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

Sponsor
NLS Pharmaceutics (Industry)
Overall Status
Completed
CT.gov ID
NCT04923594
Collaborator
(none)
67
Enrollment
22
Locations
2
Arms
9.5
Actual Duration (Months)
3
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: mazindol extended release
  • Drug: Placebo
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
67 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 :
Sep 13, 2021
Actual Primary Completion Date :
Jun 30, 2022
Actual Study Completion Date :
Jun 30, 2022

Arms and Interventions

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 Names:
  • 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.

    Outcome Measures

    Primary Outcome Measures

    1. Change in ESS Score From Baseline to Week 4 [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 [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

    Eligibility Criteria

    Criteria

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sleep Disorders Center of Alabama Birmingham Alabama United States 35213
    2 Stanford Sleep Medicine Center Redwood City California United States 94063
    3 Pacific Research Network San Diego California United States 92103
    4 St. Francis Sleep Allergy and Lung Institute Clearwater Florida United States 33765
    5 The Angel Medical Research Corporation Miami Lakes Florida United States 33016
    6 Sleep Medicine Specialists of South Florida Miami Florida United States 33126
    7 Ivetmar Medical Group Miami Florida United States 33155
    8 Treken Primary care Atlanta Georgia United States 30315
    9 NeuroTrials Research Atlanta Georgia United States 30328
    10 Clinical Research Institute Stockbridge Georgia United States 30281
    11 Hawaii Pacific Neuroscience Clinical Research Center Honolulu Hawaii United States 96817
    12 The Center For Sleep & Wake Disorders Chevy Chase Maryland United States 20815
    13 Sleep and Attention Disorders Sterling Heights Michigan United States 48314
    14 Neurology and Sleep Disorders Clinic Columbia Missouri United States 65212
    15 Carolinas Sleep Specialists Concord North Carolina United States 28025
    16 Superior Clinical Research, LLC Goldsboro North Carolina United States 27534
    17 Advanced Respiratory and Sleep Medicine Huntersville North Carolina United States 28078
    18 Intrepid Research Cincinnati Ohio United States 45245
    19 Ohio Sleep Medicine Institute Dublin Ohio United States 43017
    20 Bogan Sleep Consultants Columbia South Carolina United States 29201
    21 Dharma PA d/b/a Southwest Family Medicine Associates Dallas Texas United States 75235
    22 Sleep Therapy & Research Center San Antonio Texas United States 78229

    Sponsors and Collaborators

    • NLS Pharmaceutics

    Investigators

    • Study Director: Carlos Camozzi, MD, NLS Pharmaceutics

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    NLS Pharmaceutics
    ClinicalTrials.gov Identifier:
    NCT04923594
    Other Study ID Numbers:
    • NLS-1021
    First Posted:
    Jun 11, 2021
    Last Update Posted:
    Aug 12, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Narcolepsy
    Disorders of Excessive Somnolence
    Cataplexy
    Sleepiness
    Mazindol

    Study Results

    No Results Posted as of Aug 12, 2022