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Six Versus Two Weeks Treatment With Doxycycline in Lyme Neuroborreliosis

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ClinicalTrials.gov Identifier: NCT02553473
Recruitment Status : Enrolling by invitation
First Posted : September 17, 2015
Last Update Posted : October 13, 2017
Sponsor:
Information provided by (Responsible Party):

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: Improvment 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 Sørlandet Hospital and 5-10 other 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  (Clinical Trial)
Estimated Enrollment : 250 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
Study Start Date : October 2015
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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


Outcome Measures

Primary Outcome Measures :
  1. Improvement in composite clinical score at six months after end of treatment [ Time Frame: six months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 doxycyline
  • Lactose intolerance
  • Need to use medications contraindicated according to Summary of Product Characteristics of the Investigational Medicinal Product
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02553473


Sponsors and Collaborators
Sorlandet Hospital HF
Investigators
Principal Investigator: Anne Marit Solheim, M.D Sørlandet hospital HF
More Information

Responsible Party: Sorlandet Hospital HF
ClinicalTrials.gov Identifier: NCT02553473     History of Changes
Other Study ID Numbers: 2015-001481-25
First Posted: September 17, 2015    Key Record Dates
Last Update Posted: October 13, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Lyme Neuroborreliosis
Central Nervous System Bacterial Infections
Bacterial Infections
Lyme Disease
Borrelia Infections
Gram-Negative Bacterial Infections
Tick-Borne Diseases
Spirochaetales Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Doxycycline
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents