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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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

Brief 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.

Detailed Summary:
Sponsor: Jazz Pharmaceuticals

Current Primary Outcome:

  • Change From Baseline in the Average Sleep Latency Time (in Minutes) as Determined From the Maintenance of Wakefulness Test for ADX-N05 vs. Placebo at Last Assessment. [ Time Frame: Baseline and 12 weeks ]
    Sleep Latency - The primary analysis was a comparison of treatments vs. control groups on change from Baseline to last available post-Baseline assessment (Week 12/Last Assessment) in the average sleep latency time (in minutes) averaged across the first four trials of the MWT using a two-sample t-test.
  • Evaluate the Clinical Global Impression-Change Scores for ADX-N05 vs. Placebo at Last Assessment [ Time Frame: 12 weeks ]


Original Primary Outcome:

  • Evaluate the Change From Baseline in the Average Sleep Latency Time (in Minutes) as Determined From the Maintenance of Wakefulness Test for ADX-N05 vs. Placebo at Last Assessment. [ Time Frame: 12 weeks ]
  • Evaluate the Clinical Global Impression-Change Scores for ADX-N05 vs. Placebo at Last Assessment [ Time Frame: 12 weeks ]


Current Secondary Outcome:

  • Evaluate the Change From Baseline in Epworth Sleepiness Scale Scores for ADX-N05 vs. Placebo at Week 4 [ Time Frame: 4 weeks ]
  • Evaluate the Change From Baseline in Epworth Sleepiness Scale Scores for ADX-N05 vs. Placebo at Last Assessment [ Time Frame: 12 weeks ]
  • Evaluate the Change From Baseline in the Average Sleep Latency Time (in Minutes) as Determined From the Maintenance of Wakefulness Test (Average of the First Four Trials) Following Four Weeks of Treatment With ADX-N05 150 mg vs. Placebo [ Time Frame: 4 weeks ]
  • Evaluate the Change From Baseline in Sleep Latency Time (in Minutes) as Determined From Each of the 5 Individual Maintenance of Wakefulness Test Trials for ADX-N05 vs. Placebo at Week 4 [ Time Frame: 4 weeks ]
  • Evaluate the Change From Baseline in Sleep Latency Time (in Minutes) as Determined From Each of the 5 Individual Maintenance of Wakefulness Test Trials for ADX-N05 vs. Placebo at Last Assessment [ Time Frame: 12 weeks ]
  • Evaluate the Clinical Global Impression-Change Scores for ADX-N05 vs. Placebo at Week 4 [ Time Frame: 4 weeks ]
  • Evaluate the Patient Global Impression-Change Scores for ADX-N05 vs. Placebo at Week 4 [ Time Frame: 4 weeks ]
  • Evaluate the Patient Global Impression-Change Scores for ADX-N05 vs. Placebo at Last Assessment [ Time Frame: 12 weeks ]
  • Evaluate the Safety and Tolerability of ADX-N05 vs Placebo in Adults With Narcolepsy by Assessing Treatment Emergent Adverse Events, Vital Signs, Laboratory Results, ECGs, and Physical Exams. [ Time Frame: 12 weeks ]


Original Secondary Outcome: Same as current

Information By: Jazz Pharmaceuticals

Dates:
Date Received: September 5, 2012
Date Started: September 2012
Date Completion:
Last Updated: September 15, 2014
Last Verified: September 2014