Ignite Creation Date:
2024-05-06 @ 6:45 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05778617
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-05-18
First Post:
2023-02-16
Brief Title:
Ambroxol to Slow Progression in Parkinson Disease
Sponsor:
University College London
Organization:
University College London
Study Overview
Official Title:
Ambroxol to Slow Progression in Parkinson Disease A Phase IIIa Multi-centre Randomised Placebo-controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ASPro-PD
Brief Summary:
This is a UK only clinical trial in patients with Parkinsons 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 Parkinsons disease and to evaluate its safety and tolerability
Detailed Description:
This is a 104-week randomized double-blind multi-centre parallel group placebo-controlled clinical trial of ambroxol hydrochloride in patients with PD with a 26-week open-label extension phase Participants will undergo screening to evaluate their eligibility to participate in the trial All eligible participants will be randomised to receive either ambroxol hydrochloride 420mg or its matching placebo in a 11 ratio three times a day for 104 weeks including a 2-week dose escalation period Once the end of the blinded treatment has been reached all participants will enter the open-label extension phase and will receive ambroxol hydrochloride 420mg three times a day for 26 weeks including a 2-week dose escalation period All clinical staff study investigators and participants will be blinded to study assignments throughout the entirety of the trial
There will be an optional sub-study including 106 participants in which a cerebrospinal fluid CSF sample will be taken on two occasions via a Lumbar Puncture procedure to measure ambroxol drug levels assess whether the glucocerebrosidase enzyme has been stimulated and the levels of other substances thought to be associated with the development of PD and confirm whether the study drug has penetrated the cerebrospinal fluid and Central Nervous System
There will be an optional sub-study including 106 participants in which a cerebrospinal fluid CSF sample will be taken on two occasions via a Lumbar Puncture procedure to measure ambroxol drug levels assess whether the glucocerebrosidase enzyme has been stimulated and the levels of other substances thought to be associated with the development of PD and confirm whether the study drug has penetrated the cerebrospinal fluid and Central Nervous System
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None