Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2026-03-11 @ 2:23 PM
Study NCT ID:
NCT02808104
Status:
COMPLETED
Last Update Posted:
2017-04-06
First Post:
2016-06-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mazindol Controlled Release in Adults With Attention Deficit Hyperactivity Disorder (ADHD)
Sponsor:
NLS Pharmaceutics
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2017-04
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:
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: