The Efficacy and Safety of Minocycline in the Treatment of Drug-resistant Epilepsy in NORSE Patients

NCT05958069 | Unknown

• 1 other identifier: XJLL-KY-20232108
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Epileptic Seizures Related to Drugs

Outcome Measures

Primary Outcomes (2)

• 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);

  24 months

• Incidence of adverse events (Main safety indicators)

  such as dizziness, rash, and gastrointestinal reactions.

  24 months

Study Arms (1)

minocycline

EXPERIMENTAL

Treatment with minocycline combined with antiepileptic drugs: After enrollment, 100mg/day (50mg specification) of minocycline hydrochloride was administered for 12 consecutive weeks;

Drug: minocycline

Interventions

minocycline DRUG

Treatment with minocycline combined with antiepileptic drugs: After enrollment, 100mg/day (50mg specification) of minocycline hydrochloride was administered for 12 consecutive weeks;

Also known as: antiepileptic drugs

minocycline

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

XijingHospital

Xi'an, Shaanxi, 710032, China

Location

Related Publications (1)

• 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.

  PMID: 40481521 DERIVED

MeSH Terms

Interventions

Minocycline; Anticonvulsants

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Central Nervous System Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Wen jiang

  The First Affiliated Hospital of Air Force Military Medical University

  STUDY CHAIR

• Lei Ma

  The First Affiliated Hospital of Air Force Military Medical University

  PRINCIPAL INVESTIGATOR

• yuanyuan Wang

  XijingHospital

  PRINCIPAL INVESTIGATOR

• mengmeng Hu

  XijingHospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Model Details: Treatment with minocycline combined with antiepileptic drugs: After enrollment, 100mg/day (50mg specification) of minocycline hydrochloride was administered for 12 consecutive weeks;

Study Record Dates

• First Submitted: April 13, 2023
• First Posted: July 24, 2023
• Study Start: March 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2025
• Last Updated: July 24, 2023

Record last verified: 2023-07

Locations

CN (1)