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

Phase 2

Completed

• Conditions: Excessive Daytime Sleepiness; Narcolepsy; Cataplexy Narcolepsy
• Interventions: Drug: mazindol extended release; 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

Study Timeline

• Study First Submitted: 2021-06-09
• Study First Submitted QC: 2021-06-09
• Study First Posted: 2021-06-11
• Study Start: 2021-09-13
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-11
• Last Update Posted: 2022-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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 & 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)

Sleep Disorders Center of Alabama; 🇺🇸 Birmingham, Alabama, United States

Stanford Sleep Medicine Center; 🇺🇸 Redwood City, California, United States

Pacific Research Network; 🇺🇸 San Diego, 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 Medicine Specialists of South Florida; 🇺🇸 Miami, Florida, United States

Ivetmar Medical Group; 🇺🇸 Miami, Florida, United States

Treken Primary care; 🇺🇸 Atlanta, Georgia, United States

NeuroTrials Research; 🇺🇸 Atlanta, Georgia, United States

Clinical Research Institute; 🇺🇸 Stockbridge, Georgia, United States

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