Completed
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
What is being tested
ADX-N05
+ Placebo
Drug
Who is being recruted
Mental Disorders+4
+ Disorders of Excessive Somnolence
+ Nervous System Diseases
From 18 to 70 Years
+12 Eligibility Criteria
How is the trial designed
Treatment Study
Placebo-ControlledPhase 2
Interventional
Study Start: September 2012
Summary
Principal SponsorJazz Pharmaceuticals
Last updated: May 28, 2021
Sourced from a government-validated database.Claim as a partner
Study start date: September 1, 2012
Actual date on which the first participant was enrolled.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.
Principal SponsorJazz Pharmaceuticals
Last updated: May 28, 2021
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
93 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 70 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Mental DisordersDisorders of Excessive SomnolenceNervous System DiseasesSleep Wake DisordersSleep Disorders, IntrinsicDyssomniasNarcolepsy
Criteria
3 inclusion criteria required to participate
Diagnosis of narcolepsy
Good general health
Willing and able to comply with the study design and schedule and other requirements
9 exclusion criteria prevent from participating
Any other clinically relevant medical, behavioral or psychiatric disorder other than narcolepsy that is associated with excessive sleepiness
Body mass index > 34
Customary bedtime later than midnight
Excessive caffeine use - > 600 mg/day of caffeine or > 6 cups of coffee/day
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalADX-N05 to be taken once a day for 12 weeks
Group II
PlaceboPlacebo to match ADX-N05 to be taken once a day for 12 weeks
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 28 locations
Sleep Disorders Center of Alabama
Birmingham, United StatesOpen Sleep Disorders Center of Alabama in Google MapsPulmonary Associates
Phoenix, United StatesStanford Sleep Medicine Center
Redwood City, United StatesPacific Research Network
San Diego, United StatesCompleted28 Study Centers