Effects of N-Acetyl-L-Leucine on GM2 Gangliosdisosis (Tay-Sachs and Sandhoff Disease): A Multinational, Multicenter, Open-label, Rater-blinded Phase II Study
Phase of Trial: Phase II
Latest Information Update: 23 Oct 2019
Price : $35 *
At a glance
- Drugs L-Acetylleucine (Primary)
- Indications GM2 gangliosidoses; Sandhoff disease; Tay-Sachs disease
- Focus Therapeutic Use
- Sponsors IntraBio
- 18 Sep 2019 According to an IntraBio media release, this trial has been accepted by Independent Ethics Committees (IEC), and the Spanish Agency of Medicines and Medical Products (AEMPS) as well as National Regulatory Agencies in Germany, Slovakia, the United Kingdom, and the US Food and Drug Administration (IND 142302).
- 18 Sep 2019 According to an IntraBio media release, this trial is open for recruitment in Spain.
- 15 Sep 2019 According to an IntraBio media release, this trial is open for recruitment in Germany. 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 and it is planned the University of Giessen will begin recruitment in October 2019.