Attention Deficit Hyperactivity Disorder (ADHD)Phase 3NCT02604407
Safety and Efficacy Study of SHP465 in Adults Aged 18-55 Years With Attention-deficit/ Hyperactivity Disorder (ADHD)
A Phase 3 study testing SHP465 12.5mg capsules (one capsule daily) and SHP465 12.5mg, 25mg, or 37.5mg capsules (one capsule daily) in people with Attention Deficit Hyperactivity Disorder (ADHD), run by Shire at 45 sites in United States.
Trial summary
The study is designed to evaluate the efficacy and safety of each dose of SHP465 (12.5 and 37.5 mg) given to participants daily in the morning compared to placebo in the treatment of adults aged 18 to 55 years diagnosed with ADHD. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder (ADHD)
- What is being tested?
- SHP465 12.5mg capsules (one capsule daily) and SHP465 12.5mg, 25mg, or 37.5mg capsules (one capsule daily)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 275 participants
- Where
- 45 sitesUnited States
- Study dates
- 19 Nov 2015to 24 Mar 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subject must be 18-55 years of age
- Subject is able to provide written, personally signed and dated informed consent.
- Subject is willing and able to comply with all of the testing and requirements defined in the protocol
- Subject, who is a female, must not be pregnant.
- Subject must have a satisfactory medical assessment with no clinically significant or relevant abnormalities.
- Subject has a primary diagnosis of ADHD.
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- Subject has an adult ADHD-RS with prompts total score ≥28 at the baseline visit.
- Subject must have a minimum level of intellectual functioning, as determined by the investigator.
- Subject is able to swallow a capsule.
- Subject is currently not on ADHD therapy or is not completely satisfied with any aspect of their current ADHD therapy.
Who cannot join
- Subject has a current, comorbid psychiatric diagnosis with significant symptoms.
- Subject is considered a suicide risk in the opinion of the investigator
- Subject has a body mass index (BMI) of <18.5 kg/m2 at the screening visit.
- Subject has a BMI ≥40 kg/m2 at the screening visit.
- Subject has a concurrent chronic or acute illness, disability, or other condition.
- Subject has a history of seizure, a chronic or current tic disorder, or a current diagnosis of Tourette's disorder.
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- Subject has a history of moderate to severe hypertension.
- Subject has a known history of symptomatic cardiovascular disease
- 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.
- Subject has current abnormal thyroid function
- Subject has a documented allergy, hypersensitivity, or intolerance to amphetamine or to any excipients in the investigational product.
- Subject has failed to respond, to an adequate course(s) of amphetamine therapy.
- Subject has a history of suspected substance abuse or dependence disorder.
- Subject has a positive urine drug result at the screening visit (with the exception of subject's current stimulant therapy, if any) or 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 completed, has 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 CNS effects or affect performance.
- Subject is female and is pregnant or lactating.
Trial locations and contacts
45 sites in 1 country.
45 sites in 1 country
United States45 sites
Rainbow Research, Inc.
Barnwell, South Carolina, 29812
Florida Clinical Research Center Llc
Bradenton, Florida, 32401
McB Clinical Research
Colorado Springs, Colorado, 80910
Futuresearch Trials of Dallas, Lp
Dallas, Texas, 75231
Midwest Clinical Research Center
Dayton, Ohio, 45417
Pharmacology Research Institute
Encino, California, 91316
Gulfcoast Clinical Research Center
Fort Myers, Florida, 33912
Sarkis Clinical Trials
Gainesville, Florida, 32607
Neuroscience, Inc
Herndon, Virginia, 20170
Bayou City Research, Ltd
Houston, Texas, 77007
Red Oak Psychiatry Associates
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, Inc
Las Vegas, Nevada, 89128
Capstone Clinical
Libertyville, Illinois, 60048
Premier Psychiatric Research Institutute
Lincoln, Nebraska, 68526
Pharmacology Research Institute (Pri)
Los Alamitos, California, 90720
Florida Clinical Research Center, Llc
Maitland, Florida, 32751
Northwest Behavioral Research Center
Marietta, Georgia, 30060
Clinical Neuroscience Solutions
Memphis, Tennessee, 38119
Qps Mra, Llc
Miami, Florida, 33143
Bioscience Research Llc
Mount Kisco, New York, 10549
Coastal Carolina Research
Mt. Pleasant, South Carolina, 29464
Baber Research Group, Inc
Naperville, Illinois, 60563
Louisiana Research Associates, Inc.
New Orleans, Louisiana, 70114
Nyu Langone Medical Center
New York, New York, 10016
Pharmacology Research Institute (Pri)
Newport Beach, California, 92660
Psychiatric Care and Research Center
O'Fallon, Missouri, 63368
Ips Research Company
Oklahoma City, Oklahoma, 73103
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
Oregon Center For Clinical Investigations, Inc
Portland, Oregon, 97214
Princeton Medical Institute
Princeton, New Jersey, 08540
Richard H Weisler, Md, Pa & Associates
Raleigh, North Carolina, 27609
Rochester Center For Behavioral Medicine
Rochester Hills, Michigan, 48307
Midwest Research Group
Saint Charles, Missouri, 63304
Oregon Center For Clinical Investigations
Salem, Oregon, 97301
Summit Research Network (Seattle) Llc
Seattle, Washington, 98104
Clinical Neurophysiology Services
Sterling Heights, Michigan, 48314
Omega Medical Research
Warwick, Rhode Island, 02886
Elite Clinical Trials
Wildomar, California, 92595
About this study
Official title: A Phase 3, Randomized, Double-blind, Multicenter, Placebo-controlled, Forced-dose Titration, Safety and Efficacy Study of SHP465 in Adults Aged 18-55 Years With Attention-deficit/ Hyperactivity Disorder (ADHD)
The study is designed to evaluate the efficacy and safety of each dose of SHP465 (12.5 and 37.5 mg) given to participants daily in the morning compared to placebo in the treatment of adults aged 18 to 55 years diagnosed with ADHD.
- Being tested
- SHP465 12.5mg capsules (one capsule daily), Placebo, SHP465 12.5mg, 25mg, or 37.5mg capsules (one capsule daily)
- 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.
SHP465 12.5mg capsules (one capsule daily)Drug
one capsule daily
PlaceboOther
Matching placebo capsule that appears identical in size, weight, shape, and color (one capsule daily)
SHP465 12.5mg, 25mg, or 37.5mg capsules (one capsule daily)Drug
One capsule daily
| Study group | Role | What they receive |
|---|---|---|
| SHP465 12.5 mg | Experimental | Subjects will receive SHP465 12.5 mg Receives: Drug: SHP465 12.5mg capsules (one capsule daily) |
| SHP465 37.5 mg | Experimental | Subjects will receive SHP465 titrated up to 37.5 mg Receives: Drug: SHP465 12.5mg, 25mg, or 37.5mg capsules (one capsule daily) |
| Placebo | Placebo comparator | Subjects will receive matching placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in the Adult Attention-deficit/Hyperactivity Disorder Rating Scale-4 (ADHD-RS) With Prompts Total Score at Visit 6 (Week 4)
The ADHD-RS was developed to measure the behaviors of children with Attention deficit hyperactivity disorder (ADHD). The adult ADHD-RS with prompts consists of 18 items designated to reflect current symptomatology of ADHD based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria. Each item is scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms), with the total score for the rating scale ranging from 0 to 54. Higher score = more severe symptoms.The scale is subdivided into 2 subscales of 9 symptoms each: hyperactivity/impulsivity and inattentiveness. Adult prompts are included with the ADHD-RS to create a semistructured measurement that allows the clinician to probe the extent, frequency, breadth, severity, and consequences of these symptoms to ascertain impairment in an adult population.
Measured: Baseline, Visit 6 (Week 4)
Secondary outcomes (1)
Clinical Global Impression of Improvement (CGI-I) Score at Visit 6 (Week 4)
CGI scales permit a global evaluation of the participant's severity and improvement over time. CGI-I was performed to rate the severity of a participant's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants).
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 posted13 Nov 2015 (estimated)
- Study start19 Nov 2015
- Primary completion24 Mar 2016
- Study completion24 Mar 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 275 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
- NCT02604407
- Sponsor's protocol ID
- SHP465-306
- Status last verified
- May 2021
- First submitted
- 11 Nov 2015
- Last updated
- 3 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Weisler RH, Greenbaum M, Arnold V, Yu M, Yan B, Jaffee M, Robertson B. Efficacy and Safety of SHP465 Mixed Amphetamine Salts in the Treatment of Attention-Deficit/Hyperactivity Disorder in Adults: Results of a Randomized, Double-Blind, Placebo-Controlled, Forced-Dose Clinical Study. CNS Drugs. 2017 Aug;31(8):685-697. doi: 10.1007/s40263-017-0455-7.
PubMed 28712074
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, Multicenter, Placebo-controlled, Forced-dose Titration, Safety and Efficacy Study of SHP465 in Adults Aged 18-55 Years With Attention-deficit/ Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT02604407
- Acronym / sponsor ID
- SHP465-306
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 275 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Study start
- 19 Nov 2015 (actual)
- Primary completion
- 24 Mar 2016 (actual)
- Study completion
- 24 Mar 2016 (actual)
- First posted
- 13 Nov 2015 (estimated)
- Results
- Posted 14 Jun 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 each dose of SHP465 (12.5 and 37.5 mg) given to participants daily in the morning compared to placebo in the treatment of adults aged 18 to 55 years diagnosed with ADHD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SHP465 12.5 mg | Experimental | Drug: SHP465 12.5mg capsules (one capsule daily)Subjects will receive SHP465 12.5 mg |
| SHP465 37.5 mg | Experimental | Drug: SHP465 12.5mg, 25mg, or 37.5mg capsules (one capsule daily)Subjects will receive SHP465 titrated up to 37.5 mg |
| Placebo | Placebo comparator | Other: PlaceboSubjects will receive matching placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Subject must be 18-55 years of age
- Subject is able to provide written, personally signed and dated informed consent.
- Subject is willing and able to comply with all of the testing and requirements defined in the protocol
- Subject, who is a female, must not be pregnant.
- Subject must have a satisfactory medical assessment with no clinically significant or relevant abnormalities.
Key exclusion criteria (19 listed)
- Subject has a current, comorbid psychiatric diagnosis with significant symptoms.
- Subject is considered a suicide risk in the opinion of the investigator
- Subject has a body mass index (BMI) of <18.5 kg/m2 at the screening visit.
- Subject has a BMI ≥40 kg/m2 at the screening visit.
- Subject has a concurrent chronic or acute illness, disability, or other condition.
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 |
|---|---|---|
| SHP465 12.5mg capsules (one capsule daily)one capsule daily | Drug | SHP465 12.5 mg |
| PlaceboMatching placebo capsule that appears identical in size, weight, shape, and color (one capsule daily) | Other | Placebo |
| SHP465 12.5mg, 25mg, or 37.5mg capsules (one capsule daily)One capsule daily | Drug | SHP465 37.5 mg |
Primary outcome
Change From Baseline in the Adult Attention-deficit/Hyperactivity Disorder Rating Scale-4 (ADHD-RS) With Prompts Total Score at Visit 6 (Week 4)
Time frame: Baseline, Visit 6 (Week 4)
The ADHD-RS was developed to measure the behaviors of children with Attention deficit hyperactivity disorder (ADHD). The adult ADHD-RS with prompts consists of 18 items designated to reflect current symptomatology of ADHD based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria. Each item is scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms), with the total score for the rating scale ranging from 0 to 54. Higher score = more severe symptoms.The scale is subdivided into 2 subscales of 9 symptoms each: hyperactivity/impulsivity and inattentiveness. Adult prompts are included with the ADHD-RS to create a semistructured measurement that allows the clinician to probe the extent, frequency, breadth, severity, and consequences of these symptoms to ascertain impairment in an adult population.
1 secondary outcome
Clinical Global Impression of Improvement (CGI-I) Score 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.
- Derived from this study: PubMed 28712074Weisler RH, Greenbaum M, Arnold V, Yu M, Yan B, Jaffee M, Robertson B. Efficacy and Safety of SHP465 Mixed Amphetamine Salts in the Treatment of Attention-Deficit/Hyperactivity Disorder in Adults: Results of a Randomized, Double-Blind, Placebo-Controlled, Forced-Dose Clinical Study. CNS Drugs. 2017 Aug;31(8):685-697. doi: 10.1007/s40263-017-0455-7.
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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
45 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 12.5mg capsules (one capsule daily) and SHP465 12.5mg, 25mg, or 37.5mg capsules (one capsule daily) in people with Attention Deficit Hyperactivity Disorder (ADHD), run by Shire at 45 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 19 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 45 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 14 Jun 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 the Adult Attention-deficit/Hyperactivity Disorder Rating Scale-4 (ADHD-RS) With Prompts 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 NCT02604407, 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.