Trial · NCT00997984

Tolerability and Efficacy of AM and PM Once Daily Dosing With Extended-release Guanfacine Hydrochloride in Children 6-12 With Attention-Deficit/Hyperactivity Disorder (ADHD) (The ADHD Tempo Study)

NCT00997984, Phase 3, Completed, Shire; results first posted 2011-10-26

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Tolerability and Efficacy of AM and PM Once Daily Dosing With Extended-release Guanfacine Hydrochloride in Children 6-12 With Attention-Deficit/Hyperactivity Disorder (ADHD) (The ADHD Tempo Study). Trials, record NCT00997984. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00997984

On this page

Trial

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

Title: Tolerability and Efficacy of AM and PM Once Daily Dosing With Extended-release Guanfacine Hydrochloride in Children 6-12 With Attention-Deficit/Hyperactivity Disorder (ADHD) (The ADHD Tempo Study)
NCT number: NCT00997984
Status: Completed
Phases: Phase 3
Enrollment: 340 participants, actual
Lead sponsor: Shire
Conditions: Attention-Deficit/Hyperactivity Disorder
Interventions: extended-release guanfacine hydrochloride (SPD503), placebo, extended-release guanfacine hydrochloride
First posted: 2009-10-20
Last updated: 2021-06-08
Results first posted: 2011-10-26

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 Attention-Deficit/Hyperactivity Disorder-Rating Scale-IV (ADHD-RS-IV) Total Score at Week 8 - Last Observation Carried Forward (LOCF)	Baseline and up to 8 weeks	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	Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF	Baseline and up to 8 weeks	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	Improvement on Clinical Global Impression-Improvement (CGI-I) Scale at Week 8 - LOCF	up to 8 weeks	Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement includes a score of 1 (very much improved) or 2 (much improved) on the scale.
Secondary	Change From Baseline in Pediatric Daytime Sleepiness Scale (PDSS) Total Score at Week 8 - LOCF	Baseline and up to 8 weeks	The Pediatric Daytime Sleepiness Scale (PDSS) is an 8 question questionnaire scored on a scale from 0 (never) to 4 (always). Total scores range from 0 to 32, with increasing score reflecting greater sleepiness.
Secondary	Change From Baseline in Health Utilities Index-2/3 (HUI 2/3) Scores at Week 8 - LOCF	Baseline and up to 8 weeks	HUI is used to describe health status and to obtain utility scores by collecting data using one or more questionnaires in formats selected to match the specific study design criteria. Scoring ranges from 0.00 (dead) to 1.00 (perfect health). Higher scores represent better health status.
Secondary	Change From Baseline in Conner's Parent Rating Scale - Revised Short Version (CPRS-R:S) Score at Week 8 - LOCF	Baseline and up to 8 weeks	The Conner's Parent rating Scale-revised short version (CPRS-R) consists of 27 questions graded on a scale from 0 (not true at all) to 3 (very much true) with a total score ranging from 0 to 81. Higher scores are indicative of increased ADHD. This scale allows parents to respond on the basis of the child's behavior and help assess ADHD and evaluate problem behavior.
Secondary	Change From Baseline in the Bedtime Resistance Subscale of Child's Sleep Habits Questionnaire (CSHQ) at Week 8 - LOCF	Baseline and up to 8 weeks	The bedtime resistance subscale of CSHQ consists of 6 items scored on a scale from 1 (never/rarely) to 3 (Usually). A higher score reflects more disturbed sleep behavior.
Secondary	Post Sleep Questionnaire (PSQ) Quality of Sleep at Week 8 - LOCF	up to 8 weeks	Post Sleep Questionnaire (PSQ) overall rating of quality of sleep. There are 5 rating responses ranging from very poor to very good. No numbers are associated with the rating responses.
Secondary	Change From Baseline in Mean Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at Week 8 - LOCF	Baseline and up to 8 weeks	The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). Higher scores indicate greater functional impairment. Mean scores range from 0 to 3.
Secondary	Change From Baseline in Systolic Blood Pressure at Week 8 - LOCF	Baseline and up to 8 weeks

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 Attention-Deficit/Hyperactivity Disorder-Rating Scale-IV (ADHD-RS-IV) Total Score at Week 8 - Last Observation Carried Forward (LOCF)	Baseline and up to 8 weeks	Full Analysis Set (FAS) defined as all subjects who had taken at least 1 dose of investigational product during the study.	Units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF	Baseline and up to 8 weeks	FAS	Percent of Participants	NUMBER
SECONDARY	Improvement on Clinical Global Impression-Improvement (CGI-I) Scale at Week 8 - LOCF	up to 8 weeks	FAS	Percent of Participants	NUMBER
SECONDARY	Change From Baseline in Pediatric Daytime Sleepiness Scale (PDSS) Total Score at Week 8 - LOCF	Baseline and up to 8 weeks	Safety Population defined as all subjects who had taken at least 1 dose of investigational product during the study.	Units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Health Utilities Index-2/3 (HUI 2/3) Scores at Week 8 - LOCF	Baseline and up to 8 weeks	FAS	Units on a scale	MEAN
SECONDARY	Change From Baseline in Conner's Parent Rating Scale - Revised Short Version (CPRS-R:S) Score at Week 8 - LOCF	Baseline and up to 8 weeks	FAS	Units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in the Bedtime Resistance Subscale of Child's Sleep Habits Questionnaire (CSHQ) at Week 8 - LOCF	Baseline and up to 8 weeks	FAS	Units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Post Sleep Questionnaire (PSQ) Quality of Sleep at Week 8 - LOCF	up to 8 weeks	FAS	Percent of Participants	NUMBER
SECONDARY	Change From Baseline in Mean Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at Week 8 - LOCF	Baseline and up to 8 weeks	FAS	Units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Systolic Blood Pressure at Week 8 - LOCF	Baseline and up to 8 weeks	Safety Population	mmHg	MEAN

1 to 10 of 15Source ClinicalTrials.gov

See all 15 outcomes

Results by group120

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 Attention-Deficit/Hyperactivity Disorder-Rating Scale-IV (ADHD-RS-IV) Total Score at Week 8 - Last Observation Carried Forward (LOCF)	Placebo		-10.6	Standard Error 1.20	Units on a scale
Change From Baseline in Attention-Deficit/Hyperactivity Disorder-Rating Scale-IV (ADHD-RS-IV) Total Score at Week 8 - Last Observation Carried Forward (LOCF)	SPD503 AM		-20.0	Standard Error 1.23	Units on a scale
Change From Baseline in Attention-Deficit/Hyperactivity Disorder-Rating Scale-IV (ADHD-RS-IV) Total Score at Week 8 - Last Observation Carried Forward (LOCF)	SPD503 PM		-20.4	Standard Error 1.19	Units on a scale
Change From Baseline in Attention-Deficit/Hyperactivity Disorder-Rating Scale-IV (ADHD-RS-IV) Total Score at Week 8 - Last Observation Carried Forward (LOCF)	All-Active		-20.2	Standard Error 0.86	Units on a scale
Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF	Placebo	Normal, not at all ill	4.5		Percent of Participants
Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF	SPD503 AM	Normal, not at all ill	11.5		Percent of Participants
Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF	SPD503 PM	Normal, not at all ill	16.1		Percent of Participants
Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF	All-Active	Normal, not at all ill	13.9		Percent of Participants
Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF	Placebo	Borderline mentally ill	8.2		Percent of Participants
Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF	SPD503 AM	Borderline mentally ill	20.2		Percent of Participants

1 to 10 of 120Source ClinicalTrials.gov

See all 120 results by group

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	113
Overall Study	STARTED	SPD503 AM	113
Overall Study	STARTED	SPD503 PM	114
Overall Study	COMPLETED	Placebo	76
Overall Study	COMPLETED	SPD503 AM	79
Overall Study	COMPLETED	SPD503 PM	88
Overall Study	NOT COMPLETED	Placebo	37
Overall Study	NOT COMPLETED	SPD503 AM	34
Overall Study	NOT COMPLETED	SPD503 PM	26

Source ClinicalTrials.gov

Adverse events72

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	Somnolence	Nervous system disorders	Placebo	14	112
other	Somnolence	Nervous system disorders	SPD503 AM	50	107
other	Somnolence	Nervous system disorders	SPD503 PM	48	114
other	Somnolence	Nervous system disorders	All Active	98	221
other	Headache	Nervous system disorders	Placebo	12	112
other	Headache	Nervous system disorders	SPD503 AM	19	107
other	Headache	Nervous system disorders	SPD503 PM	18	114
other	Headache	Nervous system disorders	All Active	37	221
other	Sedation	Nervous system disorders	Placebo	3	112
other	Sedation	Nervous system disorders	SPD503 AM	15	107

1 to 10 of 72Source ClinicalTrials.gov

See all 72 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo
Total, all-cause mortality	SPD503 AM
Total, all-cause mortality	SPD503 PM
Total, all-cause mortality	All Active
Total, other adverse events	Placebo	64	112
Total, other adverse events	SPD503 AM	85	107
Total, other adverse events	SPD503 PM	95	114
Total, other adverse events	All Active	180	221
Total, serious adverse events	Placebo	0	112
Total, serious adverse events	SPD503 AM	1	107

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
23972694	RESULT	PubMed
26547425	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 comparisons0

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

None in this release.

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/NCT00997984

GET https://conductscience.org/api/trials/v1/NCT00997984/results?page=2

API reference For AI assistants