PRION-1: Quinacrine for Human Prion Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2007 by Medical Research Council.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Medical Research Council
ClinicalTrials.gov Identifier:
NCT00104663
First received: March 3, 2005
Last updated: June 11, 2009
Last verified: March 2007
  Purpose

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.


Condition Intervention
Prion Disease
Drug: Quinacrine

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Medical Research Council:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • 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)

Estimated Enrollment: 160
Study Start Date: June 2004
Estimated Study Completion Date: March 2007
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.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00104663

Locations
United Kingdom
National Prion Clinic
London, United Kingdom, WC1N 3BG
Sponsors and Collaborators
Medical Research Council
Investigators
Principal Investigator: John Collinge, MD, FRCP MRC Prion Unit
Study Director: Janet Darbyshire, MBChB, FRCP MRC Clinical Trials Unit
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00104663     History of Changes
Other Study ID Numbers: Version 1.1, Grant ID:71361
Study First Received: March 3, 2005
Last Updated: June 11, 2009
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Medical Research Council:
Creutzfeldt-Jakob disease
inherited
sporadic
acquired
new variant CJD

Additional relevant MeSH terms:
Prion Diseases
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Quinacrine
Anticestodal Agents
Antiplatyhelmintic Agents
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antiprotozoal Agents
Antinematodal Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 01, 2014