NCT05055024

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2021

Shorter than P25 for phase_2

Geographic Reach
1 country

22 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

September 23, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

October 26, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 19, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 19, 2023

Completed
Last Updated

March 13, 2023

Status Verified

March 1, 2023

Enrollment Period

1.2 years

First QC Date

September 1, 2021

Last Update Submit

March 9, 2023

Conditions

Narcolepsy With CataplexyNarcolepsyNarcolepsy Without Cataplexy

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

NLS-2 (mazindol extended release)

EXPERIMENTAL

NLS-2 (mazindol extended release) administered once a day.

Drug: Mazindol

Interventions

MazindolDRUG

Drug: NLS-2

Also known as: NLS-2, mazindol extended release
NLS-2 (mazindol extended release)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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 receives any investigational drug (other than the COVID-19 vaccine) that is not NLS-2.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

Sleep Disorders Center of Alabama

Birmingham, Alabama, 35213, United States

Location

Stanford Sleep Medicine Center

Redwood City, California, 94063, United States

Location

Pacific Research Network

San Diego, California, 92103, United States

Location

St. Francis Sleep Allergy and Lung Institute

Clearwater, Florida, 33765, United States

Location

Sleep Medicine Specialists of South Florida

Miami, Florida, 33126, United States

Location

Ivetmar Medical Group

Miami, Florida, 33155, United States

Location

The Angel Medical Research Corporation

Miami Lakes, Florida, 33016, United States

Location

Treken Primary care

Atlanta, Georgia, 30315, United States

Location

NeuroTrials Research

Atlanta, Georgia, 30328, United States

Location

Clinical Research Institute

Stockbridge, Georgia, 30281, United States

Location

Hawaii Pacific Neuroscience Clinical Research Center

Honolulu, Hawaii, 96817, United States

Location

The Center For Sleep & Wake Disorders

Chevy Chase, Maryland, 20815, United States

Location

Sleep and Attention Disorders

Sterling Heights, Michigan, 48314, United States

Location

Neurology and Sleep Disorders Clinic

Columbia, Missouri, 65212, United States

Location

Carolinas Sleep Specialists

Concord, North Carolina, 28025, United States

Location

Superior Clinical Research, LLC

Goldsboro, North Carolina, 27534, United States

Location

Advanced Respiratory and Sleep Medicine

Huntersville, North Carolina, 28078, United States

Location

Intrepid Research

Cincinnati, Ohio, 45245, United States

Location

Ohio Sleep Medicine Institute

Dublin, Ohio, 43017, United States

Location

Bogan Sleep Consultants

Columbia, South Carolina, 29201, United States

Location

Dharma PA d/b/a Southwest Family Medicine Associates

Dallas, Texas, 75235, United States

Location

Sleep Therapy & Research Center

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Narcolepsy

Interventions

Mazindol

Condition Hierarchy (Ancestors)

Disorders of Excessive SomnolenceSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

IsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Carlos Camozzi, MD

    NLS Pharmaceutics

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2021

First Posted

September 23, 2021

Study Start

October 26, 2021

Primary Completion

January 19, 2023

Study Completion

January 19, 2023

Last Updated

March 13, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

US(22)