Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00323947
Status:
COMPLETED
Last Update Posted:
2013-08-01
First Post:
2006-05-08
Brief Title:
Methylphenidate for Treating Attention Deficit Hyperactivity Disorder in Children With Both ADHD and Epilepsy
Sponsor:
Boston Childrens Hospital
Organization:
Boston Childrens Hospital
Study Overview
Official Title:
Double Blind Placebo Controlled Crossover Study of Extended Release Methylphenidate for Treatment of ADHD in Children With Epilepsy
Status:
COMPLETED
Status Verified Date:
2013-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DDTR BK-TKND | US NIH GrantContract | None | httpsreporternihgovquickSearchK23MH066835 |
| K23MH066835 | NIH | None | None |