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NCT00035139 · ClinicalTrials.gov registry record · Phase 4

Pediatric Traumatic Brain Injury: Methylphenidate Effects on Early Recovery

A Phase 4 study, sponsored by National Center for Research Resources (NCRR).

Completed
Registry status
Phase 4
Development phase

NCT00035139: Completed Phase 4 study, sponsored by National Center for Research Resources (NCRR).

NCT00035139 is a Phase 4 study that has completed, run by National Center for Research Resources (NCRR). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00035139, a Phase 4 study, has completed, sponsored by National Center for Research Resources (NCRR).

COMPLETED
Registry status
Phase 4
Development phase

Study Summary

Traumatic Brain Injury (TBI) is the leading cause of acquired long term disability among children and young adults. Deficits in attention and memory are common and persist for years after moderate or severe TBI. The similarity between these symptoms and those of children with AD/HD, the efficacy of methylphenidate in the treatment of AD/HD, and the efficacy of methylphenidate in improving recovery of animals with brain injuries, support the need to study methylphenidate effects in children with TBI. This investigation of methylphenidate in children with moderate to severe TBI aims to: (1) Assess the acute effects of 2 different dosages of methylphenidate on attention and reaction time when the medication is administered to children early in recovery; (2) Assess the ability of 8 weeks of methylphenidate to improve the rate of recovery of cognitive, memory, and attentional skills in children with TBI; (3) Identify the frequency of common methylphenidate side effects in children with TBI.

Interventions

  • DRUG methylphenidate

Trial Details

FieldValue
Phase Phase 4

What the finished NCT00035139 record still lists

NCT00035139 is an interventional study that assigns participants to a tested intervention. An enrollment target was not published in the registry record, which is common for early-stage or observational entries.

The record links to 0 conditions, and to 1 intervention - of which methylphenidate is the first listed.

NCT00035139 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00035139 about?

NCT00035139 is a clinical study titled "Pediatric Traumatic Brain Injury: Methylphenidate Effects on Early Recovery". Traumatic Brain Injury (TBI) is the leading cause of acquired long term disability among children and young adults. Deficits in attention and memory are common and persist for years after moderate or severe TBI. The similarity between these symptoms and those of children with AD/HD, the efficacy of ...

What is the current status of trial NCT00035139?

This trial is currently completed. It is a Phase 4 study.

What interventions are being tested in trial NCT00035139?

The interventions under investigation include: methylphenidate (DRUG).

Who is sponsoring clinical trial NCT00035139?

This trial is sponsored by National Center for Research Resources (NCRR), which has 94 total clinical trials registered on ClinicalTrials.gov.

Source: ClinicalTrials.gov NCT00035139, the US trial registry maintained by the National Library of Medicine. NCT00035139 (unsized enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.