NCT01485770

A Study of the Safety and Effectiveness of ADX-N05 in the Treatment of Excessive Daytime Sleepiness

A Four-week, Double-blind, Placebo-controlled, Randomized, Cross-over Study of the Safety and Efficacy of ADX-N05 in the Treatment of Excessive Daytime Sleepiness

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Jazz Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a study to evaluate the safety and effectiveness of ADX-N05 compared to placebo in the treatment of excessive daytime sleepiness in adults with narcolepsy.

Conditions

• Narcolepsy

Interventions

Type	Name	Description
DRUG	ADX-N05	150 mg once a day for seven days followed by 300 mg once a day for seven days
DRUG	Placebo	Placebo to match ADX-N05 once a day for 2 consecutive weeks

Timeline

• Start date: 2011-12-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2011-12-06
• Last updated: 2021-07-06
• Results posted: 2021-07-06

Locations

10 sites across 1 country: United States