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

Narcolepsy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04923594
• Other study ID #: NLS-1021
• Status: Completed
• Phase: Phase 2
• Start date: September 13, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: August 2022
• Source: NLS Pharmaceutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cataplexy
• Cataplexy Narcolepsy
• Disorders of Excessive Somnolence
• Excessive Daytime Sleepiness
• Narcolepsy
• Sleepiness

Intervention

Drug:
• mazindol extended release
Dosed orally, once daily for up to 3 weeks
• Placebo
Dosed orally, once daily for up to 4 weeks.

Locations

Country	Name	City	State
United States	NeuroTrials Research	Atlanta	Georgia
United States	Treken Primary care	Atlanta	Georgia
United States	Sleep Disorders Center of Alabama	Birmingham	Alabama
United States	The Center For Sleep & Wake Disorders	Chevy Chase	Maryland
United States	Intrepid Research	Cincinnati	Ohio
United States	St. Francis Sleep Allergy and Lung Institute	Clearwater	Florida
United States	Bogan Sleep Consultants	Columbia	South Carolina
United States	Neurology and Sleep Disorders Clinic	Columbia	Missouri
United States	Carolinas Sleep Specialists	Concord	North Carolina
United States	Dharma PA d/b/a Southwest Family Medicine Associates	Dallas	Texas
United States	Ohio Sleep Medicine Institute	Dublin	Ohio
United States	Superior Clinical Research, LLC	Goldsboro	North Carolina
United States	Hawaii Pacific Neuroscience Clinical Research Center	Honolulu	Hawaii
United States	Advanced Respiratory and Sleep Medicine	Huntersville	North Carolina
United States	Ivetmar Medical Group	Miami	Florida
United States	Sleep Medicine Specialists of South Florida	Miami	Florida
United States	The Angel Medical Research Corporation	Miami Lakes	Florida
United States	Stanford Sleep Medicine Center	Redwood City	California
United States	Sleep Therapy & Research Center	San Antonio	Texas
United States	Pacific Research Network	San Diego	California
United States	Sleep and Attention Disorders	Sterling Heights	Michigan
United States	Clinical Research Institute	Stockbridge	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
NLS Pharmaceutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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