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Attention Deficit Disorder With HyperactivityPhase 4NCT00323947

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

A Phase 4 study testing Extended Release Methylphenidate (OROS-Methylphenidate) in people with Attention Deficit Disorder With Hyperactivity and Epilepsy, run by Boston Children's Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 to 18 years
What is being tested?
Extended Release Methylphenidate (OROS-Methylphenidate)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
33 participants
Where
1 siteUnited States
Study dates
May 2003to Nov 2007
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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
Show all 13Show fewer
  • 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

Who cannot join

  • 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)
Show all 14Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Childrens Hospital Boston

    Boston, Massachusetts, 02115

Other trials in United States

About this study

Official title: Double Blind, Placebo Controlled, Crossover Study of Extended Release Methylphenidate for Treatment of ADHD in Children With Epilepsy

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.

Read the detailed description

Epilepsy is a brain disorder in which clusters of nerve cells in the brain periodically send abnormal signals. The normal pattern of nerve cell activity, therefore, becomes disrupted, which can result in seizures. Some symptoms of epileptic seizures include the following: strange sensations, emotions, or behavior; convulsions; muscle spasms; and loss of consciousness. Children with epilepsy are at risk for other specific disorders, such as ADHD, one of the most common mental disorders in children. ADHD is characterized by impulsiveness, hyperactivity, and inattention. Approximately one third of children with epilepsy also have ADHD. Stimulant medication is a common treatment method for ADHD. The effect of stimulant treatment on epilepsy and seizure frequency, however, is unknown. This study will evaluate the safety and effectiveness of XR-MPH, a stimulant medication, in treating ADHD in children with both ADHD and epilepsy.

People interested in participating in this double-blind study will first attend two visits for interviews and evaluations to determine eligibility for participation. Upon study entry, participants will be randomly assigned to initially receive either XR-MPH or placebo. Medication dosages and duration in the study will depend on participants' weights. Participants will first take either immediate release MPH or placebo "A" for 1 day. Any participants who experience an adverse event will be removed from the study. 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. Following the washout, participants will switch to the other treatment group for the remainder of the study and will receive either XR-MPH or placebo in the same manner. Participants will attend weekly study visits, at which they will receive medication and undergo assessments of ADHD symptoms and medication side effects. Blood will be drawn to assess medication levels at the first study visit and following both rounds of treatment. Participants who have trouble with transportation to and from the study site may complete some study visits via telephone. Upon study completion, all participants will be offered clinical treatment with the study physician. Follow-up visits will be held every 2 to 6 months for patients who choose to continue receiving care from the study physician.

Being tested
Extended Release Methylphenidate (OROS-Methylphenidate)
Keywords
ADHD, Seizures, Methylphenidate, Stimulant
Medical subject headings
Attention Deficit Disorder with Hyperactivity, Epilepsy, Seizures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Extended Release Methylphenidate (OROS-Methylphenidate)Drug

    Also called Concerta

    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.

Study groups in NCT00323947
Study groupRoleWhat they receive
1Active comparatorParticipants will take OROS-MPH then switch to placebo
Receives: Drug: Extended Release Methylphenidate (OROS-Methylphenidate)
2Placebo comparatorParticipants will take placebo then switch to OROS-MPH
Receives: Drug: Extended Release Methylphenidate (OROS-Methylphenidate)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Seizure occurence

    Measured: Measured between Weeks 1 and 4

  2. Clinical administered scores on the ADHD Rating Scale IV Parent Version

    Measured: Measured between Weeks 1 and 4

Secondary outcomes (4)

  1. CGI-ADHD-Severity

    Measured: Measured between Weeks 1 and 4

  2. ADHD Rating Scale IV Teacher Version

    Measured: Measured between Weeks 1 and 4

  3. Scores on the Barkley Side Effects Checklist-Modified

    Measured: Measured between Weeks 1 and 4

  4. Clinical Global Impressions (CGI)-ADHD-Improvement

    Measured: Measured between Weeks 1 and 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 May 2006 (estimated)
  2. Study startMay 2003
  3. Primary completionNov 2007
  4. Study completionNov 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00323947
Sponsor's protocol ID
K23MH066835
Other IDs
K23MH066835, DDTR BK-TKND
Status last verified
Jul 2013
First submitted
8 May 2006
Last updated
1 Aug 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 35844168

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Extended Release Methylphenidate (OROS-Methylphenidate) in people with Attention Deficit Disorder With Hyperactivity and Epilepsy, run by Boston Children's Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Seizure occurence (time frame: Measured between Weeks 1 and 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00323947, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2013.

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