Clinical trial NCT04923594: Four-week Study of the Safety and Efficacy of NLS-2 (Mazindol Extended Release) in the Treatment of Narcolepsy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Narcolepsy
Excessive Daytime Sleepiness
Cataplexy Narcolepsy
Lead sponsor: NLS Pharmaceutics
Sponsor class: INDUSTRY
First posted: 2021-06-11
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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)

Primary outcomes:
measure: Change in ESS Score From Baseline to Week 4
timeFrame: Baseline to Week 4
Secondary outcomes:
measure: Subjects Reported Improved on the Patient Global Impression of Change (PGIc) at Week 4
timeFrame: Baseline to Week 4
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Sleep Disorders Center of Alabama
state: Alabama
city: Redwood City
country: United States
facility: Stanford Sleep Medicine Center
state: California
city: San Diego
country: United States
facility: Pacific Research Network
state: California
city: Clearwater
country: United States
facility: St. Francis Sleep Allergy and Lung Institute
state: Florida
city: Miami Lakes
country: United States
facility: The Angel Medical Research Corporation
state: Florida
city: Miami
country: United States
facility: Sleep Medicine Specialists of South Florida
state: Florida
city: Miami
country: United States
facility: Ivetmar Medical Group
state: Florida
city: Atlanta
country: United States
facility: Treken Primary care
state: Georgia
city: Atlanta
country: United States
facility: NeuroTrials Research
state: Georgia
city: Stockbridge
country: United States
facility: Clinical Research Institute
state: Georgia
city: Honolulu
country: United States
facility: Hawaii Pacific Neuroscience Clinical Research Center
state: Hawaii
city: Chevy Chase
country: United States
facility: The Center For Sleep & Wake Disorders
state: Maryland
city: Sterling Heights
country: United States
facility: Sleep and Attention Disorders
state: Michigan
city: Columbia
country: United States
facility: Neurology and Sleep Disorders Clinic
state: Missouri
city: Concord
country: United States
facility: Carolinas Sleep Specialists
state: North Carolina
city: Goldsboro
country: United States
facility: Superior Clinical Research, LLC
state: North Carolina
city: Huntersville
country: United States
facility: Advanced Respiratory and Sleep Medicine
state: North Carolina
city: Cincinnati
country: United States
facility: Intrepid Research
state: Ohio
city: Dublin
country: United States
facility: Ohio Sleep Medicine Institute
state: Ohio
city: Columbia
country: United States
facility: Bogan Sleep Consultants
state: South Carolina
city: Dallas
country: United States
facility: Dharma PA d/b/a Southwest Family Medicine Associates
state: Texas
city: San Antonio
country: United States
facility: Sleep Therapy & Research Center
state: Texas
Study officials:
affiliation: NLS Pharmaceutics
name: Carlos Camozzi, MD
role: STUDY_DIRECTOR
References: