Comparison of two and six weeks treatment with doxycyline in neuroborreliosis

Lyme borreliosis; a scientific approach to reduce diagnostic and therapeutic uncertainties (BorrSci) WP2; SIX VERSUS TWO WEEKS TREATMENT WITH DOXYCYCLINE IN LYME NEUROBORRELIOSIS; A MULTICENTER, NON-INFERIORITY, PENTA-BLIND, RANDOMIZED TRIAL - BorrSciWP2

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-001481-25-NO

Enrollment

250

Registered

2015-08-27

Start date

2015-09-07

Completion date

Unknown

Last updated

2022-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lyme Neuroborreliosis

Interventions

Trade Name: Doksycyklin "Hexal" Pharmaceutical Form: Capsule Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Neurological symptoms suggestive of LNB without other obvious reasons and one or both of a .Cerebrospinal fluid pleocytosis (>5 leukocytes/mm3) b. Intrathecal Bb antibody production 2.Signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50

Exclusion criteria

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 SmPC of the IMP

Design outcomes

Primary

Measure	Time frame
Main Objective: To answer the question “is two weeks of doxycycline treatment (currently suggested treatment) at least as effective as six weeks doxycycline treatment in Lyme Neuroborreliosis?” ;Secondary Objective: 1. To provide a better understanding of the pathogenesis of LNB and long-term complaints 2. To search for new biomarkers in LNB 3. To collect clinical data, blood, and CSF from well-characterized LNB patients in a biobank for future research ;Primary end point(s): Composite clinical score ;Timepoint(s) of evaluation of this end point: Six months after ended treatment	—

Measure

Time frame

Main Objective: To answer the question “is two weeks of doxycycline treatment (currently suggested treatment) at least as effective as six weeks doxycycline treatment in Lyme Neuroborreliosis?” ;Secondary Objective: 1. To provide a better understanding of the pathogenesis of LNB and long-term complaints 2. To search for new biomarkers in LNB 3. To collect clinical data, blood, and CSF from well-characterized LNB patients in a biobank for future research ;Primary end point(s): Composite clinical score ;Timepoint(s) of evaluation of this end point: Six months after ended treatment

—

Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: Adverse events during and 4 weeks after treatment FSS, PHQ-15, Blood and CSF findings six and 12 months after ended treatment In a subset of patients: MRI during treatment and six months after ended treatment Neuropsychological testing six months after ended treatment;Secondary end point(s): Fatigue Severity Scale (FSS) Patient Health Questionnaire (PHQ-15) Short Form 36 (SF-36) Blood and CSF findings MRI, and neuropsychological assessments in a subset of patients Adverse events	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: Adverse events during and 4 weeks after treatment FSS, PHQ-15, Blood and CSF findings six and 12 months after ended treatment In a subset of patients: MRI during treatment and six months after ended treatment Neuropsychological testing six months after ended treatment;Secondary end point(s): Fatigue Severity Scale (FSS) Patient Health Questionnaire (PHQ-15) Short Form 36 (SF-36) Blood and CSF findings MRI, and neuropsychological assessments in a subset of patients Adverse events

—

Countries

Norway

Contacts

Public ContactCoordinating investigator

Sørlandet Sykehus HF

unn.ljostad@sshf.no4741208824

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026