An Open Label Study of NLS-2 (Mazindol Extended Release) in Subjects With Narcolepsy
NCT ID: NCT05055024
Last Updated: 2023-03-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
52 participants
INTERVENTIONAL
2021-10-26
2023-01-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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NLS-2 (mazindol extended release)
NLS-2 (mazindol extended release) administered once a day.
Mazindol
Drug: NLS-2
Interventions
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Mazindol
Drug: NLS-2
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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NLS Pharmaceutics
INDUSTRY
Responsible Party
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Principal Investigators
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Carlos Camozzi, MD
Role: STUDY_DIRECTOR
NLS Pharmaceutics
Locations
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Sleep Disorders Center of Alabama
Birmingham, Alabama, United States
Stanford Sleep Medicine Center
Redwood City, California, United States
Pacific Research Network
San Diego, California, United States
St. Francis Sleep Allergy and Lung Institute
Clearwater, Florida, United States
Sleep Medicine Specialists of South Florida
Miami, Florida, United States
Ivetmar Medical Group
Miami, Florida, United States
The Angel Medical Research Corporation
Miami Lakes, Florida, United States
Treken Primary care
Atlanta, Georgia, United States
NeuroTrials Research
Atlanta, Georgia, United States
Clinical Research Institute
Stockbridge, Georgia, United States
Hawaii Pacific Neuroscience Clinical Research Center
Honolulu, Hawaii, United States
The Center For Sleep & Wake Disorders
Chevy Chase, Maryland, United States
Sleep and Attention Disorders
Sterling Heights, Michigan, United States
Neurology and Sleep Disorders Clinic
Columbia, Missouri, United States
Carolinas Sleep Specialists
Concord, North Carolina, United States
Superior Clinical Research, LLC
Goldsboro, North Carolina, United States
Advanced Respiratory and Sleep Medicine
Huntersville, North Carolina, United States
Intrepid Research
Cincinnati, Ohio, United States
Ohio Sleep Medicine Institute
Dublin, Ohio, United States
Bogan Sleep Consultants
Columbia, South Carolina, United States
Dharma PA d/b/a Southwest Family Medicine Associates
Dallas, Texas, United States
Sleep Therapy & Research Center
San Antonio, Texas, United States
Countries
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Other Identifiers
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NLS-1022
Identifier Type: -
Identifier Source: org_study_id
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