Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06185985
Status:
RECRUITING
Last Update Posted:
2024-03-25
First Post:
2023-12-15
Brief Title:
Open-label Safety and Efficacy of SPN-812 Viloxazine Extended-release Capsule in Adults With ADHD and Mood Symptoms
Sponsor:
Supernus Pharmaceuticals Inc
Organization:
Supernus Pharmaceuticals Inc
Study Overview
Official Title:
A Phase IV Open-Label Decentralized Clinical Trial to Evaluate the Efficacy and Safety of Qelbree in Adults With Attention-DeficitHyperactivity Disorder and Mood Symptoms
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Open label flexible dose decentralized clinical trial evaluating the efficacy and safety of SPN-812 in adults with ADHD and mood symptoms
Detailed Description:
This is a Phase IV open-label flexible dose decentralized clinical trial to evaluate the efficacy and safety of SPN-812 in adults with ADHD and mood symptoms Adults 18 years and older with ADHD will be recruited consented and screened for eligibility Following the Screening Period up to 4 weeks eligible participants will be treated with Study medication for up to 14 weeks Treatment Period The total study duration is approximately 18 weeks and there are up to 6 virtual study visits or Televisits All Televisits are conducted via an application downloaded to participants mobile phone There are up to 2 Televisits during the Screening period and 3 Televisits during the Treatment period Subjects initiate SPN-812 dosing at 200 mg once daily during first week and then titrate up to 400mg once daily during the second week At the Investigators discretion based subjects clinical response and tolerability the dose of SPN-812 can be increased or decreased to optimal dose within the range between 200 and 600 mg once daily during the remaining Treatment period Participants will answer questions during structured clinical interviews with an investigator during Televisits and complete additional questionnaires and scales via the mobile app
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None