CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 55 enrolled
Drug / intervention
Methylphenidatedrug
Likely dose
Methylphenidate 20mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02178995
NCT02178995Phase 4Completed

Methylphenidate Treatment of Attentional and Cognitive Deficits in Epilepsy

Kimford Jay Meador·interventional·Posted Jul 1, 2014·Updated May 30, 2017

In Brief

A Phase 4 clinical trial evaluating Methylphenidate for Epilepsy and 2 related conditions. Completed, enrolled 55 participants across 1 site.

Detailed Summary

Methylphenidate (MPH) has long been used to improve attention and cognitive difficulties associated with ADHD, including in children with ADHD and epilepsy (Torres et al., 2008). Methylphenidate (MPH) is also helpful in treating attention and other cognitive difficulties in a variety of other neurological and medical conditions (Kajs-Wyllie, 2002; Prommer, 2012). We seek to evaluate the potential efficacy and safety of this medication in treating attention deficits, as well as other cognitive difficulties, experienced by adult patients with epilepsy. To our knowledge, there are currently very few studies which explicitly examine the impact of MPH on measureable attention deficits and other cognitive deficits in adult patients with epilepsy. We hope to quantify what impact, if any, methylphenidate has on attention, in addition to other specific measureable cognitive functions, in patients with cognitive complaints and epilepsy, and contribute to a growing body of evidence which supports the safety of methylphenidate's use for attention deficits in patients with epilepsy. As other effective treatments for attention and other cognitive difficulties in patients with epilepsy are not currently available, MPH could represent an important option in the treatment of such patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJul 1, 2014
Enrollment StartAug 1, 2014
Primary CompletionSep 1, 2015
Study CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 12.0 years ago

Interventions

Methylphenidatedrug

Participants with epilepsy will first receive blinded, single-dose capsules which contain either: Placebo 20mg of methylphenidate or 10mg of methylphenidate. At each visit, they will receive one capsule and then complete the neurocognitive batteries and neuropsychiatric questionnaires. There will be no medication administered between visits during this time. Following the final randomized visit, interested participants will be prescribed 10mg of methylphenidate twice daily, to be increased to 20mg of methylphenidate twice daily. After four weeks, their scores on the batteries and questionnaires will again be assessed.