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NCT04419272 · ClinicalTrials.gov registry record · Phase 4

Methylphenidate for the Treatment of Epilepsy-related Cognitive Deficits

A Phase 4 study of Epilepsy, sponsored by VA Office of Research and Development.

Recruiting
Registry status
Phase 4
Development phase
226
Enrollment target
4
Study locations

NCT04419272 is a Phase 4 study of Epilepsy that is actively recruiting participants, run by VA Office of Research and Development. The registered enrollment target is 226 participants, below the 951-participant average among 160 other Epilepsy trials with a reported enrollment target (76% lower). The trial reports 4 study locations across 4 states.

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The verdict

NCT04419272, a Phase 4 study of Epilepsy, is actively recruiting participants, sponsored by VA Office of Research and Development.

RECRUITING
Registry status
Phase 4
Development phase
226 participants
Enrollment target
4
Study locations

Study Summary

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.

Conditions Studied

Interventions

  • OTHER Placebo
  • DRUG Methylphenidate

Study Locations (4)

Florida

  • Miami VA Healthcare System, Miami, FL - Miami

Massachusetts

  • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA - Boston

New York

  • VA NY Harbor Healthcare System, New York, NY - New York

Oregon

  • VA Portland Health Care System, Portland, OR - Portland

Trial Details

FieldValue
Enrollment Target 226 participants
Start Date 2023-08-14
Est. Completion 2027-09-30
Phase Phase 4

Sponsor

VA Office of Research and Development

1,668 total trials

What the Registry Record Tells You About NCT04419272

The ClinicalTrials.gov registry entry for NCT04419272 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 226 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 951-participant average among 160 other Epilepsy trials with a reported enrollment target (76% lower). The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Epilepsy appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT04419272 reports 4 study locations spanning 4 distinct geographic areas - top geographies include Florida, Massachusetts, New York.

Frequently Asked Questions

What is clinical trial NCT04419272 about?

NCT04419272 is a clinical study titled "Methylphenidate for the Treatment of Epilepsy-related Cognitive Deficits". 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...

What is the current status of trial NCT04419272?

This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 226 participants. The study started on 2023-08-14. Estimated completion is 2027-09-30.

What conditions does trial NCT04419272 study?

This clinical trial studies the following conditions: Epilepsy.

What interventions are being tested in trial NCT04419272?

The interventions under investigation include: Placebo (OTHER), Methylphenidate (DRUG).

Who is sponsoring clinical trial NCT04419272?

This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04419272 being conducted?

This trial has 4 study locations across Florida, Massachusetts, New York, Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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