Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Methylphenidate for Attention Problems After Pediatric TBI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Brief Summary:
Traumatic Brain Injury (TBI) - methylphenidate treatment

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury TBI ADHD Drug: Methylphenidate Drug: Placebo Phase 4

Detailed Description:
The objectives of the study are to (1) determine the efficacy and dose-response of methylphenidate treatment of attention problems after pediatric traumatic brain injury (TBI) and (2) provide a better understanding of the relationship of a prior history of attention deficit hyperactivity disorder (ADHD), ADHD subtypes after TBI, executive function, and attentional control to treatment efficacy. The proposed clinical trial will enroll 50 children, age 6-17 years, with attention problems >6 months after moderate to severe TBI into a randomized, double-blind, placebo-controlled, cross-over design trial with 3 dose conditions (low, medium, and high).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Methylphenidate
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.
Drug: Methylphenidate
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.
Drug: Placebo



Primary Outcome Measures :
  1. Parent report measures [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Neuropsychological Testing [ Time Frame: 5 years ]
  2. Teacher Report Measures [ Time Frame: 5 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Between ages of 6-17
  • Sustained Moderate to Severe TBI
  • TBI occurred at least 6 months prior to beginning the study
  • TBI occurred no earlier than 5 years of age
  • Positive endorsement of 6 out of 9 items on the Vanderbilt ADHD inattention or hyperactivity scale

Exclusion Criteria:

  • History of developmental disability or mental retardation
  • Current active participation in ADHD-related behavioral intervention
  • History of psychiatric condition requiring an inpatient admission in past 12 months
  • Actively taking medications with a contraindication to Concerta that cannot be discontinued
  • Current use of stimulant medication or ADHD specific medications that cannot be discontinued
  • Non-blunt head injury
  • Family history of arrhythmia
  • Pregnancy

Information from the National Library of Medicine

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


Locations
Layout table for location information
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
Layout table for investigator information
Principal Investigator: Brad Kurowski, MS, MD Children's Hospital Medical Center, Cincinnati

Layout table for additonal information
Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT01933217     History of Changes
Other Study ID Numbers: 1K23HD074683-01A1 ( U.S. NIH Grant/Contract )
First Posted: September 2, 2013    Key Record Dates
Last Update Posted: November 18, 2016
Last Verified: November 2016
Keywords provided by Children's Hospital Medical Center, Cincinnati:
TBI
traumatic brain injury
ADHD
methylphenidate
Concerta
attention problems
Additional relevant MeSH terms:
Layout table for MeSH terms
Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Methylphenidate
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents