ADHDPhase 3NCT01274221
Safety and Efficacy of SPD489 in Adolescent Subjects Aged 13-17 Years With Attention-Deficit/Hyperactivity Disorder (ADHD)
A Phase 3 study testing SPD489 in people with ADHD, run by Shire at 6 sites in United States.
Trial summary
The primary objective of the study is to evaluate the efficacy of SPD489 compared to placebo in adolescent subjects (13-17 years of age inclusive) with ADHD in the analog classroom setting based on the Permanent Product Measure of Performance (PERMP) total score assessed across 2, 4, 9, 13, 14, and 15 hours post-dose… Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- ADHD
- What is being tested?
- SPD489
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 6 sitesUnited States
- Study dates
- 6 Mar 2011to 4 May 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subject must be male or female, 13-17 years of age inclusive, at the time of consent.
- The parent/LAR must be available at approximately 7:00 AM (±2 hours) to dispense the dose of investigational product for the study duration.
- Subject, who is a female, must have a negative serum beta human chorionic gonadotropin (HCG) pregnancy test and a negative urine pregnancy test and agree to comply with any applicable contraceptive requirements of the protocol.
- Subject meets the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision (DSM-IV-TR) criteria for a primary diagnosis of ADHD based on a detailed psychiatric evaluation.
- Subject has an Attention Deficit/Hyperactivity Disorder Rating Scale-Fourth Edition (ADHD-RS-IV) total score ≥28.
- Subject is functioning at an age-appropriate level intellectually.
- Subject is able to swallow a capsule.
Who cannot join
- Subject has a current, controlled (with medications prohibited in this study) or uncontrolled, comorbid psychiatric diagnosis with significant symptoms such as any significant comorbid Axis II disorder or significant Axis I disorder (such as post traumatic stress disorder, psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, depressive or anxiety disorder) or other symptomatic manifestations that, in the opinion of the examining clinician, will contraindicate treatment with SPD489 or confound efficacy or safety assessments.
- Subject has a documented history of aggressive behavior serious enough to preclude participation in regular classroom activities, as determined by the Investigator. Oppositional defiant disorder is not exclusionary.
- Subject is currently considered a suicide risk in the opinion of the Investigator, has previously made a suicide attempt, or has a prior history of, or is currently, demonstrating active suicidal ideation. Subjects with intermittent passive suicidal ideation are not necessarily excluded based on the assessment of the Investigator
- Subject is underweight.
- Subject is significantly overweight.
- Subject has a concurrent chronic or acute illness (such as severe allergic rhinitis or an infectious process requiring antibiotics), disability, or other condition that might confound the results of safety assessments conducted in the study or that might increase risk to the subject.
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- Subject has a history of seizures (other than infantile febrile seizures), a chronic or current tic disorder, a current diagnosis, and/or a known family history of Tourette's Disorder. Subject has a history of tics that are judged by the Investigator to be exclusionary.
- Subject has a known history of symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems that may place him/her at increased vulnerability to the sympathomimetic effects of a stimulant drug.
- Subject has a known family history of sudden cardiac death or ventricular arrhythmia.
- Subject has any clinically significant electrocardiogram (ECG) or clinically significant laboratory abnormality.
- Subject has current abnormal thyroid function. Treatment with a stable dose of thyroid medication for at least 3 months is permitted.
- Subject has a documented allergy, hypersensitivity, or intolerance to amphetamine or to any excipients in the investigational product.
- Subject has failed to respond to 1 or more adequate courses (dose and duration) of amphetamine therapy.
- Subject has a history of suspected substance abuse or dependence disorder (excluding nicotine) in accordance with DSM-IV-TR criteria.
- Subject has a positive urine drug result (with the exception of subject's current stimulant therapy, if any).
- Subject has taken another investigational product or has taken part in a clinical study within 30 days prior to the Screening visit.
- Subject has previously been screened for this study or has participated in any other SPD489/NRP104 clinical studies.
- Subject has glaucoma.
- Subject is taking other medications that have central nervous system (CNS) effects or affect performance, such as sedating antihistamines and decongestant sympathomimetics, or are monoamine oxidase inhibitors. Stable use of bronchodilator inhalers is not exclusionary.
- Subject is female and is pregnant or lactating.
- Subject is well controlled on his/her current ADHD medication with acceptable tolerability.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Florida Clinical Research Center, LLC
Bradenton, Florida, 34208
Bayou City Research, Ltd.
Houston, Texas, 77007
Center for Psychiatry and Behavioral Medicine, Inc.
Las Vegas, Nevada, 89128
Clinical Study Centers, LLC
Little Rock, Arkansas, 72205
John M. Turnbow, MD, PA
Lubbock, Texas, 79423
Vince and Associates Clinical Research, Inc.
Overland Park, Kansas, 66211
About this study
Official title: A Phase 3b, Randomized, Double-blind, Multicenter, Placebo Controlled, Dose Optimization, Crossover, Analog Classroom, Safety and Efficacy Study of SPD489 in Adolescent Subjects Aged 13-17 Years With Attention-Deficit/Hyperactivity Disorder (ADHD))
The primary objective of the study is to evaluate the efficacy of SPD489 compared to placebo in adolescent subjects (13-17 years of age inclusive) with ADHD in the analog classroom setting based on the Permanent Product Measure of Performance (PERMP) total score assessed across 2, 4, 9, 13, 14, and 15 hours post-dose on the last day of each double-blind crossover period.
- Conditions
- ADHD
- Being tested
- SPD489, 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.
SPD489Drug
Also called Vyvanse, Lisdexamfetamine dimesylate, LDX
1 capsule per day throughout the open-label treatment phase and for one week of the double-blind crossover phase
PlaceboOther
1 capsule per day for one week of the double-blind crossover phase
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
| SPD489 | Active comparator | Not described Receives: Drug: SPD489 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Permanent Product Measure of Performance (PERMP) Total Score
Measured: 7 Days
Secondary outcomes (5)
Attention Deficit/Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) Total Score
Measured: 7 Days
Conners' Parent Rating Scale - Revised (CPRS-R) Total Score
Measured: 7 Days
Clinical Global Impressions - Global Improvement (CGI-I) Rating Scale Score
Measured: 7 Days
Vital Signs (includes oral or tympanic temperature, sitting blood pressure, pulse and respiratory rate) and Body Height and Weight
Measured: Baseline, Weeks 7, 14, 21, 28, 35 and 42
Columbia-Suicide Severity Rating Scale (C-SSRS)
Measured: Baseline, Weeks 7, 14, 21, 28, 35 and 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2011 (estimated)
- Study start6 Mar 2011 (estimated)
- Primary completion4 May 2011 (estimated)
- Study completion4 May 2011 (estimated)
Why it stopped: Cancellation was not safety related but a shift in study priorities for Shire.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 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
- NCT01274221
- Sponsor's protocol ID
- SPD489-321
- Status last verified
- May 2021
- First submitted
- 7 Jan 2011
- Last updated
- 3 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3b, Randomized, Double-blind, Multicenter, Placebo Controlled, Dose Optimization, Crossover, Analog Classroom, Safety and Efficacy Study of SPD489 in Adolescent Subjects Aged 13-17 Years With Attention-Deficit/Hyperactivity Disorder (ADHD))
- ClinicalTrials.gov ID
- NCT01274221
- Acronym / sponsor ID
- SPD489-321
- Conditions
- ADHD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Cancellation was not safety related but a shift in study priorities for Shire.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Study start
- 6 Mar 2011 (estimated)
- Primary completion
- 4 May 2011 (estimated)
- Study completion
- 4 May 2011 (estimated)
- First posted
- 11 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study is to evaluate the efficacy of SPD489 compared to placebo in adolescent subjects (13-17 years of age inclusive) with ADHD in the analog classroom setting based on the Permanent Product Measure of Performance (PERMP) total score assessed across 2, 4, 9, 13, 14, and 15 hours post-dose on the last day of each double-blind crossover period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Placebo |
| SPD489 | Active comparator | Drug: SPD489 |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Subject must be male or female, 13-17 years of age inclusive, at the time of consent.
- The parent/LAR must be available at approximately 7:00 AM (±2 hours) to dispense the dose of investigational product for the study duration.
- Subject, who is a female, must have a negative serum beta human chorionic gonadotropin (HCG) pregnancy test and a negative urine pregnancy test and agree to comply with any applicable contraceptive requirements of the protocol.
- Subject meets the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision (DSM-IV-TR) criteria for a primary diagnosis of ADHD based on a detailed psychiatric evaluation.
- Subject has an Attention Deficit/Hyperactivity Disorder Rating Scale-Fourth Edition (ADHD-RS-IV) total score ≥28.
Key exclusion criteria (21 listed)
- Subject has a current, controlled (with medications prohibited in this study) or uncontrolled, comorbid psychiatric diagnosis with significant symptoms such as any significant comorbid Axis II disorder or significant Axis I disorder (such as post traumatic stress disorder, psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, depressive or anxiety disorder) or other symptomatic manifestations that, in the opinion of the examining clinician, will contraindicate treatment with SPD489 or confound efficacy or safety assessments.
- Subject has a documented history of aggressive behavior serious enough to preclude participation in regular classroom activities, as determined by the Investigator. Oppositional defiant disorder is not exclusionary.
- Subject is currently considered a suicide risk in the opinion of the Investigator, has previously made a suicide attempt, or has a prior history of, or is currently, demonstrating active suicidal ideation. Subjects with intermittent passive suicidal ideation are not necessarily excluded based on the assessment of the Investigator
- Subject is underweight.
- Subject is significantly overweight.
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 |
|---|---|---|
| SPD489Also: Vyvanse, Lisdexamfetamine dimesylate, LDX1 capsule per day throughout the open-label treatment phase and for one week of the double-blind crossover phase | Drug | SPD489 |
| Placebo1 capsule per day for one week of the double-blind crossover phase | Other | Placebo |
Primary outcome
Permanent Product Measure of Performance (PERMP) Total Score
Time frame: 7 Days
5 secondary outcomes
Attention Deficit/Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) Total Score
Time frame: 7 Days
Conners' Parent Rating Scale - Revised (CPRS-R) Total Score
Time frame: 7 Days
Clinical Global Impressions - Global Improvement (CGI-I) Rating Scale Score
Time frame: 7 Days
Vital Signs (includes oral or tympanic temperature, sitting blood pressure, pulse and respiratory rate) and Body Height and Weight
Time frame: Baseline, Weeks 7, 14, 21, 28, 35 and 42
Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Baseline, Weeks 7, 14, 21, 28, 35 and 42
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2021.
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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
6 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 SPD489 in people with ADHD, run by Shire at 6 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 7 inclusion and 21 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: withdrawn, as of the sponsor's last update on 3 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 6 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Permanent Product Measure of Performance (PERMP) Total Score (time frame: 7 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jun 2021.