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

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ClinicalTrials.gov Identifier: NCT04923594
Recruitment Status : Completed
First Posted : June 11, 2021
Last Update Posted : August 12, 2022
Sponsor:
Information provided by (Responsible Party):
NLS Pharmaceutics

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Narcolepsy Excessive Daytime Sleepiness Cataplexy Narcolepsy Drug: mazindol extended release Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : September 13, 2021
Actual Primary Completion Date : June 30, 2022
Actual Study Completion Date : June 30, 2022

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: NLS-2 (mazindol extended release)
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)
 Drug: mazindol extended release
Dosed orally, once daily for up to 3 weeks
Other Name: NLS-2
Placebo Comparator: Placebo
Dosed orally, once daily for up to 4 weeks
 Drug: Placebo
Dosed orally, once daily for up to 4 weeks.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04923594


Locations
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Sponsors and Collaborators
NLS Pharmaceutics
Investigators
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Study Director: Carlos Camozzi, MD NLS Pharmaceutics
More Information
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Responsible Party: NLS Pharmaceutics
ClinicalTrials.gov Identifier: NCT04923594    
Other Study ID Numbers: NLS-1021
First Posted: June 11, 2021    Key Record Dates
Last Update Posted: August 12, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Narcolepsy
Disorders of Excessive Somnolence
Cataplexy
Sleepiness
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Mazindol
 Central Nervous System Stimulants
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Dopamine Uptake Inhibitors
Dopamine Agents