Mazindol for Narcolepsy

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Bogan Sleep Consultants, Columbia, SC
Narcolepsy+3 More
Mazindol - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is looking at the long-term effects of a drug called NLS-2 in people with narcolepsy. Mazindol is used to treat Narcolepsy and has been previously approved by the FDA for a different condition. No patients in this trial will receive a placebo.

Eligible Conditions

  • Narcolepsy
  • Narcolepsy Without Cataplexy
  • Narcolepsy With Cataplexy

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Narcolepsy

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 24 weeks

24 weeks
To evaluate the safety and tolerability of NLS-2 in adult subjects with narcolepsy type 1 (NT1) or narcolepsy type 2 (NT2)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Narcolepsy

Trial Design

1 Treatment Group

NLS-2 (mazindol extended release)
1 of 1
Experimental Treatment

60 Total Participants · 1 Treatment Group

Primary Treatment: Mazindol · No Placebo Group · Phase 2

NLS-2 (mazindol extended release)
Drug
Experimental Group · 1 Intervention: Mazindol · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 24 weeks
Closest Location: Bogan Sleep Consultants · Columbia, SC
Photo of columbia 1Photo of columbia 2Photo of columbia 3
2020First Recorded Clinical Trial
4 TrialsResearching Narcolepsy
3 CompletedClinical Trials

Who is running the clinical trial?

NLS PharmaceuticsLead Sponsor
2 Previous Clinical Trials
151 Total Patients Enrolled
1 Trials studying Narcolepsy
67 Patients Enrolled for Narcolepsy
Carlos Camozzi, MDStudy DirectorNLS Pharmaceutics
1 Previous Clinical Trials
67 Total Patients Enrolled
1 Trials studying Narcolepsy
67 Patients Enrolled for Narcolepsy

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
The subject is able to receive NLS-2 for the 24-week Treatment Phase of this study, in the Investigator's opinion.
Any female participant who is able to have children must agree to use a form of contraception that will prevent pregnancy for the duration of the study.
the subject has returned all study questionnaires; and the subject has not lost any study visits
The subject must complete all of the Study NLS-1021 study requirements and assessments up to visit 6.
The subject agrees to participate in the open-label extension study.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.