Trial · NCT01081132

Dose-optimization in Adolescents Aged 13-17 Diagnosed With Attention-deficit/Hyperactivity Disorder (ADHD) Using Extended-release Guanfacine HCl

NCT01081132, Phase 3, Completed, Shire; results first posted 2014-05-23

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Dose-optimization in Adolescents Aged 13-17 Diagnosed With Attention-deficit/Hyperactivity Disorder (ADHD) Using Extended-release Guanfacine HCl. Trials, record NCT01081132. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01081132

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Trial

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

Title: Dose-optimization in Adolescents Aged 13-17 Diagnosed With Attention-deficit/Hyperactivity Disorder (ADHD) Using Extended-release Guanfacine HCl
NCT number: NCT01081132
Status: Completed
Phases: Phase 3
Enrollment: 314 participants, actual
Lead sponsor: Shire
Conditions: Attention-Deficit/Hyperactivity Disorder
Interventions: Extended-release Guanfacine Hydrochloride, Placebo
First posted: 2010-03-05
Last updated: 2021-06-28
Other registries' IDs: eudract:2011-002221-21
Results first posted: 2014-05-23
Limitations and caveats: For the secondary outcomes, the p-values are not controlled for multiplicity, therefore they should be considered as descriptive not inferential.

Source ClinicalTrials.gov

Registered outcomes17

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

List	Outcome	Time frame	Description
Primary	Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Week 13	Baseline through week 13	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.
Secondary	Percent of Subjects With an Assessment of Normal/Borderline Mentally Ill on Clinical Global Impression-Severity of Illness (CGI-S) Scale at the Last On-Treatment Assessment	Baseline through week 13	CGI-S assesses the severity of the subject's condition on a 7-point scale: 1 (normal, not at all ill), 2 (borderline mentally ill), 3 (mildly ill), 4 (moderately ill), 5 (markedly ill), 6 (severely ill), 7 (among the most extremely ill)
Secondary	Change From Baseline in the Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Learning and School Domain Scores at Week 13	Baseline and week 13	The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). The Learning and School Domain consists of 10-items. Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.
Secondary	Change From Baseline in the WFIRS-P Family Domain Score at Week 13	Baseline and week 13	The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). The Family Domain consists of 10-items. Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.
Secondary	Change From Baseline in the WFIRS-P Behavior in School Domain Score at Week 13	Baseline and week 13	The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.
Secondary	Change From Baseline in the WFIRS-P Global Domain Score at Week 13	Baseline and week 13	The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.
Secondary	Change From Baseline in the WFIRS-P Risk Domain Score at Week 13	Baseline and week 13	The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). The Risk Domain consists of 10-items. Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.
Secondary	Change From Baseline in the WFIRS-P Social Domain Score at Week 13	Baseline and week 13	The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). The Social Domain consists of 7-items. Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.
Secondary	Change From Baseline in the WFIRS-P Child Self-Concept Domain Score at Week 13	Baseline and week 13	The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). The Child Self-Concept Domain consists of 3-items. Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.
Secondary	Change From Baseline in the WFIRS-P Life Skills Domain Score at Week 13	Baseline and week 13	The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). The Life Skills Domain consists of 10-items. Mean scores range from 0 to 3. Higher scores indicate greater functional 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	Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Week 13	Baseline through week 13	The Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product. A mixed model repeated measures (MMRM) was used to analyze the observed change from the Baseline Visit scores at all post-baseline, pre-taper, on-treatment visits.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Percent of Subjects With an Assessment of Normal/Borderline Mentally Ill on Clinical Global Impression-Severity of Illness (CGI-S) Scale at the Last On-Treatment Assessment	Baseline through week 13	Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.	percentage of subjects	NUMBER
SECONDARY	Change From Baseline in the Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Learning and School Domain Scores at Week 13	Baseline and week 13	Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in the WFIRS-P Family Domain Score at Week 13	Baseline and week 13	Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in the WFIRS-P Behavior in School Domain Score at Week 13	Baseline and week 13	Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in the WFIRS-P Global Domain Score at Week 13	Baseline and week 13	Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in the WFIRS-P Risk Domain Score at Week 13	Baseline and week 13	Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in the WFIRS-P Social Domain Score at Week 13	Baseline and week 13	Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in the WFIRS-P Child Self-Concept Domain Score at Week 13	Baseline and week 13	Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in the WFIRS-P Life Skills Domain Score at Week 13	Baseline and week 13	Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.	units on a scale	LEAST_SQUARES_MEAN

1 to 10 of 17Source ClinicalTrials.gov

See all 17 outcomes

Results by group70

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

Outcome	Group	Value	Spread	Units
Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Week 13	PLACEBO	-18.527	Standard Error 1.0841	units on a scale
Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Week 13	SPD503	-24.552	Standard Error 1.0625	units on a scale
Percent of Subjects With an Assessment of Normal/Borderline Mentally Ill on Clinical Global Impression-Severity of Illness (CGI-S) Scale at the Last On-Treatment Assessment	PLACEBO	36.1		percentage of subjects
Percent of Subjects With an Assessment of Normal/Borderline Mentally Ill on Clinical Global Impression-Severity of Illness (CGI-S) Scale at the Last On-Treatment Assessment	SPD503	50.6		percentage of subjects
Change From Baseline in the Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Learning and School Domain Scores at Week 13	PLACEBO	-0.457	Standard Error 0.058	units on a scale
Change From Baseline in the Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Learning and School Domain Scores at Week 13	SPD503	-0.572	Standard Error 0.058	units on a scale
Change From Baseline in the WFIRS-P Family Domain Score at Week 13	PLACEBO	-0.314	Standard Error 0.055	units on a scale
Change From Baseline in the WFIRS-P Family Domain Score at Week 13	SPD503	-0.371	Standard Error 0.054	units on a scale
Change From Baseline in the WFIRS-P Behavior in School Domain Score at Week 13	PLACEBO	-0.376	Standard Error 0.051	units on a scale
Change From Baseline in the WFIRS-P Behavior in School Domain Score at Week 13	SPD503	-0.459	Standard Error 0.050	units on a scale

1 to 10 of 70Source ClinicalTrials.gov

See all 70 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	PLACEBO	157
Overall Study	STARTED	SPD503	157
Overall Study	COMPLETED	PLACEBO	102
Overall Study	COMPLETED	SPD503	105
Overall Study	NOT COMPLETED	PLACEBO	55
Overall Study	NOT COMPLETED	SPD503	52

Source ClinicalTrials.gov

Adverse events58

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	Events
other	Abdominal pain	Gastrointestinal disorders	PLACEBO	6	155	7
other	Abdominal pain	Gastrointestinal disorders	SPD503	9	157	10
other	Abdominal pain upper	Gastrointestinal disorders	PLACEBO	7	155	7
other	Abdominal pain upper	Gastrointestinal disorders	SPD503	10	157	11
other	Diarrhoea	Gastrointestinal disorders	PLACEBO	13	155	15
other	Diarrhoea	Gastrointestinal disorders	SPD503	12	157	17
other	Dry mouth	Gastrointestinal disorders	PLACEBO	0	155	0
other	Dry mouth	Gastrointestinal disorders	SPD503	12	157	12
other	Nausea	Gastrointestinal disorders	PLACEBO	21	155	22
other	Nausea	Gastrointestinal disorders	SPD503	19	157	22

1 to 10 of 58Source ClinicalTrials.gov

See all 58 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	PLACEBO
Total, all-cause mortality	SPD503
Total, other adverse events	PLACEBO	120	155
Total, other adverse events	SPD503	147	157
Total, serious adverse events	PLACEBO	2	155
Total, serious adverse events	SPD503	4	157

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
26506582	DERIVED

Source 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
SPD503 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.

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Read this trial from software.

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

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