Autoimmune EncephalitisPhase 2NCT06033846
Efficacy and Safety of Adjunctive Minocycline in the Treatment of Autoimmune Encephalitis
A Phase 2 study testing Minocycline in people with Autoimmune Encephalitis, run by Xijing Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autoimmune Encephalitis
- What is being tested?
- Minocycline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2023to 16 Jul 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Adjunctive Minocycline in the Treatment of Autoimmune Encephalitis: Open-lable, Randomised, Proof of Concept Study
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
- Being tested
- Minocycline
- Keywords
- autoimmune encephalitis, minocycline
- Medical subject headings
- Autoimmune Diseases of the Nervous System, cyclopia sequence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MinocyclineDrug
Also called minocycline hydrochloride
treatment with minocycline combined with first-line drugs for autoimmune encephalitis
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Treatment group | Experimental | Drug: Minocyclin 200 mg oral minocycline for a total of 30 days Receives: Drug: Minocycline |
| Control group | No intervention | first-line drugs for autoimmune encephalitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montreal-Cognitive Assessment (MoCA)scores
the change in MoCA scores from baseline to 3 months
Measured: 3 months
Secondary outcomes (5)
modified rankin scale (mRS) scores
The proportion of patients achieving a ≥1-point or ≥2-point improvement in mRS scores at 1 month
Measured: 1 month
MoCA scores
change in MoCA scores from baseline to months 1, 6, and 12
Measured: from baseline to months 1, 6, and 12
mini-mental state examination (MMSE) scores
change in MoCA scores from baseline to months 1, 3, 6, and 12
Measured: from baseline to months 1, 3, 6, and 12
Hamilton anxiety scale (HAMA) scores
changes in HAMA scores from baseline to months 1, 3, 6, and 12
Measured: from baseline to months 1, 3, 6, and 12
Hamilton depression scale (HAMD) scores
changes in HAMA scores from baseline to months 1, 3, 6, and 12
Measured: from baseline to months 1, 3, 6, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start1 Oct 2023
- Primary completion3 Jun 2024
- Study completion16 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autoimmune EncephalitisStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06033846
- Sponsor's protocol ID
- XJLL-KY-20232121
- Status last verified
- Mar 2025
- First submitted
- 18 Aug 2023
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhang Y, Zhao J, Fan Z, Wang X, Shi X, Wang X, Wan T, Du F, Wu K, Jiang W. Efficacy and Safety of Adjunctive Minocycline in the Treatment of Autoimmune Encephalitis (MEET): A Proof of Concept Study. J Neuroimmune Pharmacol. 2026 Mar 28;21(1):16. doi: 10.1007/s11481-026-10290-1.
PubMed 41902986
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Adjunctive Minocycline in the Treatment of Autoimmune Encephalitis: Open-lable, Randomised, Proof of Concept Study
- ClinicalTrials.gov ID
- NCT06033846
- Acronym / sponsor ID
- XJLL-KY-20232121
- Conditions
- Autoimmune Encephalitis
- Keywords
- autoimmune encephalitis, minocycline
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 3 Jun 2024 (actual)
- Study completion
- 16 Jul 2025 (actual)
- First posted
- 13 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Treatment group | Experimental | Drug: MinocyclineDrug: Minocyclin 200 mg oral minocycline for a total of 30 days |
| Control group | No intervention | –first-line drugs for autoimmune encephalitis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MinocyclineAlso: minocycline hydrochloridetreatment with minocycline combined with first-line drugs for autoimmune encephalitis | Drug | Experimental: Treatment group |
Primary outcome
Montreal-Cognitive Assessment (MoCA)scores
Time frame: 3 months
the change in MoCA scores from baseline to 3 months
5 secondary outcomes
modified rankin scale (mRS) scores
Time frame: 1 month
MoCA scores
Time frame: from baseline to months 1, 6, and 12
mini-mental state examination (MMSE) scores
Time frame: from baseline to months 1, 3, 6, and 12
Hamilton anxiety scale (HAMA) scores
Time frame: from baseline to months 1, 3, 6, and 12
Hamilton depression scale (HAMD) scores
Time frame: from baseline to months 1, 3, 6, and 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Derived from this study: PubMed 41902986Zhang Y, Zhao J, Fan Z, Wang X, Shi X, Wang X, Wan T, Du F, Wu K, Jiang W. Efficacy and Safety of Adjunctive Minocycline in the Treatment of Autoimmune Encephalitis (MEET): A Proof of Concept Study. J Neuroimmune Pharmacol. 2026 Mar 28;21(1):16. doi: 10.1007/s11481-026-10290-1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Minocycline in people with Autoimmune Encephalitis, run by Xijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montreal-Cognitive Assessment (MoCA)scores (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06033846, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.