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

Narcolepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05055024
• Other study ID #: NLS-1022
• Status: Completed
• Phase: Phase 2
• Start date: October 26, 2021
• Est. completion date: January 19, 2023

Study information

• Verified date: March 2023
• Source: NLS Pharmaceutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: January 19, 2023
• Est. primary completion date: January 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cataplexy
• Narcolepsy
• Narcolepsy With Cataplexy
• Narcolepsy Without Cataplexy

Intervention

Drug:
• Mazindol
Drug: NLS-2

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
NLS Pharmaceutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the safety and tolerability of NLS-2 in adult subjects with narcolepsy type 1 (NT1) or narcolepsy type 2 (NT2)	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.	24 weeks