Parkinson Parkinson's disease
Conditions
Interventions
Patients will start with oral tablets of Ambroxol 600mg or placebo, which will
increase with 600mg per week, to a maximum of 3 times 600mg a day for a period
of 48 weeks. At 48 weeks all participant
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Diagnosis of Parkinson*s disease, according to Movement Disorders Society (MDS) criteria
Exclusion criteria
Exclusion criteria: - The refusal to be informed about an unforeseen clinical finding - Pregnant or breast feeding women - Use of an implanted Deep Brain Stimulation (DBS) system - MRI imcompatible implants in the body
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the comparison of MDS-UPDRS part III motor subscale in the practically defined OFF medication state at 60 weeks after a 12 week washout period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are: - Safety and tolerability by examine adverse events - F-DOPA PET - MRI - Montreal Cognitive Assessment (MoCA) - Non-Motor Symptoms scale (NMSS) - Parkinson*s Disease 39 item Quality of life questionnaire (PDQ-39) - GCase activity measured using a flow cytometry based assay of peripheral blood mononuclear cells (PBMCs) | — |
Countries
Netherlands
Outcome results
None listed