Methylphenidate for the Treatment of Epilepsy-related Cognitive Deficits

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

• Epilepsy

Interventions

DRUG

Methylphenidate

10mg twice per day, at 8am and 12pm, for one week, then increased to 20mg twice daily, at 8am and 12pm, for the next 7 weeks during the double-blinded period.

OTHER

Placebo

When assigned to receive the placebo during the double-blinded period, subjects will be given a sugar pill for 8 weeks. The sugar pill will be taken twice per day, at 8am and 12pm.

DRUG

Methylphenidate

During the open-label extension phase, dosing will begin at 10mg twice per day, at 8am and 12pm, for one week. The dosage will then increase to 20mg twice daily, at 8am and 12pm, for the next 7 weeks.

Sponsors & Collaborators

• VA New York Harbor Healthcare System

  collaborator FED

• Portland VA Medical Center

  collaborator FED

• Miami VA Healthcare System

  collaborator FED

• VA Boston Healthcare System

  collaborator FED

• VA Office of Research and Development

  lead FED

Principal Investigators

• Beth A Leeman-Markowski, MD · VA NY Harbor Healthcare System, New York, NY

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-08-14

Primary Completion

2028-05-31

Completion

2028-05-31

FDA Drug

Yes

Countries

• United States

Study Locations