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An open label, historical control, study to assess the impact on bacteriological healing of Prednisolone in patients with neuroborreliosis-caused peripheral facial palsy receiving treatment with Doxycycline

An open label, historical control, study to assess the impact on bacteriological healing of Prednisolone in patients with neuroborreliosis-caused peripheral facial palsy receiving treatment with Doxycycline

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-018143-25-SE
Enrollment
30
Registered
2010-02-16
Start date
2010-05-06
Completion date
Unknown
Last updated
2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Facialispares orsakad av CNS-infektion med Borrelia burgdorferi. (Neuroborrelios-orsakad facialispares) MedDRA version: 12.1 Level: LLT Classification code 10052057 Term: Neuroborreliosis MedDRA version: 12.1 Level: LLT Classification code 10016060 Term: Facial palsy

Interventions

Trade Name: Prednisolon Pharmaceutical Form: Tablet INN or Proposed INN: PREDNISOLONE CAS Number: 50-24-8 Current Sponsor code: Prednisolon Other descriptive name: Prednisolon Concentration unit: mg m

Sponsors

Västra Götalandsregionen
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Ålder > 18 år Facialispares med duration = 7 dagar I CSV monocytära celler > 5/µl och albumin > 420 mg/ml. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Överkänslighet mot någon av de använda läkemedlen För kvinnor i fertil ålder: graviditet, amning, ej användande av kontraception Behandling med antibiotika eller kortison senaste 14 dagarna Diabetes Nyligen skallskada Svår psykiatrisk sjukdom.

Design outcomes

Primary

MeasureTime frame
Main Objective: Att kontrollera att behandling med kortison i tillägg till vedertagen antibiotikabehandling med doxyxyklin inte försämrar infektionsläkningen vid borrelia-orsakad perifer facialispares.;Secondary Objective: Inga.;Primary end point(s): Nivå av monocytära celler i CNS 6 veckor efter avslutad behandling.

Countries

Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026