Attention Deficit Hyperactivity DisorderPhase 3NCT02493777
A Pivotal Efficacy Trial to Evaluate HLD200 in Children With ADHD in a Classroom Setting
A Phase 3 study testing HLD200 methylphenidate hydrochloride (MPH) Capsules in people with Attention Deficit Hyperactivity Disorder, run by Ironshore Pharmaceuticals and Development, Inc at 7 sites in United States.
Trial summary
This Phase 3 pivotal efficacy trial will examine the effects of HLD200 (methylphenidate) in patients aged 6-12 years with ADHD in a laboratory classroom setting. This study has a 6-week open-label treatment optimization period followed by a one week randomized, double-blind, placebo-controlled test phase. 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?
- HLD200 methylphenidate hydrochloride (MPH) Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 125 participants
- Where
- 7 sitesUnited States
- Study dates
- Jul 2015to Mar 2016
- 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
- Subjects must be male or female children (6 to 12 years at the time of consent).
- Subjects must have a diagnosis of ADHD as defined by DSM5 criteria and confirmation using the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID).
- Subjects must have a Baseline ADHD-RS-IV score at or above the 90th percentile normalized for sex and age in at least 1 of the following categories: 1) Hyperactive Impulse; 2) Inattentive; or 3) Total Score. In addition, this ADHD-RS-IV Total Score must be greater or equal to 26.
- Subjects must have a Clinical Global Impression of Severity (CGI-S) score greater than or equal to 4 and a CGI-P score >10 at the Baseline Visit.
- Subjects who are not currently on MPH treatment must either 1) have prior experience with MPH treatment and have shown clinical response to therapy during that time; or 2) be treated with the same dose of MPH and show a clinical response with acceptable tolerability to MPH for ≥2 weeks prior to screening.
- Parental or legal guardian confirmation of before-school function impairment and difficulties performing morning routine.
Show all 14Show fewer
- Regular weekday morning routine of no less than 30 minutes.
- Subject must be considered clinically appropriate for treatment with MPH and HLD200, including ability to swallow treatment capsules.
- Subject must be in general good health based upon medical history, physical examination, and laboratory results (including urine drug screen).
- Subject and parent or legal guardian must be able to read, write, and/or understand at a level sufficient to provide informed consent (parent/legal guardian) and assent (subject) prior to study participation and to complete study-related materials. Subject and a parent/legal guardian must plan to be available for the entire study period.
- Female subjects of childbearing potential (i.e., post-menarche) are required to have a negative result on urine pregnancy testing at screening (and will be given specific instructions for avoiding pregnancy during the study).
- A medically highly effective form of birth control must be used during the study and for 90 days thereafter for subjects of either sex of childbearing potential. Examples of medically highly effective forms of birth control are as follows:
- No sexual activity
- Use of acceptable methods of birth control including intra-uterine device, oral, implantable, or injectable contraceptives.
Who cannot join
- History of, or current, medical condition or laboratory result which, in the opinion of the investigator, unfavorably alters the risk-benefit of study participation, may jeopardize subject safety, or may interfere with the satisfactory completion of the study and study-related procedures.
- Serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other cardiac problems that may place the subject at increased vulnerability to the sympathomimetic effects of a stimulant drug.
- History of seizure disorder (except febrile seizures prior to age 5 and at least 1 year prior to study participation), Tourette's disorder, or intellectual disability of minor severity or greater (DSM5 criteria).
- History of psychosis, bipolar disorder, anorexia nervosa, bulimia, or suicide attempt. Current depression, anxiety, conduct/behavior disorder, substance use disorder, or other psychiatric condition which, in the investigator's opinion, may jeopardize subject safety or may interfere with the satisfactory completion of the study and study-related procedures.
- Active suicidal ideation as evidenced by an ideation score of 2 or greater on the C-SSRS.
- History of severe allergic reaction to MPH.
Show all 17Show fewer
- History of no response or intolerance to the adverse effects of MPH;
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, or creatinine greater than 1.5x the upper limit of normal. Elevated bilirubin due only to Gilbert's syndrome is not exclusionary.
- History of alcohol abuse or illicit drug use.
- Use of prescription medications (except allowed medications; see Section 8.1.2) within 7 days of Baseline (Visit 2), except for ADHD stimulant medication (5 days) and monoamine oxidase inhibitors (MAOIs) (14 days), and over-the-counter medications (except birth control and allowed medications) within the 3 days preceding Baseline (Visit 2). Medications not covered in allowed medications or prohibited medications (Section 8.1.1) must be cleared by the medical monitor prior to enrolling the subject.
- Participation in a clinical study with an investigational drug within the 30 days preceding study enrollment.
- Previous treatment experience with HLD200.
- Positive screening for illicit drug use or nicotine and/or current health conditions or use of medications that might confound the results of the study or increase risk to the subject.
- In the opinion of the investigator, the subject may have problems complying with the protocol or the procedures of the protocol, or could face unnecessary safety risks from the study. This includes current health conditions or use of medications that might confound the results of the study or increase risk to the subject.
- Subject's systolic or diastolic blood pressure measurement exceeds the 95th percentile for age, sex, and height at the Baseline visit.
- Subject is significantly underweight based on Centers for Disease Control and Prevention body mass index (BMI)-for-age sex-specific values at the Screening Visit. Significantly underweight is defined as a BMI <5th percentile.
- Subject is significantly overweight based on Centers for Disease Control and Prevention BMI-for-age sex specific values at the Screening Visit. Significantly overweight is defined as a BMI >95th percentile.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Florida Clinical Research Center, LLC
Bradenton, Florida, 34201
Bayou City Research, Ltd
Houston, Texas, 77007
Center for Psychiatry and Behavioral Medicine, Inc.
Las Vegas, Nevada, 89128
Westex Clinical Investigations
Lubbock, Texas, 79423
Florida Clinical Research Center, LLC
Maitland, Florida, 32751
South Shore Psychiatric Services, PC
Marshfield, Massachusetts, 02050
AVIDA Inc.
Newport Beach, California, 92660
About this study
Official title: Ph 3 Multicenter OL Treatment-optimized RDBPC Forced-withdrawal, Parallel Grp Study to Evaluate Safety & Efficacy of Evening Dosed HLD200, a Novel DR/ER Formulation (DELEXIS) of MPH HCl in Children Aged 6-12 With ADHD in Classroom Setting
This Phase 3 pivotal efficacy trial will examine the effects of HLD200 (methylphenidate) in patients aged 6-12 years with ADHD in a laboratory classroom setting. This study has a 6-week open-label treatment optimization period followed by a one week randomized, double-blind, placebo-controlled test phase.
Read the detailed description
To address the unmet need for early morning ADHD symptom control, Ironshore has developed a novel drug delivery system that incorporates the active MPH ingredient in a delayed release/extended release formulation. This formulation provides a controlled, approximately 8-hour delay in initial drug release, followed by a subsequent controlled rate of drug release throughout the day. The goal of this system is to enable nighttime dosing of MPH to provide control of ADHD symptoms at the beginning of the next morning and throughout the remainder of the day.
The phase 3 study used an open-label treatment-optimization phase followed by a double-blind, placebo-controlled, 1-week, parallel-group treatment phase to assess safety and tolerability, as well as the time course of treatment effect, of evening-dosed HLD200 in pediatric subjects with a diagnosis of ADHD. At Visit 2, subjects began daily evening (8:00 pm ±30 minutes) treatment with 20 or 40 mg HLD200 (based on prior treatment history) for a period of 1 week and then had up to 4 additional weekly visits (Visits 3 to 6) for treatment adjustments to achieve both a) an optimal daily dose and b) an optimal treatment time prior to beginning the Double-blind Placebo-controlled Test Phase.
During Visits 3, 4, 5, and 6, investigators were permitted to titrate the dose of study drug (up or down) in 20 to 40 mg increments until either achieving the "optimal" daily dose or reaching a maximum daily dose of 100 mg/day and/or a maximum dose not exceeding 3.7 mg/kg (based on Visit 2 [baseline] weight). The final permitted dose level change was at Visit 6, after which, that dose was to be continued through Visit 7 to randomization at Visit 8. The subject underwent an assessment of study drug tolerability and, if necessary, could have his/her dose reduced. In concert with dose strength adjustments, treatment time adjustments were permitted during Visits 3, 4, 5, and 6 in increments of ±0.5 to 1.0 hour until an "optimal" treatment time was achieved (between 6:30 pm to 9:30 pm; at least 1 hour following completion of dinner). The time for changing final dose timing was at Visit 6 and continued through Visit 7 to randomization at Visit 8.
During the 1-week parallel-group phase, at Visit 8 subjects were randomly assigned (1:1 ratio) in double-blind fashion to either HLD200 or placebo treatments over the next 7 evenings. The placebo group received matching placebo at their optimal treatment time, while the HLD200 group received HLD200 at their optimal daily dose and treatment time.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- HLD200 methylphenidate hydrochloride (MPH) Capsules, Placebo
- 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 (MPH) CapsulesDrug
Also called methylphenidate
HLD200 doses: 20, 40, 60, 80 or 100 mg
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| HLD200 (methylphenidate) | Experimental | The investigational drug for this study is HLD200 MPH MR capsules comprised of the active pharmaceutical ingredient (MPH) in a dual-coated drug-layered core. Following open-label treatment optimization, subjects will be randomized (1:1) to double-blind HLD200 to be taken once daily during the evening for a period of 1-week prior to testing. Receives: Drug: HLD200 methylphenidate hydrochloride (MPH) Capsules |
| Placebo | Placebo comparator | Placebo capsules will be composed of microcrystalline cellulose beads in place of MPH containing beads found in the HLD200 capsules. Following open-label treatment optimization, subjects will be randomized (1:1) to double-blind placebo to be taken once daily during the evening for a period of 1-week prior to testing. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Swanson, Kotkin, Agler, M-Flynn and Pelham Combined Score (SKAMP CS) - Model-adjusted Average of All Post-dose Time Points Assessed During a Laboratory Classroom Test Day (Visit 9).
The SKAMP is a validated, 13-item, observer-rated scale designed to assess the level of impairment of classroom-observed behaviors (Wigal and Wigal, 2006). Items 1 through 4 assess subject attention; items 5 through 8 assess deportment; items 9 through 11 assess quality of work; while items 12 and 13 assess subject compliance with teacher/classroom rules. Each individual item is rated on a 7-point scale from 0 (normal, no impairment) to 6 (maximal impairment). When all individual item scores are summed together, they produce a 13-item combined score that ranges from 0 to 78, with higher scores signifying greater impairment. In the present study, the SKAMP rating scale was utilized across 9 sessions occuring at 8:00 am, 9:00 am, 10:00 am, 12:00 pm, 2:00 pm, 4:00 pm, 6:00 pm, 7:00 pm, and 8:00 pm of the laboratory classroom day. Successful training of qualified individuals on the SKAMP scale was required before raters were allowed to perform study assessments.
Measured: 12-hours from 8:00 am to 8:00 pm
Secondary outcomes (1)
Parent Rating of Evening and Morning Behavior Revised, Morning Subscale (PREMB-R AM).
The PREMB-R is an 11-item rating scale designed to assess at-home functional impairments in children with ADHD during both early morning (AM) and late afternoon/evening (PM) time periods. With demonstrated validity and reliablility (Faraone et al., 2015), the AM subscale total score (sum of items 1 to 3) was designated in this study as a key secondary endpoint. Items are scored from 0 (none) to 3 (a lot), with higher scores signifying greater impairment of function. The PREMB-R rating scale was completed by parents during the 2-days prior to study visits at the beginning and end of the open-label period (Visits 2 and 8, respectively), as well as at the end of the randomized, double-blind period (Visit 9). At each visit, these ratings were used only for review by the clinician (MD, PhD, DO, licensed social worker, or any trained mental health professional approved by the sponsor) as part of a structured interview to enable collection of a clinician-rated PREMB-R AM subscale score.
Measured: PREMB-R AM mean subscale score for the 2-days prior to Visit 9.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionFeb 2016
- Study completionMar 2016
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 (8)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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ironshore Pharmaceuticals and Development, Inc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ann Childress, MD, Principal investigator, Center for Psychiatry And Behavioral Medicine Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02493777
- Sponsor's protocol ID
- HLD200-107
- Status last verified
- Jul 2021
- First submitted
- 7 Jul 2015
- Last updated
- 23 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Storebo OJ, Storm MRO, Pereira Ribeiro J, Skoog M, Groth C, Callesen HE, Schaug JP, Darling P, Huus CL, Zwi M, Kirubakaran R, Simonsen E, Gluud C. Methylphenidate for children and adolescents with attention deficit hyperactivity disorder (ADHD). Cochrane Database Syst Rev. 2025 Dec 4;12(12):CD009885. doi: 10.1002/14651858.CD009885.pub4.
PubMed 41342306Katzman MA, Otcheretko V, Po MD, Uchida CL, Incledon B. Adverse Events During Dosing of Delayed-release/Extended-release Methylphenidate: Learnings From the Open-label Phase of a Registration Trial and a Real-world Postmarketing Surveillance Program. Clin Ther. 2023 Dec;45(12):1212-1221. doi: 10.1016/j.clinthera.2023.09.009. Epub 2023 Sep 27.
PubMed 37770309Storebo OJ, Storm MRO, Pereira Ribeiro J, Skoog M, Groth C, Callesen HE, Schaug JP, Darling Rasmussen P, Huus CL, Zwi M, Kirubakaran R, Simonsen E, Gluud C. Methylphenidate for children and adolescents with attention deficit hyperactivity disorder (ADHD). Cochrane Database Syst Rev. 2023 Mar 27;3(3):CD009885. doi: 10.1002/14651858.CD009885.pub3.
PubMed 36971690Goldberg JF. Adjunctive Mood Stabilizers Are Not the Same as a Placebo-Only Arm in Bipolar Depression Trials: Reply to Terao. J Clin Psychiatry. 2021 Jun 22;82(4):21lr13919b. doi: 10.4088/JCP.21lr13919b. No abstract available.
PubMed 34166589Terao T. Antidepressant Effects of Combined Mood Stabilizers May Account for High Placebo Response Rates. J Clin Psychiatry. 2021 Jun 22;82(4):21lr13919. doi: 10.4088/JCP.21lr13919. No abstract available.
PubMed 34166588Childress AC, Cutler AJ, Po MD, DeSousa NJ, Warrington LE, Sallee FR, Incledon B. Symptomatic and Functional Response and Remission From the Open-Label Treatment-Optimization Phase of a Study With DR/ER-MPH in Children With ADHD. J Clin Psychiatry. 2021 Jun 22;82(4):21m13914. doi: 10.4088/JCP.21m13914.
PubMed 34166587Childress AC, Uchida CL, Po MD, DeSousa NJ, Incledon B. A Post Hoc Comparison of Prior ADHD Medication Dose and Optimized Delayed-release and Extended-release Methylphenidate Dose in a Pivotal Phase III Trial. Clin Ther. 2020 Dec;42(12):2332-2340. doi: 10.1016/j.clinthera.2020.10.004. Epub 2020 Nov 7.
PubMed 33168234Childress AC, Cutler AJ, Marraffino A, McDonnell MA, Turnbow JM, Brams M, DeSousa NJ, Incledon B, Sallee FR, Wigal SB. A Randomized, Double-Blind, Placebo-Controlled Study of HLD200, a Delayed-Release and Extended-Release Methylphenidate, in Children with Attention-Deficit/Hyperactivity Disorder: An Evaluation of Safety and Efficacy Throughout the Day and Across Settings. J Child Adolesc Psychopharmacol. 2020 Feb;30(1):2-14. doi: 10.1089/cap.2019.0070. Epub 2019 Aug 29.
PubMed 31464511
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ph 3 Multicenter OL Treatment-optimized RDBPC Forced-withdrawal, Parallel Grp Study to Evaluate Safety & Efficacy of Evening Dosed HLD200, a Novel DR/ER Formulation (DELEXIS) of MPH HCl in Children Aged 6-12 With ADHD in Classroom Setting
- ClinicalTrials.gov ID
- NCT02493777
- Acronym / sponsor ID
- HLD200-107
- Conditions
- Attention Deficit Hyperactivity Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Ironshore Pharmaceuticals and Development, IncUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 10 Jul 2015 (estimated)
- Results
- Posted 3 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase 3 pivotal efficacy trial will examine the effects of HLD200 (methylphenidate) in patients aged 6-12 years with ADHD in a laboratory classroom setting. This study has a 6-week open-label treatment optimization period followed by a one week randomized, double-blind, placebo-controlled test phase.
Detailed description
To address the unmet need for early morning ADHD symptom control, Ironshore has developed a novel drug delivery system that incorporates the active MPH ingredient in a delayed release/extended release formulation. This formulation provides a controlled, approximately 8-hour delay in initial drug release, followed by a subsequent controlled rate of drug release throughout the day. The goal of this system is to enable nighttime dosing of MPH to provide control of ADHD symptoms at the beginning of the next morning and throughout the remainder of the day.
The phase 3 study used an open-label treatment-optimization phase followed by a double-blind, placebo-controlled, 1-week, parallel-group treatment phase to assess safety and tolerability, as well as the time course of treatment effect, of evening-dosed HLD200 in pediatric subjects with a diagnosis of ADHD. At Visit 2, subjects began daily evening (8:00 pm ±30 minutes) treatment with 20 or 40 mg HLD200 (based on prior treatment history) for a period of 1 week and then had up to 4 additional weekly visits (Visits 3 to 6) for treatment adjustments to achieve both a) an optimal daily dose and b) an optimal treatment time prior to beginning the Double-blind Placebo-controlled Test Phase.
During Visits 3, 4, 5, and 6, investigators were permitted to titrate the dose of study drug (up or down) in 20 to 40 mg increments until either achieving the "optimal" daily dose or reaching a maximum daily dose of 100 mg/day and/or a maximum dose not exceeding 3.7 mg/kg (based on Visit 2 [baseline] weight). The final permitted dose level change was at Visit 6, after which, that dose was to be continued through Visit 7 to randomization at Visit 8. The subject underwent an assessment of study drug tolerability and, if necessary, could have his/her dose reduced. In concert with dose strength adjustments, treatment time adjustments were permitted during Visits 3, 4, 5, and 6 in increments of ±0.5 to 1.0 hour until an "optimal" treatment time was achieved (between 6:30 pm to 9:30 pm; at least 1 hour following completion of dinner). The time for changing final dose timing was at Visit 6 and continued through Visit 7 to randomization at Visit 8.
During the 1-week parallel-group phase, at Visit 8 subjects were randomly assigned (1:1 ratio) in double-blind fashion to either HLD200 or placebo treatments over the next 7 evenings. The placebo group received matching placebo at their optimal treatment time, while the HLD200 group received HLD200 at their optimal daily dose and treatment time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HLD200 (methylphenidate) | Experimental | Drug: HLD200 methylphenidate hydrochloride (MPH) CapsulesThe investigational drug for this study is HLD200 MPH MR capsules comprised of the active pharmaceutical ingredient (MPH) in a dual-coated drug-layered core. Following open-label treatment optimization, subjects will be randomized (1:1) to double-blind HLD200 to be taken once daily during the evening for a period of 1-week prior to testing. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo capsules will be composed of microcrystalline cellulose beads in place of MPH containing beads found in the HLD200 capsules. Following open-label treatment optimization, subjects will be randomized (1:1) to double-blind placebo to be taken once daily during the evening for a period of 1-week prior to testing. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (14 listed)
- Subjects must be male or female children (6 to 12 years at the time of consent).
- Subjects must have a diagnosis of ADHD as defined by DSM5 criteria and confirmation using the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID).
- Subjects must have a Baseline ADHD-RS-IV score at or above the 90th percentile normalized for sex and age in at least 1 of the following categories: 1) Hyperactive Impulse; 2) Inattentive; or 3) Total Score. In addition, this ADHD-RS-IV Total Score must be greater or equal to 26.
- Subjects must have a Clinical Global Impression of Severity (CGI-S) score greater than or equal to 4 and a CGI-P score >10 at the Baseline Visit.
- Subjects who are not currently on MPH treatment must either 1) have prior experience with MPH treatment and have shown clinical response to therapy during that time; or 2) be treated with the same dose of MPH and show a clinical response with acceptable tolerability to MPH for ≥2 weeks prior to screening.
Key exclusion criteria (17 listed)
- History of, or current, medical condition or laboratory result which, in the opinion of the investigator, unfavorably alters the risk-benefit of study participation, may jeopardize subject safety, or may interfere with the satisfactory completion of the study and study-related procedures.
- Serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other cardiac problems that may place the subject at increased vulnerability to the sympathomimetic effects of a stimulant drug.
- History of seizure disorder (except febrile seizures prior to age 5 and at least 1 year prior to study participation), Tourette's disorder, or intellectual disability of minor severity or greater (DSM5 criteria).
- History of psychosis, bipolar disorder, anorexia nervosa, bulimia, or suicide attempt. Current depression, anxiety, conduct/behavior disorder, substance use disorder, or other psychiatric condition which, in the investigator's opinion, may jeopardize subject safety or may interfere with the satisfactory completion of the study and study-related procedures.
- Active suicidal ideation as evidenced by an ideation score of 2 or greater on the C-SSRS.
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 (MPH) CapsulesAlso: methylphenidateHLD200 doses: 20, 40, 60, 80 or 100 mg | Drug | HLD200 (methylphenidate) |
| Placebo | Drug | Placebo |
Primary outcome
Swanson, Kotkin, Agler, M-Flynn and Pelham Combined Score (SKAMP CS) - Model-adjusted Average of All Post-dose Time Points Assessed During a Laboratory Classroom Test Day (Visit 9).
Time frame: 12-hours from 8:00 am to 8:00 pm
The SKAMP is a validated, 13-item, observer-rated scale designed to assess the level of impairment of classroom-observed behaviors (Wigal and Wigal, 2006). Items 1 through 4 assess subject attention; items 5 through 8 assess deportment; items 9 through 11 assess quality of work; while items 12 and 13 assess subject compliance with teacher/classroom rules. Each individual item is rated on a 7-point scale from 0 (normal, no impairment) to 6 (maximal impairment). When all individual item scores are summed together, they produce a 13-item combined score that ranges from 0 to 78, with higher scores signifying greater impairment. In the present study, the SKAMP rating scale was utilized across 9 sessions occuring at 8:00 am, 9:00 am, 10:00 am, 12:00 pm, 2:00 pm, 4:00 pm, 6:00 pm, 7:00 pm, and 8:00 pm of the laboratory classroom day. Successful training of qualified individuals on the SKAMP scale was required before raters were allowed to perform study assessments.
1 secondary outcome
Parent Rating of Evening and Morning Behavior Revised, Morning Subscale (PREMB-R AM).
Time frame: PREMB-R AM mean subscale score for the 2-days prior to Visit 9.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41342306Storebo OJ, Storm MRO, Pereira Ribeiro J, Skoog M, Groth C, Callesen HE, Schaug JP, Darling P, Huus CL, Zwi M, Kirubakaran R, Simonsen E, Gluud C. Methylphenidate for children and adolescents with attention deficit hyperactivity disorder (ADHD). Cochrane Database Syst Rev. 2025 Dec 4;12(12):CD009885. doi: 10.1002/14651858.CD009885.pub4.
- Derived from this study: PubMed 37770309Katzman MA, Otcheretko V, Po MD, Uchida CL, Incledon B. Adverse Events During Dosing of Delayed-release/Extended-release Methylphenidate: Learnings From the Open-label Phase of a Registration Trial and a Real-world Postmarketing Surveillance Program. Clin Ther. 2023 Dec;45(12):1212-1221. doi: 10.1016/j.clinthera.2023.09.009. Epub 2023 Sep 27.
- Derived from this study: PubMed 36971690Storebo OJ, Storm MRO, Pereira Ribeiro J, Skoog M, Groth C, Callesen HE, Schaug JP, Darling Rasmussen P, Huus CL, Zwi M, Kirubakaran R, Simonsen E, Gluud C. Methylphenidate for children and adolescents with attention deficit hyperactivity disorder (ADHD). Cochrane Database Syst Rev. 2023 Mar 27;3(3):CD009885. doi: 10.1002/14651858.CD009885.pub3.
- Derived from this study: PubMed 34166589Goldberg JF. Adjunctive Mood Stabilizers Are Not the Same as a Placebo-Only Arm in Bipolar Depression Trials: Reply to Terao. J Clin Psychiatry. 2021 Jun 22;82(4):21lr13919b. doi: 10.4088/JCP.21lr13919b. No abstract available.
- Derived from this study: PubMed 34166588Terao T. Antidepressant Effects of Combined Mood Stabilizers May Account for High Placebo Response Rates. J Clin Psychiatry. 2021 Jun 22;82(4):21lr13919. doi: 10.4088/JCP.21lr13919. No abstract available.
- Derived from this study: PubMed 34166587Childress AC, Cutler AJ, Po MD, DeSousa NJ, Warrington LE, Sallee FR, Incledon B. Symptomatic and Functional Response and Remission From the Open-Label Treatment-Optimization Phase of a Study With DR/ER-MPH in Children With ADHD. J Clin Psychiatry. 2021 Jun 22;82(4):21m13914. doi: 10.4088/JCP.21m13914.
- Derived from this study: PubMed 33168234Childress AC, Uchida CL, Po MD, DeSousa NJ, Incledon B. A Post Hoc Comparison of Prior ADHD Medication Dose and Optimized Delayed-release and Extended-release Methylphenidate Dose in a Pivotal Phase III Trial. Clin Ther. 2020 Dec;42(12):2332-2340. doi: 10.1016/j.clinthera.2020.10.004. Epub 2020 Nov 7.
- Derived from this study: PubMed 31464511Childress AC, Cutler AJ, Marraffino A, McDonnell MA, Turnbow JM, Brams M, DeSousa NJ, Incledon B, Sallee FR, Wigal SB. A Randomized, Double-Blind, Placebo-Controlled Study of HLD200, a Delayed-Release and Extended-Release Methylphenidate, in Children with Attention-Deficit/Hyperactivity Disorder: An Evaluation of Safety and Efficacy Throughout the Day and Across Settings. J Child Adolesc Psychopharmacol. 2020 Feb;30(1):2-14. doi: 10.1089/cap.2019.0070. Epub 2019 Aug 29.
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Conduct Disorder
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Recruiting
Micronutrient Supplementation and Chronotherapy in Children With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
ADHD
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.
7 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 HLD200 methylphenidate hydrochloride (MPH) Capsules in people with Attention Deficit Hyperactivity Disorder, run by Ironshore Pharmaceuticals and Development, Inc at 7 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 14 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 23 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 7 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. 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 3 Oct 2018). 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?
Swanson, Kotkin, Agler, M-Flynn and Pelham Combined Score (SKAMP CS) - Model-adjusted Average of All Post-dose Time Points Assessed During a Laboratory Classroom Test Day (Visit 9). (time frame: 12-hours from 8:00 am to 8:00 pm). 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 NCT02493777, which also lists 8 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 23 Jul 2021; AzTrials last refreshed its copy on 7 Nov 2026.