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

Primary Purpose

Narcolepsy, Excessive Daytime Sleepiness, Cataplexy Narcolepsy

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

About this trial

This is an interventional treatment trial for Narcolepsy

Eligibility Criteria

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

Key Inclusion Criteria:

  • Males and females between 18 and 65 years of age, inclusive
  • Diagnosis of narcolepsy according to ICSD-3 (International Classification of Sleep Disorders, 3rd Edition) or Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria
  • Body mass index from 18 to 40 kg/m2, inclusive
  • Consent to use a medically acceptable method of contraception
  • Willing and able to provide written informed consent

Key Exclusion Criteria:

  • Female subjects who are pregnant, nursing, or lactating
  • Any other clinically relevant medical, behavioral, or psychiatric disorder other than narcolepsy that is associated with excessive sleepiness
  • History or presence of bipolar disorder, bipolar related disorders, schizophrenia, schizophrenia spectrum disorders, or other psychotic disorders according to DSM-5 criteria
  • Use of any over-the-counter (OTC) or prescription medications that could affect the evaluation of excessive sleepiness
  • Use of any medications that could affect the evaluation of cataplexy
  • Received an investigational drug in the past 30 days or five half-lives (whichever is longer)

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 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

NLS-2 (mazindol extended release)

Placebo

Arm Description

2 mg dosed orally, once daily for 1 week; followed by 3 mg dosed orally, once daily for up to 3 weeks (total of 4 weeks)

Dosed orally, once daily for up to 4 weeks

Outcomes

Primary Outcome Measures

Change in ESS Score From Baseline to Week 4
Change in Epworth Sleepiness Scale (ESS) score from Baseline to Week 4. A negative change from baseline represents improvement in excessive sleepiness. The ESS is a self-administered questionnaire with 8 questions. Each activity is scored on a scale ranging from 0-3, with 0 = would never fall asleep, and 3 = high chance of falling asleep. The total score ranges from 0-24, with a higher number representing an increased propensity for sleepiness.

Secondary Outcome Measures

Subjects Reported Improved on the Patient Global Impression of Change (PGIc) at Week 4
Percentage of subjects reported as improved (minimally, much, or very much) on the PGIc at Week 4. PGIc is rated by subjects and measures the change in their condition since treatment starts on a 7-point scale ranging from 1= very much improved to 7= very much worse

Full Information

First Posted
June 9, 2021
Last Updated
August 11, 2022
Sponsor
NLS Pharmaceutics
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1. Study Identification

Unique Protocol Identification Number
NCT04923594
Brief Title
Four-week Study of the Safety and Efficacy of NLS-2 (Mazindol Extended Release) in the Treatment of Narcolepsy
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
September 13, 2021 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Narcolepsy, Excessive Daytime Sleepiness, Cataplexy Narcolepsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NLS-2 (mazindol extended release)
Arm Type
Active Comparator
Arm Description
2 mg dosed orally, once daily for 1 week; followed by 3 mg dosed orally, once daily for up to 3 weeks (total of 4 weeks)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Dosed orally, once daily for up to 4 weeks
Intervention Type
Drug
Intervention Name(s)
mazindol extended release
Other Intervention Name(s)
NLS-2
Intervention Description
Dosed orally, once daily for up to 3 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Dosed orally, once daily for up to 4 weeks.
Primary Outcome Measure Information:
Title
Change in ESS Score From Baseline to Week 4
Description
Change in Epworth Sleepiness Scale (ESS) score from Baseline to Week 4. A negative change from baseline represents improvement in excessive sleepiness. The ESS is a self-administered questionnaire with 8 questions. Each activity is scored on a scale ranging from 0-3, with 0 = would never fall asleep, and 3 = high chance of falling asleep. The total score ranges from 0-24, with a higher number representing an increased propensity for sleepiness.
Time Frame
Baseline to Week 4
Secondary Outcome Measure Information:
Title
Subjects Reported Improved on the Patient Global Impression of Change (PGIc) at Week 4
Description
Percentage of subjects reported as improved (minimally, much, or very much) on the PGIc at Week 4. PGIc is rated by subjects and measures the change in their condition since treatment starts on a 7-point scale ranging from 1= very much improved to 7= very much worse
Time Frame
Baseline to Week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Males and females between 18 and 65 years of age, inclusive Diagnosis of narcolepsy according to ICSD-3 (International Classification of Sleep Disorders, 3rd Edition) or Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria Body mass index from 18 to 40 kg/m2, inclusive Consent to use a medically acceptable method of contraception Willing and able to provide written informed consent Key Exclusion Criteria: Female subjects who are pregnant, nursing, or lactating Any other clinically relevant medical, behavioral, or psychiatric disorder other than narcolepsy that is associated with excessive sleepiness History or presence of bipolar disorder, bipolar related disorders, schizophrenia, schizophrenia spectrum disorders, or other psychotic disorders according to DSM-5 criteria Use of any over-the-counter (OTC) or prescription medications that could affect the evaluation of excessive sleepiness Use of any medications that could affect the evaluation of cataplexy Received an investigational drug in the past 30 days or five half-lives (whichever is longer)
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

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

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