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

Air Force Military Medical University of People's Liberation Army

Status and phase: Completed; Phase 2

Conditions: Autoimmune Encephalitis

Treatments: Drug: Minocycline

Study type: Interventional

Funder types: Other

Identifiers

NCT06033846

XJLL-KY-20232121

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 2 patient groups

Experimental: Treatment group

Experimental group

Description:

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

Treatment:

Drug: Minocycline

Control group

No Intervention group

Description:

first-line drugs for autoimmune encephalitis