Six Versus Two Weeks Treatment With Doxycycline in Lyme Neuroborreliosis
Condition: Neuroborreliosis, Borrelia Burgdorferi
MeSH terms: Lyme Neuroborreliosis
Intervention: Doxycycline; Placebo
Intervention MeSH terms: Doxycycline
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 121.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Neurological symptoms suggestive of LNB without other obvious reasons and one or both
             of

               1. Cerebrospinal fluid pleocytosis ≥5 leukocytes pr mm3

               2. Intrathecal Bb antibody production

          2. Signed informed consent

        Exclusion Criteria:

          -  Age less than 18 years

          -  Pregnancy, breast-feeding

          -  Adverse reaction to tetracyclines

          -  Treatment with cephalosporin, penicillin, or tetracycline the last 14 days

          -  Serious liver or kidney disease that contraindicates use of doxycycline

          -  Lactose intolerance

          -  Need to use medications contraindicated according to Summary of Product
             Characteristics of the Investigational Medicinal Product