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

Primary Purpose

Narcolepsy With Cataplexy, Narcolepsy, Narcolepsy Without Cataplexy

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Mazindol
Sponsored by
NLS Pharmaceutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Narcolepsy With Cataplexy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sleep Disorders Center of Alabama
  • Stanford Sleep Medicine Center
  • Pacific Research Network
  • St. Francis Sleep Allergy and Lung Institute
  • The Angel Medical Research Corporation
  • Sleep Medicine Specialists of South Florida
  • Ivetmar Medical Group
  • Treken Primary care
  • NeuroTrials Research
  • Clinical Research Institute
  • Hawaii Pacific Neuroscience Clinical Research Center
  • The Center For Sleep & Wake Disorders
  • Sleep and Attention Disorders
  • Neurology and Sleep Disorders Clinic
  • Carolinas Sleep Specialists
  • Superior Clinical Research, LLC
  • Advanced Respiratory and Sleep Medicine
  • Intrepid Research
  • Ohio Sleep Medicine Institute
  • Bogan Sleep Consultants
  • Dharma PA d/b/a Southwest Family Medicine Associates
  • Sleep Therapy & Research Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NLS-2 (mazindol extended release)

Arm Description

NLS-2 (mazindol extended release) administered once a day.

Outcomes

Primary Outcome Measures

To evaluate the safety and tolerability of NLS-2 in adult subjects with narcolepsy type 1 (NT1) or narcolepsy type 2 (NT2)
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.

Secondary Outcome Measures

Full Information

First Posted
September 1, 2021
Last Updated
March 9, 2023
Sponsor
NLS Pharmaceutics
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1. Study Identification

Unique Protocol Identification Number
NCT05055024
Brief Title
An Open Label Study of NLS-2 (Mazindol Extended Release) in Subjects With Narcolepsy
Official Title
A 6-Month Multicenter, Open-Labelled Extension of the Clinical Trial NLS-1021 in Narcoleptic Patients With and Without Cataplexy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
October 26, 2021 (Actual)
Primary Completion Date
January 19, 2023 (Actual)
Study Completion Date
January 19, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NLS Pharmaceutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Narcolepsy With Cataplexy, Narcolepsy, Narcolepsy Without Cataplexy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NLS-2 (mazindol extended release)
Arm Type
Experimental
Arm Description
NLS-2 (mazindol extended release) administered once a day.
Intervention Type
Drug
Intervention Name(s)
Mazindol
Other Intervention Name(s)
NLS-2, mazindol extended release
Intervention Description
Drug: NLS-2
Primary Outcome Measure Information:
Title
To evaluate the safety and tolerability of NLS-2 in adult subjects with narcolepsy type 1 (NT1) or narcolepsy type 2 (NT2)
Description
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.
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos Camozzi, MD
Organizational Affiliation
NLS Pharmaceutics
Official's Role
Study Director
Facility Information:
Facility Name
Sleep Disorders Center of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35213
Country
United States
Facility Name
Stanford Sleep Medicine Center
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Facility Name
Pacific Research Network
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
St. Francis Sleep Allergy and Lung Institute
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
The Angel Medical Research Corporation
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Sleep Medicine Specialists of South Florida
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Ivetmar Medical Group
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Treken Primary care
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30315
Country
United States
Facility Name
NeuroTrials Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Clinical Research Institute
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
Hawaii Pacific Neuroscience Clinical Research Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Facility Name
The Center For Sleep & Wake Disorders
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Sleep and Attention Disorders
City
Sterling Heights
State/Province
Michigan
ZIP/Postal Code
48314
Country
United States
Facility Name
Neurology and Sleep Disorders Clinic
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Facility Name
Carolinas Sleep Specialists
City
Concord
State/Province
North Carolina
ZIP/Postal Code
28025
Country
United States
Facility Name
Superior Clinical Research, LLC
City
Goldsboro
State/Province
North Carolina
ZIP/Postal Code
27534
Country
United States
Facility Name
Advanced Respiratory and Sleep Medicine
City
Huntersville
State/Province
North Carolina
ZIP/Postal Code
28078
Country
United States
Facility Name
Intrepid Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45245
Country
United States
Facility Name
Ohio Sleep Medicine Institute
City
Dublin
State/Province
Ohio
ZIP/Postal Code
43017
Country
United States
Facility Name
Bogan Sleep Consultants
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Facility Name
Dharma PA d/b/a Southwest Family Medicine Associates
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Sleep Therapy & Research Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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