NCT02808104

Mazindol Controlled Release in Adults With Attention Deficit Hyperactivity Disorder (ADHD)

A Double-Blind Placebo-Controlled Phase II Study to Determine the Efficacy, Safety, Tolerability and Pharmacokinetics of a Controlled Release (CR) Formulation of Mazindol in Adults With DSM-5 Attention Deficit Hyperactivity Disorder (ADHD)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: NLS Pharmaceutics · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether a controlled release formulation of mazindol is more effective than a placebo in the treatment of Attention Hyperactivity Disorder (ADHD) in adults.

Detailed description

This study is an outpatient, randomized, double-blind, placebo-controlled trial in which adult subjects with ADHD will be randomized to either oral mazindol controlled release or placebo once daily. Subjects will be treated with study medication or placebo for 6 weeks with visits occurring weekly to measure efficacy and any adverse events with adjustment of medication dosing as necessary.

Conditions

• Attention Deficit Disorder With Hyperactivity

Interventions

Type	Name	Description
DRUG	mazindol

Timeline

• Start date: 2016-08-01
• Primary completion: 2017-03-28
• Completion: 2017-03-28
• First posted: 2016-06-21
• Last updated: 2017-04-06

Locations

7 sites across 1 country: United States