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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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25 September 2012 |
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Main ID: |
EUCTR2010-022233-28-IT |
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Date of registration:
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05/03/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Scientific title:
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Fatal familial insomnia: preventive treatment with doxycycline of at risk individuals - Doxycycline in FFI individuals |
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Date of first enrolment:
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20/06/2011 |
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Target sample size:
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Recruitment status: |
Authorised-recruitment may be ongoing or finished |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-022233-28 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: yes
Number of treatment arms in the trial: 1
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Phase:
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Countries of recruitment
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Italy
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Contacts
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Name:
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Dipartimento Neuroscienze
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Address:
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Via G.La Masa 19
20156
Milano
Italy |
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Telephone:
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0239014462 |
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Email:
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forloni@marionegri.it |
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Affiliation:
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Istituto di Ricerche Farmacologiche Mario Negri |
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Name:
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Dipartimento Neuroscienze
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Address:
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Via G.La Masa 19
20156
Milano
Italy |
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Telephone:
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0239014462 |
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Email:
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forloni@marionegri.it |
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Affiliation:
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Istituto di Ricerche Farmacologiche Mario Negri |
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Key inclusion & exclusion criteria
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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
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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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
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Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
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Intervention(s)
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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 number: 1-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Primary end point(s): Survival after 10 years
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Main Objective: To prevent the FFI onset in subjects carrying the Prion D178N/129M
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Secondary Objective: Clinical monitoring of subjects carrying the Prion D178N/129M
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Source(s) of Monetary Support
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Telethon
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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