Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00104663
Status:
COMPLETED
Last Update Posted:
2015-04-07
First Post:
2005-03-03
Brief Title:
PRION-1 Quinacrine for Human Prion Disease
Sponsor:
Medical Research Council
Organization:
Medical Research Council
Study Overview
Official Title:
PRION-1 Quinacrine for Human Prion Disease A Partially Randomized Patient Preference Trial to Evaluate the Activity and Safety of Quinacrine in Human Prion Disease
Status:
COMPLETED
Status Verified Date:
2015-04
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:
None
Brief Summary:
PRION-1 aims to assess the activity and safety of Quinacrine Mepacrine hydrochloride in human prion disease It also aims to establish an appropriate framework for the clinical assessment of therapeutic options for human prion disease that can be refined or expanded in the future as new agents become available
Detailed Description:
The human prion diseases have been traditionally classified into Creutzfeldt-Jakob disease CJD Gerstmann-Sträussler-Scheinker GSS disease and kuru They can alternatively be classified into three causal categories sporadic acquired and inherited The appearance of a new human prion disease variant CJD vCJD in the United Kingdom from 1995 onwards and the experimental evidence that this is caused by the same prion strain as that causing bovine spongiform encephalopathy BSE in cattle has raised the possibility that a major epidemic of vCJD will occur in the United Kingdom and other countries as a result of dietary or other exposure to BSE prions These concerns have led to intensified efforts to develop therapeutic interventions
Quinacrine has been previously used to treat other diseases such as malaria however it was found to have serious side effects and is no longer licensed in the United Kingdom There is only very limited evidence from laboratory tests for the potential use of quinacrine in human prion disease and the evidence to date for any possible clinical benefit is very scarce The PRION-1 trial is being undertaken since there are no other drugs currently available which are considered suitable for human evaluation
Quinacrine has been previously used to treat other diseases such as malaria however it was found to have serious side effects and is no longer licensed in the United Kingdom There is only very limited evidence from laboratory tests for the potential use of quinacrine in human prion disease and the evidence to date for any possible clinical benefit is very scarce The PRION-1 trial is being undertaken since there are no other drugs currently available which are considered suitable for human evaluation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Grant ID71361 | None | None | None |