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NCT Number: NCT05055024

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

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.

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Key information

Conditions

Narcolepsy With Cataplexy Disorders of Excessive Somnolence Dyssomnias Mental Disorders Narcolepsy Narcolepsy Without Cataplexy Nervous System Diseases Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mazindol

Drug

Drug: NLS-2

Other names: NLS-2, mazindol extended release

Primary outcomes

  1. To evaluate the safety and tolerability of NLS-2 in adult subjects with narcolepsy type 1 (NT1) or narcolepsy type 2 (NT2)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

NLS Pharmaceutics

Industry

Registry information

Official study title

A 6-Month Multicenter, Open-Labelled Extension of the Clinical Trial NLS-1021 in Narcoleptic Patients With and Without Cataplexy

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Sep 23, 2021
Registry last updated
Mar 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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