A randomized, double-blind study versus placebo for the evaluation of the efficacy of doxycycline administered by oral route in patients affected by sporadic Creutzfeldt-Jakob disease

Phase 2

Recruiting

Conditions: A81.0
Creutzfeldt-Jakob disease

Registration Number: DRKS00000179

Lead Sponsor: niversitätsmedizin Göttingen,Georg-August-Universität

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 28

Inclusion Criteria

1. Age 18 to 80 years
2. Diagnosis of probable or definite sporadic CJD according to the WHO criteria
3. First symptoms reported no more than 6 months ago
4. Brain MRI within 6 months and an EEG within 12 months prior
5. No contraindications to the use of Tetracyclines
6. Written informed consent by patient or legal representative
7. Women of child-bearing age have to use effectiv contraception (oral contraception alone not sufficient, since Doxycyline compromises the absorption of orally administered contraceptives)

Exclusion Criteria

1. Family history of a prion desease
2. End-stage liver, heart or renal disease
3. Active malignancy
4. Female subjects who are pregnant or lactating
5. Known intolerance/anaphylaxis to tetracycline
6. Receiving an experimental drug or having participated in a clinical trial within 12 weeks prior to screening
7. Employees of the investigator or study center with direct involvement in the proposed study or other studies under the direction of that investigator or study centre
8. Living will prohibiting the use of intensive-care or life-prolonging treatment
9. Administration of absolutely necessary medication interacting with study medications

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome is the total survival time of the patient from onset of symptoms.

Secondary Outcome Measures

Name	Time	Method
Secondary outcome parameters are the time from randomization to loss of autonomous feeding, loss of sphincter control, and reaching the clinical stage of akinetic mutism. Relevant data obtained in the MMSE and SMMSE, NPI, Barthel index, Reaction Level Scale, concentration of tau protein in the cerebrospinal fluid and MRI will be considered as additional outcome parameters and will be utilized to describe disease characteristics, disease evolution, and quality of life.