NCT03088267

Dyanavel® XR Extended-Release Oral Suspension in the Treatment of Children With ADHD: A Laboratory School Study

Dyanavel® XR Extended-Release Oral Suspension in the Treatment of Children Wit

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Tris Pharma, Inc. · Industry
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

This study was conducted to assess the efficacy and safety of DYANAVEL XR (amphetamine extended-release oral suspension, CII) for the treatment of symptoms of attention-deficit/hyperactivity disorder (ADHD) in children aged 6-12 years.

Detailed description

This is a randomized, double-blind, two treatment, two sequence, placebo-controlled crossover study to assess the efficacy and safety of dose Dyanavel XR in reducing signs and symptoms of ADHD compared with placebo in pediatric subjects ages 6 to 12 years with ADHD.

Conditions

• Attention Deficit Hyperactivity Disorder

Interventions

Type	Name	Description
DRUG	amphetamine extended-release oral suspension, 2.5 mg/mL	5 mL1 (5 mg), 7 mL (17.5 mg) or 8 mL (20 mg) PO
DRUG	Placebo extended-release oral suspension	6, 7 or 8 mL PO

Timeline

• Start date: 2017-02-11
• Primary completion: 2017-02-25
• Completion: 2017-10-30
• First posted: 2017-03-23
• Last updated: 2019-07-22
• Results posted: 2019-07-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study