An Open Label Study of NLS-2 (Mazindol Extended Release) in Subjects With Narcolepsy

March 9, 2023 updated by: NLS Pharmaceutics

A 6-Month Multicenter, Open-Labelled Extension of the Clinical Trial NLS-1021 in Narcoleptic Patients With and Without Cataplexy

This is a multicenter, open-label extension of the clinical study NLS-1021, evaluating long-term safety, tolerability, pharmacokinetics (PK), and therapeutic response to treatment with NLS-2 in adult subjects with narcolepsy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35213
        • Sleep Disorders Center of Alabama
    • California
      • Redwood City, California, United States, 94063
        • Stanford Sleep Medicine Center
      • San Diego, California, United States, 92103
        • Pacific Research Network
    • Florida
      • Clearwater, Florida, United States, 33765
        • St. Francis Sleep Allergy and Lung Institute
      • Miami, Florida, United States, 33155
        • Ivetmar Medical Group
      • Miami, Florida, United States, 33126
        • Sleep Medicine Specialists of South Florida
      • Miami Lakes, Florida, United States, 33016
        • The Angel Medical Research Corporation
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Neurotrials Research
      • Atlanta, Georgia, United States, 30315
        • Treken Primary care
      • Stockbridge, Georgia, United States, 30281
        • Clinical Research Institute
    • Hawaii
      • Honolulu, Hawaii, United States, 96817
        • Hawaii Pacific Neuroscience Clinical Research Center
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • The Center for Sleep & Wake Disorders
    • Michigan
      • Sterling Heights, Michigan, United States, 48314
        • Sleep and Attention Disorders
    • Missouri
      • Columbia, Missouri, United States, 65212
        • Neurology and Sleep Disorders Clinic
    • North Carolina
      • Concord, North Carolina, United States, 28025
        • Carolinas Sleep Specialists
      • Goldsboro, North Carolina, United States, 27534
        • Superior Clinical Research, LLC
      • Huntersville, North Carolina, United States, 28078
        • Advanced Respiratory and Sleep Medicine
    • Ohio
      • Cincinnati, Ohio, United States, 45245
        • Intrepid Research
      • Dublin, Ohio, United States, 43017
        • Ohio Sleep Medicine Institute
    • South Carolina
      • Columbia, South Carolina, United States, 29201
        • Bogan Sleep Consultants
    • Texas
      • Dallas, Texas, United States, 75235
        • Dharma PA D/B/A Southwest Family Medicine Associates
      • San Antonio, Texas, United States, 78229
        • Sleep Therapy & Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The subject must complete all Study NLS-1021 study requirements and assessments up to Visit 6;
  • The subject is able, in the opinion of the Investigator, to receive NLS-2 for the 24-week Treatment Phase of this study;
  • Biological females of childbearing potential must agree to use a medically acceptable double-barrier method of contraception for at least 30 days prior to Day 1 and until completion of the study;
  • The subject is able to comply with the open-labelled extension design schedule and other study requirements;
  • The subject provides written informed consent for the open-label extension study.

Exclusion Criteria:

  • The subject meets any Exclusion Criteria for Study NLS-1021 at Visit 6 of that study;
  • The subject receives any investigational drug (other than the COVID-19 vaccine) that is not NLS-2.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NLS-2 (mazindol extended release)
NLS-2 (mazindol extended release) administered once a day.
Drug: Mazindol
Drug: NLS-2
Other Names:
  • NLS-2
  • mazindol extended release

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the safety and tolerability of NLS-2 in adult subjects with narcolepsy type 1 (NT1) or narcolepsy type 2 (NT2)
Time Frame: 24 weeks
Summaries of the number and percentage of subjects who experienced Treatment Emergent Adverse Events (TEAEs), TEAEs related to study drug, SAEs, or discontinued study drug or withdrew from the study due to an AE.
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NLS Pharmaceutics

Investigators

  • Study Director: Carlos Camozzi, MD, NLS Pharmaceutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 26, 2021

Primary Completion (Actual)

January 19, 2023

Study Completion (Actual)

January 19, 2023

Study Registration Dates

First Submitted

September 1, 2021

First Submitted That Met QC Criteria

September 14, 2021

First Posted (Actual)

September 23, 2021

Study Record Updates

Last Update Posted (Actual)

March 13, 2023

Last Update Submitted That Met QC Criteria

March 9, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NLS-1022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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