GNX oral suspension, TID for Adenoma Sebaceum

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Adenoma Sebaceum+2 More
GNX oral suspension, TID - Drug
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

2 of 3
This is further along than 85% of similar trials

Other trials for Adenoma Sebaceum

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

3 of 3
This is further along than 85% of similar trials

Other trials for Adenoma Sebaceum

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: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial 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 preview

Michael Gill - B. Sc.

First Published: October 30th, 2021

Last Reviewed: October 31st, 2022

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.