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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01205464 |
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Date of registration:
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17/09/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effects of Doxycycline on Persistent Symptoms Post-neuroborreliosis
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Scientific title:
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Immunomodulatory and Clinical Effects of Doxycycline on Persistent Symptoms After Treatment of Neuroborreliosis: A Double-blind, Randomised, Crossover Study |
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Date of first enrolment:
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February 2005 |
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Target sample size:
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15 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01205464 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science
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Phase:
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N/A
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Countries of recruitment
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Sweden
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Contacts
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Name:
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Pia Forsberg, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Infectious Diseases, Faculty of Health Sciences, Linköping university, Sweden |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- a history of adequately diagnosed and treated neuroborreliosis (presence of
intrathecal borrelia-antibody production)
- persistence of symptoms (with debut in conjunction with neuroborreliosis) of typical
character, such as headache, radiculitis, cognitive dysfunction, fatigue, mood
disorders, paresthesia or paresis > 6 months post-treatment of neuroborreliosis
Exclusion Criteria:
- systemic immunosuppression (treatment with corticosteroids, cytostatics etc)
- ongoing infection at inclusion
- allergy against doxycycline
- pregnancy
- breast feeding
- psychiatric disease
- multiple sclerosis
- rheumatoid arthritis
- diabetes mellitus type 1 or II
- inflammatory systemic diseases
- liver ohc kidney dysfunction
- treatment with didanosine, quinapril, antacids
- malignancy
Age minimum:
18 Years
Age maximum:
85 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Paresis
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Paresthesia
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Fatigue
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Radicular Pain
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Cognitive Dysfunction
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Intervention(s)
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Drug: Doxycycline
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Drug: Placebo
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Primary Outcome(s)
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Improvement in persistent symptoms
[Time Frame: 12 weeks]
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Secondary Outcome(s)
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Changes in cytokine levels in plasma/serum in patients during treatment with DOX/PBO
[Time Frame: 12 weeks]
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Secondary ID(s)
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151:2004/25331
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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