Trial · NCT00697515

Safety and Efficacy Workplace Environment Study of Lisdexamfetamine Dimesylate (LDX) in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)

NCT00697515, Phase 3, Completed, Shire; results first posted 2010-02-01

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Efficacy Workplace Environment Study of Lisdexamfetamine Dimesylate (LDX) in Adults With Attention-Deficit Hyperactivity Disorder (ADHD). Trials, record NCT00697515. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00697515

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Trial

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

Title: Safety and Efficacy Workplace Environment Study of Lisdexamfetamine Dimesylate (LDX) in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)
NCT number: NCT00697515
Status: Completed
Phases: Phase 3
Enrollment: 142 participants, actual
Lead sponsor: Shire
Conditions: ADHD
Interventions: LDX, Placebo
First posted: 2008-06-16
Last updated: 2021-06-09
Results first posted: 2010-02-01

Source ClinicalTrials.gov

Registered outcomes17

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

List	Outcome	Time frame	Description
Primary	Permanent Product Measure of Performance (PERMP) Total Score Over the Treatment Day in the Crossover Phase	2, 4, 8, 10, 12 and 14 hours post-dose on Day 7	The Permanent Product Measure of Performance (PERMP) is a skill adjusted math test. The PERMP score is the sum of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session. The scores range from 0-800 with higher scores indicating better performance.
Secondary	PERMP Total Score by Timepoint in the Crossover Phase	2, 4, 8, 10, 12 and 14 hours post-dose on Day 7	The Permanent Product Measure of Performance (PERMP) is a skill adjusted math test. The PERMP score is the sum of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session. The scores range from 0-800 with higher scores indicating better performance.
Secondary	PERMP Score for the Number of Math Problems Attempted by Timepoint in the Crossover Phase	2, 4, 8, 10, 12 and 14 hours post-dose on Day 7	The Permanent Product Measure of Performance (PERMP) is a skill adjusted math test. The PERMP score is the sum of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session. The scores range from 0-800 with higher scores indicating better performance.
Secondary	PERMP Score for the Number of Math Problems Answered Correctly by Timepoint in the Crossover Phase	2, 4, 8, 10, 12 and 14 hours post-dose on Day 7	The Permanent Product Measure of Performance (PERMP) is a skill adjusted math test. The PERMP score is the sum of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session. The scores range from 0-800 with higher scores indicating better performance.
Secondary	Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale With Prompts (ADHD-RS) Total Score at up to 28 Days in the Dose Optimization Phase	Baseline and 7, 14, 21 and 28 days	The Attention Deficit Hyperactivity Disorder Rating Scale with Prompts (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.
Secondary	ADHD-RS With Prompts Total Score in the Crossover Phase	7 days	The Attention Deficit Hyperactivity Disorder Rating Scale with Prompts (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.
Secondary	Assessment of Clinical Global Impression-Severity of Illness (CGI-S) in the Dose Optimization Phase	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	Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) in the Dose Optimization Phase	7, 14, 21 and 28 days	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.
Secondary	Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) in the Crossover Phase	7 days	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.
Secondary	Change From Baseline in the Brown Attention Deficit Disorder Scale (BADDS) Total Scores at 26 Days in the Dose Optimization Phase	Baseline and 26 days	The BADDS assessment consists of 40 items rated on a scale from 0 (never) to 3 (almost daily). The total score ranges from 0 to 120 with increasing scores indicating more severe impairment.

1 to 10 of 17Source ClinicalTrials.gov

See all 17 registered outcomes

Outcomes17

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Permanent Product Measure of Performance (PERMP) Total Score Over the Treatment Day in the Crossover Phase	2, 4, 8, 10, 12 and 14 hours post-dose on Day 7	Intent to Treat (ITT) population defined as all subjects who are randomized and have at least one post-dose primary efficacy assessment.	Units on a scale	LEAST_SQUARES_MEAN
SECONDARY	PERMP Total Score by Timepoint in the Crossover Phase	2, 4, 8, 10, 12 and 14 hours post-dose on Day 7	ITT	Units on a scale	LEAST_SQUARES_MEAN
SECONDARY	PERMP Score for the Number of Math Problems Attempted by Timepoint in the Crossover Phase	2, 4, 8, 10, 12 and 14 hours post-dose on Day 7	ITT	Units on a scale	LEAST_SQUARES_MEAN
SECONDARY	PERMP Score for the Number of Math Problems Answered Correctly by Timepoint in the Crossover Phase	2, 4, 8, 10, 12 and 14 hours post-dose on Day 7	ITT	Units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale With Prompts (ADHD-RS) Total Score at up to 28 Days in the Dose Optimization Phase	Baseline and 7, 14, 21 and 28 days	Enrolled Efficacy Population (EEP) defined as all subjects who have taken one dose of study medication in the Dose Optimization Phase and had one post-Baseline efficacy assessment.	Units on a scale	MEAN
SECONDARY	ADHD-RS With Prompts Total Score in the Crossover Phase	7 days	ITT	Units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Assessment of Clinical Global Impression-Severity of Illness (CGI-S) in the Dose Optimization Phase	Baseline	EEP	Participants	NUMBER
SECONDARY	Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) in the Dose Optimization Phase	7, 14, 21 and 28 days	EEP	Participants	NUMBER
SECONDARY	Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) in the Crossover Phase	7 days	ITT	Participants	NUMBER
SECONDARY	Change From Baseline in the Brown Attention Deficit Disorder Scale (BADDS) Total Scores at 26 Days in the Dose Optimization Phase	Baseline and 26 days	EEP	Units on a scale	MEAN

1 to 10 of 17Source ClinicalTrials.gov

See all 17 outcomes

Results by group67

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

Outcome	Group	Category	Value	Spread	Units
Permanent Product Measure of Performance (PERMP) Total Score Over the Treatment Day in the Crossover Phase	SPD489		312.9	Standard Error 8.59	Units on a scale
Permanent Product Measure of Performance (PERMP) Total Score Over the Treatment Day in the Crossover Phase	Placebo		289.5	Standard Error 8.59	Units on a scale
PERMP Total Score by Timepoint in the Crossover Phase	SPD489	2.0 hours post-dose	301.5	Standard Error 8.78	Units on a scale
PERMP Total Score by Timepoint in the Crossover Phase	Placebo	2.0 hours post-dose	285.9	Standard Error 8.78	Units on a scale
PERMP Total Score by Timepoint in the Crossover Phase	SPD489	4.0 hours post-dose	314.1	Standard Error 9.16	Units on a scale
PERMP Total Score by Timepoint in the Crossover Phase	Placebo	4.0 hours post-dose	284.7	Standard Error 9.16	Units on a scale
PERMP Total Score by Timepoint in the Crossover Phase	SPD489	8.0 hours post-dose	311.4	Standard Error 9.07	Units on a scale
PERMP Total Score by Timepoint in the Crossover Phase	Placebo	8.0 hours post-dose	287.1	Standard Error 9.07	Units on a scale
PERMP Total Score by Timepoint in the Crossover Phase	SPD489	10.0 hours post-dose	313.5	Standard Error 8.82	Units on a scale
PERMP Total Score by Timepoint in the Crossover Phase	Placebo	10.0 hours post-dose	288.8	Standard Error 8.82	Units on a scale

1 to 10 of 67Source ClinicalTrials.gov

See all 67 results by group

Participant flow18

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

Period	Milestone	Group	Participants
Dose Optimization Period	STARTED	SPD489 First	142
Dose Optimization Period	STARTED	Placebo First	0
Dose Optimization Period	COMPLETED	SPD489 First	127
Dose Optimization Period	COMPLETED	Placebo First	0
Dose Optimization Period	NOT COMPLETED	SPD489 First	15
Dose Optimization Period	NOT COMPLETED	Placebo First	0
First Intervention (Crossover Period)	STARTED	SPD489 First	63
First Intervention (Crossover Period)	STARTED	Placebo First	64
First Intervention (Crossover Period)	COMPLETED	SPD489 First	53
First Intervention (Crossover Period)	COMPLETED	Placebo First	52

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events20

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	Dry mouth	Gastrointestinal disorders	SPD489	43	142
other	Dry mouth	Gastrointestinal disorders	Placebo	0	117
other	Nausea	Gastrointestinal disorders	SPD489	11	142
other	Nausea	Gastrointestinal disorders	Placebo	0	117
other	Feeling jittery	General disorders	SPD489	8	142
other	Feeling jittery	General disorders	Placebo	0	117
other	Irritability	General disorders	SPD489	12	142
other	Irritability	General disorders	Placebo	0	117
other	Upper respiratory tract infection	Infections and infestations	SPD489	14	142
other	Upper respiratory tract infection	Infections and infestations	Placebo	9	117

1 to 10 of 20Source ClinicalTrials.gov

See all 20 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	113	142
Total, other adverse events	Placebo	23	117
Total, serious adverse events	SPD489	0	142
Total, serious adverse events	Placebo	0	117

Source ClinicalTrials.gov

Papers4

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
20576091	RESULT	PubMed
20861583	DERIVED	PubMed
21566420	RESULT	PubMed
21973229	RESULT	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 comparisons2

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

Comparison	Source
SPD489 vs Placebo: Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) in the Crossover Phase	Trial comparisons
SPD489 vs Placebo: serious adverse events	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/NCT00697515

GET https://conductscience.org/api/trials/v1/NCT00697515/results?page=2

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