Attention Deficit Hyperactivity Disorder (ADHD)Phase 3NCT02466425
Safety and Efficacy Study of SHP465 in Children and Adolescents Aged 6-17 Years With Attention-Deficit Hyperactivity Disorder (ADHD)
A Phase 3 study testing SHP465 in people with Attention Deficit Hyperactivity Disorder (ADHD), run by Shire at 36 sites in United States.
Trial summary
The study is designed to evaluate the efficacy and safety of SHP465 in the treatment of ADHD in children and adolescents (aged 6-17 years). The primary objective of this study is to evaluate the efficacy of SHP465 administered as a daily morning dose compared to placebo in the treatment of children and adolescents… Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder (ADHD)
- What is being tested?
- SHP465
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 264 participants
- Where
- 36 sitesUnited States
- Study dates
- 18 Jun 2015to 16 Feb 2016
- 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
- Subject must be 6-17 years of age, inclusive, at the time of consent.
- Subject's parent or legally authorized representative (LAR) must provide signature of informed consent, and there must be documentation of assent (if applicable) by the subject indicating that the subject is aware of the investigational nature of the study and the required procedures and restrictions in accordance with the ICH GCP Guideline E6 (1996) and applicable regulations before completing any study-related procedures.
- Subject and parent/LAR are willing and able to comply with all of the testing and requirements defined in the protocol, including oversight of morning dosing. Specifically, the parent/LAR must be available at approximately 7:00AM (±2 hours) to dispense the dose of investigational product for the study duration.
- Subject, who is a female and of child-bearing potential, must not have a positive serum beta human chorionic gonadotropin pregnancy test at the Screening Visit (Visit 1) and must have a negative urine pregnancy test at the Baseline Visit (Visit 2) and agree to comply with any applicable contraceptive requirements of the protocol.
- Subject must have a satisfactory medical assessment with no clinically significant or relevant abnormalities.
- Subject meets DSM-IV-TR criteria for a primary diagnosis of ADHD based on a detailed psychiatric evaluation.
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- Subject has an ADHD-RS-IV Total Score >28 at the Baseline Visit (Visit 2).
- Subject is functioning at an age-appropriate level intellectually, as determined by the study Investigator.
- Subject is currently not on ADHD therapy, or is not completely satisfied with any aspect of their current ADHD therapy.
- Subject is able to swallow a capsule whole.
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 SHP465 or confound efficacy or safety assessments. Comorbid psychiatric diagnoses will be established with the Screening Visit (Visit 1) interview of the K-SADS-PL and additional modules if warranted by the results of the initial interview. Subjects may continue participation in a behavioral modification program during the study as long as they have been participating in the program for at least 1 month at the time of the Baseline Visit (Visit 2).
- Subject meets DSM-IV-TR diagnosis of conduct disorder. Oppositional defiant disorder is not exclusionary.
- Subject is considered a suicide risk in the opinion of the Investigator, has previously made a suicide attempt, 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 based on Centers for Disease Control and Prevention body mass index (BMI)-for-age sex-specific values at the Screening Visit (Visit 1). Underweight is defined as a BMI <3rd percentile
- Subject is significantly overweight based on Centers for Disease Control and Prevention BMI-for-age sex specific values at the Screening Visit (Visit 1). Significantly overweight is defined as a BMI >97th percentile for this study
- 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. Similarly, the subject will be excluded if he or she has any additional condition(s) that, in the Investigator's opinion, would prohibit the subject from completing the study or would not be in the best interest of the subject. The additional conditions would include any significant illness or unstable medical condition that could lead to difficulty complying with the protocol. Mild, stable asthma is not exclusionary.
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- Subject has a history of seizure (other than infantile febrile seizures), a chronic or current tic disorder, or a current diagnosis of Tourette's Disorder. Subject has a history of tics that are judged by the Investigator to be exclusionary.
- Subject's blood pressure measurements exceed the 90th percentile for age, sex, and height (based on the Blood Pressure Levels by Age and Height Percentile [for boys and girls]) at the Screening Visit (Visit 1) and the Baseline Visit (Visit 2)
- Subject has a known history of hypertension
- 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 medication.
- Subject has a known family history of sudden cardiac death or ventricular arrhythmia.
- Subject has any clinically significant ECG or clinically significant laboratory abnormality at the Screening Visit (Visit 1).
- Subject has current abnormal thyroid function, defined as abnormal thyroid stimulating hormone and thyroxine at the Screening Visit (Visit 1). 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, based on Investigator judgment, to an adequate course(s) (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. Subjects with a lifetime history of amphetamine, cocaine, or other stimulant abuse and/or dependence will be excluded.
- Subject has a positive urine drug result at the Screening Visit (Visit 1) (with the exception of subject's current stimulant therapy, if any) or the Baseline Visit (Visit 2), if repeated unless the Investigator can verify that the positive result at the Screening Visit (Visit 1) is attributed to medication that has been prescribed to the subject and will be discontinued prior to the Baseline Visit (Visit 2). A positive result at the Screening Visit (Visit 1) attributed to a prescribed medication requires a re-test and a negative result at the Baseline Visit (Visit 2) to confirm subject eligibility.
- Subject has taken another investigational product or has taken part in a clinical study within 30 days prior to the Screening Visit (Visit 1).
- Subject has previously completed, discontinued, or was withdrawn from this study.
- Subject is taking any medication that is excluded or has not been appropriately washed out according to the protocol requirements.
- Subject is required to take or anticipates the need to take medications that have central nervous system 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
Trial locations and contacts
36 sites in 1 country.
36 sites in 1 country
United States36 sites
Rainbow Research
Barnwell, South Carolina, 29812
Florida Clinical Research Center, Llc
Bradenton, Florida, 34201
McB Clinical Research Centers
Colorado Springs, Colorado, 80910
Futuresearch Trials of Dallas, Lp
Dallas, Texas, 75231
Midwest Clinical Research Center
Dayton, Ohio, 45417
Harmonex Neuroscience Research
Dothan, Alabama, 36303
Sarkis Clinical Trials
Gainesville, Florida, 32607
Bayou City Research
Houston, Texas, 77007
Red Oak Psychiatry Associates, Pa
Houston, Texas, 77090
Houston Clinical Trials, Llc
Houston, Texas, 77098
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32256
Eastside Therapeutic Resource
Kirkland, Washington, 98033
Center For Psychiatry and Behavioral Medicine
Las Vegas, Nevada, 89128
Capstone Clinical Research
Libertyville, Illinois, 60048
Westex Clinical Investigations
Lubbock, Texas, 79423
Northwest Behavioral Research Center
Marietta, Georgia, 30060
Clinical Neuroscience Solution, Inc
Memphis, Tennessee, 38119
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464
Baber Research Group Inc
Naperville, Illinois, 60563
Louisiana Research Associates, Inc
New Orleans, Louisiana, 70114
Psychiatric Care and Research Center
O'Fallon, Missouri, 63368
Nrc Research Institute
Orange, California, 92868
Medical Research Group of Central Florida
Orange City, Florida, 32763
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32801
Psychiatric Associates
Overland Park, Kansas, 66211
Research Across America
Plano, Texas, 75093
Rochester Center For Behavioral Medicine
Rochester Hills, Michigan, 48307
Midwest Research Group
Saint Charles, Missouri, 63304
Oregon Center For Clinical Investigations, Inc
Salem, Oregon, 97301
Pcsd Feighner Research
San Diego, California, 92108
Miami Research Associates, Llc
South Miami, Florida, 33143
Encompass Clinical Research
Spring Valley, California, 91978
Tulsa Clinical Research, Llc
Tulsa, Oklahoma, 74104
Omega Medical Research
Warwick, Rhode Island, 02886
Janus Center For Psychiatric Research
West Palm Beach, Florida, 33407
Elite Clinical Trials, Inc
Wildomar, California, 92595
About this study
Official title: A Phase 3, Randomized, Double-blind, Multi-center, Placebo Controlled, Dose-Optimization, Safety and Efficacy Study of SHP465 in Children and Adolescents Aged 6-17 Years With Attention-Deficit Hyperactivity Disorder (ADHD)
The study is designed to evaluate the efficacy and safety of SHP465 in the treatment of ADHD in children and adolescents (aged 6-17 years). The primary objective of this study is to evaluate the efficacy of SHP465 administered as a daily morning dose compared to placebo in the treatment of children and adolescents (6-17 years of age inclusive) diagnosed with ADHD.
- Being tested
- SHP465, 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.
SHP465Drug
12.5mg and 25mg capsules (one capsule daily)
PlaceboDrug
Matching placebo capsule that appear identical in size, weight, shape, color
| Study group | Role | What they receive |
|---|---|---|
| SHP465 | Experimental | Subjects will receive SHP465 (12.5mg and 25mg capsules) or matching placebo. Subjects will take 1 capsule daily throughout the study at approximately 7:00am (+/- 2 hours) Receives: Drug: SHP465 |
| Placebo | Placebo comparator | Subjects will receive SHP465 (12.5mg and 25mg capsules) or matching placebo. Subjects will take 1 capsule daily throughout the study at approximately 7:00am (+/- 2 hours) 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-IV (ADHD-RS-IV) Total Score at Visit 6 (Week 4)
The ADHD-RS-IV consists of 18 items designed to reflect current symptomatology of ADHD based on diagnostic and statistical manual of mental disorders, fourth edition - text revision (DSM-IV-TR) criteria. Each item is scored on a 4-point scale ranging from 0 (reflecting no symptoms) to 3 (reflecting severe symptoms) with total scores ranging from 0-54. The 18 items may be grouped into 2 subscales: hyperactivity/impulsivity (even-numbered items 2-18) and inattentiveness (odd-numbered items 1-17). Higher score = more severe symptoms.
Measured: Baseline, Visit 6 (Week 4)
Secondary outcomes (1)
Clinical Global Impression of Improvement (CGI-I) at Visit 6 (Week 4)
CGI-I was performed to rate the severity of a participant's condition on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).
Measured: Visit 6 (Week 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2015 (estimated)
- Study start18 Jun 2015
- Primary completion16 Feb 2016
- Study completion16 Feb 2016
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 Hyperactivity Disorder (ADHD)Studies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 264 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
- NCT02466425
- Sponsor's protocol ID
- SHP465-305
- Status last verified
- May 2021
- First submitted
- 3 Jun 2015
- Last updated
- 3 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Brams M, Childress AC, Greenbaum M, Yu M, Yan B, Jaffee M, Robertson B. SHP465 Mixed Amphetamine Salts in the Treatment of Attention-Deficit/Hyperactivity Disorder in Children and Adolescents: Results of a Randomized, Double-Blind Placebo-Controlled Study. J Child Adolesc Psychopharmacol. 2018 Feb;28(1):19-28. doi: 10.1089/cap.2017.0053. Epub 2017 Aug 17.
PubMed 28816509
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 3, Randomized, Double-blind, Multi-center, Placebo Controlled, Dose-Optimization, Safety and Efficacy Study of SHP465 in Children and Adolescents Aged 6-17 Years With Attention-Deficit Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT02466425
- Acronym / sponsor ID
- SHP465-305
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Study start
- 18 Jun 2015 (actual)
- Primary completion
- 16 Feb 2016 (actual)
- Study completion
- 16 Feb 2016 (actual)
- First posted
- 9 Jun 2015 (estimated)
- Results
- Posted 20 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is designed to evaluate the efficacy and safety of SHP465 in the treatment of ADHD in children and adolescents (aged 6-17 years). The primary objective of this study is to evaluate the efficacy of SHP465 administered as a daily morning dose compared to placebo in the treatment of children and adolescents (6-17 years of age inclusive) diagnosed with ADHD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SHP465 | Experimental | Drug: SHP465Subjects will receive SHP465 (12.5mg and 25mg capsules) or matching placebo. Subjects will take 1 capsule daily throughout the study at approximately 7:00am (+/- 2 hours) |
| Placebo | Placebo comparator | Drug: PlaceboSubjects will receive SHP465 (12.5mg and 25mg capsules) or matching placebo. Subjects will take 1 capsule daily throughout the study at approximately 7:00am (+/- 2 hours) |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Subject must be 6-17 years of age, inclusive, at the time of consent.
- Subject's parent or legally authorized representative (LAR) must provide signature of informed consent, and there must be documentation of assent (if applicable) by the subject indicating that the subject is aware of the investigational nature of the study and the required procedures and restrictions in accordance with the ICH GCP Guideline E6 (1996) and applicable regulations before completing any study-related procedures.
- Subject and parent/LAR are willing and able to comply with all of the testing and requirements defined in the protocol, including oversight of morning dosing. Specifically, the parent/LAR must be available at approximately 7:00AM (±2 hours) to dispense the dose of investigational product for the study duration.
- Subject, who is a female and of child-bearing potential, must not have a positive serum beta human chorionic gonadotropin pregnancy test at the Screening Visit (Visit 1) and must have a negative urine pregnancy test at the Baseline Visit (Visit 2) and agree to comply with any applicable contraceptive requirements of the protocol.
- Subject must have a satisfactory medical assessment with no clinically significant or relevant abnormalities.
Key exclusion criteria (22 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 SHP465 or confound efficacy or safety assessments. Comorbid psychiatric diagnoses will be established with the Screening Visit (Visit 1) interview of the K-SADS-PL and additional modules if warranted by the results of the initial interview. Subjects may continue participation in a behavioral modification program during the study as long as they have been participating in the program for at least 1 month at the time of the Baseline Visit (Visit 2).
- Subject meets DSM-IV-TR diagnosis of conduct disorder. Oppositional defiant disorder is not exclusionary.
- Subject is considered a suicide risk in the opinion of the Investigator, has previously made a suicide attempt, 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 based on Centers for Disease Control and Prevention body mass index (BMI)-for-age sex-specific values at the Screening Visit (Visit 1). Underweight is defined as a BMI <3rd percentile
- Subject is significantly overweight based on Centers for Disease Control and Prevention BMI-for-age sex specific values at the Screening Visit (Visit 1). Significantly overweight is defined as a BMI >97th percentile for this study
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 |
|---|---|---|
| SHP46512.5mg and 25mg capsules (one capsule daily) | Drug | SHP465 |
| PlaceboMatching placebo capsule that appear identical in size, weight, shape, color | Drug | Placebo |
Primary outcome
Change From Baseline in Attention-Deficit Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) Total Score at Visit 6 (Week 4)
Time frame: Baseline, Visit 6 (Week 4)
The ADHD-RS-IV consists of 18 items designed to reflect current symptomatology of ADHD based on diagnostic and statistical manual of mental disorders, fourth edition - text revision (DSM-IV-TR) criteria. Each item is scored on a 4-point scale ranging from 0 (reflecting no symptoms) to 3 (reflecting severe symptoms) with total scores ranging from 0-54. The 18 items may be grouped into 2 subscales: hyperactivity/impulsivity (even-numbered items 2-18) and inattentiveness (odd-numbered items 1-17). Higher score = more severe symptoms.
1 secondary outcome
Clinical Global Impression of Improvement (CGI-I) at Visit 6 (Week 4)
Time frame: Visit 6 (Week 4)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 28816509Brams M, Childress AC, Greenbaum M, Yu M, Yan B, Jaffee M, Robertson B. SHP465 Mixed Amphetamine Salts in the Treatment of Attention-Deficit/Hyperactivity Disorder in Children and Adolescents: Results of a Randomized, Double-Blind Placebo-Controlled Study. J Child Adolesc Psychopharmacol. 2018 Feb;28(1):19-28. doi: 10.1089/cap.2017.0053. Epub 2017 Aug 17.
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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
36 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 SHP465 in people with Attention Deficit Hyperactivity Disorder (ADHD), run by Shire at 36 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 10 inclusion and 22 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 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 36 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 20 Mar 2017). 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-IV (ADHD-RS-IV) Total Score at Visit 6 (Week 4) (time frame: Baseline, Visit 6 (Week 4)). 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 NCT02466425, 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 3 Jun 2021.