Narcolepsy, Narcolepsy With Cataplexy, Narcolepsy Without Cataplexy
Conditions
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.
Interventions
DRUGMazindol
Drug: NLS-2
Sponsors
NLS Pharmaceutics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed