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Six Versus Two Weeks Treatment With Doxycycline in Lyme Neuroborreliosis

Primary Purpose

Neuroborreliosis, Borrelia Burgdorferi

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Doxycycline
Placebo
Sponsored by
Sorlandet Hospital HF
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuroborreliosis, Borrelia Burgdorferi

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Doxycycline for 6 weeks

    Doxycycline for 2 weeks + placebo

    Arm Description

    Doxycycline 200 mg once daily for six weeks

    Doxycycline 200 mg once daily for two weeks + placebo for four weeks.

    Outcomes

    Primary Outcome Measures

    Improvement in composite clinical score at six months after end of treatment

    Secondary Outcome Measures

    Full Information

    First Posted
    September 16, 2015
    Last Updated
    March 10, 2022
    Sponsor
    Sorlandet Hospital HF
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02553473
    Brief Title
    Six Versus Two Weeks Treatment With Doxycycline in Lyme Neuroborreliosis
    Official Title
    Six Versus Two Weeks Treatment With Doxycycline in Lyme Neuroborreliosis; a Multicenter, Non-inferiority, Penta-blind, Randomized Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2015 (Actual)
    Primary Completion Date
    January 2020 (Actual)
    Study Completion Date
    February 2021 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Sorlandet Hospital HF

    4. Oversight

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Neuroborreliosis, Borrelia Burgdorferi

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    121 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Doxycycline for 6 weeks
    Arm Type
    Active Comparator
    Arm Description
    Doxycycline 200 mg once daily for six weeks
    Arm Title
    Doxycycline for 2 weeks + placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Doxycycline 200 mg once daily for two weeks + placebo for four weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Doxycycline
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Primary Outcome Measure Information:
    Title
    Improvement in composite clinical score at six months after end of treatment
    Time Frame
    six months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Neurological symptoms suggestive of LNB without other obvious reasons and one or both of Cerebrospinal fluid pleocytosis ≥5 leukocytes pr mm3 Intrathecal Bb antibody production 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Anne Marit Solheim, M.D
    Organizational Affiliation
    Sørlandet hospital HF
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Six Versus Two Weeks Treatment With Doxycycline in Lyme Neuroborreliosis

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