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An Open Label Study of NLS-2 (Mazindol Extended Release) in Subjects With Narcolepsy

NCT05055024 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2023-03-13

No results posted yet for this study

Summary

This is a multicenter, open-label extension of the clinical study NLS-1021, evaluating long-term safety, tolerability, pharmacokinetics (PK), and therapeutic response to treatment with NLS-2 in adult subjects with narcolepsy.

Conditions

  • Narcolepsy With Cataplexy
  • Narcolepsy
  • Narcolepsy Without Cataplexy

Interventions

DRUG

Mazindol

Drug: NLS-2

Sponsors & Collaborators

  • NLS Pharmaceutics

    lead INDUSTRY

Principal Investigators

  • Carlos Camozzi, MD · NLS Pharmaceutics

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-26
Primary Completion
2023-01-19
Completion
2023-01-19
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT05055024 on ClinicalTrials.gov