Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2025-12-25 @ 8:43 PM
Study NCT ID:
NCT05958069
Status:
UNKNOWN
Last Update Posted:
2023-07-24
First Post:
2023-04-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Efficacy and Safety of Minocycline in the Treatment of Drug-resistant Epilepsy in NORSE Patients
Sponsor:
Xijing Hospital
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2023-07
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: