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: Drug: Mazindol

• 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

Study Timeline

• Study First Submitted: 2021-09-01
• Study First Submitted QC: 2021-09-14
• Study First Posted: 2021-09-23
• Study Start: 2021-10-26
• Primary Completion: 2023-01-19
• Study Completion: 2023-01-19
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-09
• Last Update Posted: 2023-03-13

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

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.

Trial Locations

Locations (22)

NeuroTrials Research; 🇺🇸 Atlanta, Georgia, United States

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

St. Francis Sleep Allergy and Lung Institute; 🇺🇸 Clearwater, Florida, United States

Sleep and Attention Disorders; 🇺🇸 Sterling Heights, Michigan, United States

Ohio Sleep Medicine Institute; 🇺🇸 Dublin, Ohio, United States

The Center For Sleep & Wake Disorders; 🇺🇸 Chevy Chase, Maryland, United States

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

Bogan Sleep Consultants; 🇺🇸 Columbia, South Carolina, United States

Superior Clinical Research, LLC; 🇺🇸 Goldsboro, North Carolina, United States

Neurology and Sleep Disorders Clinic; 🇺🇸 Columbia, Missouri, United States

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

Sleep Medicine Specialists of South Florida; 🇺🇸 Miami, Florida, United States

Sleep Therapy & Research Center; 🇺🇸 San Antonio, Texas, United States

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

Intrepid Research; 🇺🇸 Cincinnati, Ohio, United States

Pacific Research Network; 🇺🇸 San Diego, California, United States

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

Carolinas Sleep Specialists; 🇺🇸 Concord, North Carolina, United States

Dharma PA d/b/a Southwest Family Medicine Associates; 🇺🇸 Dallas, Texas, United States

Advanced Respiratory and Sleep Medicine; 🇺🇸 Huntersville, North Carolina, United States

The Angel Medical Research Corporation; 🇺🇸 Miami Lakes, Florida, United States

Hawaii Pacific Neuroscience Clinical Research Center; 🇺🇸 Honolulu, Hawaii, United States