Neuroborreliosis, Borrelia BurgdorferiPhase 3NCT02553473
Six Versus Two Weeks Treatment With Doxycycline in Lyme Neuroborreliosis
A Phase 3 study testing Doxycycline in people with Neuroborreliosis, Borrelia Burgdorferi, run by Sorlandet Hospital HF.
Trial summary
Comparison of Doxycycline 200 mg once daily for six weeks versus Doxycycline 200 mg once daily for two weeks + placebo for four weeks. Primary objective is to answer the question "is two weeks doxycycline treatment (currently suggested treatment) at least as effective as six weeks doxycycline treatment in Lyme… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroborreliosis, Borrelia Burgdorferi
- What is being tested?
- Doxycycline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 121 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to Feb 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Neurological symptoms suggestive of LNB without other obvious reasons and one or both of
- Cerebrospinal fluid pleocytosis ≥5 leukocytes pr mm3
- Intrathecal Bb antibody production
- Signed informed consent
Who cannot join
- Age less than 18 years
- Pregnancy, breast-feeding
- Adverse reaction to tetracyclines
- Treatment with cephalosporin, penicillin, or tetracycline the last 14 days
- Serious liver or kidney disease that contraindicates use of doxycycline
- Lactose intolerance
- Need to use medications contraindicated according to Summary of Product Characteristics of the Investigational Medicinal Product
About this study
Official title: Six Versus Two Weeks Treatment With Doxycycline in Lyme Neuroborreliosis; a Multicenter, Non-inferiority, Penta-blind, Randomized Trial
Comparison of Doxycycline 200 mg once daily for six weeks versus Doxycycline 200 mg once daily for two weeks + placebo for four weeks. Primary objective is to answer the question "is two weeks doxycycline treatment (currently suggested treatment) at least as effective as six weeks doxycycline treatment in Lyme Neuroborreliosis?".Key secondary objectives are to provide a better understanding of the pathogenesis and long-term complaints, and to search for new biomarkers in Lyme Neuroborreliosis (LNB) by collecting clinical data, blood, and cerebrospinal fluid (CSF) in a biobank for future research
Endpoints:
Read more
Primary endpoint: Improvement on a composite clinical score from inclusion to six months after ended treatment defined as clinical score at inclusion minus clinical score at six months.
Secondary endpoints: Improvement on a composite clinical score 12 months after ended treatment. Fatigue Severity Scale (FSS),Patient Health Questionnaire (PHQ-15), Short Form 36 (SF-36) and blood and CSF findings at inclusion, after 6 and 12 months.
The study design is a multicenter, non-inferiority, randomized, penta-blind, placebo-controlled trial. 120 patients will be included from approximately 8 Norwegian hospitals.
Main inclusion criteria are neurological symptoms suggestive of LNB without other obvious reasons, one or both of a) Cerebrospinal fluid pleocytosis (>5 leukocytes/mm3) b) intrathecal Bb antibody Production and signed informed consent. Safety assessments during the trial: Comparison of clinical outcome six months after end of treatment between the two treatment groups. Subjective experiences and blood tests including hematology and biochemistry for four weeks after ended treatment.
- Conditions
- Neuroborreliosis, Borrelia Burgdorferi
- Being tested
- Doxycycline, Placebo
- Medical subject headings
- Lyme Neuroborreliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxycyclineDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Doxycycline for 6 weeks | Active comparator | Doxycycline 200 mg once daily for six weeks Receives: Drug: Doxycycline |
| Doxycycline for 2 weeks + placebo | Placebo comparator | Doxycycline 200 mg once daily for two weeks + placebo for four weeks. Receives: Drug: Doxycycline; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Composite Clinical Score From Inclusion to Six Months After Ended Treatment
Clinical change on composite clinical score (CCS) defined as score at inclusion minus score at 6 months after treatment.CCS consisted of 32 variables,scored from 0 to 2 points.Minimum 0 points,maximum 64 points.High scale score indicated worse outcome.
Variables scored:Malaise,Fatigue,Headache,Neck and/or back pain,Abdominal and/or breast pain,Arm pain,Leg pain,Generalised pain located to joints and/or muscles,Memory and/or concentration problems,Other,Facial palsy,Paresis of the eye muscles,Reduced hearing,Other cranial neuropathies,Cervical radicular sensory findings,Cervical radicular paresis,Thoracic radicular sensory findings,Lumbar radicular sensory findings,Lumbar radicular paresis,Non-radicular sensory findings,Non-radicular paresis,Other,Central findings in one extremity,Central findings in a hemi pattern,Central findings in both legs,Central findings in all extremities,Gait ataxia,Dysphasia/aphasia, Nystagmus,Involuntary movement including tremor,Cognitive impairment,Other.
Measured: Six months after end of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2015 (estimated)
- Study startOct 2015
- Primary completionJan 2020
- Study completionFeb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Neuroborreliosis, Borrelia BurgdorferiStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sorlandet Hospital HF
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Anne Marit Solheim, M.D, Principal investigator, Sørlandet hospital HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02553473
- Sponsor's protocol ID
- 2015-001481-25
- Other IDs
- 2015
- Status last verified
- Jun 2021
- First submitted
- 16 Sep 2015
- Last updated
- 23 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Six Versus Two Weeks Treatment With Doxycycline in Lyme Neuroborreliosis; a Multicenter, Non-inferiority, Penta-blind, Randomized Trial
- ClinicalTrials.gov ID
- NCT02553473
- Acronym / sponsor ID
- 2015-001481-25
- Conditions
- Neuroborreliosis, Borrelia Burgdorferi
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Sorlandet Hospital HFOther government
- Study start
- Oct 2015 (actual)
- Primary completion
- Jan 2020 (actual)
- Study completion
- Feb 2021 (actual)
- First posted
- 17 Sep 2015 (estimated)
- Results
- Posted 23 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparison of Doxycycline 200 mg once daily for six weeks versus Doxycycline 200 mg once daily for two weeks + placebo for four weeks. Primary objective is to answer the question "is two weeks doxycycline treatment (currently suggested treatment) at least as effective as six weeks doxycycline treatment in Lyme Neuroborreliosis?".Key secondary objectives are to provide a better understanding of the pathogenesis and long-term complaints, and to search for new biomarkers in Lyme Neuroborreliosis (LNB) by collecting clinical data, blood, and cerebrospinal fluid (CSF) in a biobank for future research
Endpoints:
Primary endpoint: Improvement on a composite clinical score from inclusion to six months after ended treatment defined as clinical score at inclusion minus clinical score at six months.
Secondary endpoints: Improvement on a composite clinical score 12 months after ended treatment. Fatigue Severity Scale (FSS),Patient Health Questionnaire (PHQ-15), Short Form 36 (SF-36) and blood and CSF findings at inclusion, after 6 and 12 months.
The study design is a multicenter, non-inferiority, randomized, penta-blind, placebo-controlled trial. 120 patients will be included from approximately 8 Norwegian hospitals.
Main inclusion criteria are neurological symptoms suggestive of LNB without other obvious reasons, one or both of a) Cerebrospinal fluid pleocytosis (>5 leukocytes/mm3) b) intrathecal Bb antibody Production and signed informed consent. Safety assessments during the trial: Comparison of clinical outcome six months after end of treatment between the two treatment groups. Subjective experiences and blood tests including hematology and biochemistry for four weeks after ended treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Doxycycline for 6 weeks | Active comparator | Drug: DoxycyclineDoxycycline 200 mg once daily for six weeks |
| Doxycycline for 2 weeks + placebo | Placebo comparator | Drug: Doxycycline, Drug: PlaceboDoxycycline 200 mg once daily for two weeks + placebo for four weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Neurological symptoms suggestive of LNB without other obvious reasons and one or both of
- Signed informed consent
Key exclusion criteria (7 listed)
- Age less than 18 years
- Pregnancy, breast-feeding
- Adverse reaction to tetracyclines
- Treatment with cephalosporin, penicillin, or tetracycline the last 14 days
- Serious liver or kidney disease that contraindicates use of doxycycline
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 |
|---|---|---|
| Doxycycline | Drug | Doxycycline for 2 weeks + placebo, Doxycycline for 6 weeks |
| Placebo | Drug | Doxycycline for 2 weeks + placebo |
Primary outcome
Difference in Composite Clinical Score From Inclusion to Six Months After Ended Treatment
Time frame: Six months after end of treatment.
Clinical change on composite clinical score (CCS) defined as score at inclusion minus score at 6 months after treatment.CCS consisted of 32 variables,scored from 0 to 2 points.Minimum 0 points,maximum 64 points.High scale score indicated worse outcome. Variables scored:Malaise,Fatigue,Headache,Neck and/or back pain,Abdominal and/or breast pain,Arm pain,Leg pain,Generalised pain located to joints and/or muscles,Memory and/or concentration problems,Other,Facial palsy,Paresis of the eye muscles,Reduced hearing,Other cranial neuropathies,Cervical radicular sensory findings,Cervical radicular paresis,Thoracic radicular sensory findings,Lumbar radicular sensory findings,Lumbar radicular paresis,Non-radicular sensory findings,Non-radicular paresis,Other,Central findings in one extremity,Central findings in a hemi pattern,Central findings in both legs,Central findings in all extremities,Gait ataxia,Dysphasia/aphasia, Nystagmus,Involuntary movement including tremor,Cognitive impairment,Other.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Anne Marit Solheim, M.D principal investigator
Sørlandet hospital HF
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Doxycycline in people with Neuroborreliosis, Borrelia Burgdorferi, run by Sorlandet Hospital HF.
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 4 inclusion and 7 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 23 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Difference in Composite Clinical Score From Inclusion to Six Months After Ended Treatment (time frame: Six months after end of treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jan 2024.