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NCT01107496 · ClinicalTrials.gov registry record · Phase 1

Evaluation of Immediate-Release Viloxazine in Adults With ADHD

A Phase 1 study, sponsored by Supernus Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
52
Enrollment target

NCT01107496: Completed Phase 1 study, sponsored by Supernus Pharmaceuticals.

NCT01107496 is a Phase 1 study that has completed, run by Supernus Pharmaceuticals. The registered enrollment target is 52 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01107496, a Phase 1 study, has completed, sponsored by Supernus Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
52 participants
Enrollment target

Study Summary

This will be a randomized, double-blind, 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, inclusive, with a diagnosis of ADHD.

Primary Outcome

The percent of subjects who took at least one dose of immediate-release viloxazine (Safety Population; N) and who reported at least one Adverse Event (n). The percent is calculated by dividing "the number of subjects who reported at least one Adverse Event (n)" by "the number of subjects in the Safety Population (N)" and multiplying the product by 100. The higher the percentage, the higher the incidence in the Safety Population

Interventions

  • DRUG Placebo
  • DRUG IR Viloxazine

Trial Details

FieldValue
Enrollment Target 52 participants
Start Date 2010-06
Est. Completion 2010-12
Phase Phase 1
Supernus Pharmaceuticals

57 total trials

What the finished NCT01107496 record still lists

NCT01107496 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01107496 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01107496 about?

NCT01107496 is a clinical study titled "Evaluation of Immediate-Release Viloxazine in Adults With ADHD". This will be a randomized, double-blind, 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, inclusive, with a diagnosis of ADHD.

What is the current status of trial NCT01107496?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2010-06. Estimated completion is 2010-12.

What interventions are being tested in trial NCT01107496?

The interventions under investigation include: Placebo (DRUG), IR Viloxazine (DRUG).

Who is sponsoring clinical trial NCT01107496?

This trial is sponsored by Supernus Pharmaceuticals, which has 57 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01107496's enrollment target sits among peer trials

52 956th of 2000 higher than 1,032 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01107496, the US trial registry maintained by the National Library of Medicine. NCT01107496 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.