Six Versus Two Weeks Treatment With Doxycycline in Lyme Neuroborreliosis

NCT02553473 | Completed Phase 3 Results

• 1 other identifier: 2015-001481-25
• Study Type: interventional
• Target: 121
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Neuroborreliosis, Borrelia Burgdorferi

Outcome Measures

Primary Outcomes (1)

• Difference in Composite Clinical Score From Inclusion to Six Months After Ended Treatment

  Clinical change on composite clinical score (CCS) defined as score at inclusion minus score at 6 months after treatment.CCS consisted of 32 variables,scored from 0 to 2 points.Minimum 0 points,maximum 64 points.High scale score indicated worse outcome. Variables scored:Malaise,Fatigue,Headache,Neck and/or back pain,Abdominal and/or breast pain,Arm pain,Leg pain,Generalised pain located to joints and/or muscles,Memory and/or concentration problems,Other,Facial palsy,Paresis of the eye muscles,Reduced hearing,Other cranial neuropathies,Cervical radicular sensory findings,Cervical radicular paresis,Thoracic radicular sensory findings,Lumbar radicular sensory findings,Lumbar radicular paresis,Non-radicular sensory findings,Non-radicular paresis,Other,Central findings in one extremity,Central findings in a hemi pattern,Central findings in both legs,Central findings in all extremities,Gait ataxia,Dysphasia/aphasia, Nystagmus,Involuntary movement including tremor,Cognitive impairment,Other.

  Six months after end of treatment.

Study Arms (2)

Doxycycline for 6 weeks

ACTIVE COMPARATOR

Doxycycline 200 mg once daily for six weeks

Drug: Doxycycline

Doxycycline for 2 weeks + placebo

PLACEBO COMPARATOR

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

Drug: Doxycycline; Drug: Placebo

Interventions

Doxycycline DRUG

Doxycycline for 2 weeks + placebo; Doxycycline for 6 weeks

Placebo DRUG

Doxycycline for 2 weeks + placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sorlandet Hospital HF: lead

MeSH Terms

Conditions

Lyme Neuroborreliosis

Interventions

Doxycycline

Condition Hierarchy (Ancestors)

Central Nervous System Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Lyme Disease; Gram-Negative Bacterial Infections; Borrelia Infections; Spirochaetales Infections; Central Nervous System Infections; Tick-Borne Diseases; Vector Borne Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Results Point of Contact

• Title: Anne Marit Solheim, MD
• Organization: Sørlandet hospital HF

anne.marit.solheim@sshf.no

0047 38 07 39 10

Study Officials

• Anne Marit Solheim, M.D

  Sørlandet hospital HF

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2015
• First Posted: September 17, 2015
• Study Start: October 1, 2015
• Primary Completion: January 1, 2020
• Study Completion: February 1, 2021
• Last Updated: January 23, 2024
• Results First Posted: January 23, 2024

Record last verified: 2021-06