Tests ambroxol in adults with Parkinson's disease and a GBA1 mutation
Tests ambroxol in adults with Parkinson's disease who carry a GBA1 mutation.
Plain-language title generated from the registry record
Registry title: GREAT; GRoningen Early-PD Ambroxol Treatment Trial
Key facts
- Where
- Groningen, NetherlandsSee the site
- Phase
- Phase 2
Where in Netherlands
- Universitair Medisch Centrum GroningenGroningen, NetherlandsTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Universitair Medisch Centrum Groningen
- Trial code
- NCT05830396EU 2024-514976-41-00
- Record updated
- 23 September 2024
- Original description
To investigate the disease modifying properties of ambroxol in PD patients with a GBA1-mutationRead full original descriptionShow less
GREAT; GRoningen Early-PD Ambroxol Treatment Trial
To investigate the disease modifying properties of ambroxol in PD patients with a GBA1-mutation
Inclusion: Diagnosis of Parkinson's Disease according to Movement Disorders Society (MDS) criteria; GBA1-mutation; Disease duration of PD < 10 years at time of inclusion; Able to write written informed consent, understanding study protocol and perform protocol related actions; Willingness and ability to self-administer oral ambroxol or placebo medication.
Exclusion: MRI incompatible implants in the body; History of known sensitivity to the study medication; Any clinically significant or unstable medical or surgical condition that in the opinion of the principal investigator may put the participant at risk when participating in the study or may influence the results of the study or affect the participant’s ability to take part in the study, as determined by medical history, physical examinations, electrocardiogram (ECG), or laboratory tests; The refusal to be informed about an unforeseen clinical finding; Use of an implanted Deep Brain Stimulation (DBS) system; Pregnant or breastfeeding women.