Your session is about to expire
← Back to Search
Vatiquinone for Mitochondrial Disease (MIT-E Trial)
MIT-E Trial Summary
This trial will test a new seizure medication called vatiquinone against a placebo. There will be a 28 day period to establish a baseline of seizure frequency, followed by a 24 week period where participants will be given either the medication or the placebo. After that, there is a 48 week extension phase where participants will receive the medication.
MIT-E Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.MIT-E Trial Design
Find a Location
Who is running the clinical trial?
Media Library
- You have had epilepsy related to mitochondrial disease for at least 6 months, unless you are under 2 years old and meet all other screening criteria.You have other health conditions that could make it hard to understand the study results, like fat malabsorption syndrome or mitochondrial disorders.Your blood test shows high levels of creatinine.You have taken vatiquinone before.You are allergic to vatiquinone or sesame oil.You have had an EEG test within the last 6 months to check for seizures.You have a genetic test showing you have specific inherited mitochondrial diseases, like Alpers/POLG, Leigh syndrome, or MELAS, or other confirmed mitochondrial diseases like PCH6 or MERRF.Your AST or ALT levels are more than three times higher than the normal range during screening.Even with taking at least 2 anti-seizure medications, you have had at least 6 visible seizures in the last 28 days before the study starts. You have had at least 2 visible seizures in the first 14 days and at least 2 in the second 14 days before the study starts. You have not had 20 consecutive days without a seizure, and you have recorded at least 80% of your seizures in a diary.You are taking a medication that has not been approved for treating mitochondrial diseases, or using homemade cannabidiol (CBD) products not approved by the government.You are currently taking strong medications that affect how other drugs work, like itraconazole or rifampin. If you are taking these medications, you must stop taking them at least 4 weeks before joining the study. Additionally, you should avoid using grapefruit or St John's wort during the study.You are currently taking idebenone along with the study drug.Your blood clotting test shows a higher than normal result.
- Group 1: Vatiquinone
- Group 2: Placebo
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What is the extent of Vatiquinone's clinical testing history?
"Currently, there are 4 different clinical trials underway to study the efficacy of Vatiquinone. Out of those 4, 2 have progressed to Phase 3 testing. The majority of these trials are taking place in Seattle, but there are a total 62 medical centres running these studies across the United States."
Are there any remaining slots that patients could fill in this research?
"The answer is affirmative, active recruitment for clinical trial participants is occurring. The original posting was on September 28th 2020 with the latest update being on September 19th 2022. Sixty individuals are needed to complete the study at 13 different locations."
Are there other places in America where this research is being conducted?
"Patients are currently being accepted at this clinical trial's 23 total locations, which include Boston Children Hospital in Boston, Massachusetts, John Hopkins Medicine in Baltimore, Maryland, and Children's National Medical Center - Department Of Neurology in Washington, District of Columbia."
Have other similar medical trials been conducted before this one?
"Vatiquinone was first studied in 2010 by PTC Therapeutics. The Phase 2 drug approval followed the initial 94-person trial. Currently, there are 4 ongoing studies involving vatiquinone across 13 different countries and 27 cities."
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger