Attention Deficit Disorder With HyperactivityPhase 2NCT00150592
Safety, Tolerability and Efficacy of SPD503 in Treating ADHD in Children Aged 6-17
A Phase 2 study testing SPD503 (Guanfacine HCl) in people with Attention Deficit Disorder With Hyperactivity, run by Shire.
Trial summary
The purpose of this study is to determine the effects of SPD503 compared to placebo on tasks of sustained attention in children and adolescents aged 6-17 diagnosed with ADHD. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity
- What is being tested?
- SPD503 (Guanfacine HCl)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 182 participants
- Where
- No sites listed yet
- Study dates
- 12 May 2005to 5 Oct 2005
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subjects with a primary diagnosis of ADHD
- Minimum baseline visit ADHD-RS-IV score of 24 and a baseline CGI-S score =>4
- Male or non-pregnant female subject who agrees to comply with any applicable contraceptive requirements
- Subject weighs > 55 lbs and is not morbidly overweight
Who cannot join
- Subject has a comorbid psychiatric diagnosis (except ODD) with significant symptoms such as any severe comorbid Axis II disorders or severe Axis I disorders
- Subject has a history of seizure disorder
- Subject has any specific cardiac condition or family history of significant cardiac condition
- Subject is pregnant, lactating or within six month post-partum
About this study
Official title: A Phase II Study to Assess the Safety, Tolerability and Efficacy of SPD503 Administered to Children and Adolescents Aged 6-17 With Attention-Deficit/Hyperactivity Disorder (ADHD)
The purpose of this study is to determine the effects of SPD503 compared to placebo on tasks of sustained attention in children and adolescents aged 6-17 diagnosed with ADHD.
- Being tested
- SPD503 (Guanfacine HCl), Placebo
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPD503 (Guanfacine HCl)Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| SPD503 (Guanfacine HCl) | Experimental | Not described Receives: Drug: SPD503 (Guanfacine HCl) |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Choice Reaction Time (CRT) at 6 Weeks
Choice reaction time (CRT) is a computerized assessment that trains the subject in holding down a press-pad and releasing the press-pad in response to stimuli presented on the screen. The task requires the subject to react as soon as a yellow dot appears in one of five locations, and the subject must respond by lifting their hand from the press-pad. This is the reaction time (RT) and ranges from 100 to 5000 msec. Lower scores indicate better performance.
Measured: Baseline and 6 weeks
Secondary outcomes (7)
Change From Baseline in Digital Symbol Substitution Task/Coding Test (DSST/Coding) Scores at 6 Weeks in Age Category 8-17 Years
The Digital Symbol Substitution Task/Coding Test (DSST/Coding) assesses relative contributions of speed, memory, and visual scanning. Subjects are required to copy symbols that are paired with simple geometric shapes or numbers within a specific time. Scores range from 0-65 in age category 6-7 years and 0-199 in age category 8-17 years. Higher scores indicate better performance.
Measured: Baseline and 6 weeks
Change From Baseline in DSST/Coding Scores at 6 Weeks in Age Category 6-7 Years
The Digital Symbol Substitution Task/Coding Test (DSST/Coding) assesses relative contributions of speed, memory, and visual scanning. Subjects are required to copy symbols that are paired with simple geometric shapes or numbers within a specific time. Scores range from 0-65 in age category 6-7 years and 0-199 in age category 8-17 years. Higher scores indicate better performance.
Measured: Baseline and 6 weeks
Change From Baseline in Spatial Working Memory (SWM) Scores at 6 Weeks
The Spatial Working Memory (SWM) Test is a computerized assessment of working memory and strategy performance. The subject is required to find blue "tokens" in various displayed boxes and use the "tokens" to fill a column on the right side of the screen. Subjects can only find "tokens" in new boxes, therefore they must remember where previous "tokens" were found. SWM scores including number of between errors, number of within errors, and number of double errors range 0-800 and SWM strategy scores range 8-56. Lower scores indicate better performance.
Measured: Baseline and 6 weeks
Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Total Score at 6 Weeks
Change in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) total score from baseline. 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.
Measured: Baseline and 6 weeks
Number of Participants With Improvement in Clinical Global Impression-Improvement (CGI-I) at 6 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 is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.
Measured: 6 weeks
Change From Baseline in Pediatric Daytime Sleepiness Scale (PDSS) Scores at 6 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.
Measured: Baseline and 6 weeks
Change From Baseline in Pictorial Sleepiness Scale (PSS) Scores at 6 Weeks
The Pictorial Sleepiness Scale (PSS) scores range from 1 (far left wide awake face) to 5 (far right very sleepy face). Increasing score reflects greater sleepiness.
Measured: Baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study start12 May 2005
- Primary completion5 Oct 2005
- Study completion5 Oct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00150592
- Sponsor's protocol ID
- SPD503-206
- Status last verified
- May 2021
- First submitted
- 6 Sep 2005
- Last updated
- 10 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Kollins SH, Lopez FA, Vince BD, Turnbow JM, Farrand K, Lyne A, Wigal SB, Roth T. Psychomotor functioning and alertness with guanfacine extended release in subjects with attention-deficit/hyperactivity disorder. J Child Adolesc Psychopharmacol. 2011 Apr;21(2):111-20. doi: 10.1089/cap.2010.0064. Epub 2011 Apr 10.
PubMed 21476931
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study to Assess the Safety, Tolerability and Efficacy of SPD503 Administered to Children and Adolescents Aged 6-17 With Attention-Deficit/Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT00150592
- Acronym / sponsor ID
- SPD503-206
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Study start
- 12 May 2005 (actual)
- Primary completion
- 5 Oct 2005 (actual)
- Study completion
- 5 Oct 2005 (actual)
- First posted
- 8 Sep 2005 (estimated)
- Results
- Posted 14 Oct 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effects of SPD503 compared to placebo on tasks of sustained attention in children and adolescents aged 6-17 diagnosed with ADHD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SPD503 (Guanfacine HCl) | Experimental | Drug: SPD503 (Guanfacine HCl) |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Subjects with a primary diagnosis of ADHD
- Minimum baseline visit ADHD-RS-IV score of 24 and a baseline CGI-S score =>4
- Male or non-pregnant female subject who agrees to comply with any applicable contraceptive requirements
- Subject weighs > 55 lbs and is not morbidly overweight
Key exclusion criteria (4 listed)
- Subject has a comorbid psychiatric diagnosis (except ODD) with significant symptoms such as any severe comorbid Axis II disorders or severe Axis I disorders
- Subject has a history of seizure disorder
- Subject has any specific cardiac condition or family history of significant cardiac condition
- Subject is pregnant, lactating or within six month post-partum
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPD503 (Guanfacine HCl) | Drug | SPD503 (Guanfacine HCl) |
| Placebo | Drug | Placebo |
Primary outcome
Change From Baseline in Choice Reaction Time (CRT) at 6 Weeks
Time frame: Baseline and 6 weeks
Choice reaction time (CRT) is a computerized assessment that trains the subject in holding down a press-pad and releasing the press-pad in response to stimuli presented on the screen. The task requires the subject to react as soon as a yellow dot appears in one of five locations, and the subject must respond by lifting their hand from the press-pad. This is the reaction time (RT) and ranges from 100 to 5000 msec. Lower scores indicate better performance.
7 secondary outcomes
Change From Baseline in Digital Symbol Substitution Task/Coding Test (DSST/Coding) Scores at 6 Weeks in Age Category 8-17 Years
Time frame: Baseline and 6 weeks
Change From Baseline in DSST/Coding Scores at 6 Weeks in Age Category 6-7 Years
Time frame: Baseline and 6 weeks
Change From Baseline in Spatial Working Memory (SWM) Scores at 6 Weeks
Time frame: Baseline and 6 weeks
Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Total Score at 6 Weeks
Time frame: Baseline and 6 weeks
Number of Participants With Improvement in Clinical Global Impression-Improvement (CGI-I) at 6 Weeks
Time frame: 6 weeks
Change From Baseline in Pediatric Daytime Sleepiness Scale (PDSS) Scores at 6 Weeks
Time frame: Baseline and 6 weeks
Change From Baseline in Pictorial Sleepiness Scale (PSS) Scores at 6 Weeks
Time frame: Baseline and 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21476931Kollins SH, Lopez FA, Vince BD, Turnbow JM, Farrand K, Lyne A, Wigal SB, Roth T. Psychomotor functioning and alertness with guanfacine extended release in subjects with attention-deficit/hyperactivity disorder. J Child Adolesc Psychopharmacol. 2011 Apr;21(2):111-20. doi: 10.1089/cap.2010.0064. Epub 2011 Apr 10.
- FDA recall informationLink provided by the sponsor.
- FDA-approved labelLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SPD503 (Guanfacine HCl) in people with Attention Deficit Disorder With Hyperactivity, run by Shire.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Oct 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Choice Reaction Time (CRT) at 6 Weeks (time frame: Baseline and 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00150592, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2021.