Study Investigating Irritability Related to Gastrointestinal Symptoms Currently Enrolling Teens

May 15, 2022

New Clinical Trial Will Research Experimental Drug Treatment

Axial Therapeutics is recruiting teens with autism and severe irritability to take part in their Tapestry Autism Study. This placebo-controlled clinical trial plans to research an experimental medication, AB-2004, which is designed to absorb specific substances produced by bacteria in the gastrointestinal tract to reduce their ability to enter the bloodstream and reach the brain. The Axial researchers believe that preventing these substances from reaching the brain may stop characteristics like irritability from developing. The purpose of this study is to learn how well AB-2004 improves irritability symptoms in 13 to 17-year-olds compared to placebo. The trial also seeks to determine the most effective dose of the medication. The trial’s design involves subjects taking either AB-2004 or a placebo, both formulated as a tasteless and odorless powder that can be mixed into any soft food (yogurt, applesauce, etc…), three times a day for eight weeks. Participants will then be examined by the study doctor to look for any changes in their health. Blood, urine and stool testing will also be conducted throughout the study. Blood will only be drawn three times. Participants will need to complete questionnaires about their behavior throughout the trial. In total, the study will require six visits over 14-16 weeks. There are 25 locations conducting this clinical trial across the United States, Australia, and New Zealand. Expenses for travel to and from the doctor and medical visits will be paid for by Axial Therapeutics. 

Study Announcement

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