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| Sponsored by: |
Medical Research Council |
|---|---|
| Information provided by: | Medical Research Council |
| ClinicalTrials.gov Identifier: | NCT00104663 |
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: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| 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 |
| Estimated Enrollment: | 160 |
| Study Start Date: | June 2004 |
| Estimated Study Completion Date: | March 2007 |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United Kingdom | |
| National Prion Clinic | |
| London, United Kingdom, WC1N 3BG | |
| Principal Investigator: | John Collinge, MD, FRCP | MRC Prion Unit |
| Study Director: | Janet Darbyshire, MBChB, FRCP | MRC Clinical Trials Unit |
More Information
| Study ID Numbers: | Version 1.1, Grant ID:71361 |
| Study First Received: | March 3, 2005 |
| Last Updated: | March 26, 2007 |
| ClinicalTrials.gov Identifier: | NCT00104663 History of Changes |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
|
Creutzfeldt-Jakob disease inherited sporadic acquired new variant CJD |
|
Antimalarials Creutzfeldt Jakob Disease Spongiform Encephalopathy Central Nervous System Infections Central Nervous System Diseases |
Creutzfeldt-Jakob Syndrome Anthelmintics Prion Diseases Quinacrine Neurodegenerative Diseases |
|
Anti-Infective Agents Antiprotozoal Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Antiplatyhelmintic Agents Nervous System Diseases Central Nervous System Diseases Enzyme Inhibitors Anthelmintics Neurodegenerative Diseases |
Pharmacologic Actions Anticestodal Agents Antimalarials Antiparasitic Agents Central Nervous System Infections Therapeutic Uses Prion Diseases Quinacrine Antinematodal Agents |
