NCT01681121

A Study of the Safety and Effectiveness of ADX-N05 for Excessive Daytime Sleepiness in Subjects With Narcolepsy

A Twelve-week, Double-blind, Placebo-controlled, Randomized, Parallel-group, Multi-center Study of the Safety and Efficacy of ADX-N05 in the Treatment of Excessive Daytime Sleepiness in Subjects With Narcolepsy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: Jazz Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 70 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 4 weeks followed by 300 mg once a day for 8 weeks
DRUG	Placebo	One capsule placebo to match ADX-N05 to be taken for 4 weeks followed by 2 capsules placebo to match ADX-N05 to be taken for 8 weeks

Timeline

• Start date: 2012-09-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2012-09-07
• Last updated: 2021-05-28
• Results posted: 2014-09-11

Locations

28 sites across 1 country: United States