NCT05830396RecruitingPhase 2
GREAT; GRoningen Early-PD Ambroxol Treatment Trial
Source: EU CTIS (euclinicaltrials.eu) · Last updated 23 Sept 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
To investigate the disease modifying properties of ambroxol in PD patients with a GBA1-mutation
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 3 Sept 2024
- Start date
- 23 Sept 2024
- Lead sponsor
- Universitair Medisch Centrum Groningen
- Diseases
- Parkinson disease
- NCT number
- NCT05830396
- EU CT number
- 2024-514976-41-00
- EudraCT number
- 2021-001833-38
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 80
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- MRI incompatible implants in the body
Other illness
- History of known sensitivity to the study medication
Lab values
- 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.
Other
- The refusal to be informed about an unforeseen clinical finding
- Use of an implanted Deep Brain Stimulation (DBS) system
- Pregnant or breastfeeding women
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitair Medisch Centrum Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.