PRION-1: Quinacrine for Human Prion Disease - Tabular View

Tracking Information

First Received Date ^ICMJE

March 3, 2005

Last Updated Date

June 11, 2009

Start Date ^ICMJE

June 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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 Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00104663 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

PRION-1: Quinacrine for Human Prion Disease

Official Title ^ICMJE

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

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.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Prion Disease

Intervention ^ICMJE

Drug: Quinacrine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

160

Completion Date

March 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Aged 12 years or more, diagnosed with any type of human prion disease.

Exclusion Criteria:

In a coma, or in a pre-terminal phase of disease such that prolongation of the current quality of life would not be supported
Known sensitivity to quinacrine
Been taking any other putative anti-prion therapy for less than 8 weeks

Gender

Both

Ages

12 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00104663

Responsible Party

Study ID Numbers ^ICMJE

Version 1.1, Grant ID:71361

Study Sponsor ^ICMJE

Medical Research Council

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:	John Collinge, MD, FRCP	MRC Prion Unit
Study Director:	Janet Darbyshire, MBChB, FRCP	MRC Clinical Trials Unit

Information Provided By

Medical Research Council

Verification Date

March 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP