IntraBio Inc. is pleased to confirm that the Clinical Trial IB1001-203, “Effects of N-Acetyl-L-Leucine on Ataxia-Telangiectasia (A-): A multinational, multi-center, open-label, rater-blinded Phase II study” is open for recruitment in the United States.
IB1001-203 is a multinational study that investigates the effects of the novel drug IB1001 (N-Acetyl-L-Leucine) for the treatment of Ataxia-Telangiectasia (A-T). The trial has previously been accepted by the US Food and Drug Administration (IND 138188) as well as National Authorities in the United Kingdom.
In the US, patients aged 18 and older with a confirmed genetic diagnosis of A-T may be eligible for recruitment. The trial will consist of three study phases: a baseline period, a 6-week treatment period, and a 6-week post-treatment washout period. Patients (and a caregiver) will be reimbursed for reasonable out-of-pocket expenses incurred for participating in the trial, such as travel and parking.
One trial site has been established in the United States for the IB1001-203 study. Patients and families who are interested in learning more about the trial, including the eligibility criteria and enrolment process, should contact the study site. Recruitment is expected to continue rapidly and complete by March 2020.
University of California – Los Angeles
Los Angeles, California, United States, 90095
Principal Investigator: Dr Susan Perlman, MD
Contact: Aaron Fisher, Staff Research Associate Supervisor
For the complete enrollment criteria, as well as details regarding the study assessments, multinational clinical trial sites, etc., please visit ClinicalTrials.Gov (NCT03759678).