Fatal familial insomnia: preventive treatment with doxycycline of at risk individuals - Doxycycline in FFI individuals
- Conditions
- Subjects born between 1958 and 1969 belonging to the Treviso FFI family, tested previously for Prion D178N/129M mutationMedDRA version: 14.1Level: SOCClassification code 10029205Term: Nervous system disordersSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2010-022233-28-IT
- Lead Sponsor
- IST. DI RICERCHE FARMACOLOG. M. NEGRI
- 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
Subjects born between 1958 and 1969 belonging to the Treviso FFI family, tested previously for Prion D178N/129M mutation No conditions known to be controindications to the use of tetracyclines; written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
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) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
End stage liver, heart and renal disease, active malignancy , female subjects who are pregnant or lactating
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To prevent the FFI onset in subjects carrying the Prion D178N/129M;Secondary Objective: Clinical monitoring of subjects carrying the Prion D178N/129M;Primary end point(s): Survival after 10 years
- Secondary Outcome Measures
Name Time Method