Fatigue Clinical Trial
Official title:
Immunomodulatory and Clinical Effects of Doxycycline on Persistent Symptoms After Treatment of Neuroborreliosis: A Double-blind, Randomised, Crossover Study
Verified date | February 2005 |
Source | Linkoeping University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Sweden: Medical Products Agency |
Study type | Interventional |
The aim of this randomised, double-blind crossover study was to determine whether Doxycycline has an impact on the persistent symptoms post-neuroborreliosis, through alterations in the immune response and whether such an effect could influence the clinical outcome.
Status | Completed |
Enrollment | 15 |
Est. completion date | February 2008 |
Est. primary completion date | February 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 85 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
Sweden | Clinic for Infectious Diseases, University Hospital | Linköping | Östergötland |
Lead Sponsor | Collaborator |
---|---|
Linkoeping University |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Improvement in persistent symptoms | 12 weeks | No | |
Secondary | Changes in cytokine levels in plasma/serum in patients during treatment with DOX/PBO | 12 weeks | No |
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