At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 18 enrolled
Drug / intervention
amphetamine extended-release oral suspension, 2.5 mg/mL +1 moredrug
Likely dose
amphetamine extended-release oral suspension, 2.5 mg/mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Dyanavel® XR Extended-Release Oral Suspension in the Treatment of Children Wit
In Brief
A Phase 3 clinical trial evaluating amphetamine extended-release oral suspension, 2.5 mg/mL and Placebo extended-release oral suspension for Attention Deficit Hyperactivity Disorder. Completed, enrolled 18 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAttention Deficit Hyperactivity Disorder
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartFeb 2017
Primary CompletionFeb 2017
First PostedMar 2017
Study CompletionOct 2017
TodayJul 2026
First PostedMar 23, 2017
Enrollment StartFeb 11, 2017
Primary CompletionFeb 25, 2017
Study CompletionOct 30, 2017
TodayJul 2, 2026
Enrollment to primary: 14 daysPosted 9.3 years ago
Interventions
amphetamine extended-release oral suspension, 2.5 mg/mLdrug
5 mL1 (5 mg), 7 mL (17.5 mg) or 8 mL (20 mg) PO
Placebo extended-release oral suspensiondrug
6, 7 or 8 mL PO