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AUT00201 for Myoclonic Epilepsy (AUT022201 Trial)
Phase 1
Recruiting
Led By Michael Gelfand, MD
Research Sponsored by Autifony Therapeutics Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 19 days
Awards & highlights
AUT022201 Trial Summary
This trial will test a potential treatment for MEAK, by studying its safety, tolerability, and how it is processed in the body.
Who is the study for?
This trial is for adults diagnosed with MEAK, a form of epilepsy due to a specific potassium channel mutation. Participants must be stable in health and seizure control, not have certain genetic mutations or drug abuse history, and women must test negative for pregnancy.Check my eligibility
What is being tested?
The study tests AUT00201 against a placebo in patients with MEAK. It's randomized and double-blind, meaning neither the researchers nor participants know who gets the real drug or placebo during the trial. The focus is on safety and how the body processes the drug.See study design
What are the potential side effects?
While specific side effects are not listed here, common ones may include reactions at injection sites, gastrointestinal issues like nausea or diarrhea, potential allergic reactions to ingredients in AUT00201, fatigue, headache or changes in mood.
AUT022201 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 19 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~19 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants With Treatment-Related Adverse Events after Single Dose Treatment of AUT00201 compared to Placebo
Secondary outcome measures
Change from baseline in cortical inhibition
Pharmacokinetics: Area under the plasma concentration-time curve (AUC) of AUT00201
Pharmacokinetics: Maximum Plasma Concentrations (Cmax) of AUT00201
AUT022201 Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Experimental: AUT00201Experimental Treatment1 Intervention
Single dose (oral, capsule) of AUT00201
Group II: Experimental: PlaceboPlacebo Group1 Intervention
Single dose matching placebo oral capsules
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AUT00201
2019
Completed Phase 1
~80
Find a Location
Who is running the clinical trial?
Autifony Therapeutics LimitedLead Sponsor
7 Previous Clinical Trials
310 Total Patients Enrolled
Michael Gelfand, MDPrincipal InvestigatorPenn Epilepsy Center, Department of Neurology
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a specific genetic mutation that causes epilepsy or a different mutation in the KCNC1 gene than the c.959G>A variant.You have had thoughts of hurting yourself in the past 6 months or have a history of trying to hurt yourself in the past year.You have been diagnosed with a specific genetic mutation called KCNC1 (c.959G>A; p.Arg320His) associated with a condition called MEAK.You are currently taking vigabatrin and have been taking it for less than 2 years before the first visit.You are allergic to AUT00201 or any of its ingredients.You have a positive test for hepatitis B or hepatitis C.You have a noticeable heart problem on your electrocardiogram.You have not taken felbamate within the last year, or have any liver or bone marrow problems related to past or current use of felbamate. If you have taken felbamate for over a year and don't have these problems, you can participate.You have a serious health issue related to your metabolism, liver, blood, lungs, heart, stomach, or urinary system.Women who could become pregnant must have a negative pregnancy test before the second visit.If you take medicine for seizures, your dosage should stay the same for at least 30 days before the study starts. If you don't take seizure medicine, your seizures should stay the same for at least 30 days before the study starts.Your vital signs or test results show a significant health problem.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental: Placebo
- Group 2: Experimental: AUT00201
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What dangers do individuals face when utilizing Experimental: AUT00201?
"Due to the fact that Experimental: AUT00201 is in Phase 1, which involves minimal data collection on safety and efficacy, our team at Power has assigned it a score of 1."
Answered by AI
What is the scope of involvement in this clinical trial?
"Affirmative. Records from clinicaltrials.gov demonstrate that this medical investigation, which was first posted on May 1st 2023, is actively recruiting participants. A total of 10 patients are needed to take part in the trial at one location."
Answered by AI
Does this research initiative currently accept participants?
"As established on clinicaltrials.gov, this study is actively seeking applicants. This trial had its first posting date of May 1st 2023 and the most recent update was given on May 15th 2023."
Answered by AI
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