NCT00697515 is a Phase 3 clinical trial of LDX in ADHD, sponsored by Shire.

Who is sponsoring NCT00697515?

NCT00697515 is sponsored by Shire.

What drugs are being tested in NCT00697515?

Interventions in NCT00697515: LDX, Placebo.

Is NCT00697515 still recruiting?

NCT00697515 is currently completed. Last updated 9 June 2021.

Are results published for NCT00697515?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-06-09 · How we verify

NCT00697515

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 3 Results posted Last updated 9 June 2021

What this trial tests

Phase 3 trial testing LDX in ADHD in 142 participants. Completed in 20 December 2008.

Timeline

18 July 2008

Primary endpoint
20 December 2008

20 December 2008

Quick facts

Lead sponsor	Shire
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	triple
Primary purpose	treatment
Enrollment	142
Start date	18 July 2008
Primary completion	20 December 2008
Estimated completion	20 December 2008
Sites	5 locations across United States

Drugs / interventions tested

LDX — full drug profile →
Placebo

Conditions studied

ADHD — all drugs for ADHD →

Sponsor

Shire — full company profile →

Who can join

Adults 18 to 55, any sex, with ADHD. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Permanent Product Measure of Performance (PERMP) Total Score Over the Treatment Day in the Crossover Phase Primary · 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.

Group	Value	95% CI
SPD489	312.9	± 8.59
Placebo	289.5	± 8.59

PERMP Total Score by Timepoint in the Crossover Phase Secondary · 2, 4, 8, 10, 12 and 14 hours post-dose on Day 7

2.0 hours post-dose

Group	Value	95% CI
SPD489	301.5	± 8.78
Placebo	285.9	± 8.78

4.0 hours post-dose

Group	Value	95% CI
SPD489	314.1	± 9.16
Placebo	284.7	± 9.16

8.0 hours post-dose

Group	Value	95% CI
SPD489	311.4	± 9.07
Placebo	287.1	± 9.07

10.0 hours post-dose

Group	Value	95% CI
SPD489	313.5	± 8.82
Placebo	288.8	± 8.82

12.0 hours post-dose

Group	Value	95% CI
SPD489	318.7	± 8.77
Placebo	293.1	± 8.77

14.0 hours post-dose

Group	Value	95% CI
SPD489	318.6	± 9.03
Placebo	296.7	± 9.03

PERMP Score for the Number of Math Problems Attempted by Timepoint in the Crossover Phase Secondary · 2, 4, 8, 10, 12 and 14 hours post-dose on Day 7

Over the treatment day

Group	Value	95% CI
SPD489	158.6	± 4.33
Placebo	146.6	± 4.33

2.0 hours post-dose

Group	Value	95% CI
SPD489	153.1	± 4.41
Placebo	144.9	± 4.41

4.0 hours post-dose

Group	Value	95% CI
SPD489	159.3	± 4.60
Placebo	144.2	± 4.60

8.0 hours post-dose

Group	Value	95% CI
SPD489	157.6	± 4.56
Placebo	145.3	± 4.56

10.0 hours post-dose

Group	Value	95% CI
SPD489	158.6	± 4.44
Placebo	146.1	± 4.44

12.0 hours post-dose

Group	Value	95% CI
SPD489	161.2	± 4.43
Placebo	148.4	± 4.43

14.0 hours post-dose

Group	Value	95% CI
SPD489	161.5	± 4.57
Placebo	150.4	± 4.57

PERMP Score for the Number of Math Problems Answered Correctly by Timepoint in the Crossover Phase Secondary · 2, 4, 8, 10, 12 and 14 hours post-dose on Day 7

Over the treatment day

Group	Value	95% CI
SPD489	154.4	± 4.27
Placebo	142.9	± 4.27

2.0 hours post-dose

Group	Value	95% CI
SPD489	148.4	± 4.38
Placebo	141.0	± 4.38

4.0 hours post-dose

Group	Value	95% CI
SPD489	154.8	± 4.56
Placebo	140.4	± 4.56

8.0 hours post-dose

Group	Value	95% CI
SPD489	153.7	± 4.51
Placebo	141.7	± 4.51

10.0 hours post-dose

Group	Value	95% CI
SPD489	154.8	± 4.39
Placebo	142.7	± 4.39

12.0 hours post-dose

Group	Value	95% CI
SPD489	157.4	± 4.36
Placebo	144.7	± 4.36

14.0 hours post-dose

Group	Value	95% CI
SPD489	157.1	± 4.48
Placebo	146.3	± 4.48

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 Secondary · 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.

Group	Value	95% CI
SPD489	-21.4	± 7.31

ADHD-RS With Prompts Total Score in the Crossover Phase Secondary · 7 days

Group	Value	95% CI
SPD489	18.1	± 0.94
Placebo	29.6	± 0.94

Assessment of Clinical Global Impression-Severity of Illness (CGI-S) in the Dose Optimization Phase Secondary · 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)

Normal, not at all ill

Group	Value	95% CI
SPD489	0

Borderline mentally ill

Group	Value	95% CI
SPD489	0

Mildly ill

Group	Value	95% CI
SPD489	0

Moderately ill

Group	Value	95% CI
SPD489	92

Markedly ill

Group	Value	95% CI
SPD489	46

Severely ill

Group	Value	95% CI
SPD489	4

Among the most extremely ill subjects

Group	Value	95% CI
SPD489	0

Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) in the Dose Optimization Phase Secondary · 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.

Group	Value	95% CI
SPD489	130

Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) in the Crossover Phase Secondary · 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.

Group	Value	95% CI
SPD489	70
Placebo	13

Change From Baseline in the Brown Attention Deficit Disorder Scale (BADDS) Total Scores at 26 Days in the Dose Optimization Phase Secondary · 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.

Group	Value	95% CI
SPD489	-34.1	± 20.99

Level of Satisfaction With Study Treatment on Medication Satisfaction Questionnaire (MSQ) in the Dose Optimization Phase Secondary · 26 days

MSQ is a survey rating the subject's level of satisfaction with the study treatment medication.

Very satisfied

Group	Value	95% CI
SPD489	79

Moderately satisfied

Group	Value	95% CI
SPD489	44

Not satisfied

Group	Value	95% CI
SPD489	2

Don't know

Group	Value	95% CI
SPD489	2

Change From Baseline in Adult ADHD Impact Module (AIM-A) Question 1 Score at 26 Days in the Dose Optimization Phase Secondary · Baseline and 26 days

AIM-A is a quality of life instrument. Question 1 is '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).

Group	Value	95% CI
SPD489	0.9	± 1.67

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

SPD489

Serious: 0/142 (0%)

Deaths: —

Placebo

Serious: 0/117 (0%)

Deaths: —

Other adverse events (10 terms — click to expand)

Reaction	System	SPD489	Placebo
Decreased appetite	Metabolism and nutrition disorders	—	—
Dry mouth	Gastrointestinal disorders	—	—
Headache	Nervous system disorders	—	—
Insomnia	Psychiatric disorders	—	—
Upper respiratory tract infection	Infections and infestations	—	—
Fatigue	General disorders	—	—
Irritability	General disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Feeling jittery	General disorders	—	—
Anxiety	Psychiatric disorders	—	—

Data from ClinicalTrials.gov NCT00697515 adverse events section.

Sponsor's own description

To evaluate the efficacy of LDX compared to placebo in adults with ADHD in the adult workplace environment (AWE) setting

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Randomized, double-blind, placebo-controlled, crossover study of the efficacy and safety of lisdexamfetamine dimesylate in adults with attention-deficit/hyperactivity disorder: novel findings using a simulated adult workplace environment design.
Wigal T, Brams M, Gasior M, Gao J, et al · · 2010 · cited 111× · PMID 20576091 · DOI 10.1186/1744-9081-6-34
Amphetamines for attention deficit hyperactivity disorder (ADHD) in adults.
Castells X, Blanco-Silvente L, Cunill R. · · 2018 · cited 66× · PMID 30091808 · DOI 10.1002/14651858.cd007813.pub3
Lisdexamfetamine's Efficacy in Treating Attention Deficit Hyperactivity Disorder (ADHD): A Meta-Analysis and Review.
Rutledge-Jukes H, Jonnalagadda P, McIntosh AP, Krstovski S, et al · · 2024 · cited 1× · PMID 39350825 · DOI 10.7759/cureus.68324

Verify or expand the search:

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Other Shire trials

Trials by the same sponsor.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00697515 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Shire
Last refreshed: 9 June 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00697515.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT00697515

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for ADHD

Other Shire trials

Verify against primary sources