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An Open Label Study of NLS-2 (Mazindol Extended Release) in Subjects With Narcolepsy

Phase 2
Completed
Conditions
Narcolepsy
Narcolepsy With Cataplexy
Narcolepsy Without Cataplexy
Interventions
Registration Number
NCT05055024
Lead Sponsor
NLS Pharmaceutics
Brief Summary

This is a multicenter, open-label extension of the clinical study NLS-1021, evaluating long-term safety, tolerability, pharmacokinetics (PK), and therapeutic response to treatment with NLS-2 in adult subjects with narcolepsy.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
52
Inclusion Criteria
  • The subject must complete all Study NLS-1021 study requirements and assessments up to Visit 6;
  • The subject is able, in the opinion of the Investigator, to receive NLS-2 for the 24-week Treatment Phase of this study;
  • Biological females of childbearing potential must agree to use a medically acceptable double-barrier method of contraception for at least 30 days prior to Day 1 and until completion of the study;
  • The subject is able to comply with the open-labelled extension design schedule and other study requirements;
  • The subject provides written informed consent for the open-label extension study.
Exclusion Criteria
  • The subject meets any Exclusion Criteria for Study NLS-1021 at Visit 6 of that study;
  • The subject receives any investigational drug (other than the COVID-19 vaccine) that is not NLS-2.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
NLS-2 (mazindol extended release)MazindolNLS-2 (mazindol extended release) administered once a day.
Primary Outcome Measures
NameTimeMethod
To evaluate the safety and tolerability of NLS-2 in adult subjects with narcolepsy type 1 (NT1) or narcolepsy type 2 (NT2)24 weeks

Summaries of the number and percentage of subjects who experienced Treatment Emergent Adverse Events (TEAEs), TEAEs related to study drug, SAEs, or discontinued study drug or withdrew from the study due to an AE.

Secondary Outcome Measures
NameTimeMethod

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

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