NCT04923594

Four-week Study of the Safety and Efficacy of NLS-2 (Mazindol Extended Release) in the Treatment of Narcolepsy

A Four-week, Double-blind, Placebo-controlled, Randomized, Multicenter, Parallel-group Study of the Safety and Efficacy of NLS-2 (Mazindol Extended Release) in Adults for the Treatment of Narcolepsy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: NLS Pharmaceutics · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a double-blind, randomized, placebo-controlled, multicenter trial of NLS-2 in adult patients with narcolepsy. The study will enroll approximately 60 patients and eligible patients will be treated to receive either NLS-2 or placebo for 4-weeks.

Conditions

• Narcolepsy
• Excessive Daytime Sleepiness
• Cataplexy Narcolepsy

Interventions

Type	Name	Description
DRUG	mazindol extended release	Dosed orally, once daily for up to 3 weeks
DRUG	Placebo	Dosed orally, once daily for up to 4 weeks.

Timeline

• Start date: 2021-09-13
• Primary completion: 2022-06-30
• Completion: 2022-06-30
• First posted: 2021-06-11
• Last updated: 2022-08-12

Locations

22 sites across 1 country: United States

Regulatory

• FDA-regulated drug study