Attention Deficit/Hyperactivity DisorderPhase 4NCT04987762

Safety and Tolerability Study of Adhansia XR® Extended-Release Capsules in Children

A Phase 4 study testing Adhansia XR in people with Attention Deficit/Hyperactivity Disorder, run by Purdue Pharma LP at 15 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose of this study is to assess the long-term safety of Adhansia XR in children and to characterize the pharmacokinetics (PK) in 4 to 5 year-olds. Read more about this study

Who is it for?: Ages 4 to 12 years
Conditions the study is for: Attention Deficit/Hyperactivity Disorder
What is being tested?: Adhansia XR
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 103 participants
Where: 15 sitesUnited States
Study dates: 3 Aug 2021to 27 Apr 2022
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 12 years
All sexes
No healthy volunteers
Child

Who may be able to join

Male and female subjects ≥4 and ≤12 years of age at the time of informed consent/assent.
Females of childbearing potential who are not pregnant and not nursing.
Females of childbearing potential who agree to practice a clinically accepted method of contraception during the study and for at least 1 month prior to study dosing and 1 month following completion of the study. Acceptable contraceptive methods include abstinence, oral contraception, surgical sterilization (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), intrauterine device, or diaphragm in addition to spermicidal foam and condom on male partner, or systemic contraception (eg, levonorgestrel-releasing implant).
Diagnosis of ADHD (any type: combined, predominately hyperactive impulsive type or predominately inattentive type) by a psychiatrist, psychologist, pediatrician, or licensed allied healthcare professional using the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) and confirmed by administration of a structured diagnostic interview using the Kiddie-Schedule for Affective Disorders and Schizophrenia for School Age Children-Present and Lifetime DSM-5 version (K-SADS-PL).
Subjects who have received, or are receiving treatment with medication (amphetamine, methylphenidate, or non-stimulant) for ADHD must be willing to undergo a washout period of a minimum of 3 days or 5 half-lives (whichever is longer) prior to study drug administration. The washout period for prohibited concomitant medications will be at least 5 half-lives or 3 days, whichever is longer.
If subjects are currently off treatment, this must be for any reason other than noncompliance, nonresponse, or intolerance to side effects.

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Ratings on the attention deficit/hyperactivity disorder-Rating Scale, version 5 (ADHD RS-5) when the subject is not receiving treatment for ADHD must be ≥90th percentile normative value for sex and age in at least 1 of the categories: total score, inattentive subscale, or hyperactive/impulse subscale.
Dissatisfied with his or her current pharmacological therapy for treatment of ADHD or not currently receiving pharmacological therapy for ADHD for any reason other than nonresponse, noncompliance, or tolerability issues with stimulants. Newly diagnosed and treatment naïve subjects may be included at the discretion of the investigator.
Must be functioning at an age-appropriate level intellectually as determined by an intelligence quotient (IQ) of ≥80 on a documented IQ assessment such as the Wechsler Abbreviated Scale of Intelligence II (WASI-II) vocabulary and matrix reasoning components, or the Kaufman Brief Intelligence Test, Second Edition (KBIT-2)
Parent(s)/legal guardian(s) must have the ability to read and understand the language in which the informed consent is written and are mentally and physically competent to provide written informed consent for their child.
Written or verbal assent from the subject (as applicable).
Subject and parent(s)/legal guardian/caregiver are willing and able to comply with all the protocol requirements and parent(s)/legal guardian/caregiver must be able to provide transportation for the subject to and from the clinic visits.

Who cannot join

Has a known allergy, intolerance, or hypersensitivity to methylphenidate.
History of allergic reactions to tartrazine.
Known nonresponder to methylphenidate treatment.
Subject has received a monoamine oxidase inhibitor within 2 weeks before study treatment.
Blood pressure and heart rate outside the 95th percentile for age and sex.
Subject has a current or recent history (within the past 6 months) of drug abuse or dependence disorder; or someone in the subject's immediate family has a current or recent history (within the past 6 months) of drug abuse or dependence disorder; or someone living at the subject's home has a current or recent history (within the past 6 months) of drug abuse or dependence disorder; or subject has a positive urine drug screen for stimulant medication (other than currently prescribed stimulant for the treatment of ADHD) or drugs of abuse at the screening visit.

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Has abnormal thyroid function, glaucoma, Gilles de la Tourette's disorder, a history of seizures (except simple febrile seizures), or a tic disorder. Mild medication induced tics are not exclusionary.
Primary and/or comorbid psychiatric diagnosis other than ADHD with the exception of simple phobias, motor skill disorders, communication disorders, learning disorders, and adjustment disorders so long as such disorder is judged not to interfere with study participation or the safety of the subject.
Subjects with a family history (first-degree relatives) of sudden cardiac death require review and approval by the medical monitor for participation in the study.
Subject has a history of disorders of the sensory organs, including deafness, blindness or the subject is severely or profoundly developmentally disabled.
Any clinically significant abnormality or clinically significant abnormal laboratory test results found during screening or a positive test for hepatitis A, hepatitis B, hepatitis C, or HIV found during screening (subjects who have received a hepatitis A vaccine and test positive for hepatitis A may be included in the study, at the discretion of the investigator).
Use of an investigational drug within 30 days (90 days for biologics) or participation in an investigational study within 30 days prior to dosing.
Any reason which, in the opinion of the investigator, would prevent the subject from participating in the study.
Clinically significant ECG abnormalities (including but not limited to Wolff Parkinson-White syndrome, supraventricular tachycardia, left ventricular hypertrophy, abnormal conduction defect, or other cardiac arrhythmia), or vital sign abnormalities (normal vital signs should be between 5th and 95th percentile for age) at screening.
Known history of cardiovascular disorders including hypertension, angina, arterial occlusive disease, heart failure, hemodynamically significant congenital heart disease, cardiomyopathies, myocardial infarction, potentially life-threatening arrhythmias, and channelopathies (disorders caused by the dysfunction of ion channels).
Clinically significant history of neurological, endocrinal (including thyrotoxicosis), pulmonary, hematological, immunologic, gastrointestinal, renal, hepatic or metabolic disease, or psychiatric illness other than ADHD.
History of anxiety, tension, agitation, motor tics, Tourette's syndrome or a family history (first-degree relatives) of Tourette's syndrome.
History of glaucoma.
Has a positive serum pregnancy test (if applicable) at screening.
Positive findings on the Columbia-Suicide Severity Rating Scale (C-SSRS) for suicidal ideation or behaviors at screening.
Clinically significant illness or surgery within 4 weeks prior to dosing. Subjects who experience vomiting within 24 hours prior to clinic admission will be carefully evaluated for upcoming illness/disease.
Hemoglobin <105 g/L or hematocrit <0.310 L/L at screening (subjects with abnormal hemoglobin and/or hematocrit levels deemed not clinically significant may be included in the study, at the discretion of the investigator).
Subject has received anticonvulsants (eg, phenobarbital, phenytoin, primidone), coumarin anticoagulants, prescription pressor agents, pressor agents, guanethidine, tricyclic antidepressants (imipramine, desipramine, selective serotonin inhibitors) or herbal remedies within 30 days prior to the first dosing, or melatonin within 3 days prior to the first dosing.
Other protocol specific inclusion/exclusion criteria may apply.

Trial locations and contacts

15 sites in 1 country.

City, postcode or hospital

15 sites in 1 country

United States15 sites

Northwest Clinical Research Center
Bellevue, Washington, 98007
MCB Clinical Research Centers, LLC
Colorado Springs, Colorado, 80910
iResearch Atlanta, LLC
Decatur, Georgia, 30030
Eastside Therapeutic Resource, Inc. dba Core Clinical Research
Everett, Washington, 98201
Red Oak Psychiatry Associates, PA
Houston, Texas, 77090
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32256
Clinical Research of Southern Nevada, LLC
Las Vegas, Nevada, 89128
Adaptive Clinical Research, Inc.
Lauderhill, Florida, 33319
Preferred Research Partners, Inc.
Little Rock, Arkansas, 72211
Accel Research Sites - Maitland Clinical Research Unit
Maitland, Florida, 32751
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, 38119
IPS Research Company
Oklahoma City, Oklahoma, 73106
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32801
Sisu BHR, LLC
Springfield, Massachusetts, 01103
Family Psychiatry of the Woodlands
The Woodlands, Texas, 77381

Other trials in United States

About this study

Official title: An Open-Label, Multicenter, Multiple-Dose, Safety and Tolerability Study of Adhansia XR® Extended-Release Capsules in Children 4 to 12 Years of Age

The purpose of this study is to assess the long-term safety of Adhansia XR in children and to characterize the pharmacokinetics (PK) in 4 to 5 year-olds.

Conditions: Attention Deficit/Hyperactivity Disorder
Being tested: Adhansia XR
Keywords: ADHD, methylphenidate, Adhansia XR, Pediatric
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.

Adhansia XRDrug
Methylphenidate extended-release capsules taken once daily (12.5 mg, 25 mg, 35 mg, 45 mg, 55 mg, and 70 mg)

Study groups in NCT04987762
Study group	Role	What they receive
Adhansia XR	Experimental	Adhansia XR capsules taken orally once daily in the morning Receives: Drug: Adhansia XR

What is being measured

The primary outcome is the main question the study is designed to answer.

The Number of Participants With Adverse Events as a Measure of Safety
Adverse events (AEs) were documented and reported from the time the subject/parent(s)/legal guardian provided informed consent/assent up to 7 days after the last study drug administration. AEs that were ongoing at the subject's last study visit were followed until resolution or for 30 days after study drug administration.
Measured: Up to 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Aug 202127 Apr 2022

First posted3 Aug 2021
Study start3 Aug 2021
Primary completion27 Apr 2022
Study completion27 Apr 2022

Why it stopped: due to administrative reasons not related to efficacy or safety.

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
Masking: None (open label)
Enrolment: 103 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04987762
Sponsor's protocol ID: ADA4004
Status last verified: Jul 2023
First submitted: 15 Jul 2021
Last updated: 22 Aug 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Attention Deficit/Hyperactivity Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Multicenter, Multiple-Dose, Safety and Tolerability Study of Adhansia XR® Extended-Release Capsules in Children 4 to 12 Years of Age
ClinicalTrials.gov ID: NCT04987762
Acronym / sponsor ID: ADA4004
Conditions: Attention Deficit/Hyperactivity Disorder
Keywords: ADHD, methylphenidate, Adhansia XR, Pediatric
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: due to administrative reasons not related to efficacy or safety.
Enrolment: 103 participants (actual)
Lead sponsor: Purdue Pharma LPIndustry (pharma, biotech, devices)
Study start: 3 Aug 2021 (actual)
Primary completion: 27 Apr 2022 (actual)
Study completion: 27 Apr 2022 (actual)
First posted: 3 Aug 2021 (actual)
Results: Posted 22 Aug 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to assess the long-term safety of Adhansia XR in children and to characterize the pharmacokinetics (PK) in 4 to 5 year-olds.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Adhansia XR	Experimental	Drug: Adhansia XRAdhansia XR capsules taken orally once daily in the morning

Who may qualify

Ages: 4 to 12 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (12 listed)

Male and female subjects ≥4 and ≤12 years of age at the time of informed consent/assent.
Females of childbearing potential who are not pregnant and not nursing.
Females of childbearing potential who agree to practice a clinically accepted method of contraception during the study and for at least 1 month prior to study dosing and 1 month following completion of the study. Acceptable contraceptive methods include abstinence, oral contraception, surgical sterilization (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), intrauterine device, or diaphragm in addition to spermicidal foam and condom on male partner, or systemic contraception (eg, levonorgestrel-releasing implant).
Diagnosis of ADHD (any type: combined, predominately hyperactive impulsive type or predominately inattentive type) by a psychiatrist, psychologist, pediatrician, or licensed allied healthcare professional using the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) and confirmed by administration of a structured diagnostic interview using the Kiddie-Schedule for Affective Disorders and Schizophrenia for School Age Children-Present and Lifetime DSM-5 version (K-SADS-PL).
Subjects who have received, or are receiving treatment with medication (amphetamine, methylphenidate, or non-stimulant) for ADHD must be willing to undergo a washout period of a minimum of 3 days or 5 half-lives (whichever is longer) prior to study drug administration. The washout period for prohibited concomitant medications will be at least 5 half-lives or 3 days, whichever is longer.

Key exclusion criteria (24 listed)

Has a known allergy, intolerance, or hypersensitivity to methylphenidate.
History of allergic reactions to tartrazine.
Known nonresponder to methylphenidate treatment.
Subject has received a monoamine oxidase inhibitor within 2 weeks before study treatment.
Blood pressure and heart rate outside the 95th percentile for age and sex.

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
Adhansia XRMethylphenidate extended-release capsules taken once daily (12.5 mg, 25 mg, 35 mg, 45 mg, 55 mg, and 70 mg)	Drug	Adhansia XR

Primary outcome

The Number of Participants With Adverse Events as a Measure of Safety
Time frame: Up to 9 months
Adverse events (AEs) were documented and reported from the time the subject/parent(s)/legal guardian provided informed consent/assent up to 7 days after the last study drug administration. AEs that were ongoing at the subject's last study visit were followed until resolution or for 30 days after study drug administration.

Results and safety

Results posted to the registry on 22 Aug 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Adhansia XR	103	0

Primary outcome: The Number of Participants With Adverse Events as a Measure of Safety

Time frame: Up to 9 months. Number. Unit: participants

Measure	Adhansia XR n = 103
Deaths	0
Serious Adverse Events	2
All Other Adverse Events in ≥ 5% of subjects	39

Population analysed: The safety analysis population is defined as all subjects who were administered at least 1 dose of study drug and had any safety information.

Adverse events

Time frame: Documenting and reporting of AEs began when the subject/parent(s)/legal guardian provided informed consent/assent and continued up to 7 days after the last administration of study drug. Adverse events ongoing at the subject's last study visit must have been followed until resolution or for 30 days after study drug administration. Adverse events were collected for up to 9 months.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Adhansia XR	2 of 103 (1.9%)	39 of 103 (37.9%)	0 of 103

Limitations and caveats (from the sponsor): Study terminated early - only safety data collected until termination are presented.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Attention Deficit/Hyperactivity Disorder

Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Recruiting
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RecruitingPhase 3
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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.

The record lists no contact. Use the official record to reach the sponsor.

15 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Adhansia XR in people with Attention Deficit/Hyperactivity Disorder, run by Purdue Pharma LP at 15 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 12 inclusion and 24 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: stopped early, as of the sponsor's last update on 22 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 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. 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 22 Aug 2023). 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?

The Number of Participants With Adverse Events as a Measure of Safety (time frame: Up to 9 months). 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 NCT04987762.

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 Aug 2023.