FatigueNCT01205464
Effects of Doxycycline on Persistent Symptoms Post-neuroborreliosis
A study testing Doxycycline in people with Fatigue and Radicular Pain, run by Linkoeping University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Fatigue, Radicular Pain, Cognitive Dysfunction
- What is being tested?
- Doxycycline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2005to Feb 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- systemic immunosuppression (treatment with corticosteroids, cytostatics etc)
- ongoing infection at inclusion
- allergy against doxycycline
- pregnancy
- breast feeding
- psychiatric disease
Show all 13Show fewer
- multiple sclerosis
- rheumatoid arthritis
- diabetes mellitus type 1 or II
- inflammatory systemic diseases
- liver ohc kidney dysfunction
- treatment with didanosine, quinapril, antacids
- malignancy
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Clinic for Infectious Diseases, University Hospital
Linköping, Östergötland County, 58185
About this study
Official title: Immunomodulatory and Clinical Effects of Doxycycline on Persistent Symptoms After Treatment of Neuroborreliosis: A Double-blind, Randomised, Crossover Study
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.
Read the 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.
- Conditions
- Fatigue, Radicular Pain, Cognitive Dysfunction, Paresthesia, Paresis
- Being tested
- Doxycycline, Placebo
- Keywords
- Persistent symptoms, Doxycycline, Placebo, Neuroborreliosis
- Medical subject headings
- Fatigue, Cognitive Dysfunction, Paresthesia, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxycyclineDrug
Also called Doxyferm, Vibramycin, Tetracycline
Doxycycline, 100 mg, 2 capsules once daily, 24 hour time interval, 21 days.
PlaceboDrug
Also called Sugar pill
Placebo, 100 mg, 2 capsules once daily, 24 hour dosage interval, 21 days.
| Study group | Role | What they receive |
|---|---|---|
| Doxycycline | Active comparator | Treatment with Capsule Doxycycline 200 mg, once daily, for 21 days. Receives: Drug: Doxycycline |
| Sugar pill | Placebo comparator | Capsule Placebo, 200 mg, once daily, for 21 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in persistent symptoms
Measured: 12 weeks
Secondary outcomes (1)
Changes in cytokine levels in plasma/serum in patients during treatment with DOX/PBO
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2010 (estimated)
- Study startFeb 2005
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FatigueStudies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Investigators
- Pia Forsberg, MD, Principal investigator, Department of Infectious Diseases, Faculty of Health Sciences, Linköping university, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01205464
- Sponsor's protocol ID
- 151:2004/25331
- Status last verified
- Feb 2005
- First submitted
- 17 Sep 2010
- Last updated
- 20 Sep 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22876748
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunomodulatory and Clinical Effects of Doxycycline on Persistent Symptoms After Treatment of Neuroborreliosis: A Double-blind, Randomised, Crossover Study
- ClinicalTrials.gov ID
- NCT01205464
- Acronym / sponsor ID
- 151:2004/25331
- Conditions
- Fatigue, Radicular Pain, Cognitive Dysfunction, Paresthesia, Paresis
- Keywords
- Persistent symptoms, Doxycycline, Placebo, Neuroborreliosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- Feb 2005
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 20 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Doxycycline | Active comparator | Drug: DoxycyclineTreatment with Capsule Doxycycline 200 mg, once daily, for 21 days. |
| Sugar pill | Placebo comparator | Drug: PlaceboCapsule Placebo, 200 mg, once daily, for 21 days. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (13 listed)
- systemic immunosuppression (treatment with corticosteroids, cytostatics etc)
- ongoing infection at inclusion
- allergy against doxycycline
- pregnancy
- breast feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DoxycyclineAlso: Doxyferm, Vibramycin, TetracyclineDoxycycline, 100 mg, 2 capsules once daily, 24 hour time interval, 21 days. | Drug | Doxycycline |
| PlaceboAlso: Sugar pillPlacebo, 100 mg, 2 capsules once daily, 24 hour dosage interval, 21 days. | Drug | Sugar pill |
Primary outcome
Improvement in persistent symptoms
Time frame: 12 weeks
1 secondary outcome
Changes in cytokine levels in plasma/serum in patients during treatment with DOX/PBO
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2010.
- Derived from this study: PubMed 22876748Sjowall 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pia Forsberg, MD principal investigator
Department of Infectious Diseases, Faculty of Health Sciences, Linköping university, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Doxycycline in people with Fatigue and Radicular Pain, run by Linkoeping University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in persistent symptoms (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01205464, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2010.