drugset / Trial / NCT02178995

Methylphenidate Treatment of Attention Deficits in Epilepsy

NCT02178995 ↗

Phase 4 Completed 55 enrolled Kimford Jay Meador
Non-randomizedCrossoverTriple-blindTreatment

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.

Timeline

Start
2014-08
Primary completion
2015-09
Completion
2015-12

Outcome

Mixed primary results

registry MEAN Participants With Epilepsy: Placebo: 49.8 (Standard Deviation 11.9) points NCT02178995 ↗

registry MEAN Participants With Epilepsy: Methylphenidate 10 mg Dose: 52.2 (Standard Deviation 11.6) points NCT02178995 ↗

registry p = 0.008; ANOVA NCT02178995 ↗

registry MEAN Participants With Epilepsy: Placebo: 25.2 (Standard Deviation 14.8) Points NCT02178995 ↗

registry MEAN Participants With Epilepsy: Methylphenidate 10 mg Dose: 27.4 (Standard Deviation 15.4) Points NCT02178995 ↗

registry p = 0.154; ANOVA NCT02178995 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Methylphenidate Small molecule 10 mg Oral
Subject Methylphenidate Small molecule 20 mg Oral
Subject Methylphenidate Small molecule 40 mg Oral