Epileptic Seizures Related to DrugsNCT05958069
The Efficacy and Safety of Minocycline in the Treatment of Drug-resistant Epilepsy in NORSE Patients
A study testing minocycline in people with Epileptic Seizures Related to Drugs, run by Xijing Hospital at 1 site in China.
Trial summary
Exploring the efficacy and safety of oral minocycline combined with antiepileptic drugs in the treatment of drug-resistant epilepsy in NORSE patients, obtaining preliminary research data, and providing evidence and data support for the next large-scale randomized controlled clinical study. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Epileptic Seizures Related to Drugs
- What is being tested?
- minocycline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to 1 Mar 2025
- Phase
- Interventional
- 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 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≥ 8 years old;
- It meets the NORSE diagnostic criteria: (1) newly emerging intractable status epilepticus, (2) no previous epilepsy or other related nervous system disease, (3) no clear acute structural, toxic and metabolic factors leading to intractable status epilepticus;
- NORSE medical history ≥ 6 months, with a frequency of ≥ 4 episodes per month;
- Take two or more antiepileptic drugs;
- The patient and their family members are aware of this study and sign an informed consent form.
Who cannot join
- Patients who are allergic to any component of tetracycline or product formulation;
- Persistent state of epilepsy;
- Adjustment of antiepileptic drugs during the trial period;
- Immunotherapy, ketogenic diet and other added treatments were not stable or other treatments were started during the trial;
- Epilepsy surgery;
- In the treatment of vagus nerve stimulation and transcranial magnetic stimulation;
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- Patients with severe infection, cerebrovascular disease, malignant tumor and other nervous system disease, and patients with severe dysfunction of heart, liver, kidney and other organs;
- Non epileptic seizures such as syncope and hysteria;
- Participating in clinical trials of other drugs;
- Women during lactation or pregnancy;
- Incomplete clinical data;
- The patient or family member withdraws the informed consent form.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy and Safety of Minocycline in the Treatment of Drug-resistant Epilepsy in NORSE Patients: an Open-label, One-arm Clinical Study
Exploring the efficacy and safety of oral minocycline combined with antiepileptic drugs in the treatment of drug-resistant epilepsy in NORSE patients, obtaining preliminary research data, and providing evidence and data support for the next large-scale randomized controlled clinical study.
Read the detailed description
New-onset refractory status epilepticus (NORSE) is a rare but special clinical manifestation with a high mortality rate. Most cases evolve into Super refractory status epilepticus (SRSE), with poor treatment efficacy, short-term mortality rate of 12-27%, and high long-term disability rate. Most survivors eventually develop into Drug resistant epilepsy (DRE) and experience cognitive impairment. Frequent seizures seriously affect patients' daily life and work, Controlling the frequency of seizures is particularly important. At present, the pathogenesis of this disease is still unclear, and the treatment plan is still controversial. In recent years, research has found that inflammatory and immune responses in the body may be involved in the pathogenic process. In response to the current research on the inflammatory immune mechanism and epilepsy, the use of anti-inflammatory drugs and immune modulators may be a new treatment direction.
Minocycline is a semi synthetic tetracycline broad-spectrum antibiotic with good blood-brain barrier penetration. Since the end of the 19th century, the efficacy of minocycline has been reported in many models of nervous system disease, including hemorrhagic and ischemic stroke, multiple sclerosis, amyotrophic lateral sclerosis, Parkinson's disease, etc. Because of its ability to cross the blood-brain barrier, its detoxification effect on activated microglia and its proven human safety record, it seems to be a promising candidate drug for epilepsy treatment.
In summary, minocycline has good blood-brain barrier permeability, as well as anti-inflammatory, immunomodulatory, and potential anti epileptic effects, with good safety. Therefore, this study intends to carry out a randomized controlled, open label, evaluator blind proof of concept study to explore the efficacy and safety of minocycline in the treatment of drug-resistant epilepsy in patients with NORSE.
- Conditions
- Epileptic Seizures Related to Drugs
- Being tested
- minocycline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
minocyclineDrug
Also called antiepileptic drugs
Treatment with minocycline combined with antiepileptic drugs: After enrollment, 100mg/day (50mg specification) of minocycline hydrochloride was administered for 12 consecutive weeks;
| Study group | Role | What they receive |
|---|---|---|
| minocycline | Experimental | Treatment with minocycline combined with antiepileptic drugs: After enrollment, 100mg/day (50mg specification) of minocycline hydrochloride was administered for 12 consecutive weeks; Receives: Drug: minocycline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in seizure frequency
Main efficacy endpoint: Changes in seizure frequency from baseline in patients who added minocycline during the 12 week treatment period. Epileptic seizures include countable focal motor seizures with unconscious disorders, focal seizures with conscious disorders, focal seizures evolving into bilateral motor seizures, and systemic seizures (tonic-clonic, tonic-clonic, or atonic);
Measured: 24 months
Incidence of adverse events (Main safety indicators)
such as dizziness, rash, and gastrointestinal reactions.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2023
- Study start1 Mar 2023
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Mar 2025 (estimated)
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 Epileptic Seizures Related to DrugsStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Treatment with minocycline combined with antiepileptic drugs: After enrollment, 100mg/day (50mg specification) of minocycline hydrochloride was administered for 12 consecutive weeks;
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Hui, Xijing Hospital
- Investigators
- Wen jiang, Study chair, The First Affiliated Hospital of Air Force Military Medical UniversityLei Ma, Principal investigator, The First Affiliated Hospital of Air Force Military Medical Universityyuanyuan Wang, Principal investigator, XijingHospitalmengmeng Hu, Principal investigator, XijingHospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05958069
- Sponsor's protocol ID
- XJLL-KY-20232108
- Status last verified
- Jul 2023
- First submitted
- 13 Apr 2023
- Last updated
- 24 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Feng L, Li H, Ma L, Hu M, Hui B, Sun Z, Wang X, Wang Y, Jiang W. Minocycline in chronic management of febrile infection-related epilepsy syndrome (FIRES): a case series and literature review of treatment strategies. Acta Epileptol. 2025 Jun 6;7(1):35. doi: 10.1186/s42494-025-00224-4.
PubMed 40481521
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Minocycline in the Treatment of Drug-resistant Epilepsy in NORSE Patients: an Open-label, One-arm Clinical Study
- ClinicalTrials.gov ID
- NCT05958069
- Acronym / sponsor ID
- XJLL-KY-20232108
- Conditions
- Epileptic Seizures Related to Drugs
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 24 Jul 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.
Exploring the efficacy and safety of oral minocycline combined with antiepileptic drugs in the treatment of drug-resistant epilepsy in NORSE patients, obtaining preliminary research data, and providing evidence and data support for the next large-scale randomized controlled clinical study.
Detailed description
New-onset refractory status epilepticus (NORSE) is a rare but special clinical manifestation with a high mortality rate. Most cases evolve into Super refractory status epilepticus (SRSE), with poor treatment efficacy, short-term mortality rate of 12-27%, and high long-term disability rate. Most survivors eventually develop into Drug resistant epilepsy (DRE) and experience cognitive impairment. Frequent seizures seriously affect patients' daily life and work, Controlling the frequency of seizures is particularly important. At present, the pathogenesis of this disease is still unclear, and the treatment plan is still controversial. In recent years, research has found that inflammatory and immune responses in the body may be involved in the pathogenic process. In response to the current research on the inflammatory immune mechanism and epilepsy, the use of anti-inflammatory drugs and immune modulators may be a new treatment direction.
Minocycline is a semi synthetic tetracycline broad-spectrum antibiotic with good blood-brain barrier penetration. Since the end of the 19th century, the efficacy of minocycline has been reported in many models of nervous system disease, including hemorrhagic and ischemic stroke, multiple sclerosis, amyotrophic lateral sclerosis, Parkinson's disease, etc. Because of its ability to cross the blood-brain barrier, its detoxification effect on activated microglia and its proven human safety record, it seems to be a promising candidate drug for epilepsy treatment.
In summary, minocycline has good blood-brain barrier permeability, as well as anti-inflammatory, immunomodulatory, and potential anti epileptic effects, with good safety. Therefore, this study intends to carry out a randomized controlled, open label, evaluator blind proof of concept study to explore the efficacy and safety of minocycline in the treatment of drug-resistant epilepsy in patients with NORSE.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Treatment with minocycline combined with antiepileptic drugs: After enrollment, 100mg/day (50mg specification) of minocycline hydrochloride was administered for 12 consecutive weeks;
| Arm | Type | Receives |
|---|---|---|
| minocycline | Experimental | Drug: minocyclineTreatment with minocycline combined with antiepileptic drugs: After enrollment, 100mg/day (50mg specification) of minocycline hydrochloride was administered for 12 consecutive weeks; |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 8 years old;
- It meets the NORSE diagnostic criteria: (1) newly emerging intractable status epilepticus, (2) no previous epilepsy or other related nervous system disease, (3) no clear acute structural, toxic and metabolic factors leading to intractable status epilepticus;
- NORSE medical history ≥ 6 months, with a frequency of ≥ 4 episodes per month;
- Take two or more antiepileptic drugs;
- The patient and their family members are aware of this study and sign an informed consent form.
Key exclusion criteria (12 listed)
- Patients who are allergic to any component of tetracycline or product formulation;
- Persistent state of epilepsy;
- Adjustment of antiepileptic drugs during the trial period;
- Immunotherapy, ketogenic diet and other added treatments were not stable or other treatments were started during the trial;
- Epilepsy surgery;
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: antiepileptic drugsTreatment with minocycline combined with antiepileptic drugs: After enrollment, 100mg/day (50mg specification) of minocycline hydrochloride was administered for 12 consecutive weeks; | Drug | minocycline |
Primary outcome
Changes in seizure frequency
Time frame: 24 months
Main efficacy endpoint: Changes in seizure frequency from baseline in patients who added minocycline during the 12 week treatment period. Epileptic seizures include countable focal motor seizures with unconscious disorders, focal seizures with conscious disorders, focal seizures evolving into bilateral motor seizures, and systemic seizures (tonic-clonic, tonic-clonic, or atonic);
Incidence of adverse events (Main safety indicators)
Time frame: 24 months
such as dizziness, rash, and gastrointestinal reactions.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
- Derived from this study: PubMed 40481521Feng L, Li H, Ma L, Hu M, Hui B, Sun Z, Wang X, Wang Y, Jiang W. Minocycline in chronic management of febrile infection-related epilepsy syndrome (FIRES): a case series and literature review of treatment strategies. Acta Epileptol. 2025 Jun 6;7(1):35. doi: 10.1186/s42494-025-00224-4.
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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.
Wen jiang study chair
The First Affiliated Hospital of Air Force Military Medical University
Lei Ma principal investigator
The First Affiliated Hospital of Air Force Military Medical University
yuanyuan Wang principal investigator
XijingHospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing minocycline in people with Epileptic Seizures Related to Drugs, 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 12 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: status not confirmed, as of the sponsor's last update on 24 Jul 2023. 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.
Are results available for this study?
Results are not available in the source record.
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?
Changes in seizure frequency (time frame: 24 months). The study lists 2 primary outcomes in all. 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 NCT05958069, 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 24 Jul 2023.