A Eight-Week Study of NLS-2 (Mazindol Extended Release) in Participants With Narcolepsy Type 1

NCT05914194 | Not Yet Recruiting Phase 3 FDA Drug

• 1 other identifier: NLS-1031
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to see how NLS-2 (mazindol extended-release) works on symptoms of narcolepsy, including cataplexy and excessive daytime sleepiness. Approximately 48 participants will take part in the study across the United States. The study treatment (NLS-2 or placebo) will be administered for 8 weeks. After this treatment period, the participant may have the option to participate in a separate long-term extension study during which all participants will be treated with NLS-2.

Conditions

Narcolepsy Type 1; Narcolepsy With Cataplexy

Keywords

Narcolepsy; Cataplexy; Narcolepsy Type 1; Narcolepsy with Cataplexy

Outcome Measures

Primary Outcomes (1)

• Number of cataplexy episodes at Week 8

  Cataplexy episodes is a clinical outcome measure that assesses the frequency of cataplexy episodes.

  8 weeks

Secondary Outcomes (5)

• Patient Reported Outcomes Measurement Information System-Sleep Related Impairment (PROMIS-SRI): change from baseline

  8 weeks

• Patient Reported Outcomes Measurement Information System-Sleep Disturbance (PROMIS-SD): change from baseline

  8 weeks

• Epworth Sleepiness Scale (ESS): change from baseline

  8 weeks

• Patient Global Impression of Severity (PGI-S): change from baseline

  8 weeks

• Clinician Global Impression of Severity (CGI-S): change from baseline

  8 weeks

Study Arms (2)

NLS-2

EXPERIMENTAL

Participants will receive a single NLS-2 tablet orally once daily from Day 1 to Day 56 (until the end of Week 8).

Drug: NLS-2

Placebo

PLACEBO COMPARATOR

Participants will receive a single NLS-2 placebo matching tablet orally once daily from Day 1 to Day 56 (until the end of Week 8).

Drug: Placebo

Interventions

NLS-2 DRUG

Participants will receive NLS-2 tablets orally.

Also known as: mazindol extended-release (ER), mazindol controlled-release (CR)

NLS-2

Placebo DRUG

Participants will receive NLS-2 matching placebo tablets orally.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults ≥ 18 years of age at the time of signing the informed consent.
• Documented primary diagnosis of Narcolepsy Type 1 (NT1) according to the International Classification of Sleep Disorders-Third Edition (ICSD-3) criteria.
• Willing and able to safely discontinue all prohibited medications, including medications for the treatment of narcolepsy.
• Body Mass Index (BMI) within the range of 18 - 40 kg/m2 (inclusive).

You may not qualify if:

• Any other (besides narcolepsy) clinically relevant medical, behavioral, or psychiatric disorder that is associated with excessive daytime sleepiness or cataplexy.
• History of myocardial infarction or significant cardiovascular disease, structural cardiac abnormalities, cardiomyopathy, congestive heart failure, cardiac arrhythmias, coronary artery disease, cerebrovascular disease (transient ischemic attack or stroke), or any other significant cardiac problem.
• History of long QT Syndrome or Torsades de Pointes, or an immediate family history of sudden cardiac death.
• History of pulmonary hypertension and/or valvulopathy.
• History of epilepsy, convulsions, or seizures (excluding early childhood febrile seizures).
• Significant history of head injury or head trauma.
• Recent or active suicidal ideation or behavior
• Current, or within the past year, diagnosis of substance abuse or dependence disorder (SUD) including alcohol abuse.
• Narrow-angle glaucoma.
• Severe renal or hepatic insufficiency.
• Occupation that requires variable or nighttime shift work.

Sponsors & Collaborators

• NLS Pharmaceutics: lead

MeSH Terms

Conditions

Narcolepsy; Cataplexy

Condition Hierarchy (Ancestors)

Disorders of Excessive Somnolence; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• George Apostol, MD, MS

  NLS Pharmaceutics

  STUDY CHAIR

Central Study Contacts

Jeff Bernier

CONTACT

617-905-2282; amaze@nls-pharma.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Double-Blind, Placebo-Controlled

Study Record Dates

• First Submitted: June 13, 2023
• First Posted: June 22, 2023
• Study Start: July 15, 2024
• Primary Completion: July 30, 2025
• Study Completion: July 30, 2025
• Last Updated: May 21, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share