Effects of Doxycycline on Persistent Symptoms Post-neuroborreliosis

This study has been completed.
Sponsor:
Information provided by:
Linkoeping University
ClinicalTrials.gov Identifier:
NCT01205464
First received: September 17, 2010
Last updated: NA
Last verified: February 2005
History: No changes posted
  Purpose

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 Intervention
Fatigue
Radicular Pain
Cognitive Dysfunction
Paresthesia
Paresis
Drug: Doxycycline
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Linkoeping University:

Primary Outcome Measures:
  • Improvement in persistent symptoms [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in cytokine levels in plasma/serum in patients during treatment with DOX/PBO [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: February 2005
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Linkoeping University

Additional 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
Study First Received: September 17, 2010
Last Updated: September 17, 2010
Health Authority: Sweden: Medical Products Agency

Keywords provided by Linkoeping University:
Persistent symptoms
Doxycycline
Placebo
Neuroborreliosis

Additional relevant MeSH terms:
Paresthesia
Fatigue
Paresis
Cognition Disorders
Signs and Symptoms
Neurologic Manifestations
Nervous System Diseases
Somatosensory Disorders
Sensation Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Doxycycline
Doxycycline hyclate
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on April 16, 2014