Four-week Study of the Safety and Efficacy of NLS-2 (Mazindol Extended Release) in the Treatment of Narcolepsy
- Conditions
- Excessive Daytime SleepinessNarcolepsyCataplexy Narcolepsy
- Interventions
- Drug: Placebo
- Registration Number
- NCT04923594
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 67
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NLS-2 (mazindol extended release) 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) Placebo Placebo Dosed orally, once daily for up to 4 weeks
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (22)
Clinical Research Institute
🇺🇸Stockbridge, Georgia, 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
Stanford Sleep Medicine Center
🇺🇸Redwood City, California, United States
St. Francis Sleep Allergy and Lung Institute
🇺🇸Clearwater, Florida, United States
The Angel Medical Research Corporation
🇺🇸Miami Lakes, Florida, United States
Sleep and Attention Disorders
🇺🇸Sterling Heights, Michigan, United States
Treken Primary care
🇺🇸Atlanta, Georgia, United States
NeuroTrials Research
🇺🇸Atlanta, Georgia, United States
Neurology and Sleep Disorders Clinic
🇺🇸Columbia, Missouri, 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
Hawaii Pacific Neuroscience Clinical Research Center
🇺🇸Honolulu, Hawaii, United States
The Center For Sleep & Wake Disorders
🇺🇸Chevy Chase, Maryland, United States
Sleep Disorders Center of Alabama
🇺🇸Birmingham, Alabama, United States
Ivetmar Medical Group
🇺🇸Miami, Florida, United States
Pacific Research Network
🇺🇸San Diego, California, United States
Sleep Medicine Specialists of South Florida
🇺🇸Miami, Florida, United States
Intrepid Research
🇺🇸Cincinnati, Ohio, United States
Sleep Therapy & Research Center
🇺🇸San Antonio, Texas, United States