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OpenTrials
Completed

NCT Number: NCT06033846

Efficacy and Safety of Adjunctive Minocycline in the Treatment of Autoimmune Encephalitis

Autoimmune encephalitis (AE) is an immune-mediated brain disorder characterized by varied clinical manifestations that correlate with specific types of antibodies.Typical symptoms include acute behavioral changes, psychosis, seizures, memory deficits, dyskinesias, speech impairments, and autonomic and respiratory dysregulation.While the majority of patients respond well to immunotherapeutic agents, a significant proportion remains resistant to initial and secondary-line immunotherapies.Minocycline, a semisynthetic tetracycline, is notably used for the central nervous system due to its lipophilic characteristics and its capacity to penetrate the blood-brain barrier. While the primary neuroprotective focus of minocycline in the central nervous system remains unknown, the primary effects of minocycline include the inhibition of microglial activation, mitigation of apoptosis, and reduction in reactive oxygen species generation.Protective effect has been observed in hypoxic injury, ischemic stroke, amyotrophic lateral sclerosis, traumatic spinal cord injury, multiple sclerosis, Parkinson's disease, and Huntington's disease.Can minocycline offer a protective role in AE? Consequently, we proposed a randomized, controlled trial to investigate the efficacy of minocycline in AE.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Xijing Hospital

Xi'an, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of definite autoimmune encephalitis(Graus et al 2016.)
  • Age ≥ 18 years
  • Acute or subacute onset (rapid progression of less than 3 months)
  • Reasonable exclusion of alternative causes
  • Written informed consent

Exclusion criteria

  • Known allergy to tetracycline antibiotics.
  • Pregnant women.
  • Uncontrolled serious concomitant illness.
  • Known chronic kidney disease stages 3b-5.
  • Moderate liver disease (see Child-Pugh for Classification of Severity of Liver Disease).
  • history of cognitive impairment

Treatment and study plan

Minocycline

Drug

treatment with minocycline combined with first-line drugs for autoimmune encephalitis

Other names: minocycline hydrochloride

Primary outcomes

  1. Montreal-Cognitive Assessment (MoCA)scores

    Time frame: 3 months

    the change in MoCA scores from baseline to 3 months

Secondary outcomes

  1. modified rankin scale (mRS) scores

    Time frame: 1 month

    The proportion of patients achieving a ≥1-point or ≥2-point improvement in mRS scores at 1 month

  2. MoCA scores

    Time frame: from baseline to months 1, 6, and 12

    change in MoCA scores from baseline to months 1, 6, and 12

  3. mini-mental state examination (MMSE) scores

    Time frame: from baseline to months 1, 3, 6, and 12

    change in MoCA scores from baseline to months 1, 3, 6, and 12

  4. Hamilton anxiety scale (HAMA) scores

    Time frame: from baseline to months 1, 3, 6, and 12

    changes in HAMA scores from baseline to months 1, 3, 6, and 12

  5. Hamilton depression scale (HAMD) scores

    Time frame: from baseline to months 1, 3, 6, and 12

    changes in HAMA scores from baseline to months 1, 3, 6, and 12

Other outcomes

  1. cerebrospinal fluid (CSF) levels of Soluble Triggering Receptor Expressed on Myeloid cells 2 (sTREM2)

    Time frame: from baseline to months 1, 3, 6, and 12.

    the change in CSF levels of sTREM2 levels from baseline to months 1, 3, 6, and 12.

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Registry information

Official study title

Efficacy and Safety of Adjunctive Minocycline in the Treatment of Autoimmune Encephalitis: Open-lable, Randomised, Proof of Concept Study

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Sep 13, 2023
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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