MOVES-PD
Research type
Research Study
Full title
Multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, pharmacokinetics, and pharmacodynamics of GZ/SAR402671 in patients with early-stage Parkinson’s disease carrying a GBA mutation or other pre-specified variant.
IRAS ID
216587
Contact name
Anthony Schapira
Contact email
Sponsor organisation
sanofi
Eudract number
2016-000657-12
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
U1111-1180-6918, WHO universal trial number:
Duration of Study in the UK
4 years, 4 months, 28 days
Research summary
GZ/SAR402671 has never been tested in patients with Parkinson’s disease (PD), including Parkinson’s patients who have mutations in genes (such as the glucocerebrosidase gene, GBA). Research indicates that GBA is a genetic risk factor for PD. Based on this research, it is believed that PD patients with a GBA mutation (GBA-PD) have an associated reduction in a brain protein that leads to an increase in the levels of a lipid component in brain cells. It is thought that increases in this lipid component in the brain may disrupt normal brain functioning and lead to motor problems (e.g. shaking hands, stiff muscles, short steps, poor balance, and falls) and non motor problems (e.g. sleep, memory, long term attention, and ability to plan hard tasks).
This is a phase 2 study to evaluate the risks and effectiveness of a compound, GZ/SAR402671, in patients carrying the GBA mutation. GZ/SAR402671 may possibly slow the progression of motor and/or non motor symptoms and disability. In contrast, current standard of care, such as dopamine drugs like levodopa, will improve motor symptoms, but do not affect the underlying disease process. This study will provide an evaluation of GZ/SAR402671 for the treatment of GBA-PD as well as enable a better understanding of the role of GBA as a risk factor in the development and progression of PD.
This study will be conducted globally and at one centre in the UK.REC name
London - City & East Research Ethics Committee
REC reference
17/LO/0741
Date of REC Opinion
21 May 2017
REC opinion
Favourable Opinion