Methylphenidate for Attention Problems After Pediatric TBI
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|ClinicalTrials.gov Identifier: NCT01933217|
Recruitment Status : Unknown
Verified November 2016 by Children's Hospital Medical Center, Cincinnati.
Recruitment status was: Active, not recruiting
First Posted : September 2, 2013
Last Update Posted : November 18, 2016
|Condition or disease||Intervention/treatment||Phase|
|Traumatic Brain Injury TBI ADHD||Drug: Methylphenidate Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Efficacy of Methylphenidate for Management of Long-Term Attention Problems After Pediatric Traumatic Brain Injury (TBI)|
|Study Start Date :||November 2013|
|Actual Primary Completion Date :||August 2016|
|Estimated Study Completion Date :||August 2018|
The study medication will consist of identical capsules filled Concerta® over-encapsulated to preserve double-blinding. The weekly dosages will be low, medium, and high based on weight cut-offs. Participants weighing less than 25kg will receive 18mg (low), 27mg (medium), and 36mg (high) dosages and participants weighing above 25kg will receive 18mg (low), 36mg (medium), and 54mg (high) dosages during the 3-week upward titration trial. Weekly ratings monitoring behavioral and side effect symptoms score and the Pittsburgh Side Effects Rating Scale.
Other Name: Concerta
Placebo Comparator: Placebo
The study medication will consist of identical capsules filled with an inert white power (placebo). Weekly ratings monitoring behavioral and side effect symptoms score and the Pittsburgh Side Effects Rating Scale.
- Parent report measures [ Time Frame: 5 years ]
- Neuropsychological Testing [ Time Frame: 5 years ]
- Teacher Report Measures [ Time Frame: 5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01933217
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center|
|Cincinnati, Ohio, United States, 45229|
|Principal Investigator:||Brad Kurowski, MS, MD||Children's Hospital Medical Center, Cincinnati|