An interventional study of Doxycycline and Placebo in Fatigue, Radicular Pain and Cognitive Dysfunction, sponsored by Linkoeping University. Completed at 1 site in Sweden. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2010-09-20.
Sponsored by Linkoeping University · Not applicable, Interventional, and Basic science
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.
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.
2,229 studies on the registry are indexed under Fatigue; 426 are open to participants now.
This study's enrollment of 15 is below the median of 54 across 1,757 interventional studies indexed under Fatigue.
Browse Fatigue studies →Linkoeping University is the lead sponsor of 193 studies on the registry; 40 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
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Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Treatment with Capsule Doxycycline 200 mg, once daily, for 21 days.
Drug: Doxycycline
Capsule Placebo, 200 mg, once daily, for 21 days.
Drug: Placebo
Doxycycline, 100 mg, 2 capsules once daily, 24 hour time interval, 21 days.
Also known as: Doxyferm, Vibramycin, Tetracycline
Placebo, 100 mg, 2 capsules once daily, 24 hour dosage interval, 21 days.
Also known as: 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
The record gives a start of Feb 2005, a primary completion of Feb 2008 and a completion of Feb 2008. It does not say whether these dates are actual or estimated.
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Studies of the drug tested here: Doxycycline