Clinical Trial: PRION-1: Quinacrine for Human Prion Disease
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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
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.
Sponsor: Medical Research Council
Current Primary Outcome:
- Time to death
- proportion of responders, with "responders" defined as patients showing either clinical improvement or lack of deterioration in 3 key neurological and neuropsychiatric measures
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Mini Mental State Examination (MMSE)
- Clinician's Dementia rating (CDR)
- Rankin score
- Alzheimer's Disease Assessment Scale - Cognitive (ADAS-Cog)
- Glasgow coma score
- Barthel Activities of Daily Living (ADL)
- magnetic resonance imaging scan (MRI)
- electro-encephalogram (EEG)
- cerebrospinal fluid (CSF)
Original Secondary Outcome: Same as current
Information By: Medical Research Council
Dates:
Date Received: March 3, 2005
Date Started: June 2004
Date Completion: March 2007
Last Updated: April 6, 2015
Last Verified: April 2015