Evaluation of SPN-812 (Viloxazine Extended-release Capsule) in Preschool-age Children With ADHD

Conditions

• Attention-Deficit/Hyperactivity Disorder

Eligibility Criteria

Sex

ALL

Age

48 Months - 69 Months

Healthy Volunteers

Not accepted

Interventions

• 100mg SPN-812 — DRUG
  100mg SPN-812 will be administered once daily and compared to Placebo
• Placebo — DRUG
  Placebo will be administered once daily

Study Details

This study will evaluate the efficacy and safety of SPN-812 (viloxazine extended release) in children 4 to 5 years of age with ADHD.

Key Dates

Start date

Mar 19, 2024

Status verified

Feb 2026

Primary completion

Jun 30, 2026

Completion

Jun 30, 2026

Study Design

Enrollment

286 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Placebo
  Placebo, qd
• Experimental: SPN-812
  SPN-812, qd

Primary Outcome Measure

Change from Baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale, 4th Edition, Preschool Version (ADHD-RS-IV-P) Total Score at End of Study (Week 6) [ Time Frame: Baseline and Week 6 ]

Central Contacts

• Joseph T Hull, PhD
  240-403-5324
  [email protected]
• Leslie Brijbasi
  301-838-2519
  [email protected]

Locations (47)

Find similar trials in Saraland, AL

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