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