Trial Outcomes & Findings for Dose-Optimization Study Evaluating the Efficacy, Safety and Tolerability of Vyvanse (Lisdexamfetamine Dimesylate) in Children Aged 6-12 Diagnosed With ADHD (NCT NCT00500071)

Results Overview

Change in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) total score from baseline. The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

318 participants

Primary outcome timeframe

Baseline and 7 weeks

Results posted on

2022-03-10

Participant Flow

The study had three phases; 1)screening and wash-out; 2) dose-optimization (5 weeks) and maintenance (2 weeks); 3) 30-day safety follow-up. Dosing ranged from 20-70 mg once daily of Vyvanse.

Participant milestones

Participant milestones
Measure	Vyvanse Lisdexamfetamine dimesylate (LDX)
Screening and Washout Phase STARTED	318
Screening and Washout Phase COMPLETED	317
Screening and Washout Phase NOT COMPLETED	1
Dose-optimization and Maintenance Phase STARTED	317
Dose-optimization and Maintenance Phase COMPLETED	295
Dose-optimization and Maintenance Phase NOT COMPLETED	22
30-day Safety Follow-up STARTED	295
30-day Safety Follow-up COMPLETED	278
30-day Safety Follow-up NOT COMPLETED	17

Reasons for withdrawal

Reasons for withdrawal
Measure	Vyvanse Lisdexamfetamine dimesylate (LDX)
Screening and Washout Phase Protocol Violation	1
Dose-optimization and Maintenance Phase Adverse Event	13
Dose-optimization and Maintenance Phase Protocol Violation	2
Dose-optimization and Maintenance Phase Lack of Efficacy	2
Dose-optimization and Maintenance Phase Withdrawal by Subject	1
Dose-optimization and Maintenance Phase Lack of protocol compliance	4
30-day Safety Follow-up Lost to Follow-up	17

Baseline Characteristics

Dose-Optimization Study Evaluating the Efficacy, Safety and Tolerability of Vyvanse (Lisdexamfetamine Dimesylate) in Children Aged 6-12 Diagnosed With ADHD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vyvanse n=318 Participants Lisdexamfetamine dimesylate (LDX)
Age, Categorical <=18 years	318 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age, Continuous	9.1 years STANDARD_DEVIATION 1.9 • n=93 Participants
Sex: Female, Male Female	93 Participants n=93 Participants
Sex: Female, Male Male	225 Participants n=93 Participants
Region of Enrollment United States	318 Participants n=93 Participants

PRIMARY outcome

Timeframe: Baseline and 7 weeks

Population: Intent-to-treat (ITT). ITT population defined as all subjects who took at least one dose of drug and had at least one ADHD-RS-IV total score available.

Change in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) total score from baseline. The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.

Outcome measures

Outcome measures
Measure	Vyvanse n=316 Participants Lisdexamfetamine dimesylate (LDX)
Change From Baseline in Total Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Score at 7 Weeks	-28.6 Units on a scale Standard Error 0.61

SECONDARY outcome

Timeframe: Baseline and 1, 2, 3, 4, 5, 6, and 7 weeks

Population: ITT

Change in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) total score from baseline. The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.

Outcome measures

Outcome measures
Measure	Vyvanse n=316 Participants Lisdexamfetamine dimesylate (LDX)
Weekly Change From Baseline in Total ADHD-RS-IV Score Week 1	-11.3 Units on a scale Standard Error 0.62
Weekly Change From Baseline in Total ADHD-RS-IV Score Week 2	-17.8 Units on a scale Standard Error 0.63
Weekly Change From Baseline in Total ADHD-RS-IV Score Week 3	-21.7 Units on a scale Standard Error 0.61
Weekly Change From Baseline in Total ADHD-RS-IV Score Week 4	-25.4 Units on a scale Standard Error 0.61
Weekly Change From Baseline in Total ADHD-RS-IV Score Week 5	-27.0 Units on a scale Standard Error 0.60
Weekly Change From Baseline in Total ADHD-RS-IV Score Week 6	-28.9 Units on a scale Standard Error 0.60
Weekly Change From Baseline in Total ADHD-RS-IV Score Week 7	-29.8 Units on a scale Standard Error 0.58

SECONDARY outcome

Timeframe: 7 weeks

Population: ITT

Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 or 2 on the scale.

Outcome measures

Outcome measures
Measure	Vyvanse n=316 Participants Lisdexamfetamine dimesylate (LDX)
Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I)	284 Participants

SECONDARY outcome

Timeframe: 7 weeks

Population: ITT

Parent Global Assessment (PGA) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.

Outcome measures

Outcome measures
Measure	Vyvanse n=316 Participants Lisdexamfetamine dimesylate (LDX)
Number of Participants With Improvement onParent Global Assessment (PGA)	267 Participants

SECONDARY outcome

Timeframe: Baseline and 7 weeks

Population: ITT

Expression and Emotional Scale for Children (EESC) consists of 29 items rated on a scale from 1 (not true at all) to 5 (very much true). Lower scores reflect better emotional outcomes.

Outcome measures

Outcome measures
Measure	Vyvanse n=316 Participants Lisdexamfetamine dimesylate (LDX)
Change From Baseline in Expression and Emotional Scale for Children (EESC) Scores at 7 Weeks	-7.4 Units on a scale Standard Deviation 18.3

SECONDARY outcome

Timeframe: Baseline and 7 weeks

Population: ITT

Behavior Rating Inventory of Executive Function (BRIEF) is an 86-item questionnaire composed of three scales (Global Executive Composite, Behavioral Recognition Index, and Metacognition Index). Items are rated 1 (never), 2 (sometimes), and 3 (often). Lower scores reflect better functioning.

Outcome measures

Outcome measures
Measure	Vyvanse n=316 Participants Lisdexamfetamine dimesylate (LDX)
Changes From Baseline in Behavior Rating Inventory of Executive Function (BRIEF) Scores at 7 Weeks Global Executive Composite	-17.9 Units on a scale Standard Deviation 12.5
Changes From Baseline in Behavior Rating Inventory of Executive Function (BRIEF) Scores at 7 Weeks Behavioral Recognition Index	-15.4 Units on a scale Standard Deviation 12.6
Changes From Baseline in Behavior Rating Inventory of Executive Function (BRIEF) Scores at 7 Weeks Metacognition Index	-17.6 Units on a scale Standard Deviation 12.3

Adverse Events

Vyvanse

Serious events: 2 serious events

Other events: 269 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Vyvanse n=317 participants at risk Lisdexamfetamine dimesylate (LDX)
Cardiac disorders Syncope	0.32% 1/317 • Number of events 1
Cardiac disorders Sinus arrest	0.32% 1/317 • Number of events 1

Other adverse events

Other adverse events
Measure	Vyvanse n=317 participants at risk Lisdexamfetamine dimesylate (LDX)
Gastrointestinal disorders Abdominal pain upper	13.2% 42/317
Gastrointestinal disorders Nausea	5.4% 17/317
Gastrointestinal disorders Vomiting	5.4% 17/317
General disorders Irritability	16.1% 51/317
Investigations Weight decreased	17.0% 54/317
Metabolism and nutrition disorders Decreased appetite	43.2% 137/317
Nervous system disorders Headache	13.9% 44/317
Psychiatric disorders Affect liability	7.3% 23/317
Nervous system disorders Initial insomnia	11.4% 36/317
Nervous system disorders Insomnia	16.1% 51/317

Additional Information

Study Director

Shire

Phone: +1 866 842 5335

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
Publication restrictions are in place

Restriction type: OTHER