Evaluation of Immediate-Release Viloxazine in Adults With ADHD
A Phase I/IIa Randomized, Double-Blind, Multicenter, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of Immediate-Release Viloxazine in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
Sponsor: Supernus Pharmaceuticals, Inc.
A PHASE1/PHASE2 clinical study on Attention-Deficit/Hyperactivity Disorder (ADHD), this trial is completed. The trial is conducted by Supernus Pharmaceuticals, Inc. and has accumulated 9 data snapshots since 2010. Psychiatric clinical trials are essential for establishing evidence-based treatment standards.
Study Description(click to expand)This will be a randomized, double-blind, multicenter, placebo-controlled, parallel group, safety and tolerability study in adults with ADHD. The target subjects are healthy male or female adults aged 18 to 64 years of age, inclusive, with a diagnosis of ADHD. Approximately 50 subjects will be enrolled at approximately 5 sites in the United States. Subjects will be randomized (1:1) to one of two treatment groups, immediate-release (IR) viloxazine or placebo. Primary objective is to determine the safety of IR viloxazine in adults with ADHD.
This will be a randomized, double-blind, multicenter, placebo-controlled, parallel group, safety and tolerability study in adults with ADHD. The target subjects are healthy male or female adults aged 18 to 64 years of age, inclusive, with a diagnosis of ADHD. Approximately 50 subjects will be enrolled at approximately 5 sites in the United States. Subjects will be randomized (1:1) to one of two treatment groups, immediate-release (IR) viloxazine or placebo. Primary objective is to determine the safety of IR viloxazine in adults with ADHD.
Status Flow
Change History
9 versions recorded-
Nov 2024 — Present [monthly]
Completed PHASE1/PHASE2
-
Sep 2024 — Nov 2024 [monthly]
Completed PHASE1/PHASE2
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE1/PHASE2
Phase: PHASE1_PHASE2 → PHASE1/PHASE2
-
Apr 2022 — Jul 2024 [monthly]
Completed PHASE1_PHASE2
-
Jan 2021 — Apr 2022 [monthly]
Completed PHASE1_PHASE2
▶ Show 4 earlier versions
-
Jun 2018 — Jan 2021 [monthly]
Completed PHASE1_PHASE2
-
Jun 2017 — Jun 2018 [monthly]
Completed PHASE1_PHASE2
-
Feb 2017 — Jun 2017 [monthly]
Completed PHASE1_PHASE2
-
Jan 2017 — Feb 2017 [monthly]
Completed PHASE1_PHASE2
First recorded
Jun 2010
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Supernus Pharmaceuticals, Inc.
For direct contact, visit the study record on ClinicalTrials.gov .