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This is an observational study assessing the usage of stimulant medication for ADHD in the context of pediatric epilepsy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| interventional arm | Experimental | open label flexible dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| methylphenidate hydrochloride (Jornay PM) | Drug | all participants will receive active treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impression-Improvement | Clinical Global Impression-Improvement (CGI-I) is a 1-7 point scale to assess improvement. 1 reflects "very much improved" and 7 reflects "very much not improved" | 12 weeks |
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Inclusion Criteria:
Inclusion criteria:
Exclusion Criteria:
• Previous allergic or hypersensitivity reactions to stimulant medicines including Jornay PM®
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Neuropsychiatry Study Coordinator | Contact | 443-923-7612 | ertenu@kennedykrieger.org |
| Name | Affiliation | Role |
|---|---|---|
| Jay Salpekar, MD | Hugo W. Moser Research Institute at Kennedy Krieger, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kennedy Krieger Institute | Recruiting | Baltimore | Maryland | 21205 | United States |
This is a small dataset so will not share IPD in order to preserve confidentiality.
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D001927 | Brain Diseases |
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| ID | Term |
|---|---|
| D008774 | Methylphenidate |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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observational
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open label, flexible dose
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| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |