Six Versus Two Weeks Treatment With Doxycycline in Lyme Neuroborreliosis
Status:
Completed
Trial end date:
2021-02-01
Target enrollment:
Participant gender:
Summary
Comparison of Doxycycline 200 mg once daily for six weeks versus Doxycycline 200 mg once
daily for two weeks + placebo for four weeks. Primary objective is to answer the question "is
two weeks doxycycline treatment (currently suggested treatment) at least as effective as six
weeks doxycycline treatment in Lyme Neuroborreliosis?".Key secondary objectives are to
provide a better understanding of the pathogenesis and long-term complaints, and to search
for new biomarkers in Lyme Neuroborreliosis (LNB) by collecting clinical data, blood, and
cerebrospinal fluid (CSF) in a biobank for future research
Endpoints:
Primary endpoint: Improvement on a composite clinical score from inclusion to six months
after ended treatment defined as clinical score at inclusion minus clinical score at six
months.
Secondary endpoints: Improvement on a composite clinical score 12 months after ended
treatment. Fatigue Severity Scale (FSS),Patient Health Questionnaire (PHQ-15), Short Form 36
(SF-36) and blood and CSF findings at inclusion, after 6 and 12 months.
The study design is a multicenter, non-inferiority, randomized, penta-blind,
placebo-controlled trial. 120 patients will be included from approximately 8 Norwegian
hospitals.
Main inclusion criteria are neurological symptoms suggestive of LNB without other obvious
reasons, one or both of a) Cerebrospinal fluid pleocytosis (>5 leukocytes/mm3) b) intrathecal
Bb antibody Production and signed informed consent. Safety assessments during the trial:
Comparison of clinical outcome six months after end of treatment between the two treatment
groups. Subjective experiences and blood tests including hematology and biochemistry for four
weeks after ended treatment.