HLD100-103: A Study of Delayed and Extended Release Formulation of Dextroamphetamine Sulfate (HLD100) in Children With ADHD
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: HLD100 10mg HLD100 (dextroamphetamine sulfate) DR/ER capsules (10mg) |
Drug: HLD100
Treatment
Other Names:
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| Experimental: HLD100 20mg HLD100 (dextroamphetamine sulfate) DR/ER capsules (20mg) |
Drug: HLD100
Treatment
Other Names:
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| Experimental: HLD100 30mg HLD100 (dextroamphetamine sulfate) DR/ER capsules (30mg) |
Drug: HLD100
Treatment
Other Names:
|
| Experimental: HLD100 40mg HLD100 (dextroamphetamine sulfate) DR/ER capsules (40mg) |
Drug: HLD100
Treatment
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Dose Escalation to determine optimal dosage for clinical effects [6 weeks]
Primary outcome is the determination of the dose achieving optimal clinical effect in a safe and tolerable manner
Secondary Outcome Measures
- Safety (AEs, ECG, laboratory parameters, physical examinations) [48 hours]
Safety endpoints include treatment-emergent adverse events (TEAEs), vital signs, electrocardiogram (ECG) parameters, physical examination, and the C-SSRS.
Eligibility Criteria
Criteria
Inclusion Criteria:
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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).
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Subjects must demonstrate mild-to-moderate impairment of ADHD symptoms and function per the following at screening (V1) and/or baseline (V2):
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ADHD-RS-IV score at or above the 90th percentile normalized for sex and age in total score and ≥24 at Baseline;
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CGI-S score ≥4;
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Subject body weight must be ≥20 kg.
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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.
Exclusion Criteria:
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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.
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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.
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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).
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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.
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Active suicidal ideation as evidenced by an ideation score of 2 or greater on the C-SSRS.
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History of severe allergic reaction or intolerance to amphetamine.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Center for Psychiatry and Behavioral Medicine, Inc. | Las Vegas | Nevada | United States | 89128 |
Sponsors and Collaborators
- Ironshore Pharmaceuticals and Development, Inc
Investigators
- Principal Investigator: Ann Childress, MD, Center for Psychiatry & Behavoural Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HLD100-103