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

NCT05914194 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2024-05-21

No results posted yet for this study

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

Interventions

DRUG

NLS-2

Participants will receive NLS-2 tablets orally.

DRUG

Placebo

Participants will receive NLS-2 matching placebo tablets orally.

Sponsors & Collaborators

  • NLS Pharmaceutics

    lead INDUSTRY

Principal Investigators

  • George Apostol, MD, MS · NLS Pharmaceutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-15
Primary Completion
2025-07-30
Completion
2025-07-30
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05914194 on ClinicalTrials.gov