At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 161 enrolled
Drug / intervention
SPN-812drug
Likely dose
Not stated in 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.
A Phase IV, Open-Label, Decentralized Clinical Trial to Evaluate the Efficacy and Safety of Qelbree® in Adults With Attention-Deficit/Hyperactivity Disorder and Mood Symptoms
In Brief
A Phase 4 clinical trial evaluating SPN-812 for Attention-Deficit/Hyperactivity Disorder. Completed, enrolled 161 participants across 1 site.
Detailed Summary
Open label, flexible dose, decentralized clinical trial evaluating the efficacy and safety of SPN-812 in adults with ADHD and mood symptoms.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAttention-Deficit/Hyperactivity Disorder
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
202420252026
First PostedDec 2023
Enrollment StartMar 2024
Primary CompletionDec 2024
Study CompletionDec 2024
TodayJul 2026
First PostedDec 29, 2023
Enrollment StartMar 25, 2024
Primary CompletionDec 3, 2024
Study CompletionDec 11, 2024
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 2.5 years ago
Interventions
SPN-812drug
Open-label