Doxycycline in early CJD: a double-blinded randomised phase II and observational study
2017 | journal article. A publication with affiliation to the University of Göttingen.
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Doxycycline in early CJD: a double-blinded randomised phase II and observational study
Varges, D. A.; Manthey, H.; Heinemann, U.; Ponto, C.; Schmitz, M.; Schulz-Schaeffer, W. J. & Krasnianski, A. et al. (2017)
Journal of Neurology Neurosurgery & Psychiatry, 88(2) pp. 119-125. DOI: https://doi.org/10.1136/jnnp-2016-313541
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Details
- Authors
- Varges, Daniel. A.; Manthey, Henrike; Heinemann, Uta; Ponto, Claudia; Schmitz, Matthias; Schulz-Schaeffer, Walter J.; Krasnianski, Anna; Breithaupt, Maren; Fincke, Fabian ; Kramer, Katharina; Friede, Tim; Zerr, Inga
- Abstract
- Objectives The main objective of the present study is to study the therapeutic efficiency of doxycycline in a double-blinded randomised phase II study in a cohort of patients with sporadic Creutzfeldt-Jakob disease (sCJD). Methods From the National Reference Center of TSE Surveillance in Germany, patients with probable or definite sCJD were recruited for a double-blinded randomised study with oral doxycycline (EudraCT 2006-003934-14). In addition, we analysed the data from patients with CJD who received compassionate treatment with doxycycline in a separate group. Potential factors which influence survival such as age at onset, gender, codon 129 polymorphism and cognitive functions were evaluated. The primary outcome measure was survival. Results Group 1: in the double-blinded randomised phase II study, 7 patients in the treatment group were compared with 5 controls. Group 2: 55 patients with sCJD treated with oral doxycycline were analysed and compared with 33 controls by a stratified propensity score applied to a Cox proportional hazard analysis. The results of both studies were combined by means of a random-effects meta-analysis. A slight increase in survival time in the doxycycline treatment group was observed (p=0.049, HR=0.63 (95% CI 0.402 to 0.999)). Conclusions On the basis of our studies, a larger trial of doxycycline should be performed in persons in the earliest stages of CJD.
- Issue Date
- 2017
- Status
- published
- Publisher
- Bmj Publishing Group
- Journal
- Journal of Neurology Neurosurgery & Psychiatry
- ISSN
- 1468-330X; 0022-3050