Six Versus Two Weeks Treatment With Doxycycline in Lyme Neuroborreliosis

Sponsor

Sorlandet Hospital HF (Other)

Overall Status

Completed

CT.gov ID

NCT02553473

Collaborator

(none)

121

Enrollment

Arms

64.1

Actual Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Neuroborreliosis, Borrelia Burgdorferi	Drug: Doxycycline Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

121 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Six Versus Two Weeks Treatment With Doxycycline in Lyme Neuroborreliosis; a Multicenter, Non-inferiority, Penta-blind, Randomized Trial

Actual Study Start Date :

Oct 1, 2015

Actual Primary Completion Date :

Jan 1, 2020

Actual Study Completion Date :

Feb 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Doxycycline for 6 weeks Doxycycline 200 mg once daily for six weeks	Drug: Doxycycline
Placebo Comparator: Doxycycline for 2 weeks + placebo Doxycycline 200 mg once daily for two weeks + placebo for four weeks.	Drug: Doxycycline Drug: Placebo

Arm

Intervention/Treatment

Active Comparator: Doxycycline for 6 weeks

Doxycycline 200 mg once daily for six weeks

Drug: Doxycycline

Placebo Comparator: Doxycycline for 2 weeks + placebo

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

Drug: Doxycycline

Drug: Placebo

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Sorlandet Hospital HF

Investigators

Principal Investigator: Anne Marit Solheim, M.D, Sørlandet hospital HF

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sorlandet Hospital HF

ClinicalTrials.gov Identifier:

NCT02553473

Other Study ID Numbers:

2015-001481-25

First Posted:

Sep 17, 2015

Last Update Posted:

Mar 11, 2022

Last Verified:

Jun 1, 2021

Additional relevant MeSH terms:

Lyme Neuroborreliosis

Doxycycline

Study Results

No Results Posted as of Mar 11, 2022