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

Sponsor

Xijing Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT06033846

Collaborator

(none)

Enrollment

Location

Arms

67.1

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Autoimmune Encephalitis	Drug: Minocycline	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

May 1, 2028

Anticipated Study Completion Date :

Dec 1, 2028

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental: Treatment group Drug: Minocyclin 200 mg oral minocycline for a total of 30 days	Drug: Minocycline treatment with minocycline combined with first/second-line drugs for autoimmune encephalitis Other Names: minocycline hydrochloride
No Intervention: Control group first/second-line drugs for autoimmune encephalitis

Arm

Intervention/Treatment

Experimental: Experimental: Treatment group

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

Drug: Minocycline

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

Other Names:

minocycline hydrochloride

No Intervention: Control group

first/second-line drugs for autoimmune encephalitis

Outcome Measures

Primary Outcome Measures

MoCA scores [3 months]
The proportion of patients with MoCA scores ≥26 at 3 months after enrollment.

Secondary Outcome Measures

mRS scores [1 month]
The proportion of patients with mRS scores ≤2 at discharge.
MoCA scores [1 month]
The proportion of patients with MoCA scores ≥26 at discharge.
MMSE scores [1 month]
The proportion of patients with MMSE scores ≥27 at discharge.
mRS scores [at 3 months]
The proportion of patients with mRS scores ≤2 at 3 months.
MMSE scores [at 3 months]
The proportion of patients with MMSE scores ≥27 at 3 months.
HAMA scores [at 3 months]
HAMA scores at 3 months.
HAMD scores [at 3 months]
HAMD scores at 3 months.

Other Outcome Measures

number of participants with medical laboratory results [at admission]
medical laboratory results at admission
medical imaging data [3 months]
medical imaging data at onset

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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