Attention Deficit Hyperactivity DisorderPhase 3NCT06431256
Efficacy, Safety & Pharmacokinetic (PK) Study of HLD200 in Children Aged 4-5 Years With ADHD
A Phase 3 study testing HLD200 methylphenidate hydrochloride capsules in people with Attention Deficit Hyperactivity Disorder, run by Ironshore Pharmaceuticals and Development, Inc at 13 sites in United States.
Trial summary
This study will evaluate the efficacy, safety and pharmacokinetics of HLD200 (20 mg and 40 mg) in children aged 4 to 5 years with ADHD. Read more about this study
- Who is it for?
- Ages 4 to 5 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- HLD200 methylphenidate hydrochloride capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 13 sitesUnited States
- Study dates
- 13 Sep 2024to 11 Jul 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The subject's assigned caregiver must be able to read, write, and/or understand at a level sufficient to provide informed consent and will provide this written consent (and subject will provide assent, if required by the IRB) before any study-specific activity is performed.
- Subjects must be male or female children 4 to 5 years of age at the time of consent and assent (if applicable).
- Subjects must have a diagnosis of ADHD as defined by the DSM-5 criteria with confirmation using the Mini - International Neuropsychiatric Interview for Children and Adolescents (MINI KID).
- All subjects must have an ADHD-RS-IV Preschool Version Parent Total Score of ≥28 for boys or ≥24 for girls at Baseline (Visit 2). In addition, subjects not receiving pharmacotherapy for ADHD at time of consent must have an ADHD-RS-IV Preschool Version Parent Total Score of ≥28 for boys or ≥24 for girls at Screening; if the ADHD-RS-IV total score at Screening differs from the score at Baseline (Visit 2) by greater than 20% for these subjects (i.e., subjects who are not receiving ADHD pharmacotherapy at time of consent), the Investigator must investigate the reasons for the difference in score and determine whether the subject is an appropriate candidate to participate in the study.
- Subjects not receiving pharmacotherapy for ADHD at time of consent must have a Clinical Global Impression - Severity (CGI-S) score ≥4 at Screening. All subjects must have a CGI-S score of ≥4 at Baseline (Visit 2).
- Subjects must have a Peabody Picture Vocabulary Test 4 (PPVT-4) Standard Score ≥70 at Screening.
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- Subject has undergone an adequate course of nonpharmacologic treatment or has a severe enough condition in the opinion of the Investigator to consider enrollment without undergoing prior nonpharmacological treatment.
- Subject's weight at Screening is between the 5th and 95th percentiles and subject's height at Screening is ≥ 5th percentile according to the Centers for Disease Control and Prevention growth charts by age and sex.
- Subject must have a resting pulse less than 127 bpm, systolic and diastolic blood pressure below the 95th percentile for age, gender and height according to the 2017 American Academy of Pediatrics guidelines, based on the average of 3 measurements 2 to 5 minutes apart at Visit 1 and Visit 2 (only a single measurement is required at Visit 2 unless an elevated excursion is noted which requires the averaged value of triplicate measurements). If a subject's height is above the 95th percentile, the subject must meet the systolic and diastolic blood pressure criteria for the 95th percentile height.
- Subject must be considered clinically appropriate for treatment with HLD200.
- Subject must be in general good health based upon medical history, physical examination, clinical laboratory examinations, vital signs, and 12-lead electrocardiogram (ECG).
- Subject and the subject's assigned caregiver are willing and able to participate in all study assessments and procedures, as applicable, and to follow all study requirements (including compliance with study drug), as described in the informed consent form.
Who cannot join
- History of, or current, medical or psychiatric condition, including gastrointestinal disorders (e.g., surgery, malabsorption syndrome, and other similar conditions), open-angle glaucoma, abnormally increased intraocular pressure (IOP), or laboratory result that, 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, severe hypertension, untreated thyroid disease, peripheral vasculopathy, known structural cardiac disorders, serious cardiac conditions, serious arrhythmias, known family history of sudden death, or other cardiac problems that may place the subject at increased vulnerability to the sympathomimetic effects of a stimulant drug.
- History of, or current, seizure disorder (except febrile seizures prior to age 4 and with last occurrence at least 1 year prior to study participation) or intellectual disability of mild severity or greater (DSM-5 criteria).
- Past or current diagnosis of psychosis, bipolar I or II disorder, major depressive disorder, eating disorder, conduct disorder, obsessive-compulsive disorder, autism spectrum disorder, Tourette's Syndrome or other tic disorders, disruptive mood dysregulation disorder, or confirmed genetic disorder with cognitive and/or behavioral disturbances. Subjects with oppositional defiant disorder (ODD) or anxiety disorder (e.g., separation anxiety disorder simple phobia disorder) are permitted to enroll in the study provided these diagnoses are not the primary focus of treatment, and, in the opinion of the Investigator, are not anticipated to interfere with study assessments or procedures.
- Subject is currently considered at risk of suicide in the opinion of the Investigator, or has previously made a suicide attempt, or has a history of, or is currently demonstrating active suicidal ideation or behavior, as determined by the C-SSRS at Screening and/or Baseline (Visit 2).
- History of severe allergic reaction or intolerance to methylphenidate hydrochloride (MPH).
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- Alanine aminotransferase, aspartate aminotransferase, total bilirubin, or creatinine greater than 1.5 times the upper limit of normal. Elevated bilirubin due to Gilbert's syndrome is not exclusionary.
- Use of ADHD stimulant medication within 72 hours (3 days) prior to Baseline (Visit 2); clonidine and guanfacine within 5 days prior to Baseline (Visit 2); psychotropic medications, including antidepressants (including MAOIs), mood stabilizers, and antipsychotics, within 14 days prior to Baseline (Visit 2); other prescription medications (including atomoxetine, excluding allowed medications) within 7 days prior to Baseline (Visit 2); and nonprescription/over-the-counter medications (excluding allowed medications) or herbal medications within the 3 days prior to Baseline (Visit 2). Medications not covered in allowed medications or prohibited medications must be cleared by the Medical Monitor prior to randomizing the subject.
- Participation in a clinical trial with an investigational drug within the 30 days prior to Baseline (Visit 2).
- Initiation of non-pharmacological treatment within 30 days prior to Baseline (Visit 2) or expected to initiate new non-pharmacological treatment during the study.
- Use of any other medications that might confound the results of the study or increase risk to the subject.
- In the opinion of the Investigator, the subject is well-controlled on his/her current ADHD medication with acceptable tolerability.
- Subject has a sibling or step-sibling that is concurrently participating in this study or who has previously participated in this study.
- Subject or caregiver is a participating Investigator, Sub-investigator, study coordinator, or employee of a participating Investigator, or is an immediate family member of the aforementioned.
- Any factor, which in the opinion of the Investigator would jeopardize the evaluation or safety or be associated with poor adherence to the protocol.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Advanced Research Center, Inc.
Anaheim, California, 92805
University of Cincinnati Health
Cincinnati, Ohio, 45219
CenExel iResearch, LLC
Decatur, Georgia, 30030
Harmonex, Inc.
Dothan, Alabama, 36303
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32256
Vector Clinical Trials
Las Vegas, Nevada, 89128
Alivation Research, LLC
Lincoln, Nebraska, 68526
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, 38119
South Florida Research
Miami Springs, Florida, 33166
DelRicht Research
New Orleans, Louisiana, 70115
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32801
Midwest Research Group
Saint Charles, Missouri, 63304
Coastal Pediatric Research
Summerville, South Carolina, 29486
About this study
Official title: Phase 3, Multicenter, 3-Week Fixed-dose, Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy, Safety and PK Study of Evening Dosed Methylphenidate Hydrochloride ER Capsules (HLD200) in Children Aged 4-5 Years With ADHD
This study will evaluate the efficacy, safety and pharmacokinetics of HLD200 (20 mg and 40 mg) in children aged 4 to 5 years with ADHD.
Read the detailed description
This is a multicenter, 3 week fixed dose, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy, safety and pharmacokinetics of HLD200 (20 mg and 40 mg) in children aged 4 to 5 years with ADHD.
Participants will be screened for eligibility for up to 4 weeks. Eligible participants will be treated with study medication for 3 weeks followed by a 2 week safety follow-up following the end of study treatment. The total duration of the study is up to 9 weeks. A single pharmacokinetic (PK) sample will be taken from each participant, in a prespecified PK sampling window at visit 5, for population PK analysis.
A total of 168 participants (56 per treatment arm) will be randomized at Visit 2.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- HLD200 methylphenidate hydrochloride capsules, Placebo HLD200 capsules
- 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 capsulesDrug
Also called methylphenidate
Doses: 20mg capsules
Placebo HLD200 capsulesDrug
Also called placebo
Doses: 20mg capsules
| Study group | Role | What they receive |
|---|---|---|
| Placebo Comparator | Placebo comparator | Matching placebo to HLD200 20 mg capsule (×2) for 3 weeks (prescribed at Visits 2, 3, and 4) Receives: Drug: Placebo HLD200 capsules |
| HLD200 20 mg | Experimental | HLD200 20 mg placebo capsule (×1) and HLD200 20 mg active capsule (×1) for 3 weeks (prescribed at Visits 2, 3, and 4) Receives: Drug: HLD200 methylphenidate hydrochloride capsules |
| HLD200 40 mg | Experimental | HLD200 20 mg placebo capsule (×1) and HLD200 20 mg active capsule (×1) for the first week (prescribed at Visit 2), with up-titration for the final 2 weeks to HLD200 20 mg active capsules (×2) (prescribed at Visits 3 and 4) Receives: Drug: HLD200 methylphenidate hydrochloride capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ADHD Rating Scale-IV (ADHD RS IV) Preschool Version
The ADHD RS-IV Preschool Version measures the behaviors of children with ADHD and provides examples appropriate for the developmental level of preschool children. It is an 18-item questionnaire that requires the respondent to rate the frequency of occurrence of ADHD symptoms (as defined by DSM-IV-TR criteria) using a 4-point scale from 0 (rarely or never) to 3 (very often), with the total score ranging from 0 to 54; a decrease in score indicates an improvement in ADHD symptomology.
Measured: Day 1 (Baseline), Day 8, Day 15, Day 22
Secondary outcomes (7)
Change in Clinical Global Impression - Severity (CGI-S)
The investigator, or qualified designee, will rate the severity of a subject's condition on a 7-point scale ranging from 1 (normal) to 7 (among the most extremely ill subjects).
Measured: Day 1 (Baseline), Day 8, Day 15, Day 22
PK parameter: area under the plasma concentration-time curve (AUC) at steady-state (AUCss)
The PK of MPH will be determined using a single plasma sample collected at the end of treatment (Visit 5). Subjects will be randomly assigned to 1 of 4 PK sampling time points (11 hours, 14 hours, 18 hours, or 24 hours post-dose) for this single sample collection at Visit 5. The AUCss will be calculated based on the population PK model's individual predicted concentrations.
Measured: Day 22
PK parameter: maximum plasma concentration (Cmax)
The PK of MPH will be determined using a single plasma sample collected at the end of treatment (Visit 5). Subjects will be randomly assigned to 1 of 4 PK sampling time points (11 hours, 14 hours, 18 hours, or 24 hours post-dose) for this single sample collection at Visit 5. The Cmax will be calculated based on the population PK model's individual predicted concentrations.
Measured: Day 22
PK parameter: time to maximum plasma concentration (Tmax)
The PK of MPH will be determined using a single plasma sample collected at the end of treatment (Visit 5). Subjects will be randomly assigned to 1 of 4 PK sampling time points (11 hours, 14 hours, 18 hours, or 24 hours post-dose) for this single sample collection at Visit 5. The Tmax will be calculated based on the population PK model's individual predicted concentrations.
Measured: Day 22
PK parameter: terminal elimination rate constant (λz)
The PK of MPH will be determined using a single plasma sample collected at the end of treatment (Visit 5). Subjects will be randomly assigned to 1 of 4 PK sampling time points (11 hours, 14 hours, 18 hours, or 24 hours post-dose) for this single sample collection at Visit 5. The λz will be calculated based on the population PK model's individual predicted concentrations.
Measured: Day 22
PK terminal elimination half-life (t1/2)
The PK of MPH will be determined using a single plasma sample collected at the end of treatment (Visit 5). Subjects will be randomly assigned to 1 of 4 PK sampling time points (11 hours, 14 hours, 18 hours, or 24 hours post-dose) for this single sample collection at Visit 5. The t1/2 will be calculated based on the population PK model's individual predicted concentrations.
Measured: Day 22
treatment-emergent adverse events (TEAEs)
A TEAE is any newly occurring adverse event since the initiation of study drug treatment or any adverse event already present at the initiation of study drug treatment that worsens in either intensity or frequency during or after exposure to study drug treatment.
Any clinically significant abnormal changes to ECG assessments, vital signs, clinical lab results, physical examinations, or sleep disturbance, or any suicidality during the trial, will be recorded as adverse events (unless they are signs/symptoms of a diagnosis already recorded as an AE).
Measured: Up to 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study start13 Sep 2024
- Primary completion11 Jul 2025
- Study completion11 Jul 2025
Why it stopped: FDA release from this PMR study due to their required class-labeling, with a limitation of use for all ER stimulants in pediatric patients under 6 years of age, based on results from studies with other ER stimulants in this age group.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ironshore Pharmaceuticals and Development, Inc
- Sponsor type
- University, hospital or other
- Collaborators
- Collegium Pharmaceutical, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06431256
- Sponsor's protocol ID
- HLD200-112
- Status last verified
- Nov 2025
- First submitted
- 22 May 2024
- Last updated
- 6 Nov 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3, Multicenter, 3-Week Fixed-dose, Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy, Safety and PK Study of Evening Dosed Methylphenidate Hydrochloride ER Capsules (HLD200) in Children Aged 4-5 Years With ADHD
- ClinicalTrials.gov ID
- NCT06431256
- Acronym / sponsor ID
- HLD200-112
- Conditions
- Attention Deficit Hyperactivity Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: FDA release from this PMR study due to their required class-labeling, with a limitation of use for all ER stimulants in pediatric patients under 6 years of age, based on results from studies with other ER stimulants in this age group.
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Ironshore Pharmaceuticals and Development, IncUniversity, hospital or other
- Collaborators
- Collegium Pharmaceutical, Inc.
- Study start
- 13 Sep 2024 (actual)
- Primary completion
- 11 Jul 2025 (actual)
- Study completion
- 11 Jul 2025 (actual)
- First posted
- 28 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the efficacy, safety and pharmacokinetics of HLD200 (20 mg and 40 mg) in children aged 4 to 5 years with ADHD.
Detailed description
This is a multicenter, 3 week fixed dose, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy, safety and pharmacokinetics of HLD200 (20 mg and 40 mg) in children aged 4 to 5 years with ADHD.
Participants will be screened for eligibility for up to 4 weeks. Eligible participants will be treated with study medication for 3 weeks followed by a 2 week safety follow-up following the end of study treatment. The total duration of the study is up to 9 weeks. A single pharmacokinetic (PK) sample will be taken from each participant, in a prespecified PK sampling window at visit 5, for population PK analysis.
A total of 168 participants (56 per treatment arm) will be randomized at Visit 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo Comparator | Placebo comparator | Drug: Placebo HLD200 capsulesMatching placebo to HLD200 20 mg capsule (×2) for 3 weeks (prescribed at Visits 2, 3, and 4) |
| HLD200 20 mg | Experimental | Drug: HLD200 methylphenidate hydrochloride capsulesHLD200 20 mg placebo capsule (×1) and HLD200 20 mg active capsule (×1) for 3 weeks (prescribed at Visits 2, 3, and 4) |
| HLD200 40 mg | Experimental | Drug: HLD200 methylphenidate hydrochloride capsulesHLD200 20 mg placebo capsule (×1) and HLD200 20 mg active capsule (×1) for the first week (prescribed at Visit 2), with up-titration for the final 2 weeks to HLD200 20 mg active capsules (×2) (prescribed at Visits 3 and 4) |
Who may qualify
- Ages
- 4 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- The subject's assigned caregiver must be able to read, write, and/or understand at a level sufficient to provide informed consent and will provide this written consent (and subject will provide assent, if required by the IRB) before any study-specific activity is performed.
- Subjects must be male or female children 4 to 5 years of age at the time of consent and assent (if applicable).
- Subjects must have a diagnosis of ADHD as defined by the DSM-5 criteria with confirmation using the Mini - International Neuropsychiatric Interview for Children and Adolescents (MINI KID).
- All subjects must have an ADHD-RS-IV Preschool Version Parent Total Score of ≥28 for boys or ≥24 for girls at Baseline (Visit 2). In addition, subjects not receiving pharmacotherapy for ADHD at time of consent must have an ADHD-RS-IV Preschool Version Parent Total Score of ≥28 for boys or ≥24 for girls at Screening; if the ADHD-RS-IV total score at Screening differs from the score at Baseline (Visit 2) by greater than 20% for these subjects (i.e., subjects who are not receiving ADHD pharmacotherapy at time of consent), the Investigator must investigate the reasons for the difference in score and determine whether the subject is an appropriate candidate to participate in the study.
- Subjects not receiving pharmacotherapy for ADHD at time of consent must have a Clinical Global Impression - Severity (CGI-S) score ≥4 at Screening. All subjects must have a CGI-S score of ≥4 at Baseline (Visit 2).
Key exclusion criteria (15 listed)
- History of, or current, medical or psychiatric condition, including gastrointestinal disorders (e.g., surgery, malabsorption syndrome, and other similar conditions), open-angle glaucoma, abnormally increased intraocular pressure (IOP), or laboratory result that, 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, severe hypertension, untreated thyroid disease, peripheral vasculopathy, known structural cardiac disorders, serious cardiac conditions, serious arrhythmias, known family history of sudden death, or other cardiac problems that may place the subject at increased vulnerability to the sympathomimetic effects of a stimulant drug.
- History of, or current, seizure disorder (except febrile seizures prior to age 4 and with last occurrence at least 1 year prior to study participation) or intellectual disability of mild severity or greater (DSM-5 criteria).
- Past or current diagnosis of psychosis, bipolar I or II disorder, major depressive disorder, eating disorder, conduct disorder, obsessive-compulsive disorder, autism spectrum disorder, Tourette's Syndrome or other tic disorders, disruptive mood dysregulation disorder, or confirmed genetic disorder with cognitive and/or behavioral disturbances. Subjects with oppositional defiant disorder (ODD) or anxiety disorder (e.g., separation anxiety disorder simple phobia disorder) are permitted to enroll in the study provided these diagnoses are not the primary focus of treatment, and, in the opinion of the Investigator, are not anticipated to interfere with study assessments or procedures.
- Subject is currently considered at risk of suicide in the opinion of the Investigator, or has previously made a suicide attempt, or has a history of, or is currently demonstrating active suicidal ideation or behavior, as determined by the C-SSRS at Screening and/or Baseline (Visit 2).
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 capsulesAlso: methylphenidateDoses: 20mg capsules | Drug | HLD200 20 mg, HLD200 40 mg |
| Placebo HLD200 capsulesAlso: placeboDoses: 20mg capsules | Drug | Placebo Comparator |
Primary outcome
Change in ADHD Rating Scale-IV (ADHD RS IV) Preschool Version
Time frame: Day 1 (Baseline), Day 8, Day 15, Day 22
The ADHD RS-IV Preschool Version measures the behaviors of children with ADHD and provides examples appropriate for the developmental level of preschool children. It is an 18-item questionnaire that requires the respondent to rate the frequency of occurrence of ADHD symptoms (as defined by DSM-IV-TR criteria) using a 4-point scale from 0 (rarely or never) to 3 (very often), with the total score ranging from 0 to 54; a decrease in score indicates an improvement in ADHD symptomology.
7 secondary outcomes
Change in Clinical Global Impression - Severity (CGI-S)
Time frame: Day 1 (Baseline), Day 8, Day 15, Day 22
PK parameter: area under the plasma concentration-time curve (AUC) at steady-state (AUCss)
Time frame: Day 22
PK parameter: maximum plasma concentration (Cmax)
Time frame: Day 22
PK parameter: time to maximum plasma concentration (Tmax)
Time frame: Day 22
PK parameter: terminal elimination rate constant (λz)
Time frame: Day 22
PK terminal elimination half-life (t1/2)
Time frame: Day 22
treatment-emergent adverse events (TEAEs)
Time frame: Up to 5 weeks
Results and safety
The study was stopped early (reason given: FDA release from this PMR study due to their required class-labeling, with a limitation of use for all ER stimulants in pediatric patients under 6 years of age, based on results from studies with other ER stimulants in this age group.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2025.
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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.
13 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 capsules in people with Attention Deficit Hyperactivity Disorder, run by Ironshore Pharmaceuticals and Development, Inc at 13 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 15 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 6 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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?
The study was stopped early (reason given: FDA release from this PMR study due to their required class-labeling, with a limitation of use for all ER stimulants in pediatric patients under 6 years of age, based on results from studies with other ER stimulants in this age group.). Results are not available in the source record.
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?
Change in ADHD Rating Scale-IV (ADHD RS IV) Preschool Version (time frame: Day 1 (Baseline), Day 8, Day 15, Day 22). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2025.