NCT01205464

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2005

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

September 17, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 20, 2010

Completed
Last Updated

September 20, 2010

Status Verified

February 1, 2005

Enrollment Period

3 years

First QC Date

September 17, 2010

Last Update Submit

September 17, 2010

Conditions

FatigueRadicular PainCognitive DysfunctionParesthesiaParesis

Keywords

Persistent symptomsDoxycyclinePlaceboNeuroborreliosis

Outcome Measures

Primary Outcomes (1)

  • Improvement in persistent symptoms

    12 weeks

Secondary Outcomes (1)

  • Changes in cytokine levels in plasma/serum in patients during treatment with DOX/PBO

    12 weeks

Study Arms (2)

Doxycycline

ACTIVE COMPARATOR

Treatment with Capsule Doxycycline 200 mg, once daily, for 21 days.

Drug: Doxycycline

Sugar pill

PLACEBO COMPARATOR

Capsule Placebo, 200 mg, once daily, for 21 days.

Drug: Placebo

Interventions

DoxycyclineDRUG

Doxycycline, 100 mg, 2 capsules once daily, 24 hour time interval, 21 days.

Also known as: Doxyferm, Vibramycin, Tetracycline
Doxycycline
PlaceboDRUG

Placebo, 100 mg, 2 capsules once daily, 24 hour dosage interval, 21 days.

Also known as: Sugar pill
Sugar pill

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • systemic immunosuppression (treatment with corticosteroids, cytostatics etc)
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinic for Infectious Diseases, University Hospital

Linköping, Östergötland County, 58185, Sweden

Location

Related Publications (1)

  • Sjowall J, Ledel A, Ernerudh J, Ekerfelt C, Forsberg P. Doxycycline-mediated effects on persistent symptoms and systemic cytokine responses post-neuroborreliosis: a randomized, prospective, cross-over study. BMC Infect Dis. 2012 Aug 10;12:186. doi: 10.1186/1471-2334-12-186.

    PMID: 22876748DERIVED

MeSH Terms

Conditions

FatigueCognitive DysfunctionParesthesiaParesis

Interventions

DoxycyclineTetracyclineSugars

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsCognition DisordersNeurocognitive DisordersMental DisordersSomatosensory DisordersSensation DisordersNeurologic ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

TetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsCarbohydrates

Study Officials

  • Pia Forsberg, MD

    Department of Infectious Diseases, Faculty of Health Sciences, Linköping university, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

September 17, 2010

First Posted

September 20, 2010

Study Start

February 1, 2005

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

September 20, 2010

Record last verified: 2005-02

Locations

SE(1)