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

NCT03088267 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2019-07-22

Study results available
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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.

Conditions

  • Attention Deficit Hyperactivity Disorder

Interventions

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

Sponsors & Collaborators

  • Tris Pharma, Inc.

    lead INDUSTRY

Principal Investigators

  • Sally Berry, MD, PhD · Tris Pharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-11
Primary Completion
2017-02-25
Completion
2017-10-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03088267 on ClinicalTrials.gov