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Stimulant
Evening Dosed Methylphenidate for ADHD
Phase 3
Recruiting
Research Sponsored by Ironshore Pharmaceuticals and Development, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 weeks
Awards & highlights
Pivotal Trial
Summary
This trial will test how well a new medication called HLD200 (at doses of 20 mg and 40 mg) works, if it is safe, and how the body processes it in children
Who is the study for?
This trial is for children aged 4-5 with ADHD, who have a vocabulary score within the normal range and meet specific criteria for ADHD severity. They must be in good health, with normal heart rate and blood pressure, and not undergoing other treatments that could interfere. Parents or guardians must consent to the study's duration.
What is being tested?
The trial tests HLD200 methylphenidate hydrochloride capsules (20 mg & 40 mg) against placebo capsules to assess their effectiveness, safety, and how the body processes them in young children with ADHD when taken in the evening.
What are the potential side effects?
Potential side effects of HLD200 may include sleep problems, decreased appetite, stomach pain, nausea, increased heart rate/blood pressure. These are common side effects of stimulant medications used for treating ADHD.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My child is between 4 and 5 years old.
Select...
I have been diagnosed with ADHD according to DSM-5 and confirmed by MINI KID.
Select...
I have ADHD with symptoms that need treatment, confirmed by specific test scores.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Primary Efficacy Endpoint
Secondary study objectives
Secondary Efficacy Endpoint
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: HLD200 40 mgExperimental Treatment1 Intervention
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)
Group II: HLD200 20 mgExperimental Treatment1 Intervention
HLD200 20 mg placebo capsule (×1) and HLD200 20 mg active capsule (×1) for 3 weeks (prescribed at Visits 2, 3, and 4)
Group III: Placebo ComparatorPlacebo Group1 Intervention
Matching placebo to HLD200 20 mg capsule (×2) for 3 weeks (prescribed at Visits 2, 3, and 4)
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Who is running the clinical trial?
Ironshore Pharmaceuticals and Development, IncLead Sponsor
6 Previous Clinical Trials
404 Total Patients Enrolled
6 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
404 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Collegium Pharmaceutical, Inc.Industry Sponsor
2 Previous Clinical Trials
751 Total Patients Enrolled