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

Sponsor
NLS Pharmaceutics (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05055024
Collaborator
(none)
60
Enrollment
12
Locations
1
Arm
11.9
Anticipated Duration (Months)
5
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A 6-Month Multicenter, Open-Labelled Extension of the Clinical Trial NLS-1021 in Narcoleptic Patients With and Without Cataplexy
Actual Study Start Date :
Nov 1, 2021
Anticipated Primary Completion Date :
Oct 30, 2022
Anticipated Study Completion Date :
Oct 30, 2022

Arms and Interventions

ArmIntervention/Treatment
Experimental: NLS-2 (mazindol extended release)

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

Drug: Mazindol
Drug: NLS-2
Other Names:
  • NLS-2
  • mazindol extended release
  • Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Sleep Disorders Center of AlabamaBirminghamAlabamaUnited States35213
    2Sleep Medicine Specialists of South FloridaMiamiFloridaUnited States33126
    3NeuroTrials ResearchAtlantaGeorgiaUnited States30328
    4Clinical Research InstituteStockbridgeGeorgiaUnited States30281
    5Hawaii Pacific Neuroscience Clinical Research CenterHonoluluHawaiiUnited States96817
    6The Center For Sleep & Wake DisordersChevy ChaseMarylandUnited States20815
    7Sleep and Attention DisordersSterling HeightsMichiganUnited States48314
    8Carolinas Sleep SpecialistsConcordNorth CarolinaUnited States28025
    9Advanced Respiratory and Sleep MedicineHuntersvilleNorth CarolinaUnited States28078
    10Intrepid ResearchCincinnatiOhioUnited States45245
    11Bogan Sleep ConsultantsColumbiaSouth CarolinaUnited States29201
    12Sleep Therapy & Research CenterSan AntonioTexasUnited States78229

    Sponsors and Collaborators

    • NLS Pharmaceutics

    Investigators

    • Study Director: Carlos Camozzi, MD, NLS Pharmaceutics

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    NLS Pharmaceutics
    ClinicalTrials.gov Identifier:
    NCT05055024
    Other Study ID Numbers:
    • NLS-1022
    First Posted:
    Sep 23, 2021
    Last Update Posted:
    Nov 19, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 19, 2021