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 Disease): A multinational, multi-center, open-label, rater-blinded Phase II study” is open for recruitment in Germany.
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). IB1001-202 has previously been accepted by Independent Ethics Committees, and the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) (EudraCT: 2018-004406-25), as well as National Regulatory Agencies in Spain, the United Kingdom, and the US Food and Drug Administration (IND 142302).
In Germany/Europe, patients aged 6 and older with a genetically confirmed diagnosis of GM2 Gangliosidosis 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.
Two trial sites have been officially established in Germany*: Ludwig Maximilian University (LMU) of Munich and the University of Giessen. As of September, LMU Munich is actively recruiting patients. It is planned the University of Giessen will begin recruitment in October 2019.
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:
Ludwig Maximilian University of Munich
Principal Investigator: Susanne Schneider, MD
Contact: Anita Hennig, MD
Tel: +49(0)89 4400 76777
University of Giessen
Principal Investigator: Andreas Hahn, MD
Contact: Kyriakos Martakis, MD
Tel: +49 (0)641 985 43543
*Additional German centers may be established.
For the complete enrollment criteria, as well as details regarding the study assessments, multinational clinical trial sites, etc., please visit ClinicalTrials.Gov(NCT03759665)