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

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ClinicalTrials.gov Identifier: NCT04923594
Recruitment Status : Recruiting
First Posted : June 11, 2021
Last Update Posted : November 19, 2021
Sponsor:
Information provided by (Responsible Party):
NLS Pharmaceutics

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.

Condition or disease Intervention/treatment Phase
Narcolepsy Excessive Daytime Sleepiness Cataplexy Narcolepsy Drug: mazindol extended release Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : September 13, 2021
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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)
Drug: mazindol extended release
Dosed orally, once daily for up to 3 weeks
Other Name: NLS-2

Placebo Comparator: Placebo
Dosed orally, once daily for up to 4 weeks
Drug: Placebo
Dosed orally, once daily for up to 4 weeks.




Primary Outcome Measures :
  1. Change in ESS Score From Baseline to Week 4 [ Time Frame: 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 :
  1. Subjects Reported Improved on the Patient Global Impression of Change (PGIc) at Week 4 [ Time Frame: Baseline to 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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04923594


Contacts
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Contact: Jennifer Franco 512-413-4550 jf@nls-pharma.com
Contact: Carlos Camozzi, MD +41 79 120 57 40 cc@nls-pharma.com

Locations
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United States, Alabama
Sleep Disorders Center of Alabama Recruiting
Birmingham, Alabama, United States, 35213
Contact    205-599-1020 ext 122    wbooth@sleepalabama.com   
Principal Investigator: Robert Doekel, MD         
United States, Florida
Sleep Medicine Specialists of South Florida Recruiting
Miami, Florida, United States, 33126
Contact    305-994-1825    info@southfloridasleeps.com   
Principal Investigator: Edward Mezerhane, MD         
United States, Georgia
NeuroTrials Research Recruiting
Atlanta, Georgia, United States, 30328
Contact    404-851-9934    sdale@neurotrials.com   
Principal Investigator: Russell Rosenberg, PhD         
Clinical Research Institute Recruiting
Stockbridge, Georgia, United States, 30281
Contact    678-782-5358      
Principal Investigator: Phillip Nowlin, MD         
United States, Hawaii
Hawaii Pacific Neuroscience Clinical Research Center Recruiting
Honolulu, Hawaii, United States, 96817
Contact    808-564-6141    Info@HawaiiNeuroscience.com   
Principal Investigator: Kore Liow, MD         
United States, Maryland
The Center For Sleep & Wake Disorders Recruiting
Chevy Chase, Maryland, United States, 20815
Contact    301-654-1575    mail@sleepdoc.com   
Principal Investigator: Helene Emsellem, MD         
United States, Michigan
Sleep and Attention Disorders Recruiting
Sterling Heights, Michigan, United States, 48314
Contact    586-254-0707      
Principal Investigator: Bart Sangal, MD         
United States, North Carolina
Carolinas Sleep Specialists Recruiting
Concord, North Carolina, United States, 28025
Contact    704-707-4120      
Principal Investigator: Daniel Garber, MD         
Advanced Respiratory and Sleep Medicine Recruiting
Huntersville, North Carolina, United States, 28078
Contact    704-248-0000      
Principal Investigator: Thomas Stern, MD         
United States, Ohio
Intrepid Research Recruiting
Cincinnati, Ohio, United States, 45245
Contact    513-977-8888      
Principal Investigator: Bruce Corser, MD         
United States, South Carolina
Bogan Sleep Consultants Recruiting
Columbia, South Carolina, United States, 29201
Contact    803-251-3093      
Principal Investigator: Richard Bogan, MD         
United States, Texas
Sleep Therapy & Research Center Recruiting
San Antonio, Texas, United States, 78229
Contact    726-444-5230    rafati.sue@sleeptrc.com   
Principal Investigator: James Andry, MD         
Sponsors and Collaborators
NLS Pharmaceutics
Investigators
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Study Director: Carlos Camozzi, MD NLS Pharmaceutics
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Responsible Party: NLS Pharmaceutics
ClinicalTrials.gov Identifier: NCT04923594    
Other Study ID Numbers: NLS-1021
First Posted: June 11, 2021    Key Record Dates
Last Update Posted: November 19, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Narcolepsy
Disorders of Excessive Somnolence
Cataplexy
Sleepiness
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Mazindol
Central Nervous System Stimulants
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Dopamine Uptake Inhibitors
Dopamine Agents