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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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-001858-27-IT
Enrollment
Unknown
Registered
2007-04-12
Start date
2006-06-21
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

Creutzfeldt-Jakob Disease. MedDRA version: 9.1 Level: LLT Classification code 10011384 Term: Creutzfeldt-Jakob disease

Interventions

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:

Sponsors

ISTITUTO NEUROLOGICO CARLO BESTA
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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.—

Countries

Italy

Outcome results

None listed

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