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

NLS Pharmaceutics

Status and phase

Completed

Phase 2

Conditions

Narcolepsy Without Cataplexy

Narcolepsy With Cataplexy

Narcolepsy

Treatments

Drug: Mazindol

Study type

Interventional

Funder types

Industry

Identifiers

NCT05055024

NLS-1022

Details and patient eligibility

About

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.

Enrollment

52 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.