Eligibility
Any Age
All Sexes
What conditions do you have?
Select
Study Summary
This trial is testing a new medication for people with narcolepsy who experience sudden muscle weakness (cataplexy) and excessive daytime sleepiness. The goal is to see if the medication is safe and effective. The FDA has approved AXS-12 (reboxetine) to treat narcolepsy. This is the second condition that AXS-12 (reboxetine) has been approved to treat by the FDA.
Eligible Conditions
- Narcolepsy
- Excessive Daytime Sleepiness
- Cataplexy
Treatment Effectiveness
Effectiveness Progress
This is further along than 85% of similar trials
Study Objectives
2 Primary · 2 Secondary · Reporting Duration: Change from Baseline to Week 5
Week 5
Average weekly frequency of cataplexy attacks
Average weekly frequency of concentration
Average weekly frequency of inadvertent naps
Frequency of cataplexy attacks
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Trial Design
2 Treatment Groups
AXS-12 (reboxetine)
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group
90 Total Participants · 2 Treatment Groups
Primary Treatment: AXS-12 (reboxetine) · Has Placebo Group · Phase 3
AXS-12 (reboxetine)
Drug
Experimental Group · 1 Intervention: AXS-12 (reboxetine) · Intervention Types: DrugPlacebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: DrugTrial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: change from baseline to week 5
Closest Location: Clinical Research Site · Sugar Land, TX
2005First Recorded Clinical Trial
2 TrialsResearching Narcolepsy
19 CompletedClinical Trials
Who is running the clinical trial?
Axsome Therapeutics, Inc.Lead Sponsor
23 Previous Clinical Trials
7,077 Total Patients Enrolled
3 Trials studying Narcolepsy
117 Patients Enrolled for Narcolepsy
Eligibility Criteria
Age Any Age · All Participants · 3 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You are male or female, aged between 15 and 75 years, inclusive.
The patient has a primary diagnosis of narcolepsy with cataplexy
, patients are likely to be included in the study
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
Popular Clinical Trials
Top Clinical Trials in Cities
Relevant Clinical Trials
Unbiased Results
We believe in providing patients with all the options.Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.Back to top
Conditions
Cancer Related
Treatments