CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 33 enrolled
Drug / intervention
ADX-N05 +1 moredrug
Likely dose
ADX-N05 150 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01485770
NCT01485770Phase 2Completed
CompareCT.gov

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

Jazz Pharmaceuticals·interventional·Posted Dec 6, 2011·Updated Jul 6, 2021

In Brief

A Phase 2 clinical trial evaluating ADX-N05 and Placebo for Narcolepsy. Completed, enrolled 33 participants across 10 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNarcolepsy
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 6, 2011
Enrollment StartDec 1, 2011
Primary CompletionMay 1, 2012
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 14.6 years ago

Interventions

ADX-N05drug

150 mg once a day for seven days followed by 300 mg once a day for seven days

Placebodrug

Placebo to match ADX-N05 once a day for 2 consecutive weeks