Fatal familial insomnia: preventive treatment with doxycycline of at risk individuals - Doxycycline in FFI individuals

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-022233-28-IT

Enrollment

Registered

2012-03-05

Start date

2011-06-20

Completion date

Unknown

Last updated

2024-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subjects born between 1958 and 1969 belonging to the Treviso FFI family, tested previously for Prion D178N/129M mutation MedDRA version: 14.1 Level: SOC Classification code 10029205 Term: Nervous system disorders System Organ Class: 10029205 - Nervous system disorders

Interventions

Trade Name: BASSADO Pharmaceutical Form: Tablet INN or Proposed INN: DOXYCYCLINE HYCLATE CAS Number: 24390-14-5 Concentration unit: 1X 100 milligrams/millilitre Concentration type: equal Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: End stage liver, heart and renal disease, active malignancy , female subjects who are pregnant or lactating

Design outcomes

Primary

Measure	Time frame
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	—

Countries

Italy

Contacts

Public ContactDipartimento Neuroscienze

Istituto di Ricerche Farmacologiche Mario Negri

forloni@marionegri.it0239014462

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026