Phase 4
N=51
Methylphenidate Treatment of Attention Deficits in Epilepsy
Epilepsy · Cognitive Deficits · Attention Deficits
Bottom Line
View on ClinicalTrials.gov: NCT02178995 ↗Enrolled (actual)
51
Serious AEs
0.0%
Results posted
Aug 2016
Primary outcome: Primary: Conners' Continuous Performance Test (CPT) (Double-blind Portion, Primary Variables) — -3.3; -3.58; -3.66; 0.19 Units — p=0.037
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Methylphenidate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Kimford Jay Meador
- Primary completion
- Sep 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Conners' Continuous Performance Test (CPT) (Double-blind Portion, Primary Variables) |
-3.3; -3.58; -3.66; 0.19; 0.17; 0.17 | 0.037 sig |
| PRIMARY Symbol-digit Matching Test (Double-blind Portion) |
49.8; 52.2; 50.6 | 0.008 sig |
| PRIMARY MCG Paragraph Memory Test (Double-blind Portion) |
25.2; 27.4; 28 | 0.154 |
| PRIMARY Conners CPT Outcomes (Primary Variables) (Open-Label Portion) |
0.22; 0.16; 0.20; 0.15; -2.9; -3.8 | <0.0001 sig |
| PRIMARY Symbol-digit Matching Test (Open Label Phase) |
48.1; 53.8; 55.9; 60.1 | 0.003 sig |
| PRIMARY MCG (Open-label Portion) |
18.6; 30.5; 32.7; 44.9 | <0.0001 sig |
| PRIMARY Seizure Frequency (Open-label Portion) |
2.8; 2.4 | 0.274 |
| PRIMARY QOLIE-89 Aggregate Score |
60.2; 72.0 | <0.0001 sig |
| SECONDARY CPT Scores (Double-blind Portion) (Secondary Variables) |
285.3; 286.9; 287; 0.9; 0.3; 0.3 | 0.04 sig |
| SECONDARY Seizure Frequency/Severity (Double-blind Portion) |
2.5; 2.0 | 0.7116 |
| SECONDARY QOLIE-89 Selected Cognitive Subscales (Open-label) |
50.4; 74.8; 36.8; 59.7; 58.1; 72.3 | <0.0001 sig |
| SECONDARY CPT Outcomes (Secondary Variables) (Open-label Portion) |
284.6; 287.6; 287; 287.6; 1.0; 0.1 | 0.003 sig |
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.
Eligibility Criteria
Inclusion Criteria
- For participants with seizures:
- H/o seizures of any cause
- Subjective cognitive complaints
- Stable antiepileptic drug doses which are not expected to change during the study
- Recent normal cardiac auscultation (may be done prior to enrollment by personal physician or study staff)
- Neurologist's judgement that participant is clinically appropriate for this study
- For healthy volunteers
- No history of seizures or other neurological disorders
- No history of cognitive complaints for any reason (including ADHD)
- Not on any medications which would interfere w/ cognitive testing
- English fluency
Exclusion Criteria
- IQ
- History of an adverse reaction to methylphenidate
- Age >65 or 150/95) during study. For those with BP >140/90 & <150/95, they will be monitored during the study and refer them for treatment if their BP remains elevated throughout the study.
- Uncontrolled tachycardia during study
- Progressive neurological disorders which may interfere w/ cognition for reasons other than seizures
- Glaucoma
- Other medical or neurological illnesses or symptoms which may interfere with cognition or medication (e.g., severe liver or renal disease, active infections, etc), or which make use of the medication inappropriate (e.g., severe agitation/anxiety).
- Intellectual disability sufficient to render a participant unable to consent
- Status epilepticus within the last year
- Neurosurgery which would be expected to interfere with study tasks within the last 6 months.
- Substance use history
- Met criteria for substance use disorder within the past year
- Active illicit substance use
- Alcohol use meeting criteria for substance abuse
- Unwillingness to abstain from alcohol w/in 24 hours of testing
- Personal psychiatric history
- History of a primary psychotic disorder, such as schizophrenia, or mania.
- History of suicide attempts within the last year
- Active suicidality
- Severe cognitive impairments (e.g. aphasia) which render a participant unable to consent
- Currently receiving medications which would be expected to interfere with the study tasks, if they cannot be held for study visits;
- Pregnancy or active breastfeeding;
- Women of childbearing potential who are sexually active and not willing or able to use a contraceptive strategy during the course of the study.
- Any other factor which may interfere w/ a participant's ability to consent or to complete the required cognitive tasks, or may significantly interfere with their performance on the required tests
- Concomitant use of an MAOI (if receiving methylphenidate during this study), or use of an MAOI within the last 14 days prior to receiving methylphenidate.
Data sourced from ClinicalTrials.gov (NCT02178995). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.