Effects of Doxycycline on Persistent Symptoms Post-neuroborreliosis
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| ClinicalTrials.gov Identifier: NCT01205464 |
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Recruitment Status :
Completed
First Posted : September 20, 2010
Last Update Posted : September 20, 2010
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Fatigue Radicular Pain Cognitive Dysfunction Paresthesia Paresis | Drug: Doxycycline Drug: Placebo | Not Applicable |
Persistent symptoms after treatment of neuroborreliosis (NB) are not uncommon. There is currently no evidence for improvement of symptoms after repeated or prolonged antibiotic treatment. However, clinical observations have indicated that some patients improve during treatment with doxycycline (DOX), but regain the symptoms some time after completed treatment. This may be due to an immunomodulatory effect of the drug. The aim of this randomised, double-blind crossover study was to determine whether DOX has an impact on the persistent symptoms through alterations in the immune response and whether such an effect can influence the clinical outcome.
A total of 15 patients from South-East Sweden with previously adequately diagnosed NB with diverse persistent symptoms ≥6months after antibiotic treatment were randomised in a double-blind, crossover fashion to receive either DOX 200 mg or placebo (PBO) once daily for three weeks, followed by a wash-out period of six weeks and a further three-weeks treatment with either DOX 200 mg or PBO once daily for three weeks. The primary outcome measures were improvement of the persistent symptoms and physical and mental health, evaluated using the visual analogue scale (VAS), the 36-item Short-Form General Health Survey (SF-36) and through physical examination with special emphasis on neurologic status at the follow-up visits. Secondary outcome measures were changes in drug-induced antigen-stimulated and unstimulated cytokine responses.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 15 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Basic Science |
| Official Title: | Immunomodulatory and Clinical Effects of Doxycycline on Persistent Symptoms After Treatment of Neuroborreliosis: A Double-blind, Randomised, Crossover Study |
| Study Start Date : | February 2005 |
| Actual Primary Completion Date : | February 2008 |
| Actual Study Completion Date : | February 2008 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Doxycycline
Treatment with Capsule Doxycycline 200 mg, once daily, for 21 days.
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Drug: Doxycycline
Doxycycline, 100 mg, 2 capsules once daily, 24 hour time interval, 21 days.
Other Names:
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Placebo Comparator: Sugar pill
Capsule Placebo, 200 mg, once daily, for 21 days.
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Drug: Placebo
Placebo, 100 mg, 2 capsules once daily, 24 hour dosage interval, 21 days.
Other Name: Sugar pill |
- Improvement in persistent symptoms [ Time Frame: 12 weeks ]
- Changes in cytokine levels in plasma/serum in patients during treatment with DOX/PBO [ Time Frame: 12 weeks ]
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| Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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): NCT01205464
| Sweden | |
| Clinic for Infectious Diseases, University Hospital | |
| Linköping, Östergötland, Sweden, 58185 | |
| Principal Investigator: | Pia Forsberg, MD | Department of Infectious Diseases, Faculty of Health Sciences, Linköping university, Sweden |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Pia Forsberg, Dep. of Infectious Diseases, Faculty of Health Scienses, Linköping University, Sweden |
| ClinicalTrials.gov Identifier: | NCT01205464 History of Changes |
| Other Study ID Numbers: |
151:2004/25331 |
| First Posted: | September 20, 2010 Key Record Dates |
| Last Update Posted: | September 20, 2010 |
| Last Verified: | February 2005 |
Keywords provided by Linkoeping University:
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Persistent symptoms Doxycycline Placebo Neuroborreliosis |
Additional relevant MeSH terms:
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Paresthesia Fatigue Cognitive Dysfunction Paresis Signs and Symptoms Cognition Disorders Neurocognitive Disorders Mental Disorders Neurologic Manifestations |
Nervous System Diseases Somatosensory Disorders Sensation Disorders Doxycycline Anti-Bacterial Agents Anti-Infective Agents Antimalarials Antiprotozoal Agents Antiparasitic Agents |