NCT02712996: TBIC

Treatment of Traumatic Brain Injury (TBI)-Related Attention Deficits in Children

Completed Phase 4 Results posted Last updated 13 July 2020

What this trial tests

Phase 4 trial testing Lisdexamfetamine in Traumatic Brain Injury in 20 participants. Completed in 1 July 2019.

Timeline

6 February 2017

Primary endpoint
1 July 2019

1 July 2019

Quick facts

Lead sponsor	Vanderbilt University
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	triple
Primary purpose	treatment
Enrollment	20
Start date	6 February 2017
Primary completion	1 July 2019
Estimated completion	1 July 2019
Sites	1 location across United States

Drugs / interventions tested

• Lisdexamfetamine (LISDEXAMFETAMINE) — full drug profile →
• Placebo

Conditions studied

• Traumatic Brain Injury — all drugs for Traumatic Brain Injury →
• Attention Deficit Disorder — all drugs for Attention Deficit Disorder →

Sponsor

Vanderbilt University

Who can join

Adults 6 to 16, any sex, with Traumatic Brain Injury or Attention Deficit Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Assessing Severity of Symptoms Associated With Attention-deficit/Hyperactivity Disorder (ADHD) in Children When Using Vyvanse Versus Placebo by Administering the Conners-3 Parent Form Primary · 12 weeks

The Conners-3 Parent Form is used to obtain the parent's observations about behavior in their child aged 6 to 18 years old. Parents rate the child's behavior on 45 items as not true at all (0) to very much true (3). The lowest scale score is 0 (better behavior) and the highest is 135 (worse behavior). The Conners 3-P includes content Scales of Inattention, Hyperactivity/Impulsivity, Learning Problems, Executive Functioning, Aggression, and Peer/Family Relations. Inattention scale was reported as the Primary Outcome. All scores were converted to z-scores (M=0, SD=+/-1).

Group	Value	95% CI
Lisdexamfetamine (Vyvanse)	1.00	± 1.11
Placebo	1.76	± 1.47

Assessing Executive Functioning in Children When Using Vyvanse Versus Placebo by Administering the Behavior Rating Inventory of Executive Function (BRIEF) - PARENT Primary · 12 weeks

The BRIEF Parent Questionnaire is a validated 86-item questionnaire composed of 8 clinical scales that measure different aspects of executive functioning (Initiate, Working Memory, Plan/Organize, Organization of Materials, Monitor, Inhibit, Shift, Emotional Control). For each item, parents rate whether the child engages in the behavior "never" (=1), "sometimes" (=2), or "often" (=3). The lowest scale score is 86 (better performance) and the highest is 258 (worse performance). The clinical scales form two broader Indexes (Behavioral Regulation and Metacognition) and an overall score, the Global

Group	Value	95% CI
Lisdexamfetamine (Vyvanse)	0.51	± 0.99
Placebo	1.16	± 1.33

Assessing Inattentiveness in Children Using Vyvanse Versus Placebo by Measuring Omissions on the Conners Continuous Performance Task (CPT-II). Primary · 12 weeks

Conner's Continuous Performance Task (CPT-II) measures sustained attention and response inhibition. During the CPT-II, letters were presented serially on a screen in a random order. All letters were considered target stimuli, except for the letter 'X' which is a non-target stimulus. Participants responded to target stimuli by pressing the space bar of a computer keyboard (90% of the stimuli) while withholding responses to non-target stimuli (10% of the test). Omission errors represented the number of times a participant fails to respond to target letters (all other than 'X'). Raw scores were c

Group	Value	95% CI
Vyvanse	0.63	± 1.71
Placebo	1.33	± 1.68

Assessing Physical Symptoms in Children Using Vyvanse Versus Placebo by Measuring Anxiety on the Revised Child Manifest Anxiety Scale (RCMAS) Primary · 12 weeks

RCMAS is a self-report, 37-item questionnaire in which children agree (yes = 1) or disagree (no =0) to statements about themselves. A Total Anxiety score is computed based on 28 items, which are divided into 3 anxiety subscales: physiological anxiety (10 items), worry/oversensitivity (11 items), and social concerns/concentration (7 items). The remaining nine items on the RCMAS constitute the Lie (social desirability) subscale. The lowest scale score is 0 and the highest is 37. Raw scores were converted to z-scores (M=0, SD=+/-1). Because scores are derived from affirmative responses, a high sc

Group	Value	95% CI
Vyvanse	0.12	± 0.79
Placebo	-0.23	± 0.95

Assessing Total Symptoms in Children Using Vyvanse Versus Placebo by Measuring Anxiety on the Revised Child Manifest Anxiety Scale (RCMAS) Primary · 12 weeks

RCMAS is a self-report, 37-item questionnaire in which children agree (yes = 1) or disagree (no =0) to statements about themselves. A Total Anxiety score is computed based on 28 items, which are divided into 3 anxiety subscales: physiological anxiety (10 items), worry/oversensitivity (11 items), and social concerns/concentration (7 items). The remaining nine items on the RCMAS constitute the Lie (social desirability) subscale. The lowest scale score is 0 and the highest is 37. Raw scores were converted to z-scores (M=0, SD=+/-1). Because scores are derived from affirmative responses, a high sc

Group	Value	95% CI
Vyvanse	-0.3	± 0.85
Placebo	-0.56	± 0.89

Assessing Attention Problems in Children Using Vyvanse Versus Placebo by Measuring Symptoms on the Child Behavior Checklist (CBCL) Primary · 12 weeks

The Child Behavior Checklist (CBCL) is a widely used caregiver report form identifying problem behavior in children. The patient is rated on 113 items scored on a 3-point Likert scale (0=not true; 1=somewhat/sometimes true; 2=very true/often true). CBCL consists of eight empirically-based syndrome subscales. The range of subscale scores (summed) are: Aggressive Behavior (0-36), Anxious/Depressed (0-26), Attention Problems (0-20), Rule-Breaking Behavior (0-34), Somatic Complaints (0-22), Social Problems (0-22), Thought Problems (0-30), and Withdrawn/Depressed (0-16). Raw scores were converted t

Group	Value	95% CI
Vyvanse	0.88	± 0.69
Placebo	1.37	± 0.93

Assessing Anxiety-Depression Problems in Children Using Vyvanse Versus Placebo by Measuring Symptoms on the Child Behavior Checklist (CBCL) Primary · 12 weeks

The Child Behavior Checklist (CBCL) is a widely used caregiver report form identifying problem behavior in children. The patient is rated on 113 items scored on a 3-point Likert scale (0=not true; 1=somewhat/sometimes true; 2=very true/often true). CBCL consists of eight empirically-based syndrome subscales. The range of subscale scores (summed) are: Aggressive Behavior (0-36), Anxious/Depressed (0-26), Attention Problems (0-20), Rule-Breaking Behavior (0-34), Somatic Complaints (0-22), Social Problems (0-22), Thought Problems (0-30), and Withdrawn/Depressed (0-16). Raw scores were converted t

Group	Value	95% CI
Vyvanse	0.44	± 0.52
Placebo	0.76	± 0.66

Assessing Inhibitory Control in Children When Using Vyvanse Versus Placebo Utilizing the Inhibit Subscale on the Behavior Rating Inventory of Executive Function (BRIEF) - PARENTS Primary · 12 weeks

The BRIEF Parent Questionnaire is a validated 86-item questionnaire composed of 8 clinical scales that measure different aspects of executive functioning (Initiate, Working Memory, Plan/Organize, Organization of Materials, Monitor, Inhibit, Shift, Emotional Control). For each item, parents rate whether the child engages in the behavior "never" (=1), "sometimes" (=2), or "often" (=3). The lowest scale score is 86 (better performance) and the highest is 258 (worse performance). The clinical scales form two broader Indexes (Behavioral Regulation and Metacognition) and an overall score, the Global

Group	Value	95% CI
Lisdexamfetamine (Vyvanse)	-0.05	± 1.05
Placebo	0.42	± 1.16

Assessing Ability to Tolerate Change in Children When Using Vyvanse Versus Placebo by Utilizing the Shift Subscale on the Behavior Rating Inventory of Executive Function (BRIEF) - PARENTS Primary · 12 weeks

The BRIEF Parent Questionnaire is a validated 86-item questionnaire composed of 8 clinical scales that measure different aspects of executive functioning (Initiate, Working Memory, Plan/Organize, Organization of Materials, Monitor, Inhibit, Shift, Emotional Control). For each item, parents rate whether the child engages in the behavior "never" (=1), "sometimes" (=2), or "often" (=3). The lowest scale score is 86 (better performance) and the highest is 258 (worse performance). The clinical scales form two broader Indexes (Behavioral Regulation and Metacognition) and an overall score, the Global

Group	Value	95% CI
Lisdexamfetamine (Vyvanse)	0.33	± 1.22
Placebo	1	± 1.44

Assessing Ability to Begin Tasks in Children When Using Vyvanse Versus Placebo by Utilizing the Initiate Subscale on the Behavior Rating Inventory of Executive Function (BRIEF) - PARENTS Primary · 12 weeks

The BRIEF Parent Questionnaire is a validated 86-item questionnaire composed of 8 clinical scales that measure different aspects of executive functioning (Initiate, Working Memory, Plan/Organize, Organization of Materials, Monitor, Inhibit, Shift, Emotional Control). For each item, parents rate whether the child engages in the behavior "never" (=1), "sometimes" (=2), or "often" (=3). The lowest scale score is 86 (better performance) and the highest is 258 (worse performance). The clinical scales form two broader Indexes (Behavioral Regulation and Metacognition) and an overall score, the Global

Group	Value	95% CI
Lisdexamfetamine (Vyvanse)	0.64	± 0.89
Placebo	1.23	± 1.04

Assessing Representational Memory in Children When Using Vyvanse Versus Placebo by Utilizing the Working Memory Subscale on the Behavior Rating Inventory of Executive Function (BRIEF) - PARENTS Primary · 12 weeks

The BRIEF Parent Questionnaire is a validated 86-item questionnaire composed of 8 clinical scales that measure different aspects of executive functioning (Initiate, Working Memory, Plan/Organize, Organization of Materials, Monitor, Inhibit, Shift, Emotional Control). For each item, parents rate whether the child engages in the behavior "never" (=1), "sometimes" (=2), or "often" (=3). The lowest scale score is 86 (better performance) and the highest is 258 (worse performance). The clinical scales form two broader Indexes (Behavioral Regulation and Metacognition) and an overall score, the Global

Group	Value	95% CI
Lisdexamfetamine (Vyvanse)	0.96	± 1.25
Placebo	1.69	± 1.26

Assessing Task-oriented Monitoring in Children When Using Vyvanse Versus Placebo by Utilizing the Monitor Subscale on the Behavior Rating Inventory of Executive Function (BRIEF) - PARENTS Primary · 12 weeks

The BRIEF Parent Questionnaire is a validated 86-item questionnaire composed of 8 clinical scales that measure different aspects of executive functioning (Initiate, Working Memory, Plan/Organize, Organization of Materials, Monitor, Inhibit, Shift, Emotional Control). For each item, parents rate whether the child engages in the behavior "never" (=1), "sometimes" (=2), or "often" (=3). The lowest scale score is 86 (better performance) and the highest is 258 (worse performance). The clinical scales form two broader Indexes (Behavioral Regulation and Metacognition) and an overall score, the Global

Group	Value	95% CI
Lisdexamfetamine (Vyvanse)	0.34	± 0.89
Placebo	0.84	± 1.19

Adverse events — posted to ClinicalTrials.gov

Time frame: 12 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Lisdexamfetamine (Vyvanse)

Serious: 0/17 (0%)

Deaths: 0/17

Placebo

Serious: 0/17 (0%)

Deaths: 0/17

Other adverse events (1 terms — click to expand)

Reaction	System	Lisdexamfetamine (Vyvanse)	Placebo
Anxiety	General disorders	—	—

Data from ClinicalTrials.gov NCT02712996 adverse events section.

Sponsor's own description

The purpose of this research study is to evaluate whether Vyvanse, a psychostimulant, can help children ages 6-16 with attention deficits due to traumatic brain injury (TBI). Vyvanse is currently approved for the treatment of Attention-Deficit/Hyperactivity (ADHD). The exact effects this drug may have on adults with attention deficits caused by TBI have been investigated prior. The exact effects this drug may have on children with attention deficits caused by TBI are not known, but the investigators expect that Vyvanse will be of some help in treating this population as well.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Current Clinical Trials in Traumatic Brain Injury.
   Ahmed Z. · · 2022 · cited 23× · PMID 35624914 · DOI 10.3390/brainsci12050527
2. Traumatic Brain Injury-Related Attention Deficits in Children: A Controlled Treatment Trial with Lisdexamfetamine Dimesylate (Vyvanse).
   Tramontana MG, Prokop JW, Williamson E, Duffie T, et al · · 2021 · cited 4× · PMID 33467178 · DOI 10.3390/brainsci11010117