NCT05055024

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

A 6-Month Multicenter, Open-Labelled Extension of the Clinical Trial NLS-1021 in Narcoleptic Patients With and Without Cataplexy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: NLS Pharmaceutics · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Narcolepsy With Cataplexy
• Narcolepsy
• Narcolepsy Without Cataplexy

Interventions

Type	Name	Description
DRUG	Mazindol	Drug: NLS-2

Timeline

• Start date: 2021-10-26
• Primary completion: 2023-01-19
• Completion: 2023-01-19
• First posted: 2021-09-23
• Last updated: 2023-03-13

Locations

22 sites across 1 country: United States

Regulatory

• FDA-regulated drug study