GNX oral suspension, TID for Adenoma Sebaceum
Phase-Based Progress Estimates
Effectiveness
Safety
Adenoma Sebaceum+2 More
GNX oral suspension, TID - DrugEligibility
Any Age
All Sexes
What conditions do you have?
Select
Eligibility
Any Age
All Sexes
What conditions do you have?
Select
Study Summary
This trial is testing a possible new treatment for epilepsy in people with tuberous sclerosis complex. It is a Phase 3 study, which means it is one of the last stages of testing before the drug can be approved.
Eligible Conditions
- Adenoma Sebaceum
Treatment Effectiveness
Effectiveness Progress
This is further along than 85% of similar trials
Study Objectives
1 Primary · 16 Secondary · Reporting Duration: Day 1 through Week 16
Week 12
Number (%) of participants considered treatment responders during the maintenance phase.
Seizure Frequency Change - Maintenance
Seizure Frequency During Maintenance
Week 16
Anxiety, Depression, and Mood Scale
Clinical Global Impression
Clinical Global Impression of Change in Seizure Intensity and Duration
Epilepsy and Learning Disabilities Quality of Life Scale
Number (%) of participants considered treatment responders during the double-blind phase
Pediatric Quality of Life Inventory - Family Impact Module
Responder Analysis
Seizure Control
Seizure Frequency - All Seizures
Seizure Frequency Change - Double Blind
Seizure-Free Days
Seizure-Free Interval
Short Form - 36
Week 16
Seizure Frequency During 28-day double-blind phase
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Trial Design
2 Treatment Groups
GNX
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group
162 Total Participants · 2 Treatment Groups
Primary Treatment: GNX oral suspension, TID · Has Placebo Group · Phase 3
GNX
Drug
Experimental Group · 1 Intervention: GNX oral suspension, TID · Intervention Types: DrugPlacebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: DrugTrial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day 1 through week 16
Who is running the clinical trial?
Marinus PharmaceuticalsLead Sponsor
20 Previous Clinical Trials
1,686 Total Patients Enrolled
Eligibility Criteria
Age Any Age · All Participants · 10 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You are male or female and you are aged 1 through 65 years, inclusive.
You are 7 years of age or older.
A history of at least 8 countable seizures per month in the 2 months prior to screening with no more than 1 seizure free week in each month.
You have at least 2 seizures in the 28 days following the screening visit.
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.
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Conditions
Cancer Related
Treatments