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
About this trial
This is an interventional treatment trial for Neuroborreliosis, Borrelia Burgdorferi
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
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
NCT ID
NCT02553473
First Posted
September 16, 2015
Last Updated
March 10, 2022
Sponsor
Sorlandet Hospital HF
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
Learn more about this trial
Six Versus Two Weeks Treatment With Doxycycline in Lyme Neuroborreliosis
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