The Accordance clinical trial which has reached phase 3 ( watch our forum video where Arthur Roach explains the critical path and testing, if you are not sure what this means) has been amended. The trial is evaluating the ‘Accordion pill carbidopa/levodopa’, a drug designed to treat Parkinson’s patients in the advanced stage of the disease.
Intec Pharma are conducting trials in the USA, Europe and Israel and the amendment to the study (already accepted by the US Food and Drug Administration) has reduced the sample size from 460 to 328 patients while keeping the study goals, endpoints and statistical rating of 90% the same.
The Accordion pill in combination with carbidopa and levodopa is aimed at trying to reduce the amount of time spent in an ‘off state’ by patients with advanced Parkinson’s (the study’s primary endpoint). Sinemet is a fast release carbidopa/levodopa drug already in use (I take it myself) and is serving as the comparison point for the study. According to Intec Pharma between 30% and 45% of medications currently in use are poorly soluble – Accordion acts as a sustained-release drug by prolonging its stay in the stomach and gradually feeding the medication into the upper gastrointestinal tract
This is not a brand new breakthrough as levodopa has been around for more than 50 years but if it is successful it could improve day-to-day living for Parkinson’s people. Up to 50% of patients begin to experience movement fluctuations within 2 years of starting to take levodopa. The Accordion pill will improve the duration and consistency of symptom relief, giving us more time between doses and more control with less dyskinesia (uncontrolled movements) – let’s hope it succeeds!
As the ‘Phase 3 Accordance Study’requires fewer participants than before Intec CEO Zeev Weiss says ‘ We believe that the reduction in sample size should shorten study completion timelines and reduce overall costs, and we expect to complete patient enrollment in the fourth quarter of 2017.’
If you are interested in taking part (and getting much more indepth technical information) here are the contact details:
|Fairfield General Hospital||Recruiting|
|Bury, United Kingdom, BL9 7TD|
|Contact: Jason Raw, MD +4401617783868 firstname.lastname@example.org
|Newcastle University Clinical Ageing Research||Recruiting|
|Newcastle upon Tyne, United Kingdom, NE4 5PL|
|Contact: David Burn, MD +441412012486 email@example.com
|Queens Medical Centre Nottingham, University Hospital||Recruiting|
|Nottingham, United Kingdom, NG7 2UH|
|Contact: Jonathan Evans, MD +4407957585975 firstname.lastname@example.org
|University Hospitals of North Midlands NHS Trust||Not yet recruiting|
|Staffordshire, United Kingdom, ST4 6QG|
|Contact: Simon Ellis, MD +01782715444 email@example.com