IntraBio Inc. is pleased to confirm that the Clinical Trial IB1001-202, “Effects of N-Acetyl-L-Leucine on GM2 Gangliosidosis (Tay-Sachs and Sandhoff): A multinational, multi-center, open-label, rater-blinded Phase II study” is open for recruitment in Spain.
IB1001-202 is a multinational study that investigates the effects of the novel drug IB1001 (N-Acetyl-L-Leucine) for treatment of GM2 Gangliosidosis (Tay-Sachs and Sandhoff Disease). The trial has previously been accepted by Independent Ethics Committees (IEC), and the Spanish Agency of Medicines and Medical Products (AEMPS; EudraCT: 2018-004406-25) as well as National Regulatory Agencies in Germany, Slovakia, the United Kingdom, and the US Food and Drug Administration (IND 142302).
In Spain/Europe, patients aged 6 and older with a confirmed genetic diagnosis of Tay-Sachs of Sandhoff disease 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.
Patients and families who are interested in learning more about the trial, including the eligibility criteria and enrolment process, should please contact the study team:
Bellvitge University Hospital
Principal Investigator: Jordi Gascon Bayarri, MD
Contact Email: firstname.lastname@example.org
Contact Tel: +34 932 607500 ext 2958
For the complete enrolment criteria, as well as details regarding the study assessments, multinational clinical trial sites, etc., please visit ClinicalTrials.Gov(NCT03759665)