A randomized, double-blind pilot study vs placebo for the evaluation of efficacy and tolerability of doxycline administered by oral route in patients affected by Creutzfeldt-Jakob disease. - ND
- Conditions
- Creutzfeldt-Jakob Disease.MedDRA version: 9.1Level: LLTClassification code 10011384Term: Creutzfeldt-Jakob disease
- Registration Number
- EUCTR2006-001858-27-IT
- Lead Sponsor
- ISTITUTO NEUROLOGICO CARLO BESTA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Male and female out-patients. 18 to 75 years. Probable or definite CJD, according to WHO criteria. First symptoms by no more than 6 months. Brain MRI within 6 months and EEG within 3 months. No contraindications to tetracyclines. Written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
End-stage liver, heart or renal disease. Active malignancy. Pregnacy and lactation. Subjects who received an experimantal drug of have participated in a clinical trial within 3 months prior to screening.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the effects of doxycicline, compared with placebo, in increasing survival time in patients with CJD. Safety.;Secondary Objective: Evaluation of the effects of doxycicline treatment on CJD severity evolution functional rating scales and neurological exam .;Primary end point(s): Survival time from randomization.
- Secondary Outcome Measures
Name Time Method