Methylphenidate Treatment of Attention Deficits in Epilepsy

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2014 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Kimford Jay Meador, Stanford University
ClinicalTrials.gov Identifier:
NCT02178995
First received: June 24, 2014
Last updated: July 9, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Epilepsy
Cognitive Deficits
Attention Deficits
Drug: Methylphenidate
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Methylphenidate Treatment of Attentional and Cognitive Deficits in Epilepsy

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Conners' continuous performance test (CPT) [ Time Frame: difference of 2 treatments (randomized to weeks 2, 3, or 4) from placebo (randomized to week 2, 3 or 4) ] [ Designated as safety issue: No ]
    Scores on this test measure attentiveness/vigilance and response time. Primary measure will be confidence interval differences.


Secondary Outcome Measures:
  • Seizure frequency/severity [ Time Frame: Change from baseline (day 1) to methylphenidate treatments (single doses randomized to weeks 2, 3, or 4, and end of one month treatment at end month 2) ] [ Designated as safety issue: Yes ]
    Seizure diaries will be monitored for changes in seizure frequency and/or severity associated with methylphenidate use during 2 single dose exposures and during 1 month open label.

  • Symbol-digit matching test [ Time Frame: difference of 2 treatments (randomized to weeks 2, 3, or 4) from placebo (randomized to week 2, 3 or 4) ] [ Designated as safety issue: No ]
    Symbol-digit matching test is a measure processing speed and working memory.

  • MCG paragraph memory test [ Time Frame: difference of 2 treatments (randomized to weeks 2, 3, or 4) from placebo (randomized to week 2, 3 or 4) ] [ Designated as safety issue: No ]
    MCG paragraph memory test is a measure verbal memory.

  • Beck Depression Inventory [ Time Frame: Change from baseline to end of methylphenidate open label treatment (end month 2) ] [ Designated as safety issue: No ]
    Beck Depression Inventory is a questionnaire to assess mood.

  • Beck Anxiety Inventory [ Time Frame: Change from baseline to end of methylphenidate open label treatment (end month 2) ] [ Designated as safety issue: No ]
    Beck Anxiety Inventory is a questionnaire to assess anxiety.

  • QOLIE-89 [ Time Frame: Change from baseline to end of methylphenidate open label treatment (end month 2) ] [ Designated as safety issue: No ]
    QOLIE-89 is a questionnaire to assess quality of life and subjective cognitive effects.


Estimated Enrollment: 45
Study Start Date: August 2014
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Participants with epilepsy
Participants will receive three single doses of blinded medication, either a placebo, 20mg of methylphenidate, or 40mg of methylphenidate, and will complete cognitive testing and neuropsychiatric questionnaires. This single-dose phase will be followed by an open-label 4-week treatment trial of methylphenidate.
Drug: Methylphenidate

Participants with epilepsy will first receive blinded, single-dose capsules which contain either:

Placebo 20mg of methylphenidate or 40mg 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.

Other Name: Ritalin
No Intervention: Healthy Controls
Healthy controls will complete the same neurocognitive batteries and neuropsychiatric questionnaires as individuals with epilepsy, but will not be exposed to study medication.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 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)
  2. 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

Exclusion Criteria:

  1. IQ
  2. History of an adverse reaction to methylphenidate
  3. Seizure frequency > than 1 complex partial seizures (CPS) or absence seizure per month or > than 3 generalized tonic-clonic seizures (GTCS) per year
  4. Age >60 or <18
  5. Family history of sudden cardiac death at age <40
  6. Personal medical history of

    • Arrhythmias,
    • Structural cardiac disease,
    • Other cardiac abnormality
    • Uncontrolled hypertension (BP >140/90 during study)
    • Uncontrolled tachycardia (HR >100 during study)
    • Progressive neurological disorders (e.g., dementia) which may interfere w/ cognition for reasons other than seizures
    • Glaucoma
    • Other major medical illnesses which may interfere with cognition or medication (e.g., severe liver or renal disease, active infections, etc)
    • Intellectual disability/mental retardation
  7. Substance use history

    • Met criteria for substance use disorder within the past year
    • Any active illicit substance use
    • Alcohol use meeting criteria for substance abuse
    • Unwillingness to abstain from alcohol w/in 24 hours of testing
  8. Personal psychiatric history

    • Any history of psychosis or mania
    • History of suicide attempts within the last year
    • Active suicidality
  9. Severe cognitive impairments (e.g. aphasia) which render a participant unable to consent
  10. Currently receiving medications which would be expected to interfere with the study tasks, if they cannot be held for study visits
  11. Pregnancy or active breastfeeding
  12. Women of childbearing potential who are sexually active and not willing or able to use a contraceptive strategy during the course of the study
  13. 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02178995

Contacts
Contact: Kimford Meador, MD 650-275-6648

Locations
United States, California
Stanford University Not yet recruiting
Palo Alto, California, United States, 94305
Sponsors and Collaborators
Kimford Jay Meador
Investigators
Study Director: Jesse M Adams, MD Stanford University
Principal Investigator: Kimford Meador, MD Stanford University
Study Chair: John Barry, MD Stanford University
  More Information

No publications provided

Responsible Party: Kimford Jay Meador, Professor, Stanford University
ClinicalTrials.gov Identifier: NCT02178995     History of Changes
Other Study ID Numbers: MPH in epilepsy
Study First Received: June 24, 2014
Last Updated: July 9, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Additional relevant MeSH terms:
Epilepsy
Attention Deficit Disorder with Hyperactivity
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Methylphenidate
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on September 16, 2014