Attention-Deficit Hyperactivity DisorderPhase 1/2NCT01907360

Pharmacokinetics of HLD200 in Children and Adolescents With ADHD

A Phase 1/2 study testing HLD200 (methylphenidate hydrochloride) in people with Attention-Deficit Hyperactivity Disorder, run by Ironshore Pharmaceuticals and Development, Inc at 1 site in United States.

Completed

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

Official record

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Trial summary

This study was designed to assess the pharmacokinetic effects of a single dose of HLD200 (methylphenidate hydrochloride) in children and adolescents with ADHD. Read more about this study

Who is it for?: Ages 6 to 17 years
Conditions the study is for: Attention-Deficit Hyperactivity Disorder
What is being tested?: HLD200 (methylphenidate hydrochloride)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 29 participants
Where: 1 siteUnited States
Study dates: Aug 2013to Oct 2013
Phase: Phase 1/2
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 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

Male and female adolescents (13-17 years) and children (6-12 years).
Previous diagnosis of ADHD and confirmation using the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID).
ADHD symptoms controlled on a stable dose of ADHD medication. Subjects should be on MPH or have previous history of symptom control during treatment with MPH.
Physical examination free of clinically significant findings, unless deemed NCS by the Investigator and Medical Monitor;
Able to swallow treatment capsules;
Available for entire study period;
Provision of informed consent (from the parent[s] and/or legal representative[s]) and assent (from the subject); and
Female subjects of childbearing potential (i.e., post-menarche) required to have a negative result on urine pregnancy testing (and will be given specific instructions on avoiding pregnancy during trial)

Who cannot join

Any known history or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, ophthalmologic disease, unless deemed NCS by the Investigator and the Medical Monitor;
Presence of any significant physical or organ abnormality;
Any illness during the 4 weeks before this study, unless deemed NCS by the Investigator and the Clinical and/or Medical Monitor;
Severe comorbid psychiatric diagnosis that may affect subject safety or confound results (e.g., psychosis, bipolar disorder);
Known history of moderate to severe asthma;
Known history of severe allergic reaction (including drugs, food, insect bites, environmental allergens);

Show all 16Show fewer

Known history of seizures (except febrile seizures prior to age 5), anorexia nervosa, bulimia or current diagnosis or family history of Tourette's disorder;
Subject who are severely underweight or overweight.
Clinical value outside of the acceptable ranges, unless deemed NCS significant per the Investigator;
Positive history for hepatitis B, hepatitis C and Human Immunodeficiency Virus (HIV);
Positive screening for illicit drug use, and/or current health conditions or use of medications that might confound the results of the study or increase risk to the subject;
Use of prescription medications (except ADHD medications) within 7 days and over-the counter medications (except birth control) within the 3 days preceding study enrollment, unless deemed acceptable by the Investigator and Clinical and/or Medical Monitor;
Blood draws of 50 ml to 249 ml within the 30 days, 250 ml to 449 ml within the 45 days and ≥ 450 ml within the 60 days preceding study enrollment;
Participation in clinical trial with an investigational drug within the 30 days preceding study enrollment;
Intolerance to venipuncture; and
Current suicidal ideation or history of suicidality determined as a significant finding on the Columbia-Suicide Severity Rating Scale (C-SSRS) by the investigator (Baseline C-SSRS for adolescents; Pediatric Baseline C-SSRS for children).

Trial locations and contacts

1 site in 1 country.

United States1 site

Centre for Psychiatry & Behavioral Medicine, Inc.
Las Vegas, Nevada, 89128

Other trials in United States

About this study

Official title: A Phase I/II, Single Center, Single-Treatment, Open-Label, Adaptive Clinical Trial Design Examining the Pharmacokinetic Effects of up to Two Separate HLD200 Modified Release Formulations of Methylphenidate in Adolescent and Pediatric Subjects With ADHD

This study was designed to assess the pharmacokinetic effects of a single dose of HLD200 (methylphenidate hydrochloride) in children and adolescents with ADHD.

Read the detailed description

This study utilized a single-center, open-label, single-treatment, fasted design to examine the rate and extent of absorption of evening-administered HLD200 in children (6-12 years) and adolescents (13-17 years) with ADHD.

Following a screening period that included five days washout to allow for clearance of any prior ADHD medications, subjects were domiciled in-clinic and administered HLD200 (B-formulation; 54 mg; oral capsule) at 9 pm under fasted conditions. Subjects were then observed for safety and tolerability and a total of 18 blood samples collected during a 48 hour period (at t=0, 4, 6, 8, 9, 10, 11, 12, 13, 14, 15, 16, 18, 20, 22, 24, 36 and 48 hours post-dosing). These samples were then assayed for methylphenidate plasma concentrations and this data used for calculation of pharmacokinetic parameters.

Conditions: Attention-Deficit Hyperactivity Disorder
Being tested: HLD200 (methylphenidate hydrochloride)
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.

HLD200 (methylphenidate hydrochloride)Drug
Also called JORNAY PM

Study groups in NCT01907360
Study group	Role	What they receive
HLD200 (methylphenidate hydrochloride) in Adolescents	Experimental	HLD200 (B formulation, 54 mg, oral capsules) administered as a single treatment in the evening to children aged 13-17 years. Receives: Drug: HLD200 (methylphenidate hydrochloride)
HLD200 (methylphenidate hydrochloride) in Children	Experimental	HLD200 (B formulation, 54 mg, oral capsules) administered as a single treatment in the evening to children aged 6-12 years. Receives: Drug: HLD200 (methylphenidate hydrochloride)

What is being measured

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

PK Parameters for Rate and Extent of Absorption of MPH: Lag Time
The absorption lag time for methylphenidate in plasma expressed in hours is the difference in time between the drug administration and the last time point where the drug concentration was below the limit of assay quantitation.
Measured: 48hrs
PK Parameters for Rate and Extent of Absorption of MPH: Cmax
The maximum drug concentration of methylphenidate in plasma.
Measured: 48hrs
PK Parameters for Rate and Extent of Absorption of MPH: Tmax
The time to reach maximum concentration of methylphenidate in plasma.
Measured: 48hrs
PK Parameters for Rate and Extent of Absorption of MPH: AUC0-tz
Area under the methylphenidate plasma concentration-time curve to time point tz (AUC0-tz), where tz was the last time point over the time interval with a measurable drug concentration
Measured: 48hrs
PK Parameters for Rate and Extent of Absorption of MPH: AUC0-inf
The area under the methylphenidate plasma concentration-time curve to infinite time
Measured: 48hrs

Timeline

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

Aug 2013Oct 2013

First posted24 Jul 2013 (estimated)
Study startAug 2013
Primary completionOct 2013
Study completionOct 2013

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 1/2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Model description: Open-label, single-treatment
Masking: None (open label)
Enrolment: 29 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01907360
Sponsor's protocol ID: HLD200-102
Status last verified: Nov 2021
First submitted: 12 Jul 2013
Last updated: 23 Dec 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Childress A, Mehrotra S, Gobburu J, McLean A, DeSousa NJ, Incledon B. Single-Dose Pharmacokinetics of HLD200, a Delayed-Release and Extended-Release Methylphenidate Formulation, in Healthy Adults and in Adolescents and Children with Attention-Deficit/Hyperactivity Disorder. J Child Adolesc Psychopharmacol. 2018 Feb;28(1):10-18. doi: 10.1089/cap.2017.0044. Epub 2017 Oct 17.
PubMed 29039979

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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An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
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Lisdexamfetamine For the Treatment of Conduct Disorder in Children
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RecruitingObservational study
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Micronutrient Supplementation and Chronotherapy in Children With ADHD
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All Attention-Deficit Hyperactivity Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I/II, Single Center, Single-Treatment, Open-Label, Adaptive Clinical Trial Design Examining the Pharmacokinetic Effects of up to Two Separate HLD200 Modified Release Formulations of Methylphenidate in Adolescent and Pediatric Subjects With ADHD
ClinicalTrials.gov ID: NCT01907360
Acronym / sponsor ID: HLD200-102
Conditions: Attention-Deficit Hyperactivity Disorder
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 29 participants (actual)
Lead sponsor: Ironshore Pharmaceuticals and Development, IncUniversity, hospital or other
Study start: Aug 2013
Primary completion: Oct 2013 (actual)
Study completion: Oct 2013 (actual)
First posted: 24 Jul 2013 (estimated)
Results: Posted 20 Sep 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 was designed to assess the pharmacokinetic effects of a single dose of HLD200 (methylphenidate hydrochloride) in children and adolescents with ADHD.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2
Model description: Open-label, single-treatment

Arm	Type	Receives
HLD200 (methylphenidate hydrochloride) in Adolescents	Experimental	Drug: HLD200 (methylphenidate hydrochloride)HLD200 (B formulation, 54 mg, oral capsules) administered as a single treatment in the evening to children aged 13-17 years.
HLD200 (methylphenidate hydrochloride) in Children	Experimental	Drug: HLD200 (methylphenidate hydrochloride)HLD200 (B formulation, 54 mg, oral capsules) administered as a single treatment in the evening to children aged 6-12 years.

Who may qualify

Ages: 6 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (8 listed)

Male and female adolescents (13-17 years) and children (6-12 years).
Previous diagnosis of ADHD and confirmation using the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID).
ADHD symptoms controlled on a stable dose of ADHD medication. Subjects should be on MPH or have previous history of symptom control during treatment with MPH.
Physical examination free of clinically significant findings, unless deemed NCS by the Investigator and Medical Monitor;
Able to swallow treatment capsules;

Key exclusion criteria (16 listed)

Any known history or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, ophthalmologic disease, unless deemed NCS by the Investigator and the Medical Monitor;
Presence of any significant physical or organ abnormality;
Any illness during the 4 weeks before this study, unless deemed NCS by the Investigator and the Clinical and/or Medical Monitor;
Severe comorbid psychiatric diagnosis that may affect subject safety or confound results (e.g., psychosis, bipolar disorder);
Known history of moderate to severe asthma;

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
HLD200 (methylphenidate hydrochloride)Also: JORNAY PM	Drug	HLD200 (methylphenidate hydrochloride) in Adolescents, HLD200 (methylphenidate hydrochloride) in Children

Primary outcome

PK Parameters for Rate and Extent of Absorption of MPH: Lag Time
Time frame: 48hrs
The absorption lag time for methylphenidate in plasma expressed in hours is the difference in time between the drug administration and the last time point where the drug concentration was below the limit of assay quantitation.
PK Parameters for Rate and Extent of Absorption of MPH: Cmax
Time frame: 48hrs
The maximum drug concentration of methylphenidate in plasma.
PK Parameters for Rate and Extent of Absorption of MPH: Tmax
Time frame: 48hrs
The time to reach maximum concentration of methylphenidate in plasma.
PK Parameters for Rate and Extent of Absorption of MPH: AUC0-tz
Time frame: 48hrs
Area under the methylphenidate plasma concentration-time curve to time point tz (AUC0-tz), where tz was the last time point over the time interval with a measurable drug concentration
PK Parameters for Rate and Extent of Absorption of MPH: AUC0-inf
Time frame: 48hrs
The area under the methylphenidate plasma concentration-time curve to infinite time

Results and safety

Results posted to the registry on 20 Sep 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
Adolescents (13-17yrs)	18	18
Children (6-12 Yrs)	11	11

Primary outcome: PK Parameters for Rate and Extent of Absorption of MPH: Lag Time

Time frame: 48hrs. Mean (Standard Deviation). Unit: hours

Measure	HLD200 in Adolescents (13-17 Years) n = 18	HLD200 in Children (6-12 Yrs) n = 11
Value	6.3 (1.3)	3.3 (2.7)

Population analysed: All enrolled subjects included in analysis population.

Primary outcome: PK Parameters for Rate and Extent of Absorption of MPH: Cmax

Time frame: 48hrs. Mean (Standard Deviation). Unit: ng/mL

Measure	HLD200 in Adolescents (13-17 Years) n = 18	HLD200 in Children (6-12 Yrs) n = 11
Value	7.17 (1.7)	11.64 (4.2)

Population analysed: All enrolled subjects included in analysis population.

Primary outcome: PK Parameters for Rate and Extent of Absorption of MPH: Tmax

Time frame: 48hrs. Mean (Standard Deviation). Unit: hours

Measure	HLD200 in Adolescents (13-17 Years) n = 18	HLD200 in Children (6-12 Yrs) n = 11
Value	17.1 (2.5)	17.7 (2.5)

Population analysed: All enrolled subjects included in analysis population.

Primary outcome: PK Parameters for Rate and Extent of Absorption of MPH: AUC0-tz

Time frame: 48hrs. Mean (Standard Deviation). Unit: ng.hr/mL

Measure	HLD200 in Adolescents (13-17 Years) n = 18	HLD200 in Children (6-12 Yrs) n = 11
Value	105.5 (31.7)	205.6 (80.4)

Population analysed: All enrolled subjects included in analysis population.

Adverse events

Time frame: Baseline to 48 hours after the HLD200 dose. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Adolescents (13-17yrs)	0 of 18 (0%)	10 of 18 (55.6%)	0 of 18
Children (6-12 Yrs)	0 of 11 (0%)	6 of 11 (54.5%)	0 of 11

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29039979Childress A, Mehrotra S, Gobburu J, McLean A, DeSousa NJ, Incledon B. Single-Dose Pharmacokinetics of HLD200, a Delayed-Release and Extended-Release Methylphenidate Formulation, in Healthy Adults and in Adolescents and Children with Attention-Deficit/Hyperactivity Disorder. J Child Adolesc Psychopharmacol. 2018 Feb;28(1):10-18. doi: 10.1089/cap.2017.0044. Epub 2017 Oct 17.

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
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Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
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RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
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Recruiting
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Attention Deficit Hyperactivity Disorder (ADHD)
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.

Ann Childress, M.D. principal investigator

Centre for Psychiatry & Behavioral Medicine, Inc.

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

Questions about this trial

What is this clinical trial studying?

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 8 inclusion and 16 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 23 Dec 2021. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 20 Sep 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?

PK Parameters for Rate and Extent of Absorption of MPH: Lag Time (time frame: 48hrs). The study lists 5 primary outcomes in all. 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 NCT01907360, 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 23 Dec 2021.