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

NLS Pharmaceutics

Status and phase: Completed; Phase 2

Conditions: Cataplexy Narcolepsy; Excessive Daytime Sleepiness; Narcolepsy

Treatments: Drug: Placebo; Drug: mazindol extended release

Study type: Interventional

Funder types: Industry

Identifiers

NCT04923594

NLS-1021

Details and patient eligibility

About

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.

Enrollment: 67 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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67 participants in 2 patient groups, including a placebo group

NLS-2 (mazindol extended release)

Active Comparator group

Description:

2 mg dosed orally, once daily for 1 week; followed by 3 mg dosed orally, once daily for up to 3 weeks (total of 4 weeks)

Treatment:

Drug: mazindol extended release

Placebo

Placebo Comparator group

Description:

Dosed orally, once daily for up to 4 weeks

Treatment:

Drug: Placebo