Attention Deficit Hyperactivity DisorderPhase 3CEESNCT02255513
A Trial Evaluating the Efficacy and Safety of HLD200 in Children With ADHD
A Phase 3 study testing HLD200 in people with Attention Deficit Hyperactivity Disorder, run by Ironshore Pharmaceuticals and Development, Inc at 4 sites in United States.
Trial summary
This study will examine the efficacy and safety of HLD200 in patients age 6-12 years with ADHD using a classroom 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
- What is being tested?
- HLD200
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 4 sitesUnited States
- Study dates
- May 2014to Oct 2014
- 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
- Male and female children (6-12 years at study entry)
- Previous diagnosis of ADHD and confirmation using the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID)
- 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)
- Female subjects of childbearing potential (i.e., post-menarche) required to have a negative result on urine pregnancy test (and will be given specific instructions for 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
- Presence of any significant physical or organ abnormality
- Any illness during the 4 weeks before this study
- Comorbid psychiatric diagnosis that may affect subject safety or confound results (e.g., psychosis, bipolar disorder)
- Known history of severe asthma (in the opinion of the investigator) unless deemed currently controlled
- Known history of severe allergic reaction to MPH
Show all 14Show 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 (in the opinion of the Investigator)
- Any clinical laboratory value outside of the acceptable ranges, unless deemed NCS significant per the Investigator
- Positive history for hepatitis B, hepatitis C or 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 or Medical Monitor
- Participation in clinical trial with an investigational drug within the 30 days preceding study enrollment
- Current suicidal ideation or history of suicidality determined as a significant finding on the C-SSRS by the investigator (Baseline C-SSRS for adolescents; Pediatric Baseline C-SSRS for children).
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Duke University Medical Center
Durham, North Carolina, 27705
Center for Psychiatry and Behavioral Medicine, Inc.
Las Vegas, Nevada, 89128
South Shore Psychiatric Services, PC
Marshfield, Massachusetts, 02050
AVIDA, Inc.
Newport Beach, California, 92660
About this study
Official title: A Phase III Clinical Endpoint Evaluation Study Examining the Safety and Efficacy of HLD200 in Pediatric Subjects With Attention-Deficit Hyperactivity Disorder.
This study will examine the efficacy and safety of HLD200 in patients age 6-12 years with ADHD using a classroom study design.
Read the detailed description
The study consists of two distinct treatment phases. The first is the 6-week open-label, treatment optimization phase during which subjects are titrated to an optimal daily dose of HLD200. Subjects are then randomized to receive either optimal HLD200 or matched placebo treatment for an additional week prior to final testing during a laboratory school day.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- HLD200, 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.
HLD200Drug
Also called methylphenidate hydrochloride (MPH)
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| HLD200 | Experimental | HLD200 (methylphenidate hydrochloride) 20, 40, 60, 80, or 100 mg capsules
Subjects were allowed to titrate to their optimal HLD200 dose during a 6 week open-label, treatment optimization phase before being randomized to continue their HLD200 treatment over an one week double-blind, placebo-controlled phase. HLD200 was administered orally, once daily each evening. Receives: Drug: HLD200 |
| Placebo | Placebo comparator | Placebo capsules (dose matched to HLD200 capsules)
Subjects were allowed to titrate to their optimal HLD200 dose during a 6 week open-label, treatment optimization phase before being randomized to receive placebo treatment over a one week double-blind, placebo-controlled phase. Treatments were administered orally, once daily each evening. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
SKAMP
Swanson, Kotkin, Agler, M-Flynn and Pelham (SKAMP) Combined Scores - Average of 8:00 am to 4:00 pm assessments from the laboratory school day.
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 6 sessions occurring at 8:00 am, 9:00 am, 10:00 am, 12:00 pm, 2:00 pm, 4:00 pm of the laboratory school day.
Measured: 8-hours from 8:00 am to 4:00 pm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2014 (estimated)
- Study startMay 2014
- Primary completionOct 2014
- Study completionOct 2014
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.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ironshore Pharmaceuticals and Development, Inc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. Ann Childress, M.D., Principal investigator, Center for Psychiatry And Behavioral Medicine Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02255513
- Sponsor's protocol ID
- HLD200-106
- Acronym
- CEES
- Status last verified
- Jan 2021
- First submitted
- 29 May 2014
- Last updated
- 30 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Clinical Endpoint Evaluation Study Examining the Safety and Efficacy of HLD200 in Pediatric Subjects With Attention-Deficit Hyperactivity Disorder.
- ClinicalTrials.gov ID
- NCT02255513
- Acronym / sponsor ID
- CEES / HLD200-106
- Conditions
- Attention Deficit Hyperactivity Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Ironshore Pharmaceuticals and Development, IncUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 2 Oct 2014 (estimated)
- Results
- Posted 10 Feb 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 will examine the efficacy and safety of HLD200 in patients age 6-12 years with ADHD using a classroom study design.
Detailed description
The study consists of two distinct treatment phases. The first is the 6-week open-label, treatment optimization phase during which subjects are titrated to an optimal daily dose of HLD200. Subjects are then randomized to receive either optimal HLD200 or matched placebo treatment for an additional week prior to final testing during a laboratory school day.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HLD200 | Experimental | Drug: HLD200HLD200 (methylphenidate hydrochloride) 20, 40, 60, 80, or 100 mg capsules Subjects were allowed to titrate to their optimal HLD200 dose during a 6 week open-label, treatment optimization phase before being randomized to continue their HLD200 treatment over an one week double-blind, placebo-controlled phase. HLD200 was administered orally, once daily each evening. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo capsules (dose matched to HLD200 capsules) Subjects were allowed to titrate to their optimal HLD200 dose during a 6 week open-label, treatment optimization phase before being randomized to receive placebo treatment over a one week double-blind, placebo-controlled phase. Treatments were administered orally, once daily each evening. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Male and female children (6-12 years at study entry)
- Previous diagnosis of ADHD and confirmation using the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID)
- 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)
Key exclusion criteria (14 listed)
- Any known history or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, ophthalmologic disease
- Presence of any significant physical or organ abnormality
- Any illness during the 4 weeks before this study
- Comorbid psychiatric diagnosis that may affect subject safety or confound results (e.g., psychosis, bipolar disorder)
- Known history of severe asthma (in the opinion of the investigator) unless deemed currently controlled
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 |
|---|---|---|
| HLD200Also: methylphenidate hydrochloride (MPH) | Drug | HLD200 |
| Placebo | Drug | Placebo |
Primary outcome
SKAMP
Time frame: 8-hours from 8:00 am to 4:00 pm
Swanson, Kotkin, Agler, M-Flynn and Pelham (SKAMP) Combined Scores - Average of 8:00 am to 4:00 pm assessments from the laboratory school day. 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 6 sessions occurring at 8:00 am, 9:00 am, 10:00 am, 12:00 pm, 2:00 pm, 4:00 pm of the laboratory school day.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Dr. Ann Childress, M.D. principal investigator
Center for Psychiatry And Behavioral Medicine Inc.
4 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 in people with Attention Deficit Hyperactivity Disorder, run by Ironshore Pharmaceuticals and Development, Inc at 4 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 6 inclusion and 14 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 30 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 10 Feb 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?
SKAMP (time frame: 8-hours from 8:00 am to 4:00 pm). 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 30 Jun 2021.