Attention Deficit Disorder With HyperactivityPhase 3NCT00150618
Safety and Efficacy of SPD503 in Treating ADHD in Children and Adolescents Aged 6-17
A Phase 3 study testing SPD503 (1 mg), SPD503 (2 mg) and SPD503 (3 mg) in people with Attention Deficit Disorder With Hyperactivity, run by Shire.
Trial summary
The purpose of this study is to determine the efficacy of SPD503 compared to placebo in the treatment of children and adolescents aged 6-17 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 (1 mg), SPD503 (2 mg) and SPD503 (3 mg)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 324 participants
- Where
- No sites listed yet
- Study dates
- 30 Mar 2004to 7 Oct 2004
- Phase
- Phase 3
- 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
- Females of childbearing potential must have a negative serum beta human chorionic gonadotropin (HCG) pregnancy test
- Male or non-pregnant female subject who agrees to comply with any applicable contraceptive requirements
Who cannot join
- Subject has a current, uncontrolled, comorbid psychiatric diagnosis with significant symptoms such as severe comorbid Axis II disorders or severe Axis I disorders
- Subject weighs less than 55 lbs or is morbidly overweight with a BMI => 35
- Subject has a history of seizure during the last 2 years or a serious tic disorder, including Tourette's Disorder
- Subject is pregnant or lactating
About this study
Official title: A Phase III, Randomized, Double-Blind, Multi-Center, Parallel-Group, Placebo-Controlled Safety and Efficacy Study of SPD503 in Children and Adolescents Aged 6-17 With Attention Deficit Hyperactivity Disorder (ADHD)
The purpose of this study is to determine the efficacy of SPD503 compared to placebo in the treatment of children and adolescents aged 6-17 with ADHD.
- Being tested
- SPD503 (1 mg), SPD503 (2 mg), SPD503 (3 mg), SPD503 (4 mg), 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 (1 mg)Drug
Also called Guanfacine hydrochloride
SPD503 (2 mg)Drug
SPD503 (3 mg)Drug
SPD503 (4 mg)Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| SPD503 (Guanfacine HCl) (1 mg) | Experimental | Not described Receives: Drug: SPD503 (1 mg) |
| SPD503 (2 mg) | Experimental | Not described Receives: Drug: SPD503 (2 mg) |
| SPD503 (3 mg) | Experimental | Not described Receives: Drug: SPD503 (3 mg) |
| SPD503 (4 mg) | Experimental | Not described Receives: Drug: SPD503 (4 mg) |
| 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 Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) 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
Secondary outcomes (4)
Change From Baseline in Conner's Parent Rating Scale-revised Short Version (CPRS-R) Score at 6 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.
Measured: Baseline and 6 weeks
Number of Participants With Improvement in Clinical Global Impression-Improvement (CGI-I)
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
Number of Participants With Improvement in Parent Global Assessment (PGA)
Parent Global Assessment (PGA) 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 Child Health Questionnaire-Parent Form (CHQ-PF50) Score at 6 Weeks
The Child Health Questionnaire-Parent Form (CHQ-PF50) was developed to measure the physical and psychosocial well-being of children aged 5 years of age and older. Total scoring ranges from 0-100. Increases in scores represent improved well-being in subjects as assessed by their parents.
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 start30 Mar 2004
- Primary completion7 Oct 2004
- Study completion7 Oct 2004
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 324 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
- NCT00150618
- Sponsor's protocol ID
- SPD503-304
- Status last verified
- May 2021
- First submitted
- 6 Sep 2005
- Last updated
- 10 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Sallee FR, McGough J, Wigal T, Donahue J, Lyne A, Biederman J; SPD503 STUDY GROUP. Guanfacine extended release in children and adolescents with attention-deficit/hyperactivity disorder: a placebo-controlled trial. J Am Acad Child Adolesc Psychiatry. 2009 Feb;48(2):155-65. doi: 10.1097/CHI.0b013e318191769e.
PubMed 19106767
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 III, Randomized, Double-Blind, Multi-Center, Parallel-Group, Placebo-Controlled Safety and Efficacy Study of SPD503 in Children and Adolescents Aged 6-17 With Attention Deficit Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT00150618
- Acronym / sponsor ID
- SPD503-304
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 324 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Study start
- 30 Mar 2004 (actual)
- Primary completion
- 7 Oct 2004 (actual)
- Study completion
- 7 Oct 2004 (actual)
- First posted
- 8 Sep 2005 (estimated)
- Results
- Posted 15 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 efficacy of SPD503 compared to placebo in the treatment of children and adolescents aged 6-17 with ADHD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| SPD503 (Guanfacine HCl) (1 mg) | Experimental | Drug: SPD503 (1 mg) |
| SPD503 (2 mg) | Experimental | Drug: SPD503 (2 mg) |
| SPD503 (3 mg) | Experimental | Drug: SPD503 (3 mg) |
| SPD503 (4 mg) | Experimental | Drug: SPD503 (4 mg) |
| 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 (3 listed)
- Subjects with a primary diagnosis of ADHD
- Females of childbearing potential must have a negative serum beta human chorionic gonadotropin (HCG) pregnancy test
- Male or non-pregnant female subject who agrees to comply with any applicable contraceptive requirements
Key exclusion criteria (4 listed)
- Subject has a current, uncontrolled, comorbid psychiatric diagnosis with significant symptoms such as severe comorbid Axis II disorders or severe Axis I disorders
- Subject weighs less than 55 lbs or is morbidly overweight with a BMI => 35
- Subject has a history of seizure during the last 2 years or a serious tic disorder, including Tourette's Disorder
- Subject is pregnant or lactating
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 (1 mg)Also: Guanfacine hydrochloride | Drug | SPD503 (Guanfacine HCl) (1 mg) |
| SPD503 (2 mg) | Drug | SPD503 (2 mg) |
| SPD503 (3 mg) | Drug | SPD503 (3 mg) |
| SPD503 (4 mg) | Drug | SPD503 (4 mg) |
| Placebo | Drug | Placebo |
Primary outcome
Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Score at 6 Weeks
Time frame: Baseline and 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.
4 secondary outcomes
Change From Baseline in Conner's Parent Rating Scale-revised Short Version (CPRS-R) Score at 6 Weeks
Time frame: Baseline and 6 weeks
Number of Participants With Improvement in Clinical Global Impression-Improvement (CGI-I)
Time frame: 6 weeks
Number of Participants With Improvement in Parent Global Assessment (PGA)
Time frame: 6 weeks
Change From Baseline in Child Health Questionnaire-Parent Form (CHQ-PF50) Score 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 19106767Sallee FR, McGough J, Wigal T, Donahue J, Lyne A, Biederman J; SPD503 STUDY GROUP. Guanfacine extended release in children and adolescents with attention-deficit/hyperactivity disorder: a placebo-controlled trial. J Am Acad Child Adolesc Psychiatry. 2009 Feb;48(2):155-65. doi: 10.1097/CHI.0b013e318191769e.
- 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 3 study testing SPD503 (1 mg), SPD503 (2 mg) and SPD503 (3 mg) 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 3 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 15 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 Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Score 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 NCT00150618, 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.