ADHDPhase 3NCT00367835
SPD503 (Guanfacine Hydrochloride) in ADHD Plus Oppositional Symptoms
A Phase 3 study testing SPD503 (Guanfacine hydrochloride) in people with ADHD, run by Shire at 34 sites in United States.
Trial summary
To assess efficacy and safety of SPD503(guanfacine hydrochloride) in subjects with ADHD and oppositional symptoms. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- ADHD
- What is being tested?
- SPD503 (Guanfacine hydrochloride)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 217 participants
- Where
- 34 sitesUnited States
- Study dates
- 4 Dec 2006to 4 Jan 2008
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Healthy subjects with ADHD and oppositional symptoms
- ADHD-RS>=24
- CGI >=4
- T-score of Opp subscale CPRS-R:L >=65
- Normal ECG and BP
- >= 55 lbs
Who cannot join
None listed.
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
United States34 sites
Piedmont Neuropsychiatry
Charlotte, North Carolina, 28226
University of Cincinnati
Cincinnati, Ohio, 45267
CRI Worldwide, LLC
Clementon, New Jersey, 08021
Discovery and Wellness Center for Children
Cleveland, Ohio, 44106
Duke Child & Family Study Center
Durham, North Carolina, 27705
Valley Clinical Research
El Centro, California, 92243
Sarkis Clinical Trials
Gainesville, Florida, 32607
University of Florida
Gainesville, Florida, 32610
NeuroScience, Inc
Herndon, Virginia, 20170
Amedica Research Institute, Inc
Hialeah, Florida, 33013
Claghorn-Lesem Research Clinic Inc
Houston, Texas, 77008
Red Oak Psychiatry Associates, PA
Houston, Texas, 77090
Eastside Therapeutic Resource
Kirkland, Washington, 98033
Capstone Clinical Research
Libertyville, Illinois, 60048
CORE Research, Inc
Maitland, Florida, 32751
Miami Research Associates
Miami, Florida, 33143
Dominion Clinical Research
Midlothian, Virginia, 23112
BHI Inc
Moore, Oklahoma, 73160
Mount Sinai School of Medicine
New York, New York, 10029
IPS Research Company
Oklahoma City, Oklahoma, 73103
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Clinical Neuroscience Solutions, Inc
Orlando, Florida, 32806
Vince and Associates Clinical Research
Overland Park, Kansas, 66212
Pedia Research
Owensboro, Kentucky, 42301
Four Rivers Clinical Research
Paducah, Kentucky, 42003
CRI Worldwide, LLC
Philadelphia, Pennsylvania, 19149
HOPE Research Institute
Phoenix, Arizona, 85050
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Oregon Center for Clinical Investigations, Inc
Portland, Oregon, 97210
University of Rochester, School of Medicine and Dentistry
Rochester, New York, 14618
Peninsula Research Associates Inc
Rolling Hills Estates, California, 90274
Oregon Center for Clinical Investigations, Inc
Salem, Oregon, 97301
SUNY Upsate Medical University
Syracuse, New York, 13210
Childrens Developmental Center
Winter Park, Florida, 32792
About this study
Official title: A Double-Blind, Randomized, Multi-Center, Flexible Dose Study Evaluating the Efficacy and Safety of SPD503 (Guanfacine Hydrochloride) in Children Aged 6-12 With Symptoms of Oppositionality and a Diagnosis of Attention Deficit/Hyperactivity Disorder
To assess efficacy and safety of SPD503(guanfacine hydrochloride) in subjects with ADHD and oppositional symptoms.
- Conditions
- ADHD
- Being tested
- SPD503 (Guanfacine hydrochloride), 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 hydrochloride)Drug
Subjects will start at 1mg tablet each morning and will subsequently be titrated (in 1 mg weekly increments) to optimal dose based upon tolerance and response to investigational product (not to exceed 4 mg/day).
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| SPD503 (Guanfacine hydrochloride) | Experimental | Not described Receives: Drug: SPD503 (Guanfacine hydrochloride) |
| 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 the Oppositional Subscale of the Conners' Parent Rating Scale-Revised Long Form (CPRS-R:L) Score at Up to 8 Weeks
The oppositional subscale of the CPRS-R:L contains 10 items designed to reflect criteria for oppositional defiance disorder (ODD). Each item is scored on a range from 0 (not true at all) to 3 (very much true) with total scores ranging from 0 to 30. Higher scores are reflective of more severe symptoms.
Measured: Baseline and up to 8 weeks
Secondary outcomes (10)
Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Total Score at 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.
Measured: Baseline and up to 8 weeks
Assessment of Clinical Global Impression-Severity of Illness (CGI-S)
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)
Measured: up to 8 weeks
Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I)
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: up to 8 weeks
Change From Baseline in the 40-Item Conduct Problem Scale of the New York Parent's Rating Scale-School-aged (NYPRS-S) Score at Up to 8 Weeks
Each item on the NYPRS-S is scored from a range of 0 (not at all) to 3 (very much) with total scores ranging from 0 to 120. Higher scores are reflective of increased disease severity.
Measured: Baseline and up to 8 weeks
Change From Baseline in the Parent Stress Index-Short Form (PSI/SF) Score at Up to 8 Weeks
The response to each of the 36 items on the PSI/SF is converted to a five-point scale from 1 (strongly agree) to 5 (strongly disagree) with total scores ranging from 36 to 180. A higher score is reflective of less stress for the parents.
Measured: Baseline and up to 8 weeks
Number of Participants With Overall Satisfaction on the Medication Satisfaction Survey (MSS)
The Medication Satisfaction Survey (MSS) consists of 11 questions each being answered with one of six responses (strongly agree, agree, somewhat agree, somewhat disagree, disagree, strongly disagree). Overall satisfaction with their child taking the study medication, Question #11, with a response of "strongly agree" or "agree".
Measured: up to 8 weeks
Change From Baseline in Electrocardiogram Results (QTcF Interval) at Up to 8 Weeks
QTcF is the QT interval using Fridericia's correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate (e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation.
Measured: Baseline and up to 8 weeks
Change From Baseline in Pulse Rate at Up to 8 Weeks
Measured: Baseline and up to 8 weeks
Change From Baseline in Systolic Blood Pressure at Up to 8 Weeks
Measured: Baseline and up to 8 weeks
Change From Baseline in Diastolic Blood Pressure at Up to 8 Weeks
Measured: Baseline and up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2006 (estimated)
- Study start4 Dec 2006
- Primary completion4 Jan 2008
- Study completion4 Jan 2008
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 ADHDStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 217 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
- NCT00367835
- Sponsor's protocol ID
- SPD503-307
- Status last verified
- Jun 2021
- First submitted
- 22 Aug 2006
- Last updated
- 14 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Connor DF, Findling RL, Kollins SH, Sallee F, Lopez FA, Lyne A, Tremblay G. Effects of guanfacine extended release on oppositional symptoms in children aged 6-12 years with attention-deficit hyperactivity disorder and oppositional symptoms: a randomized, double-blind, placebo-controlled trial. CNS Drugs. 2010 Sep;24(9):755-68. doi: 10.2165/11537790-000000000-00000.
PubMed 20806988
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Multi-Center, Flexible Dose Study Evaluating the Efficacy and Safety of SPD503 (Guanfacine Hydrochloride) in Children Aged 6-12 With Symptoms of Oppositionality and a Diagnosis of Attention Deficit/Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT00367835
- Acronym / sponsor ID
- SPD503-307
- Conditions
- ADHD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Study start
- 4 Dec 2006 (actual)
- Primary completion
- 4 Jan 2008 (actual)
- Study completion
- 4 Jan 2008 (actual)
- First posted
- 23 Aug 2006 (estimated)
- Results
- Posted 26 Nov 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess efficacy and safety of SPD503(guanfacine hydrochloride) in subjects with ADHD and oppositional symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SPD503 (Guanfacine hydrochloride) | Experimental | Drug: SPD503 (Guanfacine hydrochloride) |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Healthy subjects with ADHD and oppositional symptoms
- ADHD-RS>=24
- CGI >=4
- T-score of Opp subscale CPRS-R:L >=65
- Normal ECG and BP
Key exclusion criteria (0 listed)
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 hydrochloride)Subjects will start at 1mg tablet each morning and will subsequently be titrated (in 1 mg weekly increments) to optimal dose based upon tolerance and response to investigational product (not to exceed 4 mg/day). | Drug | SPD503 (Guanfacine hydrochloride) |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Change From Baseline in the Oppositional Subscale of the Conners' Parent Rating Scale-Revised Long Form (CPRS-R:L) Score at Up to 8 Weeks
Time frame: Baseline and up to 8 weeks
The oppositional subscale of the CPRS-R:L contains 10 items designed to reflect criteria for oppositional defiance disorder (ODD). Each item is scored on a range from 0 (not true at all) to 3 (very much true) with total scores ranging from 0 to 30. Higher scores are reflective of more severe symptoms.
10 secondary outcomes
Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Total Score at Up to 8 Weeks
Time frame: Baseline and up to 8 weeks
Assessment of Clinical Global Impression-Severity of Illness (CGI-S)
Time frame: up to 8 weeks
Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I)
Time frame: up to 8 weeks
Change From Baseline in the 40-Item Conduct Problem Scale of the New York Parent's Rating Scale-School-aged (NYPRS-S) Score at Up to 8 Weeks
Time frame: Baseline and up to 8 weeks
Change From Baseline in the Parent Stress Index-Short Form (PSI/SF) Score at Up to 8 Weeks
Time frame: Baseline and up to 8 weeks
Number of Participants With Overall Satisfaction on the Medication Satisfaction Survey (MSS)
Time frame: up to 8 weeks
Change From Baseline in Electrocardiogram Results (QTcF Interval) at Up to 8 Weeks
Time frame: Baseline and up to 8 weeks
Change From Baseline in Pulse Rate at Up to 8 Weeks
Time frame: Baseline and up to 8 weeks
Change From Baseline in Systolic Blood Pressure at Up to 8 Weeks
Time frame: Baseline and up to 8 weeks
Change From Baseline in Diastolic Blood Pressure at Up to 8 Weeks
Time frame: Baseline and up to 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20806988Connor DF, Findling RL, Kollins SH, Sallee F, Lopez FA, Lyne A, Tremblay G. Effects of guanfacine extended release on oppositional symptoms in children aged 6-12 years with attention-deficit hyperactivity disorder and oppositional symptoms: a randomized, double-blind, placebo-controlled trial. CNS Drugs. 2010 Sep;24(9):755-68. doi: 10.2165/11537790-000000000-00000.
- 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
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SPD503 (Guanfacine hydrochloride) in people with ADHD, run by Shire at 34 sites in United States.
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 6 inclusion and 0 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 14 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 26 Nov 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 the Oppositional Subscale of the Conners' Parent Rating Scale-Revised Long Form (CPRS-R:L) Score at Up to 8 Weeks (time frame: Baseline and up to 8 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 NCT00367835, 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 14 Jun 2021.