Attention Deficit Hyperactivity DisorderPhase 4NCT03610464
Pharmacokinetic Study of DYANAVEL XR (Amphetamine) Extended-release Oral Suspension, in Children Aged 4 to 5 Years
A Phase 4 study testing Amphetamine Extended Release Suspension [Dyanavel] in people with Attention Deficit Hyperactivity Disorder, run by Tris Pharma, Inc. at 1 site in United States.
Trial summary
The objective of this study was to evaluate the plasma amphetamine concentration/time profile of amphetamine extended release oral suspension in children aged 4 to 5 years with attention-deficit/hyperactivity disorder, following a single 2.5 mg dose of amphetamine extended release oral suspension. Read more about this study
- Who is it for?
- Ages 4 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Amphetamine Extended Release Suspension [Dyanavel]
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2018to 23 May 2018
- Phase
- Phase 4
- 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 4 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Male or female aged 4 to 5 years at the time of enrollment into this study;
- Body weight ≥ 28 lb. at screening visit;
- Diagnosed with ADHD by a psychiatrist, psychologist, developmental pediatrician, pediatrician, or an experienced licensed allied health professional approved by the Sponsor by using the DSM-5 criteria and supported by a structured Kiddie-Schedule for Affective Disorders and Schizophrenia-Present and Lifetime version (K-SADS-PL) interview, administered at the Screening Visit (Visit 0);
- Provide written informed consent (parent/guardian) 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
- History of chronic medical illnesses including seizure disorder (excluding a history of febrile seizures), moderate to severe hypertension, untreated thyroid disease, known structural cardiac disorders, serious cardiac conditions, serious arrhythmias, cardiomyopathy and 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 ≥ 2 times the upper limit of normal, blood urea nitrogen, or creatinine)
- Clinically significant (CS) abnormal ECG or cardiac findings on physical examination (including the presence of a pathologic murmur)
- Use of the following medications within 30 days of dosing:
- MAOI - monoamine oxidase inhibitors (e.g., Selegiline, isocarboxazid, phenelzine, tranylcypromine);
Show all 17Show fewer
- Tricyclic Antidepressants (e.g. Desipramine, protriptyline);
- Use of the following medications within 3 days of dosing
- 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 dosing
- Planned use of prohibited drugs or agents from the screening visit through the end of the study. Medications used to support sleep may be acceptable with the written approval of the sponsor or medical monitor
- Abnormal CS laboratory test value at screening that, in the opinion of the sponsor or medical monitor, would preclude study participation
- Known history of allergy/hypersensitivity to amphetamine or any of the components of AMPH EROS, heparin flush and topical anesthetics
- 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 anesthetics within 30 days of dosing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacokinetic Study of DYANAVEL XR (Amphetamine) Extended-release Oral Suspension, in Children Aged 4 to 5 Years With Attention-deficit/Hyperactivity Disorder
The objective of this study was to evaluate the plasma amphetamine concentration/time profile of amphetamine extended release oral suspension in children aged 4 to 5 years with attention-deficit/hyperactivity disorder, following a single 2.5 mg dose of amphetamine extended release oral suspension.
Read the detailed description
DYANAVEL® XR is an extended-release oral suspension that contains 2.5 mg/mL amphetamine base (amphetamine extended-release oral suspension; AMPH EROS). Drug-resin complexation is formed with the amphetamine and sodium polystyrene sulfonate, an ion exchange resin. The extended release feature of the product is achieved by coating a portion of the drug/resin complexes with an extended release coating. AMPH EROS contains approximately a 3.2:1 ratio of d-amphetamine compared to l-amphetamine.
The objective of this study was to evaluate the plasma amphetamine concentration/time profile of AMPH EROS in children aged 4 to 5 years with attention-deficit/hyperactivity disorder, following a single 2.5 mg dose of AMPH EROS.
These data will guide appropriate dosing in planned safety and efficacy studies with AMPH EROS in a preschool population with attention-deficit/hyperactivity disorder.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Amphetamine Extended Release Suspension [Dyanavel]
- 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 Suspension [Dyanavel]Drug
Also called DYANAVEL XR, amphetamine extended release oral suspension
1 mL of study drug (AMPH EROS, 2.5 mg/mL), pharmacokinetic analysis
| Study group | Role | What they receive |
|---|---|---|
| Study patients (AMPH EROS) | Experimental | All patients treated with extended-release oral suspension (AMPH EROS) that contains 2.5 mg/mL amphetamine base Receives: Drug: Amphetamine Extended Release Suspension [Dyanavel] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Concentrations of d- and L-amphetamine
Plasma Concentration of d- and l-amphetamine measured at 0, 1, 3, 4, 6, 8, 10, 12, and 28 hours postdose.
Measured: 0-28 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start7 May 2018
- Primary completion23 May 2018
- Study completion23 May 2018
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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This was an open-label, single-site, single-dose one-period, one-treatment study in 5 pediatric subjects diagnosed with ADHD, otherwise healthy. Subjects received a single, 1 mL dose of AMPH EROS 2.5 mg/mL, from which PK was assessed over a 28 hour period.
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tris Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Antonio Pardo, MD, Study director, Tris Pharma, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03610464
- Sponsor's protocol ID
- TRI102-PPK-300
- Status last verified
- Jun 2019
- First submitted
- 23 Jul 2018
- Last updated
- 25 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Study of DYANAVEL XR (Amphetamine) Extended-release Oral Suspension, in Children Aged 4 to 5 Years With Attention-deficit/Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT03610464
- Acronym / sponsor ID
- TRI102-PPK-300
- Conditions
- Attention Deficit Hyperactivity Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Tris Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 May 2018 (actual)
- Primary completion
- 23 May 2018 (actual)
- Study completion
- 23 May 2018 (actual)
- First posted
- 1 Aug 2018 (actual)
- Results
- Posted 25 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study was to evaluate the plasma amphetamine concentration/time profile of amphetamine extended release oral suspension in children aged 4 to 5 years with attention-deficit/hyperactivity disorder, following a single 2.5 mg dose of amphetamine extended release oral suspension.
Detailed description
DYANAVEL® XR is an extended-release oral suspension that contains 2.5 mg/mL amphetamine base (amphetamine extended-release oral suspension; AMPH EROS). Drug-resin complexation is formed with the amphetamine and sodium polystyrene sulfonate, an ion exchange resin. The extended release feature of the product is achieved by coating a portion of the drug/resin complexes with an extended release coating. AMPH EROS contains approximately a 3.2:1 ratio of d-amphetamine compared to l-amphetamine.
The objective of this study was to evaluate the plasma amphetamine concentration/time profile of AMPH EROS in children aged 4 to 5 years with attention-deficit/hyperactivity disorder, following a single 2.5 mg dose of AMPH EROS.
These data will guide appropriate dosing in planned safety and efficacy studies with AMPH EROS in a preschool population with attention-deficit/hyperactivity disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This was an open-label, single-site, single-dose one-period, one-treatment study in 5 pediatric subjects diagnosed with ADHD, otherwise healthy. Subjects received a single, 1 mL dose of AMPH EROS 2.5 mg/mL, from which PK was assessed over a 28 hour period.
| Arm | Type | Receives |
|---|---|---|
| Study patients (AMPH EROS) | Experimental | Drug: Amphetamine Extended Release Suspension [Dyanavel]All patients treated with extended-release oral suspension (AMPH EROS) that contains 2.5 mg/mL amphetamine base |
Who may qualify
- Ages
- 4 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Male or female aged 4 to 5 years at the time of enrollment into this study;
- Body weight ≥ 28 lb. at screening visit;
- Diagnosed with ADHD by a psychiatrist, psychologist, developmental pediatrician, pediatrician, or an experienced licensed allied health professional approved by the Sponsor by using the DSM-5 criteria and supported by a structured Kiddie-Schedule for Affective Disorders and Schizophrenia-Present and Lifetime version (K-SADS-PL) interview, administered at the Screening Visit (Visit 0);
- Provide written informed consent (parent/guardian) prior to participation in the study.
Key exclusion criteria (17 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
- History of chronic medical illnesses including seizure disorder (excluding a history of febrile seizures), moderate to severe hypertension, untreated thyroid disease, known structural cardiac disorders, serious cardiac conditions, serious arrhythmias, cardiomyopathy and 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 ≥ 2 times the upper limit of normal, blood urea nitrogen, or creatinine)
- Clinically significant (CS) abnormal ECG or cardiac findings on physical examination (including the presence of a pathologic murmur)
- Use of the following medications within 30 days of dosing:
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 Suspension [Dyanavel]Also: DYANAVEL XR, amphetamine extended release oral suspension1 mL of study drug (AMPH EROS, 2.5 mg/mL), pharmacokinetic analysis | Drug | Study patients (AMPH EROS) |
Primary outcome
Plasma Concentrations of d- and L-amphetamine
Time frame: 0-28 hours postdose
Plasma Concentration of d- and l-amphetamine measured at 0, 1, 3, 4, 6, 8, 10, 12, and 28 hours postdose.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Antonio Pardo, MD study director
Tris Pharma, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Amphetamine Extended Release Suspension [Dyanavel] 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 4 inclusion and 17 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 25 Jun 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 25 Jun 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?
Plasma Concentrations of d- and L-amphetamine (time frame: 0-28 hours postdose). 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 25 Jun 2019.