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

NCT ID: NCT06033846

Last Updated: 2025-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2025-07-16

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental: Treatment group

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

Group Type: EXPERIMENTAL

Minocycline

Intervention Type: DRUG

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

Control group

first-line drugs for autoimmune encephalitis

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Minocycline

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

Intervention Type: DRUG

Other Intervention Names

minocycline hydrochloride

Eligibility Criteria

Inclusion Criteria

1. Diagnosis of definite autoimmune encephalitis(Graus et al 2016.)

2. Age ≥ 18 years

3. Acute or subacute onset (rapid progression of less than 3 months)

4. Reasonable exclusion of alternative causes

5. Written informed consent

Exclusion Criteria

1. Known allergy to tetracycline antibiotics.

2. Pregnant women.

3. Uncontrolled serious concomitant illness.

4. Known chronic kidney disease stages 3b-5.

5. Moderate liver disease (see Child-Pugh for Classification of Severity of Liver Disease).

6. history of cognitive impairment

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xijing Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Xijing Hospital

Xi'an, , China

Countries

China

Other Identifiers

XJLL-KY-20232121

Identifier Type: -

Identifier Source: org_study_id