Four-week Study of the Safety and Efficacy of NLS-2 (Mazindol Extended Release) in the Treatment of Narcolepsy
NCT ID: NCT04923594
Last Updated: 2022-08-12
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
67 participants
INTERVENTIONAL
2021-09-13
2022-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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NLS-2 (mazindol extended release)
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)
mazindol extended release
Dosed orally, once daily for up to 3 weeks
Placebo
Dosed orally, once daily for up to 4 weeks
Placebo
Dosed orally, once daily for up to 4 weeks.
Interventions
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mazindol extended release
Dosed orally, once daily for up to 3 weeks
Placebo
Dosed orally, once daily for up to 4 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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)
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-1021
Identifier Type: -
Identifier Source: org_study_id
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