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

NLS Pharmaceutics67 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Narcolepsy Excessive Daytime Sleepiness Cataplexy Narcolepsy

Interventions

mazindol extended releaseDRUG

Dosed orally, once daily for up to 3 weeks

PlaceboDRUG

Dosed orally, once daily for up to 4 weeks.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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)

Locations (22)

Sleep Disorders Center of Alabama

Birmingham, Alabama, United States

Outcomes

Primary Outcomes

Change in ESS Score From Baseline to Week 4

Change in Epworth Sleepiness Scale (ESS) score from Baseline to Week 4. A negative change from baseline represents improvement in excessive sleepiness. The ESS is a self-administered questionnaire with 8 questions. Each activity is scored on a scale ranging from 0-3, with 0 = would never fall asleep, and 3 = high chance of falling asleep. The total score ranges from 0-24, with a higher number representing an increased propensity for sleepiness.

Time frame: Baseline to Week 4

Secondary Outcomes

Subjects Reported Improved on the Patient Global Impression of Change (PGIc) at Week 4

Percentage of subjects reported as improved (minimally, much, or very much) on the PGIc at Week 4. PGIc is rated by subjects and measures the change in their condition since treatment starts on a 7-point scale ranging from 1= very much improved to 7= very much worse

Time frame: Baseline to Week 4

Data from ClinicalTrials.gov

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