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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05055024
Recruitment Status : Completed
First Posted : September 23, 2021
Last Update Posted : March 13, 2023
Sponsor:
Information provided by (Responsible Party):
NLS Pharmaceutics

Study Description
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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 disease Intervention/treatment Phase
Narcolepsy With Cataplexy Narcolepsy Narcolepsy Without Cataplexy Drug: Mazindol Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 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 : October 26, 2021
Actual Primary Completion Date : January 19, 2023
Actual Study Completion Date : January 19, 2023

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Arms and Interventions
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Arm Intervention/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
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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) [ Time Frame: 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
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05055024


Locations
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Sponsors and Collaborators
NLS Pharmaceutics
Investigators
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Study Director: Carlos Camozzi, MD NLS Pharmaceutics
More Information
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Responsible Party: NLS Pharmaceutics
ClinicalTrials.gov Identifier: NCT05055024    
Other Study ID Numbers: NLS-1022
First Posted: September 23, 2021    Key Record Dates
Last Update Posted: March 13, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Narcolepsy
Cataplexy
Disorders of Excessive Somnolence
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Mazindol
Central Nervous System Stimulants
 Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Dopamine Uptake Inhibitors
Dopamine Agents