Methylphenidate for Treating Attention Deficit Hyperactivity Disorder in Children With Both ADHD and Epilepsy

NCT00323947 | Completed Phase 4 DMC

• 2 other identifiers: K23MH066835DDTR BK-TKND
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the safety and effectiveness of extended release methylphenidate (XR-MPH) in treating attention deficit hyperactivity disorder (ADHD) in children with both ADHD and epilepsy.

Conditions

Attention Deficit Disorder With Hyperactivity; Epilepsy

Keywords

ADHD; Seizures; Methylphenidate; Stimulant

Outcome Measures

Primary Outcomes (2)

• Seizure occurence

  Measured between Weeks 1 and 4

• Clinical administered scores on the ADHD Rating Scale IV Parent Version

  Measured between Weeks 1 and 4

Secondary Outcomes (4)

• CGI-ADHD-Severity

  Measured between Weeks 1 and 4

• ADHD Rating Scale IV Teacher Version

  Measured between Weeks 1 and 4

• Scores on the Barkley Side Effects Checklist-Modified

  Measured between Weeks 1 and 4

• Clinical Global Impressions (CGI)-ADHD-Improvement

  Measured between Weeks 1 and 4

Study Arms (2)

1

ACTIVE COMPARATOR

Participants will take OROS-MPH then switch to placebo

Drug: Extended Release Methylphenidate (OROS-Methylphenidate)

2

PLACEBO COMPARATOR

Participants will take placebo then switch to OROS-MPH

Drug: Extended Release Methylphenidate (OROS-Methylphenidate)

Interventions

Extended Release Methylphenidate (OROS-Methylphenidate) DRUG

Participants will first take either immediate release MPH or placebo "A" for 1 day. On Day 2 of treatment, participants assigned to receive XR-MPH will begin taking it, and participants assigned to receive placebo will switch to placebo "B." This treatment phase will continue for 6 days to 4 weeks, depending on weight, and will then be followed by a 1-week medication washout period. Target dose depends on the weight of the participant. Possible dose forms include 18, 36, 54 mg OROS-MPH.

Also known as: Concerta

1; 2

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Speaks English
• Intelligence Quotient (IQ) of greater than 35 and scores greater than 35 on the Scales of Independent Behavior - Revised (SIB-R) Broad Independence Scale (both IQ and adaptive functioning at the Moderate Mental Retardation level or higher)
• Diagnosis of epilepsy by International League Against Epilepsy (ILEA) criteria 26 (repeated, afebrile, unprovoked seizures with a seizure within the past 5 years)
• Diagnostic and Statistical Manual (DSM)-IV diagnosis of ADHD
• Scores at least 4 on the CGI severity scale for ADHD
• Scores greater than 90% on the ADHD Rating Scale (ADHD RS), Parent Version; investigator scored for age and sex on either the inattentive, hyperactive-impulsive, or total score at first visit
• Has not taken stimulants or alpha-adrenergic medications for more than 2 weeks prior to study entry
• If taking antidepressants, neuroleptics, or lithium, doses have been stable for more than 4 weeks
• Currently on an antiepileptic drug (AED) regimen with stable doses for more than 4 weeks prior to study entry
• Seizure-free for more than 1 month prior to study entry
• Prescribing clinician for epilepsy anticipates the need for a stable AED regimen for the duration of the study
• Guardian gives permission for study personnel to communicate with prescribing epilepsy clinician
• Teacher agrees to fill out ADHD RS at baseline and at the end of each arm of the study

You may not qualify if:

• Has had a seizure within the month preceding study entry
• Change in AED regimen or dose within 4 weeks of study entry
• History of moderate or severe adverse event related to MPH
• History of any psychotic disorder
• Current acute major depression or bipolar mania
• Current psychiatric disorder requiring pharmacotherapy (other than ADHD)
• Unstable significant medical condition other than epilepsy
• Any known conditions that may make treatment with MPH medically inadvisable
• Not currently working with a physician for epilepsy treatment
• Previously participated in a trial that provided adequate treatment with XR-MPH
• Weighs less than 9 kg
• Pregnant
• Unwilling to use an effective form of contraception
• Child has taken a stimulant (MPH, an amphetamine preparation, or pemoline), alpha-adrenergic (clonidine or guanfacine), or other ADHD medication within 2 weeks of the screening telephone interview. Children will not be withdrawn from psychotropic medications in order to be enrolled in the study.

Sponsors & Collaborators

• Boston Children's Hospital: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Childrens Hospital Boston

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• Eaton C, Yong K, Walter V, Mbizvo GK, Rhodes S, Chin RF. Stimulant and non-stimulant drug therapy for people with attention deficit hyperactivity disorder and epilepsy. Cochrane Database Syst Rev. 2022 Jul 13;7(7):CD013136. doi: 10.1002/14651858.CD013136.pub2.

  PMID: 35844168 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Epilepsy; Seizures

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Joseph M. Gonzalez-Heydrich, MD

  Children's Hospital Boston, Harvard Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2006
• First Posted: May 10, 2006
• Study Start: May 1, 2003
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: August 1, 2013

Record last verified: 2013-07

Locations

US (1)