Attention Deficit Hyperactivity DisorderPhase 3NCT03088267
Dyanavel® XR Extended-Release Oral Suspension in the Treatment of Children With ADHD: A Laboratory School Study
A Phase 3 study testing amphetamine extended-release oral suspension, 2.5 mg/mL in people with Attention Deficit Hyperactivity Disorder, run by Tris Pharma, Inc. at 1 site in United States.
Trial summary
This study was conducted to assess the efficacy and safety of DYANAVEL XR (amphetamine extended-release oral suspension, CII) for the treatment of symptoms of attention-deficit/hyperactivity disorder (ADHD) in children aged 6-12 years. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- amphetamine extended-release oral suspension, 2.5 mg/mL
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2017to 30 Oct 2017
- 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
- Males or females aged 6 to 12 years at the time of screening, inclusive
- Diagnosed with ADHD by a psychiatrist within 6 months of study enrolment or newly diagnosed with ADHD using the DSM-5 criteria for ADHD
- An ADHD-RS-5 score at Screening ≥90th percentile for sex and age in at least one of the following categories:
- Hyperactive-impulsive subscale,
- Inattentive subscale, or
- Total score. Subjects who do not meet this criteria at screening can have ADHD-RS-5 repeated at baseline, after washout of stimulant medication for a minimum of 24 hours prior to baseline.
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- In the clinical judgment of the Investigator, the subject must be in need of pharmacological treatment for ADHD.
- Females of childbearing potential must be non-lactating and must have a negative serum pregnancy test at screening
- Provide written informed consent (parent/guardian) and assent (child aged 10 - 12 years only) prior to participation in the study
Who cannot join
- Diagnosed with any DSM-5 active disorder (other than ADHD) with the exception of specific phobias, learning disorders, motor skills disorders, communication disorders, oppositional defiant disorder, elimination disorders, and sleep disorders
- Known history of chronic medical illnesses including severe hypertension, untreated thyroid disease, peripheral vasculopathy, known structural cardiac disorders, serious cardiac conditions, serious arrhythmias, cardiomyopathy, known family history of sudden death
- Known history or presence of significant renal or hepatic disease, as indicated by clinical laboratory assessment (liver function test results ≥ two times the upper limit of normal, blood urea nitrogen, or creatinine).
- Clinically significant abnormal ECG or cardiac findings on physical examination (including the presence of a pathologic murmur)
- Use of the following medications within 30 days of Baseline Visit:
- MAOI - monoamine oxidase inhibitors (e.g., Selegiline, isocarboxazid, phenelzine, tranylcypromine)
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- Tricyclic Antidepressants (e.g. Desipramine, protriptyline)
- Use of the following medications within 3 days of Baseline Visit
- Gastrointestinal acidifying agents (e.g., guanethidine, reserpine, glutamic acid HCl, ascorbic acid)
- Urinary acidifying agents (e.g., ammonium chloride, sodium acid phosphate, methenamine salts)
- Use of atomoxetine within 14 days of Baseline Visit
- Planned use of prohibited drugs or agents from the Screening visit through the end of the study
- Abnormal clinically significantly laboratory test value at screening that, in the opinion of the Investigator, would preclude study participation
- Known history of allergy/hypersensitivity to amphetamine or any of the components of Dyanavel XR, or topical anaesthetics
- Known history of lack of response to amphetamine
- Parent or guardian's inability or unwillingness to follow directions of the Investigator or study research staff.
- Any uncontrolled medical condition that in the opinion of the Investigator would preclude study participation
- History of significant illness requiring hospitalization, or surgery requiring anaesthetics within 30 days of Baseline Visit
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Psychiatry and Behavioral Medicine
Las Vegas, Nevada, 89128
About this study
Official title: Dyanavel® XR Extended-Release Oral Suspension in the Treatment of Children Wit
This study was conducted to assess the efficacy and safety of DYANAVEL XR (amphetamine extended-release oral suspension, CII) for the treatment of symptoms of attention-deficit/hyperactivity disorder (ADHD) in children aged 6-12 years.
Read the detailed description
This is a randomized, double-blind, two treatment, two sequence, placebo-controlled crossover study to assess the efficacy and safety of dose Dyanavel XR in reducing signs and symptoms of ADHD compared with placebo in pediatric subjects ages 6 to 12 years with ADHD.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- amphetamine extended-release oral suspension, 2.5 mg/mL, Placebo extended-release oral suspension
- 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.
amphetamine extended-release oral suspension, 2.5 mg/mLDrug
Also called Dyanavel XR
5 mL1 (5 mg), 7 mL (17.5 mg) or 8 mL (20 mg) PO
Placebo extended-release oral suspensionDrug
6, 7 or 8 mL PO
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment | Active comparator | Double blind amphetamine extended-release oral suspension, 2.5 mg/mL, 6, 7 or 8 mL po QAM Receives: Drug: amphetamine extended-release oral suspension, 2.5 mg/mL; Drug: Placebo extended-release oral suspension |
| Placebo Treatment | Placebo comparator | Double blind placebo, 6, 7 or 8 mL po QAM Receives: Drug: amphetamine extended-release oral suspension, 2.5 mg/mL; Drug: Placebo extended-release oral suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Combined Scores, Baseline to 30 Minutes Post Dose
Change in SKAMP-C (Swanson, Kotkin, Agler, M-Flynn, and Pelham combined) score from pre-dose, by treatment. The SKAMP-C is a rating scale that assesses functional impairment related to ADHD in the classroom, including the performance of academic tasks, following class rules, and interacting with peers and adults in the classroom. The SKAMP-C is a 13-item, 7-score rating system (0=normal to 7=maximal impairment). The higher the score, the worse the impairment. A decrease from baseline in the combined (all 13 items) score indicates improvement. The SKAMP-C is used to assess the time course of treatment effects in laboratory classroom studies.
Measured: Change in SKAMP-C score from baseline to 30 minutes postdose.
Secondary outcomes (1)
Change in Permanent Product Measure of Performance (PERMP-C) Score (Problems Answered Correctly)
Change from pre-dose in PERMP-C scores (Permanent Product Measure of Performance; defined as the number of problems attempted and number of problems solved correctly) at 30 minutes post-dose and at 3 hours post-dose. The PERMP-C is designed to assess compliance and academic productivity in school children. It is a 10-minute timed test in which the number of problems attempted and correct are assessed prior to and after an intervention. Scoring is based on problems attempted and correct. An increase in numerical score is indicative of improvement.
Measured: 30 minutes postdose and 3 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2017
- Study start11 Feb 2017
- Primary completion25 Feb 2017
- Study completion30 Oct 2017
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 DisorderStudies 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
- Model description
- This is a randomized, double-blind, two treatment, two sequence, placebo-controlled crossover study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tris Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sally Berry, MD, PhD, Study chair, Tris Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03088267
- Sponsor's protocol ID
- TRI102-ADD-300
- Status last verified
- Jul 2019
- First submitted
- 9 Mar 2017
- Last updated
- 22 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Childress AC, Kando JC, King TR, Pardo A, Herman BK. Early-Onset Efficacy and Safety Pilot Study of Amphetamine Extended-Release Oral Suspension in the Treatment of Children with Attention-Deficit/Hyperactivity Disorder. J Child Adolesc Psychopharmacol. 2019 Feb;29(1):2-8. doi: 10.1089/cap.2018.0078. Epub 2018 Dec 21.
PubMed 30575407
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dyanavel® XR Extended-Release Oral Suspension in the Treatment of Children Wit
- ClinicalTrials.gov ID
- NCT03088267
- Acronym / sponsor ID
- TRI102-ADD-300
- Conditions
- Attention Deficit Hyperactivity Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Tris Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Feb 2017 (actual)
- Primary completion
- 25 Feb 2017 (actual)
- Study completion
- 30 Oct 2017 (actual)
- First posted
- 23 Mar 2017 (actual)
- Results
- Posted 9 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was conducted to assess the efficacy and safety of DYANAVEL XR (amphetamine extended-release oral suspension, CII) for the treatment of symptoms of attention-deficit/hyperactivity disorder (ADHD) in children aged 6-12 years.
Detailed description
This is a randomized, double-blind, two treatment, two sequence, placebo-controlled crossover study to assess the efficacy and safety of dose Dyanavel XR in reducing signs and symptoms of ADHD compared with placebo in pediatric subjects ages 6 to 12 years with ADHD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This is a randomized, double-blind, two treatment, two sequence, placebo-controlled crossover study
| Arm | Type | Receives |
|---|---|---|
| Active Treatment | Active comparator | Drug: amphetamine extended-release oral suspension, 2.5 mg/mL, Drug: Placebo extended-release oral suspensionDouble blind amphetamine extended-release oral suspension, 2.5 mg/mL, 6, 7 or 8 mL po QAM |
| Placebo Treatment | Placebo comparator | Drug: amphetamine extended-release oral suspension, 2.5 mg/mL, Drug: Placebo extended-release oral suspensionDouble blind placebo, 6, 7 or 8 mL po QAM |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Males or females aged 6 to 12 years at the time of screening, inclusive
- Diagnosed with ADHD by a psychiatrist within 6 months of study enrolment or newly diagnosed with ADHD using the DSM-5 criteria for ADHD
- An ADHD-RS-5 score at Screening ≥90th percentile for sex and age in at least one of the following categories:
- In the clinical judgment of the Investigator, the subject must be in need of pharmacological treatment for ADHD.
- Females of childbearing potential must be non-lactating and must have a negative serum pregnancy test at screening
Key exclusion criteria (18 listed)
- Diagnosed with any DSM-5 active disorder (other than ADHD) with the exception of specific phobias, learning disorders, motor skills disorders, communication disorders, oppositional defiant disorder, elimination disorders, and sleep disorders
- Known history of chronic medical illnesses including severe hypertension, untreated thyroid disease, peripheral vasculopathy, known structural cardiac disorders, serious cardiac conditions, serious arrhythmias, cardiomyopathy, known family history of sudden death
- Known history or presence of significant renal or hepatic disease, as indicated by clinical laboratory assessment (liver function test results ≥ two times the upper limit of normal, blood urea nitrogen, or creatinine).
- Clinically significant abnormal ECG or cardiac findings on physical examination (including the presence of a pathologic murmur)
- Use of the following medications within 30 days of Baseline Visit:
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 |
|---|---|---|
| amphetamine extended-release oral suspension, 2.5 mg/mLAlso: Dyanavel XR5 mL1 (5 mg), 7 mL (17.5 mg) or 8 mL (20 mg) PO | Drug | Active Treatment, Placebo Treatment |
| Placebo extended-release oral suspension6, 7 or 8 mL PO | Drug | Active Treatment, Placebo Treatment |
Primary outcome
Change in Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Combined Scores, Baseline to 30 Minutes Post Dose
Time frame: Change in SKAMP-C score from baseline to 30 minutes postdose.
Change in SKAMP-C (Swanson, Kotkin, Agler, M-Flynn, and Pelham combined) score from pre-dose, by treatment. The SKAMP-C is a rating scale that assesses functional impairment related to ADHD in the classroom, including the performance of academic tasks, following class rules, and interacting with peers and adults in the classroom. The SKAMP-C is a 13-item, 7-score rating system (0=normal to 7=maximal impairment). The higher the score, the worse the impairment. A decrease from baseline in the combined (all 13 items) score indicates improvement. The SKAMP-C is used to assess the time course of treatment effects in laboratory classroom studies.
1 secondary outcome
Change in Permanent Product Measure of Performance (PERMP-C) Score (Problems Answered Correctly)
Time frame: 30 minutes postdose and 3 hours postdose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30575407Childress AC, Kando JC, King TR, Pardo A, Herman BK. Early-Onset Efficacy and Safety Pilot Study of Amphetamine Extended-Release Oral Suspension in the Treatment of Children with Attention-Deficit/Hyperactivity Disorder. J Child Adolesc Psychopharmacol. 2019 Feb;29(1):2-8. doi: 10.1089/cap.2018.0078. Epub 2018 Dec 21.
- Individual participant dataSharing planned: No
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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.
Sally Berry, MD, PhD study chair
Tris Pharma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing amphetamine extended-release oral suspension, 2.5 mg/mL in people with Attention Deficit Hyperactivity Disorder, run by Tris Pharma, Inc. at 1 site 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 9 inclusion and 18 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 22 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 9 Jul 2019). 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 in Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Combined Scores, Baseline to 30 Minutes Post Dose (time frame: Change in SKAMP-C score from baseline to 30 minutes postdose.). 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 NCT03088267, 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 22 Jul 2019.