Trial · NCT01101022

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

NCT01101022, Phase 4, Completed, Shire; results first posted 2012-02-13

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Efficacy of SPD489 on Executive Function Behaviors in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD). Trials, record NCT01101022. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01101022

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety and Efficacy of SPD489 on Executive Function Behaviors in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
NCT number: NCT01101022
Status: Completed
Phases: Phase 4
Enrollment: 161 participants, actual
Lead sponsor: Shire
Conditions: ADHD Specifically With Executive Function Impairment
Interventions: SPD489, Placebo
First posted: 2010-04-09
Last updated: 2021-06-09
Results first posted: 2012-02-13

Source ClinicalTrials.gov

Registered outcomes15

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	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	Baseline and up to 10 weeks	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.
Secondary	Change From Baseline in Adult ADHD Impact Module (AIM-A) Multi-Item Scales Total Score at up to 10 Weeks	Baseline and up to 10 weeks	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.
Secondary	Change From Baseline in Informant-reported BRIEF-A T-scores at up to 10 Weeks	Baseline and up to10 weeks	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.
Secondary	Change From Baseline in Subject-reported BRIEF-A T-scores at up to 10 Weeks	Baseline and up to 10 weeks	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.
Secondary	Change From Baseline in Subject-reported BRIEF-A Clinical Subscales T-scores at up to 10 Weeks	Baseline and up to 10 weeks	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.
Secondary	Change From Baseline in Informant-reported BRIEF-A Clinical Subscales T-scores at up to 10 Weeks	Baseline and up to 10 weeks	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.
Secondary	Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) With Adult Prompts Total Score at up to 10 Weeks	Baseline and up to 10 weeks	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.
Secondary	Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline	Baseline	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)
Secondary	Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at up to 10 Weeks	Up to 10 weeks post-dose	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)
Secondary	Percent of Participants With Improvement on Clinical Global Impression - Global Improvement (CGI-I) at up to 10 Weeks	Up to 10 weeks post-dose	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.

1 to 10 of 15Source ClinicalTrials.gov

See all 15 registered outcomes

Outcomes15

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	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	Baseline and up to 10 weeks	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.	T-scores	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Adult ADHD Impact Module (AIM-A) Multi-Item Scales Total Score at up to 10 Weeks	Baseline and up to 10 weeks	FAS	Scores on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Informant-reported BRIEF-A T-scores at up to 10 Weeks	Baseline and up to10 weeks	FAS	T-scores	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Subject-reported BRIEF-A T-scores at up to 10 Weeks	Baseline and up to 10 weeks	FAS	T-scores	MEAN
SECONDARY	Change From Baseline in Subject-reported BRIEF-A Clinical Subscales T-scores at up to 10 Weeks	Baseline and up to 10 weeks	FAS	T-scores	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Informant-reported BRIEF-A Clinical Subscales T-scores at up to 10 Weeks	Baseline and up to 10 weeks	FAS	T-scores	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) With Adult Prompts Total Score at up to 10 Weeks	Baseline and up to 10 weeks	FAS	Scores on a scale	LEAST_SQUARES_MEAN
SECONDARY	Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline	Baseline	FAS	Percent of participants	NUMBER
SECONDARY	Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at up to 10 Weeks	Up to 10 weeks post-dose	FAS	Percent of participants	NUMBER
SECONDARY	Percent of Participants With Improvement on Clinical Global Impression - Global Improvement (CGI-I) at up to 10 Weeks	Up to 10 weeks post-dose	FAS	Percent of participants	NUMBER

1 to 10 of 15Source ClinicalTrials.gov

See all 15 outcomes

Results by group116

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
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	SPD489		-22.3	Standard Error 1.67	T-scores
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	Placebo		-11.1	Standard Error 1.72	T-scores
Change From Baseline in Adult ADHD Impact Module (AIM-A) Multi-Item Scales Total Score at up to 10 Weeks	SPD489	Performance and Daily Functioning	38.8	Standard Error 2.84	Scores on a scale
Change From Baseline in Adult ADHD Impact Module (AIM-A) Multi-Item Scales Total Score at up to 10 Weeks	Placebo	Performance and Daily Functioning	17.2	Standard Error 2.91	Scores on a scale
Change From Baseline in Adult ADHD Impact Module (AIM-A) Multi-Item Scales Total Score at up to 10 Weeks	SPD489	Impact of symptoms: Daily Interference	30.6	Standard Error 2.52	Scores on a scale
Change From Baseline in Adult ADHD Impact Module (AIM-A) Multi-Item Scales Total Score at up to 10 Weeks	Placebo	Impact of symptoms: Daily Interference	15.7	Standard Error 2.58	Scores on a scale
Change From Baseline in Adult ADHD Impact Module (AIM-A) Multi-Item Scales Total Score at up to 10 Weeks	SPD489	Impact of symptoms: Bother/Concern	29.3	Standard Error 2.53	Scores on a scale
Change From Baseline in Adult ADHD Impact Module (AIM-A) Multi-Item Scales Total Score at up to 10 Weeks	Placebo	Impact of symptoms: Bother/Concern	15.8	Standard Error 2.60	Scores on a scale
Change From Baseline in Adult ADHD Impact Module (AIM-A) Multi-Item Scales Total Score at up to 10 Weeks	SPD489	Relationships/Communication	21.2	Standard Error 2.49	Scores on a scale
Change From Baseline in Adult ADHD Impact Module (AIM-A) Multi-Item Scales Total Score at up to 10 Weeks	Placebo	Relationships/Communication	13.4	Standard Error 2.56	Scores on a scale

1 to 10 of 116Source ClinicalTrials.gov

See all 116 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	SPD489	79
Overall Study	STARTED	Placebo	80
Overall Study	COMPLETED	SPD489	62
Overall Study	COMPLETED	Placebo	53
Overall Study	NOT COMPLETED	SPD489	17
Overall Study	NOT COMPLETED	Placebo	27

Source ClinicalTrials.gov

Adverse events34

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Diarrhea	Gastrointestinal disorders	SPD489	6	79
other	Diarrhea	Gastrointestinal disorders	Placebo	2	80
other	Dry Mouth	Gastrointestinal disorders	SPD489	25	79
other	Dry Mouth	Gastrointestinal disorders	Placebo	6	80
other	Nausea	Gastrointestinal disorders	SPD489	2	79
other	Nausea	Gastrointestinal disorders	Placebo	5	80
other	Fatigue	General disorders	SPD489	6	79
other	Fatigue	General disorders	Placebo	3	80
other	Feeling Jittery	General disorders	SPD489	10	79
other	Feeling Jittery	General disorders	Placebo	0	80

1 to 10 of 34Source ClinicalTrials.gov

See all 34 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	SPD489
Total, all-cause mortality	Placebo
Total, other adverse events	SPD489	62	79
Total, other adverse events	Placebo	41	80
Total, serious adverse events	SPD489	0	79
Total, serious adverse events	Placebo	0	80

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
23945447	RESULT	PubMed
24106804	DERIVED	PubMed
32470230	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
SPD489 vs Placebo: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01101022

GET https://conductscience.org/api/trials/v1/NCT01101022/results?page=2

API reference For AI assistants