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Arbaclofen for Deletion Syndrome
Study Summary
This trial is testing a medication to see if it is safe and effective for children with a certain gene deletion.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2019 Phase 3 trial • 536 Patients • NCT03290131Trial Design
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Who is running the clinical trial?
Media Library
- I am currently taking more than 2 medications for mental health, not counting as-needed sleep aids.I have been treated with baclofen in the last 30 days.I have a 16p11.2 BP4-BP5 deletion diagnosis.I cannot or do not want to take medicine that dissolves in the mouth.My medications have not changed in the last 30 days.You have had a strong allergic reaction to racemic baclofen in the past.I do not have any major hearing, vision, or severe motor issues that could affect test results.I do not have any health or mental conditions that could affect my safety or the study results.I am currently taking vigabatrin, tiagabine, or riluzole.I have a genetic disorder in addition to the 16p11.2 BP4-BP5 deletion.I am currently taking medication for a psychiatric condition.I am not taking anxiety medication more than 3 times a week.I haven't had seizures in the last 6 months and am not on antiepileptics.I am between 5 and 17 years old.I have been seizure-free for 6 months on stable medication or 3 years without medication.I am not pregnant and will use birth control during and after the trial.You need special educational or therapeutic support for a developmental disability.I haven't changed my treatment or diet for my condition in the last 2 months.I plan to start or change my treatment during the study.
- Group 1: Arbaclofen
- 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
To whom does this experimental procedure extend?
"This study is for 5-17 year olds that have 16p11.2 deletion syndrome. They are looking for a maximum of 60 patients in total."
Are recruitment efforts for this trial still ongoing?
"That is correct, the online information does show that this study is looking for more participants. The 60 individuals needed for the trial will be recruited from 3 different locations, and recruitment started on September 1st, 2020 according to the most recent update on August 25th, 2020."
Are there any harmful side-effects associated with Arbaclofen?
"Arbaclofen is a Phase 2 trial medication, meaning that while there is data suggesting it is safe, there is no evidence yet of the drug's efficacy. Our team rates its safety at a 2."
Are octogenarians welcome in this trial?
"Children aged 5 to 17 can be enrolled in this trial, as long as they meet the other entrance requirements. There are a total of 4 different trials: 3 for patients under 18 and 1 for those over 65."
Is Arbaclofen a common medication in research trials?
"As of now, there are 3 ongoing clinical trials for Arbaclofen with 1 trial in Phase 3. While many of the trials for Arbaclofen are located in Houston, Texas, there are 10 locations operating clinical trials for Arbaclofen globally."
How many people are subjects in this experiment?
"That is accurate. The clinicaltrials.gov website contains information suggesting that this study, which was originally published on September 1st 2022, is still recruiting patients. They are looking for a total of 60 individuals from 3 different locations."
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