Trial Outcomes & Findings for Safety and Efficacy of SPD489 on Executive Function Behaviors in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD) (NCT NCT01101022)

Results Overview

BRIEF-A Global Executive Composite assesses behavioral aspects of executive function. Items are rated 1 (never), 2 (sometimes), and 3 (often). There is no range for a total score. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

161 participants

Primary outcome timeframe

Baseline and up to 10 weeks

Results posted on

2021-06-09

Participant Flow

161 subjects were enrolled and randomized, but 2 never received any investigational product, and therefore were not included in subject disposition going forward (n = 159).

Participant milestones

Participant milestones
Measure	SPD489 Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).	Placebo Dosed orally once a day at approximately 7:00 AM for 10 weeks.
Overall Study STARTED	79	80
Overall Study COMPLETED	62	53
Overall Study NOT COMPLETED	17	27

Reasons for withdrawal

Reasons for withdrawal
Measure	SPD489 Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).	Placebo Dosed orally once a day at approximately 7:00 AM for 10 weeks.
Overall Study Adverse Event	6	2
Overall Study Protocol Violation	4	3
Overall Study Withdrawal by Subject	3	8
Overall Study Lost to Follow-up	1	4
Overall Study Lack of Efficacy	0	7
Overall Study Sponsor decision	1	1
Overall Study Non-compliance	1	0
Overall Study Work schedule	1	1
Overall Study Vacation	0	1

Baseline Characteristics

Safety and Efficacy of SPD489 on Executive Function Behaviors in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SPD489 n=79 Participants Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).	Placebo n=80 Participants Dosed orally once a day at approximately 7:00 AM for 10 weeks.	Total n=159 Participants Total of all reporting groups
Age, Continuous	34.2 years STANDARD_DEVIATION 10.58 • n=5 Participants	34.9 years STANDARD_DEVIATION 11.02 • n=7 Participants	34.6 years STANDARD_DEVIATION 10.77 • n=5 Participants
Age, Customized <18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Customized 18 to 55 years	79 Participants n=5 Participants	80 Participants n=7 Participants	159 Participants n=5 Participants
Age, Customized >55 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	39 Participants n=5 Participants	37 Participants n=7 Participants	76 Participants n=5 Participants
Sex: Female, Male Male	40 Participants n=5 Participants	43 Participants n=7 Participants	83 Participants n=5 Participants
Region of Enrollment United States	79 Participants n=5 Participants	80 Participants n=7 Participants	159 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and up to 10 weeks

Population: Full Analysis Set (FAS) defined as all subjects who took 1 dose of investigational product in the double-blind evaluation phase and had 1 primary efficacy assessment.

BRIEF-A Global Executive Composite assesses behavioral aspects of executive function. Items are rated 1 (never), 2 (sometimes), and 3 (often). There is no range for a total score. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.

Outcome measures

Outcome measures
Measure	SPD489 n=79 Participants Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).	Placebo n=75 Participants Dosed orally once a day at approximately 7:00 AM for 10 weeks.
Change From Baseline in Subject-reported Behavior Rating Inventory of Executive Function - Adult Version Global Executive Composite T-score (BRIEF-A GEC T) at up to 10 Weeks	-22.3 T-scores Standard Error 1.67	-11.1 T-scores Standard Error 1.72

SECONDARY outcome

Timeframe: Baseline and up to 10 weeks

Population: FAS

The AIM-A was developed to assess impact of core ADHD symptoms on daily functioning and quality of life. For multi-item scales, subjects respond to items using a Likert scale with responses ranging from 1 (strongly agree) to 5 (strongly disagree). Scores were computed by deriving the mean of the item sets and transforming the scale score on a continuum from 0 to 100 using a standard formula. Higher scores indicate a better quality of life.

Outcome measures

Outcome measures
Measure	SPD489 n=79 Participants Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).	Placebo n=75 Participants Dosed orally once a day at approximately 7:00 AM for 10 weeks.
Change From Baseline in Adult ADHD Impact Module (AIM-A) Multi-Item Scales Total Score at up to 10 Weeks Performance and Daily Functioning	38.8 Scores on a scale Standard Error 2.84	17.2 Scores on a scale Standard Error 2.91
Change From Baseline in Adult ADHD Impact Module (AIM-A) Multi-Item Scales Total Score at up to 10 Weeks Impact of symptoms: Daily Interference	30.6 Scores on a scale Standard Error 2.52	15.7 Scores on a scale Standard Error 2.58
Change From Baseline in Adult ADHD Impact Module (AIM-A) Multi-Item Scales Total Score at up to 10 Weeks Impact of symptoms: Bother/Concern	29.3 Scores on a scale Standard Error 2.53	15.8 Scores on a scale Standard Error 2.60
Change From Baseline in Adult ADHD Impact Module (AIM-A) Multi-Item Scales Total Score at up to 10 Weeks Relationships/Communication	21.2 Scores on a scale Standard Error 2.49	13.4 Scores on a scale Standard Error 2.56

SECONDARY outcome

Timeframe: Baseline and up to10 weeks

Population: FAS

BRIEF-A is a validated 75-item questionnaire composed of three indexes (Global Executive Composite, Behavioral Recognition Index, and Metacognition Index). Items are rated 1 (never), 2 (sometimes), and 3 (often). Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.

Outcome measures

Outcome measures
Measure	SPD489 n=71 Participants Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).	Placebo n=71 Participants Dosed orally once a day at approximately 7:00 AM for 10 weeks.
Change From Baseline in Informant-reported BRIEF-A T-scores at up to 10 Weeks Global Executive Composite	-10.2 T-scores Standard Error 1.06	-5.3 T-scores Standard Error 1.06
Change From Baseline in Informant-reported BRIEF-A T-scores at up to 10 Weeks Behavioral Regulation Index	-8.6 T-scores Standard Error 1.04	-5.5 T-scores Standard Error 1.04
Change From Baseline in Informant-reported BRIEF-A T-scores at up to 10 Weeks Metacognition Index	-10.3 T-scores Standard Error 1.07	-4.6 T-scores Standard Error 1.07

SECONDARY outcome

Timeframe: Baseline and up to 10 weeks

Population: FAS

BRIEF-A is a validated 75-item questionnaire composed of three indexes (Global Executive Composite, Behavioral Recognition Index, and Metacognition Index). Global Executive Composite was reported as the Primary Outcome. Items are rated 1 (never), 2 (sometimes), and 3 (often). There is no range for a total score. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.

Outcome measures

Outcome measures
Measure	SPD489 n=79 Participants Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).	Placebo n=75 Participants Dosed orally once a day at approximately 7:00 AM for 10 weeks.
Change From Baseline in Subject-reported BRIEF-A T-scores at up to 10 Weeks Behavioral Regulation Index	-17.5 T-scores Standard Error 1.54	-9.2 T-scores Standard Error 1.58
Change From Baseline in Subject-reported BRIEF-A T-scores at up to 10 Weeks Metacognition Index	-22.8 T-scores Standard Error 1.63	-11.2 T-scores Standard Error 1.67

SECONDARY outcome

Timeframe: Baseline and up to 10 weeks

Population: FAS

BRIEF-A clinical subscales items are rated 1 (never), 2 (sometimes), and 3 (often). There is no range for a total score. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.

Outcome measures

Outcome measures
Measure	SPD489 n=79 Participants Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).	Placebo n=75 Participants Dosed orally once a day at approximately 7:00 AM for 10 weeks.
Change From Baseline in Subject-reported BRIEF-A Clinical Subscales T-scores at up to 10 Weeks Inhibit	-17.8 T-scores Standard Error 1.50	-9.5 T-scores Standard Error 1.54
Change From Baseline in Subject-reported BRIEF-A Clinical Subscales T-scores at up to 10 Weeks Shift	-14.5 T-scores Standard Error 1.46	-7.8 T-scores Standard Error 1.50
Change From Baseline in Subject-reported BRIEF-A Clinical Subscales T-scores at up to 10 Weeks Emotional control	-10.9 T-scores Standard Error 1.28	-5.7 T-scores Standard Error 1.31
Change From Baseline in Subject-reported BRIEF-A Clinical Subscales T-scores at up to 10 Weeks Self-monitor	-16.6 T-scores Standard Error 1.44	-8.4 T-scores Standard Error 1.48
Change From Baseline in Subject-reported BRIEF-A Clinical Subscales T-scores at up to 10 Weeks Initiate	-17.9 T-scores Standard Error 1.38	-8.6 T-scores Standard Error 1.41
Change From Baseline in Subject-reported BRIEF-A Clinical Subscales T-scores at up to 10 Weeks Working memory	-23.2 T-scores Standard Error 1.67	-11.9 T-scores Standard Error 1.71
Change From Baseline in Subject-reported BRIEF-A Clinical Subscales T-scores at up to 10 Weeks Plan/Organize	-20.8 T-scores Standard Error 1.58	-9.9 T-scores Standard Error 1.62
Change From Baseline in Subject-reported BRIEF-A Clinical Subscales T-scores at up to 10 Weeks Task monitor	-20.1 T-scores Standard Error 1.64	-10.8 T-scores Standard Error 1.68
Change From Baseline in Subject-reported BRIEF-A Clinical Subscales T-scores at up to 10 Weeks Organization of materials	-16.5 T-scores Standard Error 1.26	-7.6 T-scores Standard Error 1.30

SECONDARY outcome

Timeframe: Baseline and up to 10 weeks

Population: FAS

BRIEF-A clinical subscales items are rated 1 (never), 2 (sometimes), and 3 (often). There is no range for a total score. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.

Outcome measures

Outcome measures
Measure	SPD489 n=71 Participants Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).	Placebo n=71 Participants Dosed orally once a day at approximately 7:00 AM for 10 weeks.
Change From Baseline in Informant-reported BRIEF-A Clinical Subscales T-scores at up to 10 Weeks Inhibit	-10.2 T-scores Standard Error 1.08	-5.8 T-scores Standard Error 1.08
Change From Baseline in Informant-reported BRIEF-A Clinical Subscales T-scores at up to 10 Weeks Shift	-9.1 T-scores Standard Error 1.17	-4.3 T-scores Standard Error 1.17
Change From Baseline in Informant-reported BRIEF-A Clinical Subscales T-scores at up to 10 Weeks Emotional control	-5.9 T-scores Standard Error 0.99	-4.6 T-scores Standard Error 0.99
Change From Baseline in Informant-reported BRIEF-A Clinical Subscales T-scores at up to 10 Weeks Self-monitor	-6.8 T-scores Standard Error 1.04	-4.6 T-scores Standard Error 1.04
Change From Baseline in Informant-reported BRIEF-A Clinical Subscales T-scores at up to 10 Weeks Initiate	-8.6 T-scores Standard Error 1.00	-3.2 T-scores Standard Error 1.00
Change From Baseline in Informant-reported BRIEF-A Clinical Subscales T-scores at up to 10 Weeks Working memory	-12.0 T-scores Standard Error 1.22	-5.7 T-scores Standard Error 1.22
Change From Baseline in Informant-reported BRIEF-A Clinical Subscales T-scores at up to 10 Weeks Plan/Organize	-9.9 T-scores Standard Error 1.07	-5.0 T-scores Standard Error 1.07
Change From Baseline in Informant-reported BRIEF-A Clinical Subscales T-scores at up to 10 Weeks Task monitor	-9.7 T-scores Standard Error 1.21	-3.4 T-scores Standard Error 1.21
Change From Baseline in Informant-reported BRIEF-A Clinical Subscales T-scores at up to 10 Weeks Organization of materials	-6.2 T-scores Standard Error 0.97	-3.0 T-scores Standard Error 0.97

SECONDARY outcome

Timeframe: Baseline and up to 10 weeks

Population: FAS

The ADHD-RS 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. Lower scores indicate reduction in symptoms.

Outcome measures

Outcome measures
Measure	SPD489 n=79 Participants Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).	Placebo n=75 Participants Dosed orally once a day at approximately 7:00 AM for 10 weeks.
Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) With Adult Prompts Total Score at up to 10 Weeks	-21.4 Scores on a scale Standard Error 1.35	-10.3 Scores on a scale Standard Error 1.38

SECONDARY outcome

Timeframe: Baseline

Population: FAS

CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)

Outcome measures

Outcome measures
Measure	SPD489 n=79 Participants Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).	Placebo n=75 Participants Dosed orally once a day at approximately 7:00 AM for 10 weeks.
Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline Normal, not at all ill	0 Percent of participants	0 Percent of participants
Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline Borderline mentally ill	0 Percent of participants	0 Percent of participants
Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline Mildly ill	0 Percent of participants	0 Percent of participants
Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline Moderately ill	48.1 Percent of participants	42.7 Percent of participants
Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline Markedly ill	38.0 Percent of participants	49.3 Percent of participants
Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline Severely ill	13.9 Percent of participants	8.0 Percent of participants
Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline Among the most extremely ill	0 Percent of participants	0 Percent of participants

SECONDARY outcome

Timeframe: Up to 10 weeks post-dose

Population: FAS

CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)

Outcome measures

Outcome measures
Measure	SPD489 n=79 Participants Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).	Placebo n=75 Participants Dosed orally once a day at approximately 7:00 AM for 10 weeks.
Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at up to 10 Weeks Normal, not at all ill	13.9 Percent of participants	6.7 Percent of participants
Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at up to 10 Weeks Borderline mentally ill	38.0 Percent of participants	16.0 Percent of participants
Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at up to 10 Weeks Mildly ill	21.5 Percent of participants	10.7 Percent of participants
Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at up to 10 Weeks Moderately ill	15.2 Percent of participants	37.3 Percent of participants
Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at up to 10 Weeks Markedly ill	8.9 Percent of participants	25.3 Percent of participants
Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at up to 10 Weeks Severely ill	2.5 Percent of participants	4.0 Percent of participants
Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at up to 10 Weeks Among the most extremely ill	0 Percent of participants	0 Percent of participants

SECONDARY outcome

Timeframe: Up to 10 weeks post-dose

Population: FAS

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 (very much improved) or 2 (much improved) on the scale.

Outcome measures

Outcome measures
Measure	SPD489 n=79 Participants Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).	Placebo n=75 Participants Dosed orally once a day at approximately 7:00 AM for 10 weeks.
Percent of Participants With Improvement on Clinical Global Impression - Global Improvement (CGI-I) at up to 10 Weeks	78.5 Percent of participants	34.7 Percent of participants

SECONDARY outcome

Timeframe: Baseline and up to 10 weeks

Population: FAS

The AIM-A was developed to assess impact of core ADHD symptoms on daily functioning and quality of life. For multi-item scales, subjects respond to items using a Likert scale with responses ranging from 1 (strongly agree) to 5 (strongly disagree). Scores were computed by deriving the mean of the item sets and transforming the scale score on a continuum from 0 to 100 using a standard formula. Higher scores indicate a better quality of life.

Outcome measures

Outcome measures
Measure	SPD489 n=79 Participants Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).	Placebo n=75 Participants Dosed orally once a day at approximately 7:00 AM for 10 weeks.
Change From Baseline in AIM-A Multi-Item Scales of Living With ADHD and General Well-being Score at up to 10 Weeks Living with ADHD	14.0 Scores on a scale Standard Error 1.30	4.9 Scores on a scale Standard Error 1.33
Change From Baseline in AIM-A Multi-Item Scales of Living With ADHD and General Well-being Score at up to 10 Weeks General Well-being	19.7 Scores on a scale Standard Error 1.69	9.0 Scores on a scale Standard Error 1.73

SECONDARY outcome

Timeframe: Baseline and up to 10 weeks

Population: FAS

Question 1: 'On a scale of 1 to 10, how would you rate the overall quality of life right now?' It is rated on a scale of 1 (worst) to 10 (best). Higher scores representing a more positive rating. Question 4: 'How much do you agree with this statement: Over the past few weeks, I've had more good days than bad days?' This is rated on a scale of 1 (strongly agree) to 5 (strongly disagree). Lower scores represent better quality of life.

Outcome measures

Outcome measures
Measure	SPD489 n=79 Participants Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).	Placebo n=75 Participants Dosed orally once a day at approximately 7:00 AM for 10 weeks.
Change From Baseline in AIM-A Quality of Life Questions 1 and 4 Scores at up to 10 Weeks Question 1	1.6 Scores on a scale Standard Error 0.16	1.0 Scores on a scale Standard Error 0.16
Change From Baseline in AIM-A Quality of Life Questions 1 and 4 Scores at up to 10 Weeks Question 4	-1.0 Scores on a scale Standard Error 0.11	-0.4 Scores on a scale Standard Error 0.11

SECONDARY outcome

Timeframe: Baseline and up to 10 weeks

Population: FAS

The CAARS-O:S is an assessment tool with prompts provided to an observer who describes ADHD-related symptoms in an adult subject. The 26-item scale is scored on a 4-point scale from 0 (not at all) to 3 (very much, very frequently). There is no range for a total score. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.

Outcome measures

Outcome measures
Measure	SPD489 n=71 Participants Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).	Placebo n=71 Participants Dosed orally once a day at approximately 7:00 AM for 10 weeks.
Change From Baseline in Conner's Adult ADHD Rating Scale-Observer: Short Version (CAARS-O:S) ADHD Index T-score at up to 10 Weeks	-11.3 T-scores Standard Error 1.24	-5.8 T-scores Standard Error 1.24

SECONDARY outcome

Timeframe: Baseline and up to 10 weeks

Population: FAS

The CAARS-O:S is an assessment tool with prompts provided to an observer who describes ADHD-related symptoms in an adult subject. The 26-item scale is scored on a 4-point scale from 0 (not at all) to 3 (very much, very frequently). There is no range for a total score. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.

Outcome measures

Outcome measures
Measure	SPD489 n=71 Participants Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).	Placebo n=71 Participants Dosed orally once a day at approximately 7:00 AM for 10 weeks.
Change From Baseline in CAARS-O:S Factor-derived Subscale T-scores at up to 10 Weeks Inattention/Memory Problems	-10.0 T-scores Standard Error 1.12	-4.9 T-scores Standard Error 1.12
Change From Baseline in CAARS-O:S Factor-derived Subscale T-scores at up to 10 Weeks Hyperactivity/Restlessness	-9.1 T-scores Standard Error 1.20	-5.0 T-scores Standard Error 1.20
Change From Baseline in CAARS-O:S Factor-derived Subscale T-scores at up to 10 Weeks Impulsivity/Emotional Liability	-8.0 T-scores Standard Error 1.01	-4.0 T-scores Standard Error 1.01
Change From Baseline in CAARS-O:S Factor-derived Subscale T-scores at up to 10 Weeks Problems with Self-concept	-7.7 T-scores Standard Error 1.10	-3.3 T-scores Standard Error 1.10

SECONDARY outcome

Timeframe: Baseline and up to 10 weeks

Population: FAS

AAQoL is a validated 29-item scale consisting of 4 subscales. The AAQoL yields a total score and 4 subscale scores. Subjects rate each item on a 5-point Likert scale ranging from 1 (not at all/never) to 5 (extremely/very often). These scores are then transformed to a 0-100 point scale with higher scores indicating better quality of life.

Outcome measures

Outcome measures
Measure	SPD489 n=28 Participants Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).	Placebo n=26 Participants Dosed orally once a day at approximately 7:00 AM for 10 weeks.
Change From Baseline in Adult ADHD Quality of Life (AAQoL) Scale Total Score at up to 10 Weeks Life Productivity	38.0 Scores on a scale Standard Error 4.34	17.0 Scores on a scale Standard Error 4.51
Change From Baseline in Adult ADHD Quality of Life (AAQoL) Scale Total Score at up to 10 Weeks Psychological Health	19.3 Scores on a scale Standard Error 3.61	7.2 Scores on a scale Standard Error 3.74
Change From Baseline in Adult ADHD Quality of Life (AAQoL) Scale Total Score at up to 10 Weeks Life Outlook	18.5 Scores on a scale Standard Error 2.85	6.0 Scores on a scale Standard Error 2.96
Change From Baseline in Adult ADHD Quality of Life (AAQoL) Scale Total Score at up to 10 Weeks Relationships	17.1 Scores on a scale Standard Error 3.69	9.8 Scores on a scale Standard Error 3.83
Change From Baseline in Adult ADHD Quality of Life (AAQoL) Scale Total Score at up to 10 Weeks Total Score	25.9 Scores on a scale Standard Error 3.04	11.1 Scores on a scale Standard Error 3.16

Adverse Events

SPD489

Serious events: 0 serious events

Other events: 62 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 41 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

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

Measure	SPD489 n=79 participants at risk Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).	Placebo n=80 participants at risk Dosed orally once a day at approximately 7:00 AM for 10 weeks.
Gastrointestinal disorders Diarrhea	7.6% 6/79 Safety Population defined as all subjects who took at least 1 dose of investigational product in the double-blind evaluation phase.	2.5% 2/80 Safety Population defined as all subjects who took at least 1 dose of investigational product in the double-blind evaluation phase.
Gastrointestinal disorders Dry Mouth	31.6% 25/79 Safety Population defined as all subjects who took at least 1 dose of investigational product in the double-blind evaluation phase.	7.5% 6/80 Safety Population defined as all subjects who took at least 1 dose of investigational product in the double-blind evaluation phase.
Gastrointestinal disorders Nausea	2.5% 2/79 Safety Population defined as all subjects who took at least 1 dose of investigational product in the double-blind evaluation phase.	6.2% 5/80 Safety Population defined as all subjects who took at least 1 dose of investigational product in the double-blind evaluation phase.
General disorders Fatigue	7.6% 6/79 Safety Population defined as all subjects who took at least 1 dose of investigational product in the double-blind evaluation phase.	3.8% 3/80 Safety Population defined as all subjects who took at least 1 dose of investigational product in the double-blind evaluation phase.
General disorders Feeling Jittery	12.7% 10/79 Safety Population defined as all subjects who took at least 1 dose of investigational product in the double-blind evaluation phase.	0.00% 0/80 Safety Population defined as all subjects who took at least 1 dose of investigational product in the double-blind evaluation phase.
General disorders Irritability	10.1% 8/79 Safety Population defined as all subjects who took at least 1 dose of investigational product in the double-blind evaluation phase.	3.8% 3/80 Safety Population defined as all subjects who took at least 1 dose of investigational product in the double-blind evaluation phase.
Infections and infestations Nasopharyngitis	5.1% 4/79 Safety Population defined as all subjects who took at least 1 dose of investigational product in the double-blind evaluation phase.	5.0% 4/80 Safety Population defined as all subjects who took at least 1 dose of investigational product in the double-blind evaluation phase.
Infections and infestations Upper Respiratory Tract Infection	6.3% 5/79 Safety Population defined as all subjects who took at least 1 dose of investigational product in the double-blind evaluation phase.	1.2% 1/80 Safety Population defined as all subjects who took at least 1 dose of investigational product in the double-blind evaluation phase.
Investigations Heart Rate Increased	5.1% 4/79 Safety Population defined as all subjects who took at least 1 dose of investigational product in the double-blind evaluation phase.	2.5% 2/80 Safety Population defined as all subjects who took at least 1 dose of investigational product in the double-blind evaluation phase.
Investigations Weight Decreased	10.1% 8/79 Safety Population defined as all subjects who took at least 1 dose of investigational product in the double-blind evaluation phase.	0.00% 0/80 Safety Population defined as all subjects who took at least 1 dose of investigational product in the double-blind evaluation phase.
Metabolism and nutrition disorders Anorexia	5.1% 4/79 Safety Population defined as all subjects who took at least 1 dose of investigational product in the double-blind evaluation phase.	0.00% 0/80 Safety Population defined as all subjects who took at least 1 dose of investigational product in the double-blind evaluation phase.
Metabolism and nutrition disorders Decreased Apetite	32.9% 26/79 Safety Population defined as all subjects who took at least 1 dose of investigational product in the double-blind evaluation phase.	6.2% 5/80 Safety Population defined as all subjects who took at least 1 dose of investigational product in the double-blind evaluation phase.
Nervous system disorders Headache	25.3% 20/79 Safety Population defined as all subjects who took at least 1 dose of investigational product in the double-blind evaluation phase.	2.5% 2/80 Safety Population defined as all subjects who took at least 1 dose of investigational product in the double-blind evaluation phase.
Psychiatric disorders Initial Insomnia	10.1% 8/79 Safety Population defined as all subjects who took at least 1 dose of investigational product in the double-blind evaluation phase.	6.2% 5/80 Safety Population defined as all subjects who took at least 1 dose of investigational product in the double-blind evaluation phase.
Psychiatric disorders Insomnia	12.7% 10/79 Safety Population defined as all subjects who took at least 1 dose of investigational product in the double-blind evaluation phase.	3.8% 3/80 Safety Population defined as all subjects who took at least 1 dose of investigational product in the double-blind evaluation phase.
Psychiatric disorders Libido Decreased	5.1% 4/79 Safety Population defined as all subjects who took at least 1 dose of investigational product in the double-blind evaluation phase.	0.00% 0/80 Safety Population defined as all subjects who took at least 1 dose of investigational product in the double-blind evaluation phase.
Skin and subcutaneous tissue disorders Hyperhidrosis	6.3% 5/79 Safety Population defined as all subjects who took at least 1 dose of investigational product in the double-blind evaluation phase.	0.00% 0/80 Safety Population defined as all subjects who took at least 1 dose of investigational product in the double-blind evaluation phase.