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NCT Number: NCT04923594

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

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.

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Key information

Conditions

Narcolepsy Cataplexy Narcolepsy Disorders of Excessive Somnolence Dyssomnias Excessive Daytime Sleepiness Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sleep Disorders Center of Alabama, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

mazindol extended release

Drug

Dosed orally, once daily for up to 3 weeks

Other names: NLS-2

Placebo

Drug

Dosed orally, once daily for up to 4 weeks.

Primary outcomes

  1. Change in ESS Score From Baseline to Week 4

    Time frame: 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.

Secondary outcomes

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

    Time frame: Baseline to 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

Sponsors and collaborators

Lead sponsor

NLS Pharmaceutics

Industry

Registry information

Official study title

A Four-week, Double-blind, Placebo-controlled, Randomized, Multicenter, Parallel-group Study of the Safety and Efficacy of NLS-2 (Mazindol Extended Release) in Adults for the Treatment of Narcolepsy

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 11, 2021
Registry last updated
Aug 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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