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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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19 March 2012 |
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Main ID: |
EUCTR2006-001858-27-IT |
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Date of registration:
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12/04/2007 |
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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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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
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Scientific title:
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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 |
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Date of first enrolment:
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21/06/2006 |
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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:2006-001858-27 |
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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: no
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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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Affiliation:
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Key inclusion & exclusion criteria
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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.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Creutzfeldt-Jakob Disease.
MedDRA version: 9.1
Level: LLT
Classification code 10011384
Term: Creutzfeldt-Jakob disease
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Intervention(s)
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Trade Name: BASSADO 10CPS 100MG
Pharmaceutical Form: Tablet
INN or Proposed INN: Doxycycline
CAS Number: 24390-14-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
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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Secondary Objective: Evaluation of the effects of doxycicline treatment on CJD severity evolution functional rating scales and neurological exam .
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Main Objective: To evaluate the effects of doxycicline, compared with placebo, in increasing survival time in patients with CJD. Safety.
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Primary end point(s): Survival time from randomization.
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Secondary ID(s)
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CJD200501
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Source(s) of Monetary Support
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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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