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Effects of Doxycycline on Persistent Symptoms Post-neuroborreliosis

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ClinicalTrials.gov Identifier: NCT01205464
Recruitment Status : Completed
First Posted : September 20, 2010
Last Update Posted : September 20, 2010
Sponsor:
Information provided by:
Linkoeping University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Fatigue Radicular Pain Cognitive Dysfunction Paresthesia Paresis Drug: Doxycycline Drug: Placebo Not Applicable

Detailed Description:

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 Design
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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

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Doxycycline
Treatment with Capsule Doxycycline 200 mg, once daily, for 21 days.
 Drug: Doxycycline
Doxycycline, 100 mg, 2 capsules once daily, 24 hour time interval, 21 days.
Other Names:
  • Doxyferm
  • Vibramycin
  • Tetracycline
Placebo Comparator: Sugar pill
Capsule Placebo, 200 mg, once daily, for 21 days.
 Drug: Placebo
Placebo, 100 mg, 2 capsules once daily, 24 hour dosage interval, 21 days.
Other Name: Sugar pill


Outcome Measures
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Primary Outcome Measures :
  1. Improvement in persistent symptoms [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Changes in cytokine levels in plasma/serum in patients during treatment with DOX/PBO [ Time Frame: 12 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
Sweden
Clinic for Infectious Diseases, University Hospital
Linköping, Östergötland, Sweden, 58185
Sponsors and Collaborators
Linkoeping University
Investigators
Principal Investigator: Pia Forsberg, MD Department of Infectious Diseases, Faculty of Health Sciences, Linköping university, Sweden
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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:
Persistent symptoms
Doxycycline
Placebo
Neuroborreliosis

Additional relevant MeSH terms:
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