if stimulants would be of benefit for memory and thinking problems due to epilepsy. In this study, participants will be assigned randomly (i.e., by flip of a coin), to a group that takes MPH and a group that takes a placebo (sugar pill). Participants will not know the group to which they have been assigned. Tests of attention and memory will be completed before taking the study pills and at Week 8. All participants will then have the option of taking MPH for the next two months, and attention and memory will be tested again at Week 16. The study will determine whether methylphenidate is helpful for the treatment of attention and memory problems in adults with epilepsy, and whether the medication is safe and beneficial when taken over an extended time period.
Trial Details
NCT Number NCT04419272
Lead Sponsor VA Office of Research and Development
Collaborators: VA New York Harbor Healthcare System, Portland VA Medical Center, Miami VA Healthcare System, VA Boston Healthcare System
Conditions Epilepsy
Enrollment 226 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov