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Six Versus Two Weeks Treatment With Doxycycline in Lyme Neuroborreliosis

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ClinicalTrials.gov Identifier: NCT02553473
Recruitment Status : Enrolling by invitation
First Posted : September 17, 2015
Last Update Posted : October 13, 2017
Sponsor:
Information provided by (Responsible Party):
Sorlandet Hospital HF

September 16, 2015
September 17, 2015
October 13, 2017
October 2015
September 2019   (Final data collection date for primary outcome measure)
Improvement in composite clinical score at six months after end of treatment [ Time Frame: six months ]
Composite clinical score at six months after end of treatment [ Time Frame: six months ]
Complete list of historical versions of study NCT02553473 on ClinicalTrials.gov Archive Site
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Six Versus Two Weeks Treatment With Doxycycline in Lyme Neuroborreliosis
Six Versus Two Weeks Treatment With Doxycycline in Lyme Neuroborreliosis; a Multicenter, Non-inferiority, Penta-blind, Randomized Trial

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: Improvment 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 Sørlandet Hospital and 5-10 other 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.

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Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Neuroborreliosis, Borrelia Burgdorferi
  • Drug: Doxycycline
  • Drug: Placebo
  • Active Comparator: Doxycycline for 6 weeks
    Doxycycline 200 mg once daily for six weeks
    Intervention: Drug: Doxycycline
  • Placebo Comparator: Doxycycline for 2 weeks + placebo
    Doxycycline 200 mg once daily for two weeks + placebo for four weeks.
    Interventions:
    • Drug: Doxycycline
    • Drug: Placebo
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
250
Same as current
October 2020
September 2019   (Final data collection date for primary outcome measure)

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 doxycyline
  • Lactose intolerance
  • Need to use medications contraindicated according to Summary of Product Characteristics of the Investigational Medicinal Product
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
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NCT02553473
2015-001481-25
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Sorlandet Hospital HF
Sorlandet Hospital HF
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Principal Investigator: Anne Marit Solheim, M.D Sørlandet hospital HF
Sorlandet Hospital HF
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP