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Completed Phase 2 Interventional

Four-week Study of the Safety and Efficacy of NLS-2 (Mazindol Extended Release) in the Treatment of Narcolepsy

ClinicalTrials.gov ID: NCT04923594

Public ClinicalTrials.gov record NCT04923594. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Nov 8, 2026, 3:51 AM EST

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Official title

A Four-week, Double-blind, Placebo-controlled, Randomized, Multicenter, Parallel-group Study of the Safety and Efficacy of NLS-2 (Mazindol Extended Release) in Adults for the Treatment of Narcolepsy

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is a double-blind, randomized, placebo-controlled, multicenter trial of NLS-2 in adult patients with narcolepsy. The study will enroll approximately 60 patients and eligible patients will be treated to receive either NLS-2 or placebo for 4-weeks.

Study identification

NCT ID
NCT04923594
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
NLS Pharmaceutics
Industry
Enrollment
67 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 65 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 13, 2021 (Actual)
Primary completion
Jun 30, 2022 (Actual)
Completion
Jun 30, 2022 (Actual)
Last update posted
Aug 12, 2022

2021 – 2022

United States locations

U.S. sites
22
U.S. states
12
U.S. cities
20
Facility City State ZIP Site status
Sleep Disorders Center of Alabama Birmingham Alabama 35213 —
Stanford Sleep Medicine Center Redwood City California 94063 —
Pacific Research Network San Diego California 92103 —
St. Francis Sleep Allergy and Lung Institute Clearwater Florida 33765 —
Sleep Medicine Specialists of South Florida Miami Florida 33126 —
Ivetmar Medical Group Miami Florida 33155 —
The Angel Medical Research Corporation Miami Lakes Florida 33016 —
Treken Primary care Atlanta Georgia 30315 —
NeuroTrials Research Atlanta Georgia 30328 —
Clinical Research Institute Stockbridge Georgia 30281 —
Hawaii Pacific Neuroscience Clinical Research Center Honolulu Hawaii 96817 —
The Center For Sleep & Wake Disorders Chevy Chase Maryland 20815 —
Sleep and Attention Disorders Sterling Heights Michigan 48314 —
Neurology and Sleep Disorders Clinic Columbia Missouri 65212 —
Carolinas Sleep Specialists Concord North Carolina 28025 —
Superior Clinical Research, LLC Goldsboro North Carolina 27534 —
Advanced Respiratory and Sleep Medicine Huntersville North Carolina 28078 —
Intrepid Research Cincinnati Ohio 45245 —
Ohio Sleep Medicine Institute Dublin Ohio 43017 —
Bogan Sleep Consultants Columbia South Carolina 29201 —
Dharma PA d/b/a Southwest Family Medicine Associates Dallas Texas 75235 —
Sleep Therapy & Research Center San Antonio Texas 78229 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04923594, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 12, 2022 · Synced Nov 8, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04923594 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →