Trial Outcomes & Findings for Treatment of Traumatic Brain Injury (TBI)-Related Attention Deficits (NCT NCT01000064)

Results Overview

Conner's Continuous Performance Task (CPT-II) measure sustained attention and response inhibition. CPT-II Preservations represent responses in which reaction time was less than 100 ms; these responses are assumed to be anticipatory, random, or slow/inattentive (i.e., carried over from the previous response) because it is physiologically impossible to respond accurately in so short a time. Higher T-scores, percentiles, and means indicate worse performance.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

22 participants

Primary outcome timeframe

12 weeks

Results posted on

2017-05-19

Participant Flow

Of the 22 cases enrolled, five were lost prior to the baseline assessment (moved, unable to contact, no-showed). Two cases were left on hold. Two cases met safety end-point criteria before group assignment. This left 13 individuals who were assigned to groups.

Participant milestones

Participant milestones
Measure	Vyvanse First, Then Placebo Drug: Vyvanse 30 mg for 7 days. 50 mg for 7 days. 70 mg for 28 days. Procedure/Surgery: fMRI Brain scans (fMRI) performed 3 times. Drug: Placebo Capsules taken for 42 days.	Placebo First, Then Vyvanse Drug: Placebo Capsules taken for 42 days. Procedure/Surgery: fMRI Brain scans (fMRI) performed 3 times. Drug: Vyvanse 30 mg for 7 days. 50 mg for 7 days. 70 mg for 28 days.
Overall Study STARTED	7	6
Overall Study COMPLETED	6	5
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Vyvanse First, Then Placebo Drug: Vyvanse 30 mg for 7 days. 50 mg for 7 days. 70 mg for 28 days. Procedure/Surgery: fMRI Brain scans (fMRI) performed 3 times. Drug: Placebo Capsules taken for 42 days.	Placebo First, Then Vyvanse Drug: Placebo Capsules taken for 42 days. Procedure/Surgery: fMRI Brain scans (fMRI) performed 3 times. Drug: Vyvanse 30 mg for 7 days. 50 mg for 7 days. 70 mg for 28 days.
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=13 Participants Drug: Vyvanse 30 mg for 7 days. 50 mg for 7 days. 70 mg for 28 days. Procedure/Surgery: fMRI Brain scans (fMRI) performed 3 times. Drug: Placebo Capsules taken for 42 days.
Age, Categorical <=18 years	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	28.85 years STANDARD_DEVIATION 8.61 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Conner's Continuous Performance Task (CPT-II) measure sustained attention and response inhibition. CPT-II Preservations represent responses in which reaction time was less than 100 ms; these responses are assumed to be anticipatory, random, or slow/inattentive (i.e., carried over from the previous response) because it is physiologically impossible to respond accurately in so short a time. Higher T-scores, percentiles, and means indicate worse performance.

Outcome measures

Outcome measures
Measure	Vyvanse n=13 Participants Vyvanse: 30 mg - 70 mg capsules taken every morning for 6 weeks. fMRI: Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit.	Placebo n=13 Participants Placebo: Placebo capsules taken every morning for 6 weeks. fMRI: Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit.
Assessment of Various Components of Attention, Related Cognitive Processes and ADHD Symptoms, Using Conners Continuous Performance Task (CPT-II).	50.23 ms Standard Deviation 6.67	59.76 ms Standard Deviation 17.29

PRIMARY outcome

Timeframe: 12 weeks

Conner's Continuous Performance Task (CPT-II) measure sustained attention and response inhibition. CPT-II Hit Reaction Time (RT) Block Change measures inattention and vigilance. Lower values indicate less slowing in RT as the test progressed. High T-scores indicate decreased vigilance over time.

Outcome measures

Outcome measures
Measure	Vyvanse n=13 Participants Vyvanse: 30 mg - 70 mg capsules taken every morning for 6 weeks. fMRI: Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit.	Placebo n=13 Participants Placebo: Placebo capsules taken every morning for 6 weeks. fMRI: Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit.
Assessment of Various Components of Attention, Related Cognitive Processes and ADHD Symptoms, Using Conners Continuous Performance Task (CPT-II).	47.70 t-scores Standard Deviation 7.47	54.21 t-scores Standard Deviation 7.68

PRIMARY outcome

Timeframe: 12 weeks

Conner's Continuous Performance Task (CPT-II) measure sustained attention and response inhibition. CPT-II Hit Reaction Time (RT) Inter-Stimulus Interval (ISI) Change assesses the ability to adapt to changing inter-stimulus intervals. Inter-stimulus intervals refers to the amount of time between presentation of stimuli. High t-scores indicate that RT increased as the ISI increased; negative values indicate that RT decreased as the ISI increased. Less Hit RT ISI Change indicates less variability in RT depending on the speed of presentation.

Outcome measures

Outcome measures
Measure	Vyvanse n=13 Participants Vyvanse: 30 mg - 70 mg capsules taken every morning for 6 weeks. fMRI: Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit.	Placebo n=13 Participants Placebo: Placebo capsules taken every morning for 6 weeks. fMRI: Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit.
Assessment of Various Components of Attention, Related Cognitive Processes and ADHD Symptoms, Using Conners Continuous Performance Task (CPT-II)	58.08 t-scores Standard Deviation 17.92	65.93 t-scores Standard Deviation 17.61

PRIMARY outcome

Timeframe: 12 weeks

Conner's Continuous Performance Task (CPT-II) measure sustained attention and response inhibition. CPT-II Hit Reaction Time (RT) Standard Error (SE) measures inattention. Consistency of response times is measured by the standard error for responses to targets. Higher values indicate a greater amount of inattention.

Outcome measures

Outcome measures
Measure	Vyvanse n=13 Participants Vyvanse: 30 mg - 70 mg capsules taken every morning for 6 weeks. fMRI: Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit.	Placebo n=13 Participants Placebo: Placebo capsules taken every morning for 6 weeks. fMRI: Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit.
Assessment of Various Components of Attention, Related Cognitive Processes and ADHD Symptoms, Using Conners Continuous Performance Task (CPT-II).	54.26 ms Standard Deviation 18.21	64.04 ms Standard Deviation 15.68

PRIMARY outcome

Timeframe: 12 weeks

Digit Span repeats strings of digits of increasing length said by the examiner in the same (forward) and in reverse (backward) order. It measures working memory and concentration with a range of scaled scores from 1-19, with higher scaled scores indicating better performance when compared to population norms.

Outcome measures

Outcome measures
Measure	Vyvanse n=13 Participants Vyvanse: 30 mg - 70 mg capsules taken every morning for 6 weeks. fMRI: Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit.	Placebo n=13 Participants Placebo: Placebo capsules taken every morning for 6 weeks. fMRI: Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit.
Assessment of Various Components of Attention, Related Cognitive Processes and ADHD Symptoms, Using the Wechsler Adult Intelligence Scale -- Fourth Edition (WAIS-IV) Digit Span-Backward Subtest.	11.60 units on a scale Standard Deviation 3.86	9.40 units on a scale Standard Deviation 4.40

PRIMARY outcome

Timeframe: 12 weeks

The CAARS:L is an assessment tool that prompts an observer to provide valuable information about the client. This instrument is helpful when considering a diagnosis of ADHD or related problem. High scores on the "Inattention/Memory Problems" sub-scale may indicate difficulty in concentration, difficulty planning or completing tasks, forgetfulness, absent-mindedness, and/or being disorganized. T-scores (M = 50, SD = 10) are used to measure ratings with higher t-scores indicating greater inattention and memory problems. When a t-score is around 60, this indicates greater risk.

Outcome measures

Outcome measures
Measure	Vyvanse n=13 Participants Vyvanse: 30 mg - 70 mg capsules taken every morning for 6 weeks. fMRI: Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit.	Placebo n=13 Participants Placebo: Placebo capsules taken every morning for 6 weeks. fMRI: Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit.
Assessment of Various Components of Attention, Related Cognitive Processes and ADHD Symptoms, Using the Conners Adult ADHD Rating Scale: Long Form (CAARS:L) "Inattention/Memory Problems" Sub-scale.	51.25 t-scores Standard Deviation 13.29	56.33 t-scores Standard Deviation 12.39

PRIMARY outcome

Timeframe: 12 weeks

The BRIEF-A is a standardized rating scale developed to observe everyday behaviors associated with specific domains of the executive functions in adults ages 18 to 90 years. The "Organization of Materials" scale measures orderliness of work, living, and storage spaces. T-scores (M = 50, SD = 10) are used to interpret the individual's level of executive functioning on the BRIEF-A, with higher scores indicating more difficulty in a particular area.

Outcome measures

Outcome measures
Measure	Vyvanse n=13 Participants Vyvanse: 30 mg - 70 mg capsules taken every morning for 6 weeks. fMRI: Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit.	Placebo n=13 Participants Placebo: Placebo capsules taken every morning for 6 weeks. fMRI: Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit.
Assessment of Various Components of Attention, Related Cognitive Processes and ADHD Symptoms, Using the Behaviour Rating Inventory of Executive Function-Adult Version (BRIEF-A) "Organization of Materials" Sub-scale.	48.55 t-scores Standard Deviation 7.95	56.00 t-scores Standard Deviation 12.76

SECONDARY outcome

Timeframe: 12 weeks

Population: No data were collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Population: Based on the analysis of neurobehavioral assessment data, complications with screening, and limited sample size, the neural mechanisms of response to Vyvanse vs placebo were not significant enough to be measured and compared by fMRI. There is no data from the fMRI to be reported because it was abandoned as an aspect of this study before analysis.

Outcome measures

Outcome data not reported

Adverse Events

Vyvanse

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Michael G. Tramontana

Vanderbilt University Medical Center

Phone: 615-327-7144

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place