methylphenidate and Epilepsy

methylphenidate has been researched along with Epilepsy in 60 studies

Methylphenidate: A central nervous system stimulant used most commonly in the treatment of ATTENTION DEFICIT DISORDER in children and for NARCOLEPSY. Its mechanisms appear to be similar to those of DEXTROAMPHETAMINE. The d-isomer of this drug is referred to as DEXMETHYLPHENIDATE HYDROCHLORIDE.
methylphenidate : A racemate comprising equimolar amounts of the two threo isomers of methyl phenyl(piperidin-2-yl)acetate. A central stimulant and indirect-acting sympathomimetic, is used (generally as the hydrochloride salt) in the treatment of hyperactivity disorders in children and for the treatment of narcolepsy.
methyl phenyl(piperidin-2-yl)acetate : A amino acid ester that is methyl phenylacetate in which one of the hydrogens alpha to the carbonyl group is replaced by a piperidin-2-yl group.

Epilepsy: A disorder characterized by recurrent episodes of paroxysmal brain dysfunction due to a sudden, disorderly, and excessive neuronal discharge. Epilepsy classification systems are generally based upon: (1) clinical features of the seizure episodes (e.g., motor seizure), (2) etiology (e.g., post-traumatic), (3) anatomic site of seizure origin (e.g., frontal lobe seizure), (4) tendency to spread to other structures in the brain, and (5) temporal patterns (e.g., nocturnal epilepsy). (From Adams et al., Principles of Neurology, 6th ed, p313)

Research

Studies (60)

Authors

Clinical Trials (3)

Trial Overview

Trial Outcomes

Adverse Events Profile (Open-Label)

"This is a side-effects reporting scale for anti-epileptic medications. Because it encompasses cognitive and non-cognitive side effects, it was not considered one of our main cognitive/quality of life outcomes of interest. It is used in other studies of AED side effects, however, so was included.~The scale consists of 19 symptoms rated 1 (Never a problem) to 4 (Always or often a problem). Minimum score is 19, maximum score is 76. A higher score is WORSE." (NCT02178995)
Timeframe: Baseline (Visit 1) vs end of Open-label (week 8)

Hit Reaction Time (Double Blind)

"Hit reaction time represents the average number of milliseconds required for a participant to respond to target stimuli. There are no meaningful absolute minimum or maximum scores, though 101ms is the current fastest verified response time per our review. A higher score is WORSE.~This was not a pre-specified variable or an intentional post-hoc analysis, but it is calculated automatically and included here only for completeness of data submission." (NCT02178995)
Timeframe: Visits 2 vs 3 vs 4 on randomized medication doses.

Hit Reaction Time (Open-Label)

"Hit reaction time represents the average number of milliseconds required for a participant to respond to target stimuli. There are no meaningful absolute minimum or maximum scores, though 101ms is the current fastest verified response time per our review. A higher score is WORSE.~This was not a pre-specified variable or an intentional post-hoc analysis, but it is calculated automatically and included here only for completeness of data submission." (NCT02178995)
Timeframe: Visits 2 vs 3 vs 4 on randomized medication doses.

MCG (Open-label Portion)

MCG paragraph memory test is a measure verbal memory. Participants are read aloud a long, detailed story, and are then asked to immediately repeat all information they can remember from the story. Each pertinent story element (as pre-defined on a key) is considered 1 correct response. Minimum score is 0, maximum is 100. A higher score is better. (NCT02178995)
Timeframe: The single-dose double blind phase was followed by an open-label 4-week treatment phase.

MCG Paragraph Memory Test (Double-blind Portion)

MCG paragraph memory test is a measure of verbal memory. Participants are read aloud a long, detailed story, and are then asked to immediately repeat all information they can remember from the story. Each pertinent story element (as pre-defined on a key) is considered 1 correct response. Minimum score is 0, maximum is 100. A higher score is better. (NCT02178995)
Timeframe: Difference in scores between MPH 20mg, 10mg, or placebo, randomized to be given at weeks 2, 3, or 4

QOLIE-89 Aggregate Score

"QOLIE-89 is a questionnaire to assess quality of life and subjective cognitive effects. The aggregate score is the overall calculated score. Note: most of its questions are specific to patients with epilepsy, and therefore the questionnaire cannot be validly completed by healthy controls. Therefore, only participants with epilepsy completed the questionnaire.~QOLIE aggregate scores and subscale scores are calculated based on individual patient responses throughout the survey, and according to scoring rules as determined by the creator of the questionnaire. Scores are rated 0 (worst) to 100 (best)." (NCT02178995)
Timeframe: Change from baseline to end of methylphenidate open label treatment (end month 2)

Seizure Frequency (Open-label Portion)

Seizures per 28 'at-risk' days. This is a comparison of 28 days prior to baseline visit as compared to seizure rate while taking methylphenidate, adjusted to provide a 'number of seizures per 28 days' measurement. (NCT02178995)
Timeframe: Randomized portion is followed by 1-month open-label portion.

Seizure Frequency/Severity (Double-blind Portion)

Seizures per 28 'at-risk' days. This is a comparison of 28 days prior to baseline visit as compared to seizure rate while taking methylphenidate, adjusted to provide a 'number of seizures per 28 days' measurement. (NCT02178995)
Timeframe: Seizure rate during 28 days prior to study compared to during randomized, single-dose portion, rate adjusted to seizures per 28 patient days.

Stimulant Side-effects Checklist

"This is a questionnaire covering common stimulant side-effects, intended to help monitor for any significant or common adverse effects.~The scale lists 16 common stimulant side effects rated 0 (absent) to 9 (serious). Minimum score is 0, maximum is 144. A higher score is WORSE." (NCT02178995)
Timeframe: Baseline (Visit 1) vs end of Open-label (week 8)

Symbol-digit Matching Test (Double-blind Portion)

Symbol-digit matching test is a measure processing speed and working memory. The task involves matching nonsense symbols with numbers based on a key as quickly as possible within 90s. Score represents the number of correct responses within the time frame. Minimum score is 0. There is not a meaningful 'maximum' score, as there are too many symbols for a participant to successfully complete within the allotted time. A higher score is better. (NCT02178995)
Timeframe: Difference in scores between MPH 20mg, 10mg, or placebo during double-blind portion during which medication was randomized to weeks 2, 3, or 4.

Symbol-digit Matching Test (Open Label Phase)

Symbol-digit matching test is a measure processing speed and working memory. The task involves matching nonsense symbols with numbers based on a key as quickly as possible within 90s. Score represents the number of correct responses within the time frame. Minimum score is 0. There is not a meaningful 'maximum' score, as there are too many symbols for a participant to successfully complete within the allotted time. A higher score is better. (NCT02178995)
Timeframe: The single-dose double blind phase was followed by an open-label 4-week treatment phase.

Conners CPT Outcomes (Primary Variables) (Open-Label Portion)

"Within-groups comparison (between visit 1 and visit 5 within patients with epilepsy, comparing scores at baseline to scores on methylphenidate) as well as a comparison against healthy controls who repeated the cognitive measures an equal number of times (to assess and control for test/retest and placebo improvements).~D' represents 'detectability,' and is a derived statistic which measures a participant's ability to distinguish target stimuli from non-target stimuli, and incorporates response time and accuracy factors. The equation for deriving it is proprietary to the test which markets the CPT. A higher, or less negative, score is considered WORSE.~HRTSD represents the standard deviation of participant hit reaction time data, as measured for a variety of different stimuli types across the trial. It is a measure of the participant's ability to maintain attention across the trial. A higher score represents more variability and is considered WORSE." (NCT02178995)
Timeframe: Difference between scores at baseline (visit 1) and on methylphenidate open-label (visit 5), compared to untreated healthy controls

Conners' Continuous Performance Test (CPT) (Double-blind Portion, Primary Variables)

"Scores on this test measure attentiveness/vigilance and response time. Primary measures are: D', HRTSD D' represents 'detectability,' and is a derived statistic which measures a participant's ability to distinguish target stimuli from non-target stimuli, and incorporates response time and accuracy factors. The equation for deriving it is proprietary to the test which markets the CPT. A higher, or less negative, score is considered WORSE.~HRTSD represents the standard deviation of participant hit reaction time data, as measured for a variety of different stimuli types across the trial. It is a measure of the participant's ability to maintain attention across the trial. A higher score represents more variability and is considered WORSE." (NCT02178995)
Timeframe: difference in scores on specific variables between MPH 20mg, 10mg, and placebo (randomized to administration at weeks 2, 3, or 4)

CPT Outcomes (Secondary Variables) (Open-label Portion)

"Omissions, commissions, and hits~Hits represents the raw number of accurate responses to target stimuli, out of a maximum of 288. A higher number is better.~Omissions are errors committed when a target stimuli is not appropriately responded to. A higher number is worse. Theoretically, the maximum number of omissions would be 288. A lower number is BETTER.~Commissions are errors committed when a participant responds to a non-target stimuli. Because a participant may make multiple such errors for a given stimuli, there is no raw maximum. A lower number is BETTER." (NCT02178995)
Timeframe: Baseline (Visit 1) vs end of Open-label (week 8)

CPT Scores (Double-blind Portion) (Secondary Variables)

"Secondary variables in CPT: hits, omissions, commissions~Hits represents the raw number of accurate responses to target stimuli, out of a maximum of 288. A higher number is better.~Omissions are errors committed when a target stimuli is not appropriately responded to. A higher number is worse. Theoretically, the maximum number of omissions would be 288. A lower number is BETTER.~Commissions are errors committed when a participant responds to a non-target stimuli. Because a participant may make multiple such errors for a given stimuli, there is no raw maximum. A lower number is BETTER." (NCT02178995)
Timeframe: Difference between scores on MPH 20mg, 10mg, or placebo during randomized visits weeks 2, 3, or 4

Neuropsychiatric Questionnaires

"Beck Depression Inventory, Beck Anxiety Inventory, Apathy Evaluation Scale. These were not primary or secondary variables of interest given methylphenidate's primary expected action being on cognition. Included given one author's interest, as other studies suggesting psychiatric improvements (particularly apathy and depression) with methylphenidate.~BDI is a common clinical and research measure of depression. It has 21 questions and is scored 0 (no depression) to 63 (most severe depression). A higher score is worse.~BAI is a measure of anxiety, which also has 21 questions and is scored 0 (no anxiety) to 63 (most severe anxiety). A higher score is worse.~AES is a measure of clinical apathy, and is an 18-item scale. It rates symptoms as not at all, slightly, somewhat, or a lot, which are then converted to numerical values 1 (least apathy) to 4 (most apathy). Scores range from 18 (no apathy) to 72 (most apathy)." (NCT02178995)
Timeframe: Baseline (Visit 1) vs end of Open-label (week 8)

QOLIE-89 Additional Subscales (Open-label)

"These are the remaining subscales of the QOLIE-89. These were not pre-specified variables of interest or intentional post-hoc analyses, but are automatically calculated in scoring the QOLIE-89 and are included ONLY for completeness of data submission.~QOLIE aggregate scores and subscale scores are calculated based on individual patient responses throughout the survey, and according to scoring rules as determined by the creator of the questionnaire. Scores are rated 0 (worst) to 100 (best)." (NCT02178995)
Timeframe: Visit 1 (baseline) vs end of open-label (week 8)

QOLIE-89 Selected Cognitive Subscales (Open-label)

"Pre-selected secondary variables were cognitive subscales on the QOLIE-89 felt likely to be affected by MPH: attention/concentration; memory; language; energy/fatigue.~QOLIE aggregate scores and subscale scores are calculated based on individual patient responses throughout the survey, and according to scoring rules as determined by the creator of the questionnaire. Scores are rated 0 (worst) to 100 (best)." (NCT02178995)
Timeframe: Comparing baseline (visit 1) to end of open-label (end of week 8)

Remaining CPT Variables (Double-blind Portion)

"Remaining CPT variables are automatically calculated by the program. They were not pre-specified variables of interest nor intentional post-hoc analyses. They are included ONLY for completeness of data submission.~Hit reaction time represents to the average number of milliseconds required for a participant to respond to target stimuli. There are no meaningful absolute minimum or maximum scores, though 101ms is the current fastest verified response time per our review. A higher score is WORSE.~Variability refers to variations in response time across individual blocks of time within the trial. It differs from HRTSD in that HRTSD measures variability across the entire trial. Minimum is 0. There are no absolute maximums. A higher score is WORSE.~Perseverations are errors made either faster than physiologically possible (<100ms). Minimum is 0, there is no maximum. Higher scores are WORSE." (NCT02178995)
Timeframe: Placebo vs 10mg vs 20mg (visits 2, 3, 4)

Remaining CPT Variables (Open-label)

"These are automatically-calculated CPT variables which were not pre-specified variables of interest or intentional post-hoc analyses. They are included ONLY for completeness of data. They include hit reaction time (HRT), variability (VAR), and perseverations (PRS).~Hit reaction time represents to the average number of milliseconds required for a participant to respond to target stimuli. There are no meaningful absolute minimum or maximum scores, though 101ms is the current fastest verified response time per our review. A higher score is WORSE.~Variability refers to variations in response time across individual blocks of time within the trial. It differs from HRTSD in that HRTSD measures variability across the entire trial. Minimum is 0. There are no absolute maximums. A higher score is WORSE.~Perseverations are errors made either faster than physiologically possible (<100ms). Minimum is 0, there is no maximum. Higher scores are WORSE." (NCT02178995)
Timeframe: Baseline vs end of open-label (week 8)

Reviews

15 reviews available for methylphenidate and Epilepsy

Trials

11 trials available for methylphenidate and Epilepsy

Other Studies

34 other studies available for methylphenidate and Epilepsy