Ambroxol to Slow Progression in Parkinson Disease: A Phase IIIa Multi-centre Randomised Placebo-controlled Trial
Status: Recruiting
Location: See all (15) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
This is a UK only clinical trial in patients with Parkinson's disease (PD) of a drug called ambroxol hydrochloride, which is an already licensed drug for the treatment of respiratory conditions (such as a common cold) in many European countries. The aim of this trial is to find out whether ambroxol hydrochloride can slow down the progression of Parkinson's disease and to evaluate it's safety and tolerability.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 35
Maximum Age: 75
Healthy Volunteers: f
View:
• A diagnosis of Parkinson's disease (in accordance with the MDS diagnostic criteria) within 7 years of the screening visit confirmed by year of diagnosis.
• Adults aged ≥ 35 and ≤ 75 years.
• Hoehn and Yahr stage between 1-2.5, inclusive (in ON stage) at screening visit.
• Known glucocerebrosidase gene (GBA1) status, positive or negative (status MUST be confirmed prior to screening).
• On stable dopaminergic treatment for at least 3 months before enrolment.
• Able and willing to provide informed consent prior to any study related assessments and/or procedures.
• Able and willing to attend trial visits and comply with all study procedures for the duration of the trial.
• Willing and able to self-administer oral ambroxol medication or placebo.
Locations
Other Locations
United Kingdom
University Hospitals Birmingham
NOT_YET_RECRUITING
Birmingham
Southmead Hospital Bristol
NOT_YET_RECRUITING
Bristol
Addenbrookes NHS Trust
NOT_YET_RECRUITING
Cambridge
Western General Hospital
NOT_YET_RECRUITING
Edinburgh
Kings College London
NOT_YET_RECRUITING
London
Royal London Hospital
NOT_YET_RECRUITING
London
University College London Hospital's
RECRUITING
London
Newcastle
NOT_YET_RECRUITING
Newcastle
Northumbria
NOT_YET_RECRUITING
Newcastle Upon Tyne
The John Radcliffe Hospital
NOT_YET_RECRUITING
Oxford
Derriford Hospital
RECRUITING
Plymouth
Fairfield General Hospital
NOT_YET_RECRUITING
Salford
Salford Royal Hospital
RECRUITING
Salford
Southampton General Hospital
NOT_YET_RECRUITING
Southampton
Prince Philip Hospital
NOT_YET_RECRUITING
Wales
Contact Information
Primary
ASPro-PD Trial Team
cctu.aspro-pd@ucl.ac.uk
02031084908
Backup
Felicia Ikeji
f.ikeji@ucl.ac.uk
02076799506
Time Frame
Start Date:2025-02-25
Estimated Completion Date:2029-09
Participants
Target number of participants:330
Treatments
Active_comparator: Ambroxol hydrochloride
Participants will receive ambroxol hydrochloride (tablets) for 104 weeks (blinded treatment period). Participants will receive ambroxol hydrochloride 420mg daily for Days 1-5, then 840mg daily for Days 6-10, then 1260mg for the remainder of the blinded treatment period. Participants will then enter the open-label extension and will receive ambroxol hydrochloride 420mg daily for Days 1-5, then 840mg daily for Days 6-10, then 1260mg for the remainder of the open-label extension phase.~n=165
Placebo_comparator: Placebo
Participants will receive ambroxol hydrochloride matching placebo (tablets) for 104 weeks (blinded treatment period). Participants will receive ambroxol hydrochloride matching placebo 420mg daily for Days 1-5, then 840mg daily for Days 6-10, then 1260mg for the remainder of the blinded treatment period. Participants will then enter the open-label extension and will receive ambroxol hydrochloride 420mg daily for Days 1-5, then 840mg daily for Days 6-10, then 1260mg for the remainder of the open-label extension phase.~n=165