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 Kingdom.
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 Independent Ethics Committees (IEC), and the UK Medicines and Healthcare products Regulatory Agency (EudraCT: 2018-004407-39), as well as the US Food and Drug Administration (IND 138188).
In the UK/Europe, patients aged 6 and older with a confirmed 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 followed by a planned one-year extension phase. 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 Kingdom for adult patients (aged 18+). Patients and families who are interested in learning more about the trial, including the eligibility criteria and enrolment process, should contact their prospective study site:
Royal Papworth Hospital NHS Foundation Trust
Trial Site for Patients Aged 18+
Principal Investigator: Nicholas Oscroft, MD
Contact: Jennifer Gray, Clinical Research Manager
Tel: +44 (0) 1223 639717
For the complete enrollment criteria, as well as details regarding the study assessments, multinational clinical trial sites, etc., please visit ClinicalTrials.Gov (NCT03759678).