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

NCT06033846 | Completed Phase 2

• 1 other identifier: XJLL-KY-20232121
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Autoimmune Encephalitis

Keywords

autoimmune encephalitis; minocycline

Outcome Measures

Primary Outcomes (1)

• Montreal-Cognitive Assessment (MoCA)scores

  the change in MoCA scores from baseline to 3 months

  3 months

Secondary Outcomes (5)

• modified rankin scale (mRS) scores

  1 month

• MoCA scores

  from baseline to months 1, 6, and 12

• mini-mental state examination (MMSE) scores

  from baseline to months 1, 3, 6, and 12

• Hamilton anxiety scale (HAMA) scores

  from baseline to months 1, 3, 6, and 12

• Hamilton depression scale (HAMD) 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)

  from baseline to months 1, 3, 6, and 12.

Study Arms (2)

Experimental: Treatment group

EXPERIMENTAL

Drug: Minocyclin 200 mg oral minocycline for a total of 30 days

Drug: Minocycline

Control group

NO INTERVENTION

first-line drugs for autoimmune encephalitis

Interventions

Minocycline DRUG

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

Also known as: minocycline hydrochloride

Experimental: Treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Xijing Hospital

Xi'an, China

Location

MeSH Terms

Conditions

Autoimmune Diseases of the Nervous System; cyclopia sequence

Interventions

Minocycline

Condition Hierarchy (Ancestors)

Nervous System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2023
• First Posted: September 13, 2023
• Study Start: October 1, 2023
• Primary Completion: June 3, 2024
• Study Completion: July 16, 2025
• Last Updated: August 14, 2025

Record last verified: 2025-03

Locations

CN (1)