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

Autoimmune Encephalitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06033846
• Other study ID #: XJLL-KY-20232121
• Status: Recruiting
• Phase: Phase 2
• Start date: May 1, 2023
• Est. completion date: December 2028

Study information

• Verified date: August 2023
• Source: Xijing Hospital
• Contact: Yingchi Zhang
• Phone: 13228022186
• Email: zhangyingchi0418[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2028
• Est. primary completion date: May 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Autoimmune Diseases of the Nervous System
• Autoimmune Encephalitis
• Encephalitis
• Hashimoto Disease

Intervention

Drug:
• Minocycline
treatment with minocycline combined with first/second-line drugs for autoimmune encephalitis

Locations

Country	Name	City	State
China	Xijing Hospital	Xi'an

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	number of participants with medical laboratory results	medical laboratory results at admission	at admission
Other	medical imaging data	medical imaging data at onset	3 months
Primary	MoCA scores	The proportion of patients with MoCA scores =26 at 3 months after enrollment.	3 months
Secondary	mRS scores	The proportion of patients with mRS scores =2 at discharge.	1 month
Secondary	MoCA scores	The proportion of patients with MoCA scores =26 at discharge.	1 month
Secondary	MMSE scores	The proportion of patients with MMSE scores =27 at discharge.	1 month
Secondary	mRS scores	The proportion of patients with mRS scores =2 at 3 months.	at 3 months
Secondary	MMSE scores	The proportion of patients with MMSE scores =27 at 3 months.	at 3 months
Secondary	HAMA scores	HAMA scores at 3 months.	at 3 months
Secondary	HAMD scores	HAMD scores at 3 months.	at 3 months