ADHDPhase 3NCT03460652

KP415 Open-Label Safety Study in Children (6-12 Years of Age) With ADHD

A Phase 3 study testing KP415 oral capsule in people with ADHD, run by Zevra Therapeutics at 19 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study is a multicenter, dose-optimized, open-label safety study with KP415 in children with Attention-Deficit/Hyperactivity Disorder (ADHD). Read more about this study

Who is it for?: Ages 6 to 12 years
Conditions the study is for: ADHD
What is being tested?: KP415 oral capsule
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 282 participants
Where: 19 sitesUnited States
Study dates: 13 Mar 2018to 9 Jul 2019
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

Subject must meet Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5) criteria for a primary diagnosis of ADHD (combined, inattentive, or hyperactive/impulsive presentation) per clinical evaluation and confirmed by the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID).
Subject must have a score of at least 3 (mildly ill) on the clinician-administered Clinical Global Impressions-Severity (CGI-S) scale.
Subjects who completed the efficacy study with KP415 may be rolled over into the current study.
Subject, subject's parent/legal guardian and caregiver (if applicable) must understand and be willing and able to comply with all study procedures and visit schedule.

Who cannot join

Subject with any clinically significant chronic medical condition that may interfere with the participant's ability to participate in the study.
Subject has any diagnosis of bipolar I or II disorder, major depressive disorder, conduct disorder, obsessive-compulsive disorder, any history of psychosis, autism spectrum disorder, disruptive mood dysregulation disorder (DMDD), intellectual disability, Tourette's Syndrome, confirmed genetic disorder with cognitive and/or behavioral disturbances.
Subject has evidence of any chronic disease of the central nervous system (CNS) such as tumors, inflammation, seizure disorder, vascular disorder, potential CNS related disorders that might occur in childhood, or history of persistent neurological symptoms attributable to serious head injury.
Subject has a current (last month) psychiatric diagnosis other than specific phobia, motor skills disorders, oppositional defiant disorder, sleep disorders, elimination disorders, adjustment disorders, learning disorders, or communication disorders. Participants with school phobia or separation anxiety will not be eligible.
Subject has clinically significant suicidal ideation/behavior, based on a history of attempted suicide and the C-SSRS assessment at Screening or at any time before the last dose of study drug.
Subject has any clinically significant unstable medical abnormality, chronic disease, or a history of a clinically significant abnormality of the cardiovascular, gastrointestinal, respiratory, hepatic, or renal systems, or a disorder or history of a condition that may interfere with drug absorption, distribution, metabolism, or excretion of study drug.
Subject has a history or presence of abnormal ECGs.

Trial locations and contacts

19 sites in 1 country.

City, postcode or hospital

19 sites in 1 country

United States19 sites

FutureSearch Trials
Austin, Texas, 78731
Hassman Research Institute
Berlin, New Jersey, 08009
Meridien Research
Bradenton, Florida, 34201
Neuro-Behavioral Clinical Research
Canton, Ohio, 44718
MCB Clinical Research Centers
Colorado Springs, Colorado, 80910
Midwest Clinical Research Center, LLC
Dayton, Ohio, 45417
Bayou City Research, Ltd.
Houston, Texas, 77007
Houston Clinical Trials
Houston, Texas, 77098
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32256
Center for Psychiatry and Behavioral Medicine, Inc.
Las Vegas, Nevada, 89128
Innovative Clinical Research, Inc.
Lauderhill, Florida, 33319
Capstone Clinical Research
Libertyville, Illinois, 60048
Woodland International Research
Little Rock, Arkansas, 72211
Meridien Research
Maitland, Florida, 32751
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, 38119
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32801
Psychiatric Associates
Overland Park, Kansas, 66211
Oregon Center for Clinical Investigations, Inc.
Portland, Oregon, 97214
Oregon Center for Clinical Investigations, Inc.
Salem, Oregon, 97301

Other trials in United States

About this study

Official title: A Multicenter, Dose-Optimized, Open-Label Safety Study With KP415 in Children With Attention-Deficit/Hyperactivity Disorder

This study is a multicenter, dose-optimized, open-label safety study with KP415 in children with Attention-Deficit/Hyperactivity Disorder (ADHD).

Read the detailed description

The study will consist of a Screening Period, a Dose Optimization Phase, and a Treatment Phase and a Follow-Up Visit, as follows:

Screening Period: Subjects will undergo a screening period up to 30 days prior to entering the Dose Optimization Phase.
Dose Optimization Phase: During the Dose Optimization Phase, subjects will be titrated to doses of 20, 30 or 40 mg KP415 based on tolerability and best individual dose-response in the opinion of the Investigator.
Treatment Phase: Eligible subjects will receive single daily doses of KP415 for up to approximately 360 days (up to approximately 12 months). The dose of KP415 given in the Treatment Phase will be the dose of KP415 at the end of the Dose Optimization Phase. During the Treatment Phase, the dose of KP415 may be changed based on individual tolerability and best dose response (to either 20, 30, or 40 mg KP415 capsules). Safety, efficacy and sleep behavior assessments will be performed.
Follow-Up Visit: 3 ±2 days after administration of the last dose of the Treatment Phase, subjects will enter a Follow-Up Visit to evaluate safety parameters.

Conditions: ADHD
Being tested: KP415 oral capsule
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.

KP415 oral capsuleDrug
Also called Azstarys, SDX/d-MPH
Once-daily oral dose

Study groups in NCT03460652
Study group	Role	What they receive
Open-Label KP415	Experimental	KP415 (serdexmethylphenidate [SDX] Cl/ d-methylphenidate [d-MPH] HCl) oral capsule: 28/6 mg SDX/d-MPH (molar equivalent to 20 mg d-MPH HCl), 42/9 mg SDX/d-MPH (molar equivalent to 30 mg d-MPH HCl), 56/12 mg SDX/d-MPH (molar equivalent to 40 mg d-MPH HCl) Receives: Drug: KP415 oral capsule

What is being measured

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

Subjects With Treatment-Emergent Adverse Events (TEAEs)
TEAEs will be assessed starting following the first dose of study drug, and ending with the Follow-Up Visit or Early Termination Visit.
Measured: Up to 12 months

Secondary outcomes (3)

Change From Baseline in ADHD-RS-5 Total Score
The clinician-administered ADHD-RS-5 is an 18-item scale that rates ADHD symptoms on a 4-point scale. Each item is scored using a combination of severity and frequency ratings from a range of 0 (reflecting no symptoms or a frequency of never or rarely) to 3 (reflecting severe symptoms or a frequency of very often), so that the total ADHD-RS-5 scores range from 0 to 54. The 18 items can be divided into two 9-item subscales: One for hyperactivity/impulsivity and the other for inattentiveness.
Measured: Up to 12 months
Change From Baseline in CGI-S
The CGI-S is a clinician-rated scale that evaluates the severity of psychopathology (ADHD symptoms in this study) on a scale from 1 (not at all ill) to 7 (among the most severely ill).
Measured: Up to 12 months
Change From Baseline in Children's Sleep Habits Questionnaire
The modified, abbreviated Children's Sleep Habits Questionnaire (CSHQ) will be used to assess the sleep behavior. The CSHQ is a retrospective, 33-item parent questionnaire to examine sleep behavior in small children. Items are rated on a 3-point scale of "Usually", "Sometimes" and "Rarely" for occurrences in a number of key sleep domains: bedtime resistance, sleep onset delay, sleep duration, sleep anxiety, night wakings, parasomnias, sleep disordered breathing, and daytime sleepiness. Scores range from 33-99, with higher scores represent more disturbed sleep. Scores were obtained during a clinician-directed interview with the parent/guardian/caregiver.
Measured: Up to 12 months

Timeline

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

13 Mar 20189 Jul 2019

First posted9 Mar 2018
Study start13 Mar 2018
Primary completion20 Jun 2019
Study completion9 Jul 2019

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 (2)Papers the sponsor has linked to this study.
Other trials for ADHDStudies 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 282 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03460652
Sponsor's protocol ID: KP415.S01
Status last verified: Jun 2020
First submitted: 12 Feb 2018
Last updated: 19 Jul 2021
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Childress AC, Cutler AJ, Patel M, Oh C. Analysis of Growth Velocity in Children with Attention-Deficit/Hyperactivity Disorder Treated for up to 12 Months with Serdexmethylphenidate/Dexmethylphenidate. J Child Adolesc Psychopharmacol. 2023 May;33(4):134-142. doi: 10.1089/cap.2023.0012.
PubMed 37204277
Childress AC, Marraffino A, Cutler AJ, Oh C, Brams MN. Safety and Tolerability of Serdexmethylphenidate/Dexmethylphenidate Capsules in Children with Attention-Deficit/Hyperactivity Disorder: A 12-Month, Open-Label Safety Study. J Child Adolesc Psychopharmacol. 2023 Mar;33(2):51-58. doi: 10.1089/cap.2022.0076. Epub 2023 Feb 20.
PubMed 36809150

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?

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Study at a glance

From the registry record, last updated by the sponsor on 19 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Dose-Optimized, Open-Label Safety Study With KP415 in Children With Attention-Deficit/Hyperactivity Disorder
ClinicalTrials.gov ID: NCT03460652
Acronym / sponsor ID: KP415.S01
Conditions: ADHD
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 282 participants (actual)
Lead sponsor: Zevra TherapeuticsIndustry (pharma, biotech, devices)
Study start: 13 Mar 2018 (actual)
Primary completion: 20 Jun 2019 (actual)
Study completion: 9 Jul 2019 (actual)
First posted: 9 Mar 2018 (actual)
Results: Posted 19 Jul 2021

Clinical summary

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

This study is a multicenter, dose-optimized, open-label safety study with KP415 in children with Attention-Deficit/Hyperactivity Disorder (ADHD).

Detailed description

The study will consist of a Screening Period, a Dose Optimization Phase, and a Treatment Phase and a Follow-Up Visit, as follows:

Screening Period: Subjects will undergo a screening period up to 30 days prior to entering the Dose Optimization Phase.
Dose Optimization Phase: During the Dose Optimization Phase, subjects will be titrated to doses of 20, 30 or 40 mg KP415 based on tolerability and best individual dose-response in the opinion of the Investigator.
Treatment Phase: Eligible subjects will receive single daily doses of KP415 for up to approximately 360 days (up to approximately 12 months). The dose of KP415 given in the Treatment Phase will be the dose of KP415 at the end of the Dose Optimization Phase. During the Treatment Phase, the dose of KP415 may be changed based on individual tolerability and best dose response (to either 20, 30, or 40 mg KP415 capsules). Safety, efficacy and sleep behavior assessments will be performed.
Follow-Up Visit: 3 ±2 days after administration of the last dose of the Treatment Phase, subjects will enter a Follow-Up Visit to evaluate safety parameters.

Study design

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

Arm	Type	Receives
Open-Label KP415	Experimental	Drug: KP415 oral capsuleKP415 (serdexmethylphenidate [SDX] Cl/ d-methylphenidate [d-MPH] HCl) oral capsule: 28/6 mg SDX/d-MPH (molar equivalent to 20 mg d-MPH HCl), 42/9 mg SDX/d-MPH (molar equivalent to 30 mg d-MPH HCl), 56/12 mg SDX/d-MPH (molar equivalent to 40 mg d-MPH HCl)

Who may qualify

Ages: 6 to 12 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

Subject must meet Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5) criteria for a primary diagnosis of ADHD (combined, inattentive, or hyperactive/impulsive presentation) per clinical evaluation and confirmed by the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID).
Subject must have a score of at least 3 (mildly ill) on the clinician-administered Clinical Global Impressions-Severity (CGI-S) scale.
Subjects who completed the efficacy study with KP415 may be rolled over into the current study.
Subject, subject's parent/legal guardian and caregiver (if applicable) must understand and be willing and able to comply with all study procedures and visit schedule.

Key exclusion criteria (7 listed)

Subject with any clinically significant chronic medical condition that may interfere with the participant's ability to participate in the study.
Subject has any diagnosis of bipolar I or II disorder, major depressive disorder, conduct disorder, obsessive-compulsive disorder, any history of psychosis, autism spectrum disorder, disruptive mood dysregulation disorder (DMDD), intellectual disability, Tourette's Syndrome, confirmed genetic disorder with cognitive and/or behavioral disturbances.
Subject has evidence of any chronic disease of the central nervous system (CNS) such as tumors, inflammation, seizure disorder, vascular disorder, potential CNS related disorders that might occur in childhood, or history of persistent neurological symptoms attributable to serious head injury.
Subject has a current (last month) psychiatric diagnosis other than specific phobia, motor skills disorders, oppositional defiant disorder, sleep disorders, elimination disorders, adjustment disorders, learning disorders, or communication disorders. Participants with school phobia or separation anxiety will not be eligible.
Subject has clinically significant suicidal ideation/behavior, based on a history of attempted suicide and the C-SSRS assessment at Screening or at any time before the last dose of study drug.

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
KP415 oral capsuleAlso: Azstarys, SDX/d-MPHOnce-daily oral dose	Drug	Open-Label KP415

Primary outcome

Subjects With Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to 12 months
TEAEs will be assessed starting following the first dose of study drug, and ending with the Follow-Up Visit or Early Termination Visit.

3 secondary outcomes

Change From Baseline in ADHD-RS-5 Total Score
Time frame: Up to 12 months
Change From Baseline in CGI-S
Time frame: Up to 12 months
Change From Baseline in Children's Sleep Habits Questionnaire
Time frame: Up to 12 months

Results and safety

Results posted to the registry on 19 Jul 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active Treatment	282	155

Primary outcome: Subjects With Treatment-Emergent Adverse Events (TEAEs)

Time frame: Up to 12 months. Count of participants. Unit: Participants

Measure	Treatment-Phase Safety Population n = 238
Subjects with at least 1 TEAE	143
Subjects with a related TEAE	108
Subjects with a TEAE leading to discontinuation of study drug	6
Subjects with an SAE	2
Subjects with an AE leading to death	0

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active Treatment	3 of 238 (1.3%)	143 of 238 (60.1%)	0 of 238

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37204277Childress AC, Cutler AJ, Patel M, Oh C. Analysis of Growth Velocity in Children with Attention-Deficit/Hyperactivity Disorder Treated for up to 12 Months with Serdexmethylphenidate/Dexmethylphenidate. J Child Adolesc Psychopharmacol. 2023 May;33(4):134-142. doi: 10.1089/cap.2023.0012.
Derived from this study: PubMed 36809150Childress AC, Marraffino A, Cutler AJ, Oh C, Brams MN. Safety and Tolerability of Serdexmethylphenidate/Dexmethylphenidate Capsules in Children with Attention-Deficit/Hyperactivity Disorder: A 12-Month, Open-Label Safety Study. J Child Adolesc Psychopharmacol. 2023 Mar;33(2):51-58. doi: 10.1089/cap.2022.0076. Epub 2023 Feb 20.

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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.

Ann Childress, MD principal investigator

Center for Psychiatry And Behavioral Medicine Inc.

19 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 KP415 oral capsule in people with ADHD, run by Zevra Therapeutics at 19 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 4 inclusion and 7 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 19 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 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 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 19 Jul 2021). 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?

Subjects With Treatment-Emergent Adverse Events (TEAEs) (time frame: Up to 12 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 NCT03460652, which also lists 2 linked publications.

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 19 Jul 2021.