ASPro-PD
Research type
Research Study
Full title
Ambroxol to Slow Progression in Parkinson Disease (ASPro-PD): A Phase IIIA multi-centre randomised placebo-controlled trial
IRAS ID
1008101
Contact name
Felicia Ikeji
Contact email
Sponsor organisation
University College London Comprehensive Clinical Trials Unit
ISRCTN Number
ISRCTN93097821
Clinicaltrials.gov Identifier
Research summary
Parkinson’s disease is a condition in which parts of the brain become progressively damaged over many years and is characterised by the core motor symptoms of tremor, limb rigidity, stiffness, and slowness of movement (bradykinesia). Currently, treatment for Parkinson’s is limited to symptomatic drugs (treating symptoms) with no treatment available that can slow or prevent disease progression. The purpose of this trial is to investigate whether a drug called ambroxol can slow down the progression of Parkinson’s disease and whether it is safe to use over a prolonged period. We want to understand if ambroxol has a beneficial role in Parkinson’s disease through its ability to help increase the activity of an enzyme called GCase, which is thought to be defective in people with Parkinson’s. The trial will be conducted at participating NHS hospitals sites across the UK and will include 330 people who have been diagnosed with Parkinson’s disease within the last 7 years and are between 35 and 75 years old. There will be two groups: one group will receive ambroxol and one group will receive. a matching dummy tablet (placebo) which they will take for 2 years, after this all participants will be given ambroxol for 6 months. Questionnaires and neurological assessments will be completed, blood tests, a sebum swab (an oily secretion from your upper back), urine samples and stool samples will be required. The information we get from this trial may help improve the treatment of patients diagnosed with Parkinson’s disease.
REC name
Wales REC 2
REC reference
24/WA/0231
Date of REC Opinion
17 Oct 2024
REC opinion
Further Information Favourable Opinion