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
1 other identifier
interventional
67
1 country
22
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2021
Shorter than P25 for phase_2
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 9, 2021
CompletedFirst Posted
Study publicly available on registry
June 11, 2021
CompletedStudy Start
First participant enrolled
September 13, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2022
CompletedAugust 12, 2022
August 1, 2022
10 months
June 9, 2021
August 11, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Subjects Reported Improved on the Patient Global Impression of Change (PGIc) at Week 4
Baseline to Week 4
Study Arms (2)
NLS-2 (mazindol extended release)
ACTIVE COMPARATOR2 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)
Placebo
PLACEBO COMPARATORDosed orally, once daily for up to 4 weeks
Interventions
Dosed orally, once daily for up to 3 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Sleep Disorders Center of Alabama
Birmingham, Alabama, 35213, United States
Stanford Sleep Medicine Center
Redwood City, California, 94063, United States
Pacific Research Network
San Diego, California, 92103, United States
St. Francis Sleep Allergy and Lung Institute
Clearwater, Florida, 33765, United States
Sleep Medicine Specialists of South Florida
Miami, Florida, 33126, United States
Ivetmar Medical Group
Miami, Florida, 33155, United States
The Angel Medical Research Corporation
Miami Lakes, Florida, 33016, United States
Treken Primary care
Atlanta, Georgia, 30315, United States
NeuroTrials Research
Atlanta, Georgia, 30328, United States
Clinical Research Institute
Stockbridge, Georgia, 30281, United States
Hawaii Pacific Neuroscience Clinical Research Center
Honolulu, Hawaii, 96817, United States
The Center For Sleep & Wake Disorders
Chevy Chase, Maryland, 20815, United States
Sleep and Attention Disorders
Sterling Heights, Michigan, 48314, United States
Neurology and Sleep Disorders Clinic
Columbia, Missouri, 65212, United States
Carolinas Sleep Specialists
Concord, North Carolina, 28025, United States
Superior Clinical Research, LLC
Goldsboro, North Carolina, 27534, United States
Advanced Respiratory and Sleep Medicine
Huntersville, North Carolina, 28078, United States
Intrepid Research
Cincinnati, Ohio, 45245, United States
Ohio Sleep Medicine Institute
Dublin, Ohio, 43017, United States
Bogan Sleep Consultants
Columbia, South Carolina, 29201, United States
Dharma PA d/b/a Southwest Family Medicine Associates
Dallas, Texas, 75235, United States
Sleep Therapy & Research Center
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Carlos Camozzi, MD
NLS Pharmaceutics
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2021
First Posted
June 11, 2021
Study Start
September 13, 2021
Primary Completion
June 30, 2022
Study Completion
June 30, 2022
Last Updated
August 12, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share