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

• Status: Not yet recruiting
• Trial end date: 2022-10-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NLS Pharmaceutics
• Treatments: Mazindol

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.