At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 93 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.
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
In Brief
A Phase 2 clinical trial evaluating ADX-N05 and Placebo for Narcolepsy. Completed, enrolled 93 participants across 28 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
20132014201520162017201820192020202120222023202420252026
Enrollment StartSep 2012
First PostedSep 2012
Primary CompletionAug 2013
TodayJul 2026
First PostedSep 7, 2012
Enrollment StartSep 1, 2012
Primary CompletionAug 1, 2013
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 13.8 years ago
Interventions
ADX-N05drug
150 mg once a day for 4 weeks followed by 300 mg once a day for 8 weeks
Placebodrug
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