Ambroxol as a Disease-modifying Treatment in GBA-PD

PHASE2CompletedINTERVENTIONAL
Enrollment

65

Participants

Timeline

Start Date

March 9, 2022

Primary Completion Date

December 15, 2024

Study Completion Date

December 20, 2024

Conditions
Parkinson DiseaseGBA Gene Mutation
Interventions
DRUG

Ambroxol Hydrochloride

Drug Ambroxol hydrochloride 200 mg plus excipients. The manufacturing process of the 200 mg Ambroxol hydrochloride tablets will be performed by wet granulation, drying, mixing and compression to the target final weight.

DRUG

Placebo

Excipients

Trial Locations (3)

20133

Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan

27100

"IRCCS National Neurological Institute C. Mondino Foundation", Pavia

Unknown

"University of Campania Luigi Vanvitelli", Naples

All Listed Sponsors
collaborator

"IRCCS National Neurological Institute C. Mondino Foundation"

OTHER

collaborator

University of Campania Luigi Vanvitelli

OTHER

lead

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

OTHER