25 Participants NeededMy employer runs this trial

Methylphenidate for ADHD in Pediatric Epilepsy

NS
Overseen ByNeuropsychiatry Study Coordinator
Age: < 18
Sex: Any
Trial Phase: Phase 4
Sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Must be taking: Anti-seizure medications
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to observe how methylphenidate hydrochloride (Jornay PM) works for children with both ADHD (attention deficit hyperactivity disorder) and epilepsy. The goal is to understand the effects of this stimulant medication in children who need seizure medicine but also struggle with ADHD symptoms. Children with stable epilepsy, a diagnosis of ADHD, and no recent severe seizures might be suitable candidates for this study. As a Phase 4 trial, the research focuses on understanding how this FDA-approved and effective treatment can benefit more patients.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but it does require that you are not currently using stimulants to treat ADHD. You should discuss your specific medications with the study team to be sure.

What is the safety track record for methylphenidate hydrochloride (Jornay PM)?

Research has shown that Jornay PM (methylphenidate hydrochloride) is safe and effective for treating ADHD in children aged 6 to 17. The FDA has approved it for this use. Studies have also found that methylphenidate is safe for children with ADHD who also have epilepsy or unusual brain activity patterns.

Common side effects include headaches and increased activity levels, occurring in about 5% of children taking the medication—twice as often as those taking a placebo (a sugar pill used in testing).

Overall, evidence suggests that Jornay PM is generally well-tolerated. However, as with any medication, it is important to be aware of possible side effects and discuss them with a healthcare provider.12345

Why are researchers enthusiastic about this study treatment?

Methylphenidate hydrochloride (Jornay PM) is unique because it offers a new way of managing ADHD symptoms in children with epilepsy. Unlike traditional stimulants, which can exacerbate seizure risks, Jornay PM provides a controlled release of methylphenidate throughout the day, potentially minimizing these risks. Researchers are excited because this formulation might allow for ADHD symptom control without increasing the likelihood of seizures, offering a safer option for this sensitive patient population.

What evidence suggests that methylphenidate might be an effective treatment for ADHD in pediatric epilepsy?

Research has shown that Jornay PM, a form of methylphenidate hydrochloride, helps treat ADHD. Studies have found that this medication significantly improves ADHD symptoms. Specifically, one study noted that 73% of patients no longer had significant symptoms after three months. Jornay PM is approved for children aged 6 to 17 and effectively manages ADHD symptoms throughout the day. Research also indicates it is safe for children with epilepsy, which is crucial for those considering this treatment. Overall, the evidence supports its effectiveness and safety for managing ADHD in children, including those with epilepsy.45678

Who Is on the Research Team?

JS

Jay Salpekar, MD

Principal Investigator

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Are You a Good Fit for This Trial?

This trial is for children who have both epilepsy (controlled with medication) and ADHD that affects their daily life. They must be in good overall health, not have had recent severe seizures, and have a caregiver able to help monitor their treatment.

Inclusion Criteria

I have ADHD that affects my daily life.
I have epilepsy and need anti-seizure medication.
I am in good general health with stable vital signs.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive open-label flexible dose of stimulant medication for ADHD

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • methylphenidate hydrochloride (Jornay PM)

Trial Overview

The study observes how the ADHD medication methylphenidate hydrochloride (Jornay PM) works and is tolerated in kids with epilepsy who are already taking anti-seizure medicine.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: interventional armExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Lead Sponsor

Trials
93
Recruited
25,200+

Citations

Medication Treatment of ADHD in Pediatric Epilepsy

This is an observational study assessing the usage of stimulant medication for ADHD in the context of pediatric epilepsy. Official Title. USE of JORNAY PM® to ...

A Randomized, Double-Blind, Placebo-Controlled Study of ...

Conclusion: DR/ER-MPH was well tolerated and demonstrated significant improvements versus placebo in functional impairment throughout the day across different ...

Methylphenidate for ADHD in Pediatric Epilepsy

The study observes how the ADHD medication methylphenidate hydrochloride (Jornay PM) works and is tolerated in kids with epilepsy who are ...

Explore Uses & Efficacy for JORNAY PM (methylphenidate HCI)

Learn about the efficacy and safety of JORNAY PM (methylphenidate HCI) that provides all-day ADHD symptom management. Read the clinical data.

Pediatric Postmarketing Pharmacovigilance Review

The safety and effectiveness of JORNAY PM have been established in pediatric patients ages 6 to 17 years in two adequate and well-controlled ...

Jornay PM - accessdata.fda.gov

The safety and effectiveness of JORNAY PM have been established in pediatric patients ages 6 to 17 years in two adequate and well-controlled ...

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jornaypm-pro.com

jornaypm-pro.com/safety

Learn Safety & Side Effects of JORNAY PM (methylphenidate ...

Additional adverse reactions (≥5% and twice the rate of placebo) in JORNAY PM-treated pediatric patients 6 to 12 years are headache, psychomotor hyperactivity, ...

Methylphenidate for attention deficit hyperactivity disorder ...

Methylphenidate is safe and effective in children with ADHD and concomitant active seizures or EEG abnormalities.The present data indicate that methylphenidate ...