Date: 2016-09-29
Type of information: Initiation of the trial
phase: 2
Announcement: initiation of the trial
Company: NLS Pharma (Switzerland)
Product: mazindol
Action
mechanism: Mazindol is a wake-promoting agent, a norepinephrine and dopamine reuptake inhibitor which was previously approved in Europe and in the US for the short term treatment of obesity. Rebalancing dysfunctional central nervous system (CNS) noradrenergic and dopaminergic systems appears to be critical for the effective treatment of ADHD and narcolepsy.
Disease: Attention Deficit Hyperactivity Disorder (ADHD)
Therapeutic area: CNS diseases - Mental diseases - Neurological diseases
Country: USA
Trial
details: The purpose of this phase 2 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. (NCT02808104)
Latest
news: * On August 29, 2016, NLS Pharma Group announced that it has initiated enrollment for its “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)”.
* On June 16, 2016, NLS Pharma announced that the FDA has accepted an investigational new drug (IND) for a phase II proof-of-concept clinical trial evaluating the use of mazindol in adults with Attention Deficit Hyperactivity Disorder (ADHD). The lead investigator of the double-blind placebo-controlled Phase II study is Dr. Tim Wigal. Dr. Wigal has been author or co-author of over 125 peer-reviewed articles about ADHD and
related disorders. 7 clinical sites in the USA have been selected to participate in the study.
* On May 12, 2016, NLS Pharma announced the submission of an Investigational New Drug Application (IND) with the FDA to initiate a Phase 2Ib clinical trial with its lead compound mazindol.
