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

Primary Purpose

Autoimmune Encephalitis

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Minocycline
Sponsored by
Xijing Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autoimmune Encephalitis focused on measuring autoimmune encephalitis, minocycline

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Xijing HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental: Treatment group

Control group

Arm Description

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

first/second-line drugs for autoimmune encephalitis

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 18, 2023
Last Updated
September 11, 2023
Sponsor
Xijing Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06033846
Brief Title
Efficacy and Safety of Adjunctive Minocycline in the Treatment of Autoimmune Encephalitis
Official Title
Efficacy and Safety of Adjunctive Minocycline in the Treatment of Autoimmune Encephalitis: Open-lable, Randomised, Proof of Concept Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
May 2028 (Anticipated)
Study Completion Date
December 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xijing Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autoimmune Encephalitis
Keywords
autoimmune encephalitis, minocycline

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental: Treatment group
Arm Type
Experimental
Arm Description
Drug: Minocyclin 200 mg oral minocycline for a total of 30 days
Arm Title
Control group
Arm Type
No Intervention
Arm Description
first/second-line drugs for autoimmune encephalitis
Intervention Type
Drug
Intervention Name(s)
Minocycline
Other Intervention Name(s)
minocycline hydrochloride
Intervention Description
treatment with minocycline combined with first/second-line drugs for autoimmune encephalitis
Primary Outcome Measure Information:
Title
MoCA scores
Description
The proportion of patients with MoCA scores ≥26 at 3 months after enrollment.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
mRS scores
Description
The proportion of patients with mRS scores ≤2 at discharge.
Time Frame
1 month
Title
MoCA scores
Description
The proportion of patients with MoCA scores ≥26 at discharge.
Time Frame
1 month
Title
MMSE scores
Description
The proportion of patients with MMSE scores ≥27 at discharge.
Time Frame
1 month
Title
mRS scores
Description
The proportion of patients with mRS scores ≤2 at 3 months.
Time Frame
at 3 months
Title
MMSE scores
Description
The proportion of patients with MMSE scores ≥27 at 3 months.
Time Frame
at 3 months
Title
HAMA scores
Description
HAMA scores at 3 months.
Time Frame
at 3 months
Title
HAMD scores
Description
HAMD scores at 3 months.
Time Frame
at 3 months
Other Pre-specified Outcome Measures:
Title
number of participants with medical laboratory results
Description
medical laboratory results at admission
Time Frame
at admission
Title
medical imaging data
Description
medical imaging data at onset
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yingchi Zhang
Phone
13228022186
Email
zhangyingchi0418@163.com
Facility Information:
Facility Name
Xijing Hospital
City
Xi'an
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yingchi Zhang

12. IPD Sharing Statement

Learn more about this trial

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

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