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 |