Four-week Study of the Safety and Efficacy of NLS-2 (Mazindol Extended Release) in the Treatment of Narcolepsy

• Status: Recruiting
• Trial end date: 2022-03-31
• Target enrollment: 0
• Participant gender: All

Summary

This is a double-blind, randomized, placebo-controlled, multicenter trial of NLS-2 in adult patients with narcolepsy. The study will enroll approximately 60 patients and eligible patients will be treated to receive either NLS-2 or placebo for 4-weeks.

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

Details

• Lead Sponsor: NLS Pharmaceutics
• Treatments: Mazindol

Criteria

Key Inclusion Criteria:

• Males and females between 18 and 65 years of age, inclusive

• Diagnosis of narcolepsy according to ICSD-3 (International Classification of Sleep Disorders, 3rd Edition) or Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria

• Body mass index from 18 to 40 kg/m2, inclusive

• Consent to use a medically acceptable method of contraception

• Willing and able to provide written informed consent

Key Exclusion Criteria:

• Female subjects who are pregnant, nursing, or lactating

• Any other clinically relevant medical, behavioral, or psychiatric disorder other than narcolepsy that is associated with excessive sleepiness

• History or presence of bipolar disorder, bipolar related disorders, schizophrenia, schizophrenia spectrum disorders, or other psychotic disorders according to DSM-5 criteria

• Use of any over-the-counter (OTC) or prescription medications that could affect the evaluation of excessive sleepiness

• Use of any medications that could affect the evaluation of cataplexy

• Received an investigational drug in the past 30 days or five half-lives (whichever is longer)