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TerminatedNCT06431256

Efficacy, Safety & Pharmacokinetic (PK) Study of HLD200 in Children Aged 4-5 Years With ADHD

Medication studyAges 4–5United States
The study in practice

Understand this study

Who could participate?

Listed age limits: 4 years to 5 years.

Listed locations
Dothan, United States · Anaheim, United States and 11 more locationsSee all locations and recruitment
Activities
Medication described in the protocol · Placebo comparator
Compensation
Payment and expense reimbursement have not been verified.

What to know before participating

A point to clarify

This summary does not cover all risks or eligibility requirements. What risks or changes to my care would apply to me?

Study clarity

Things to check before joining

Study start dateStarted: September 13, 2024
Recruitment status
Terminated
Enrollment listed in the registry
26
Sponsor
Ironshore Pharmaceuticals and Development, Inc
Sponsor type
Other organization
Study type
Drug
Intervention type
Medication / drug
Study phase
Phase 3Usually a larger study designed to confirm effectiveness and safety in a broader group.
Locations
United States
Age range
From 4 Years to 5 Years
Official registry ID
NCT06431256
Official title
Show the full 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

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Recruitment & locations

Terminated

Dothan · Anaheim · Jacksonville

10 more locations
  • Miami Springs
  • Orlando
  • Decatur
  • New Orleans
  • Saint Charles
  • Lincoln
  • Las Vegas
  • Cincinnati
  • Summerville
  • Memphis

A listed location does not confirm current availability.

FAQ

Questions about this study

Who is behind this study?

The study sponsor is Ironshore Pharmaceuticals and Development, Inc.

Does this study involve medication?

Yes. The study involves medication, including HLD200 methylphenidate hydrochloride capsules and Placebo HLD200 capsules.

Who can participate?

Listed age limits: 4 years to 5 years.

Is this study still recruiting?

The registry lists this study as terminated.

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