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

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

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.

Study Overview

• Status: Completed
• Conditions: Narcolepsy; Excessive Daytime Sleepiness; Cataplexy Narcolepsy
• Intervention / Treatment: Drug: mazindol extended release; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35213
      • Sleep Disorders Center of Alabama
  • California
    • Redwood City, California, United States, 94063
      • Stanford Sleep Medicine Center
    • San Diego, California, United States, 92103
      • Pacific Research Network
  • Florida
    • Clearwater, Florida, United States, 33765
      • St. Francis Sleep Allergy and Lung Institute
    • Miami, Florida, United States, 33155
      • Ivetmar Medical Group
    • Miami, Florida, United States, 33126
      • Sleep Medicine Specialists of South Florida
    • Miami Lakes, Florida, United States, 33016
      • The Angel Medical Research Corporation
  • Georgia
    • Atlanta, Georgia, United States, 30328
      • NeuroTrials Research
    • Atlanta, Georgia, United States, 30315
      • Treken Primary care
    • Stockbridge, Georgia, United States, 30281
      • Clinical Research Institute
  • Hawaii
    • Honolulu, Hawaii, United States, 96817
      • Hawaii Pacific Neuroscience Clinical Research Center
  • Maryland
    • Chevy Chase, Maryland, United States, 20815
      • The Center for Sleep & Wake Disorders
  • Michigan
    • Sterling Heights, Michigan, United States, 48314
      • Sleep and Attention Disorders
  • Missouri
    • Columbia, Missouri, United States, 65212
      • Neurology and Sleep Disorders Clinic
  • North Carolina
    • Concord, North Carolina, United States, 28025
      • Carolinas Sleep Specialists
    • Goldsboro, North Carolina, United States, 27534
      • Superior Clinical Research, LLC
    • Huntersville, North Carolina, United States, 28078
      • Advanced Respiratory and Sleep Medicine
  • Ohio
    • Cincinnati, Ohio, United States, 45245
      • Intrepid Research
    • Dublin, Ohio, United States, 43017
      • Ohio Sleep Medicine Institute
  • South Carolina
    • Columbia, South Carolina, United States, 29201
      • Bogan Sleep Consultants
  • Texas
    • Dallas, Texas, United States, 75235
      • Dharma PA D/B/A Southwest Family Medicine Associates
    • San Antonio, Texas, United States, 78229
      • Sleep Therapy & Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline to Week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline to Week 4

Collaborators and Investigators

• Sponsor: NLS Pharmaceutics
• Investigators: Study Director: Carlos Camozzi, MD, NLS Pharmaceutics

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2021
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: June 9, 2021
• First Submitted That Met QC Criteria: June 9, 2021
• First Posted (Actual): June 11, 2021

Study Record Updates

• Last Update Posted (Actual): August 12, 2022
• Last Update Submitted That Met QC Criteria: August 11, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Disorders of Excessive Somnolence; Sleepiness; Narcolepsy; Cataplexy; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Dopamine Uptake Inhibitors; Central Nervous System Stimulants; Adrenergic Uptake Inhibitors; Mazindol
• Other Study ID Numbers: NLS-1021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No