Attention-Deficit Hyperactivity Disorder (ADHD)Phase 2HLD100-103NCT02884544
A Study of Delayed and Extended Release Formulation of Dextroamphetamine Sulfate (HLD100) in Children With ADHD
A Phase 2 study testing HLD100 in people with Attention-Deficit Hyperactivity Disorder (ADHD), run by Ironshore Pharmaceuticals and Development, Inc at 1 site in United States.
Trial summary
The phase 2 study will evaluate the safety, tolerability and efficacy of HLD100 at steady state (following up to 5 weeks of treatment) in children using an outpatient, single-center, open-label, flexible dose-escalation study design. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Attention-Deficit Hyperactivity Disorder (ADHD)
- What is being tested?
- HLD100
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to 27 Dec 2016
- Phase
- Phase 2
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subjects must have a diagnosis of ADHD as defined by DSM-5 criteria with confirmation using the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID).
- Subjects must demonstrate mild-to-moderate impairment of ADHD symptoms and function per the following at screening (V1) and/or baseline (V2):
- ADHD-RS-IV score at or above the 90th percentile normalized for sex and age in total score and ≥24 at Baseline;
- CGI-S score ≥4;
- Subject body weight must be ≥20 kg.
- Subject must be considered clinically appropriate for treatment with amphetamine and HLD100, including prior treatment experience with an amphetamine product, and ability to swallow treatment capsules.
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 with last occurrence at least 1 year prior to study participation), Tourette's disorder, or intellectual disability of minor severity or greater (DSM-5 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 or intolerance to amphetamine.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Psychiatry and Behavioral Medicine, Inc.
Las Vegas, Nevada, 89128
About this study
Official title: Phase II, Open-label, Dose-titration, Safety Study Designed to Determine the Evening Dose of a Novel Delayed and Extended Release Formulation of Dextroamphetamine Sulfate (HLD100) to Produce Optimal Clinical Effects in Children With ADHD
The phase 2 study will evaluate the safety, tolerability and efficacy of HLD100 at steady state (following up to 5 weeks of treatment) in children using an outpatient, single-center, open-label, flexible dose-escalation study design.
Read the detailed description
This dose-escalation study will examine HLD100 in 24 subjects.
The subjects (n=24) will be tested with HLD100 in ascending doses from 10mg up to 40mg.
This study will be divided into several phases: Screening, Active Treatment and Follow-Up. All visits have a 2 day window to allow for scheduling.
- Being tested
- HLD100
- 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.
HLD100Drug
Also called Dextroamphetamine sulfate, delayed release/extended release
Treatment
| Study group | Role | What they receive |
|---|---|---|
| HLD100 10mg | Experimental | HLD100 (dextroamphetamine sulfate) DR/ER capsules (10mg) Receives: Drug: HLD100 |
| HLD100 20mg | Experimental | HLD100 (dextroamphetamine sulfate) DR/ER capsules (20mg) Receives: Drug: HLD100 |
| HLD100 30mg | Experimental | HLD100 (dextroamphetamine sulfate) DR/ER capsules (30mg) Receives: Drug: HLD100 |
| HLD100 40mg | Experimental | HLD100 (dextroamphetamine sulfate) DR/ER capsules (40mg) Receives: Drug: HLD100 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Escalation to determine optimal dosage for clinical effects
Primary outcome is the determination of the dose achieving optimal clinical effect in a safe and tolerable manner
Measured: 6 weeks
Secondary outcomes (1)
Safety (AEs, ECG, laboratory parameters, physical examinations)
Safety endpoints include treatment-emergent adverse events (TEAEs), vital signs, electrocardiogram (ECG) parameters, physical examination, and the C-SSRS.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2016 (estimated)
- Study startAug 2016
- Primary completion18 Dec 2016
- Study completion27 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention-Deficit Hyperactivity Disorder (ADHD)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 22 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 & Behavoural Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02884544
- Sponsor's protocol ID
- HLD100-103
- Acronym
- HLD100-103
- Status last verified
- Jul 2021
- First submitted
- 28 Jul 2016
- Last updated
- 19 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
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
- Phase II, Open-label, Dose-titration, Safety Study Designed to Determine the Evening Dose of a Novel Delayed and Extended Release Formulation of Dextroamphetamine Sulfate (HLD100) to Produce Optimal Clinical Effects in Children With ADHD
- ClinicalTrials.gov ID
- NCT02884544
- Acronym / sponsor ID
- HLD100-103 / HLD100-103
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Ironshore Pharmaceuticals and Development, IncUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- 18 Dec 2016 (actual)
- Study completion
- 27 Dec 2016 (actual)
- First posted
- 31 Aug 2016 (estimated)
- 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.
The phase 2 study will evaluate the safety, tolerability and efficacy of HLD100 at steady state (following up to 5 weeks of treatment) in children using an outpatient, single-center, open-label, flexible dose-escalation study design.
Detailed description
This dose-escalation study will examine HLD100 in 24 subjects.
The subjects (n=24) will be tested with HLD100 in ascending doses from 10mg up to 40mg.
This study will be divided into several phases: Screening, Active Treatment and Follow-Up. All visits have a 2 day window to allow for scheduling.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HLD100 10mg | Experimental | Drug: HLD100HLD100 (dextroamphetamine sulfate) DR/ER capsules (10mg) |
| HLD100 20mg | Experimental | Drug: HLD100HLD100 (dextroamphetamine sulfate) DR/ER capsules (20mg) |
| HLD100 30mg | Experimental | Drug: HLD100HLD100 (dextroamphetamine sulfate) DR/ER capsules (30mg) |
| HLD100 40mg | Experimental | Drug: HLD100HLD100 (dextroamphetamine sulfate) DR/ER capsules (40mg) |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Subjects must have a diagnosis of ADHD as defined by DSM-5 criteria with confirmation using the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID).
- Subjects must demonstrate mild-to-moderate impairment of ADHD symptoms and function per the following at screening (V1) and/or baseline (V2):
- Subject body weight must be ≥20 kg.
- Subject must be considered clinically appropriate for treatment with amphetamine and HLD100, including prior treatment experience with an amphetamine product, and ability to swallow treatment capsules.
Key exclusion criteria (6 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 with last occurrence at least 1 year prior to study participation), Tourette's disorder, or intellectual disability of minor severity or greater (DSM-5 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 |
|---|---|---|
| HLD100Also: Dextroamphetamine sulfate, delayed release/extended releaseTreatment | Drug | HLD100 10mg, HLD100 20mg, HLD100 30mg, HLD100 40mg |
Primary outcome
Dose Escalation to determine optimal dosage for clinical effects
Time frame: 6 weeks
Primary outcome is the determination of the dose achieving optimal clinical effect in a safe and tolerable manner
1 secondary outcome
Safety (AEs, ECG, laboratory parameters, physical examinations)
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2021.
- Individual participant dataSharing planned: No
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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 & Behavoural Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HLD100 in people with Attention-Deficit Hyperactivity Disorder (ADHD), run by Ironshore Pharmaceuticals and Development, Inc at 1 site 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 6 inclusion and 6 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 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 phase mean?
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Dose Escalation to determine optimal dosage for clinical effects (time frame: 6 weeks). 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 19 Jul 2021.