NCT00104663

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2004

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 4, 2005

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

April 7, 2015

Status Verified

April 1, 2015

First QC Date

March 3, 2005

Last Update Submit

April 6, 2015

Conditions

Prion Disease

Keywords

Creutzfeldt-Jakob diseaseinheritedsporadicacquirednew variant CJD

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (9)

  • Mini Mental State Examination (MMSE)

  • Clinician's Dementia rating (CDR)

  • Rankin score

  • Alzheimer's Disease Assessment Scale - Cognitive (ADAS-Cog)

  • Glasgow coma score

  • +4 more secondary outcomes

Interventions

QuinacrineDRUG

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Prion Clinic

London, WC1N 3BG, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Prion DiseasesCreutzfeldt-Jakob Syndrome

Interventions

Quinacrine

Condition Hierarchy (Ancestors)

Central Nervous System InfectionsInfectionsCentral Nervous System DiseasesNervous System DiseasesNeurodegenerative DiseasesDementiaBrain DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AminoacridinesAcridinesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • John Collinge, MD, FRCP

    MRC Prion Unit

    PRINCIPAL INVESTIGATOR

  • Janet Darbyshire, MBChB, FRCP

    MRC Clinical Trials Unit

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

March 3, 2005

First Posted

March 4, 2005

Study Start

June 1, 2004

Study Completion

March 1, 2007

Last Updated

April 7, 2015

Record last verified: 2015-04

Locations

GB(1)