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. 2016 Dec 8;2016(12):CD006978. doi: 10.1002/14651858.CD006978.pub2

NCT02553473.

Trial name or title Six versus two weeks treatment with doxycycline in Lyme neuroborreliosis
Methods Multicenter, non‐inferiority, randomized, penta‐blind (participant, caregiver, investigator, outcomes assessor), placebo‐controlled study
Participants 250 adults (18 years and older) with neuroborreliosis (Borrelia burgdorferi) from Norwegian hospitals
Inclusion criteria: neurological symptoms suggestive of Lyme neuroborreliosis without other obvious causes, one or both of a) cerebrospinal fluid pleocytosis (> 5 leukocytes/mm3), b) intrathecal B. burgdorferi antibody production
Interventions Doxycycline 200 mg once daily for 6 weeks versus doxycycline 200 mg once daily for 2 weeks + placebo for 4 weeks
Outcomes Primary: composite clinical score at 6 months after the end of treatment
Secondary: Fatigue Severity Scale (FSS), Patient Health Questionnaire (PHQ‐15), 36‐Item Short‐Form Health Survey (SF‐36), and blood and cerebrospinal fluid findings at inclusion and after 6 and 12 months
Safety
Starting date October 2015
Contact information Sorlandet Hospital
Notes Estimated completion 2020