An Open Label Study of NLS-2 (Mazindol Extended Release) in Subjects With Narcolepsy
- Conditions
- NarcolepsyNarcolepsy With CataplexyNarcolepsy 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
- 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.
- 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
Group Intervention Description NLS-2 (mazindol extended release) Mazindol NLS-2 (mazindol extended release) administered once a day.
- Primary Outcome Measures
Name Time Method 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
Name Time Method
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
Scroll for more (12 remaining)Sleep Disorders Center of Alabama🇺🇸Birmingham, Alabama, United States