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Central Nervous System Stimulant

NLS-2 (mazindol extended release) for Excessive Daytime Sleepiness

Phase 2
Waitlist Available
Research Sponsored by NLS Pharmaceutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 4
Awards & highlights

Study Summary

This study is evaluating whether a drug called NLS-2 can help people with narcolepsy.

Eligible Conditions
  • Excessive Daytime Sleepiness
  • Narcolepsy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 4
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 4 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in ESS Score From Baseline to Week 4
Secondary outcome measures
Subjects Reported Improved on the Patient Global Impression of Change (PGIc) at Week 4

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: NLS-2 (mazindol extended release)Active Control1 Intervention
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)
Group II: PlaceboPlacebo Group1 Intervention
Dosed orally, once daily for up to 4 weeks

Find a Location

Who is running the clinical trial?

NLS PharmaceuticsLead Sponsor
3 Previous Clinical Trials
184 Total Patients Enrolled
Carlos Camozzi, MDStudy DirectorNLS Pharmaceutics
1 Previous Clinical Trials
52 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Indiana
Texas
How old are they?
18 - 65
What site did they apply to?
Stanford Sleep Medicine Center
Dharma PA d/b/a Southwest Family Medicine Associates
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Recent research and studies
clinicaltrials.govStudy
Four-week Study of the Safety and Efficacy of NLS-2 (Mazindol Extended Release) in the Treatment of Narcolepsy
2021. "Four-week Study of the Safety and Efficacy of NLS-2 (Mazindol Extended Release) in the Treatment of Narcolepsy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04923594.
~19 spots leftby Apr 2025
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