Clinical trial NCT05055024: An Open Label Study of NLS-2 (Mazindol Extended Release) in Subjects With Narcolepsy
Official title: A 6-Month Multicenter, Open-Labelled Extension of the Clinical Trial NLS-1021 in Narcoleptic Patients With and Without Cataplexy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Narcolepsy With Cataplexy
Narcolepsy
Narcolepsy Without Cataplexy
Lead sponsor: NLS Pharmaceutics
Sponsor class: INDUSTRY
First posted: 2021-09-23
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: To evaluate the safety and tolerability of NLS-2 in adult subjects with narcolepsy type 1 (NT1) or narcolepsy type 2 (NT2)
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Sleep Disorders Center of Alabama
state: Alabama
city: Redwood City
country: United States
facility: Stanford Sleep Medicine Center
state: California
city: San Diego
country: United States
facility: Pacific Research Network
state: California
city: Clearwater
country: United States
facility: St. Francis Sleep Allergy and Lung Institute
state: Florida
city: Miami Lakes
country: United States
facility: The Angel Medical Research Corporation
state: Florida
city: Miami
country: United States
facility: Sleep Medicine Specialists of South Florida
state: Florida
city: Miami
country: United States
facility: Ivetmar Medical Group
state: Florida
city: Atlanta
country: United States
facility: Treken Primary care
state: Georgia
city: Atlanta
country: United States
facility: NeuroTrials Research
state: Georgia
city: Stockbridge
country: United States
facility: Clinical Research Institute
state: Georgia
city: Honolulu
country: United States
facility: Hawaii Pacific Neuroscience Clinical Research Center
state: Hawaii
city: Chevy Chase
country: United States
facility: The Center For Sleep & Wake Disorders
state: Maryland
city: Sterling Heights
country: United States
facility: Sleep and Attention Disorders
state: Michigan
city: Columbia
country: United States
facility: Neurology and Sleep Disorders Clinic
state: Missouri
city: Concord
country: United States
facility: Carolinas Sleep Specialists
state: North Carolina
city: Goldsboro
country: United States
facility: Superior Clinical Research, LLC
state: North Carolina
city: Huntersville
country: United States
facility: Advanced Respiratory and Sleep Medicine
state: North Carolina
city: Cincinnati
country: United States
facility: Intrepid Research
state: Ohio
city: Dublin
country: United States
facility: Ohio Sleep Medicine Institute
state: Ohio
city: Columbia
country: United States
facility: Bogan Sleep Consultants
state: South Carolina
city: Dallas
country: United States
facility: Dharma PA d/b/a Southwest Family Medicine Associates
state: Texas
city: San Antonio
country: United States
facility: Sleep Therapy & Research Center
state: Texas
Study officials:
affiliation: NLS Pharmaceutics
name: Carlos Camozzi, MD
role: STUDY_DIRECTOR
References: