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

Completed · Phase 2

Conditions studied: Narcolepsy With Cataplexy, Narcolepsy, Narcolepsy Without Cataplexy

In brief

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.

Key facts

Study ID

NCT05055024

Run by

NLS Pharmaceutics

People needed

52

Starts

2021-10-26

Expected to finish

2023-01-19

Last updated by the study team

2023-03-13

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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