SIF001 for Epilepsy
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment called SIF001, a monoclonal antibody, to determine its safety and efficacy for people with epilepsy. Researchers aim to assess how the body handles different doses and the drug's effects. The trial includes individuals with epilepsy who experience frequent motor seizures despite taking up to three anti-seizure medications. Participants must have stable epilepsy treatments for at least eight weeks before joining. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.
Do I need to stop my current medications to join the trial?
If you have epilepsy and are taking 1 to 3 anti-seizure medications, you can continue them as long as they have been stable for 8 weeks before screening and remain stable during the study. For healthy volunteers, you should not have used any over-the-counter or prescription medications, except for limited amounts of paracetamol or ibuprofen, within 7 days or 5 half-lives of the drug before dosing.
Is there any evidence suggesting that SIF001 is likely to be safe for humans?
Research shows that SIF001, a treatment being tested for epilepsy, is in the early stages of human safety testing. As a Phase 1 trial, the main goal is to assess how well participants tolerate the treatment and identify any side effects.
Detailed results from earlier studies on SIF001's safety are not yet available. However, as a Phase 1 trial, safety details are still being determined. Participants are closely monitored to observe their body's response to the treatment. If SIF001 proves safe, it will advance to the next testing stages.
For those considering joining this trial, it's important to know that safety checks are a key part of this early testing phase.12345Why do researchers think this study treatment might be promising for epilepsy?
SIF001 is unique because it offers a new approach to treating epilepsy by being administered intravenously, potentially allowing for faster action compared to oral medications. Most epilepsy treatments, like those involving sodium channel blockers or GABA enhancers, are taken orally and take time to reach effective blood levels. SIF001’s intravenous delivery could provide rapid relief, which is particularly beneficial during acute seizures. Researchers are excited about this treatment because it targets epilepsy with a potentially quicker onset of action, which could be a game-changer for managing severe or sudden episodes.
What evidence suggests that SIF001 might be an effective treatment for epilepsy?
Research on SIF001, which participants in this trial may receive, remains in the early stages, and detailed information from human studies is not yet available. SIF001 is a monoclonal antibody designed to target specific proteins in the body. The aim is to reduce the frequency or severity of seizures in people with epilepsy. Monoclonal antibodies have successfully treated other conditions by precisely targeting disease causes. Although exact results for SIF001 are not yet available, its design suggests potential effectiveness in managing epilepsy symptoms.36789
Are You a Good Fit for This Trial?
This trial is for healthy individuals and those with epilepsy. Participants must meet specific health criteria to ensure safety during the study, but exact inclusion and exclusion details are not provided.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive SIF001 or placebo intravenously over one hour in a dose escalation study
Follow-up
Participants are monitored for safety and effectiveness after treatment
Pharmacokinetic Monitoring
Assessment of pharmacokinetic parameters such as AUC, Cmax, and immunogenicity
What Are the Treatments Tested in This Trial?
Interventions
- SIF001
Trial Overview
The study tests SIF001, a new monoclonal antibody that could potentially treat epilepsy. It involves gradually increasing doses to evaluate its safety and how it's processed by the body compared to a placebo.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
SIF001 infused intravenously over one hour
Placebo infused intravenously over one hour
Find a Clinic Near You
Who Is Running the Clinical Trial?
Suninflam Inc
Lead Sponsor
Citations
NCT07051629 | Dose Escalation Study to Assess the ...
This is a dose escalation study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of SIF001, a monoclonal antibody with the potential ...
Impact of Third-Generation Antiseizure Medications on People ...
The percentage of individuals who achieved a ≥ 50% reduction in seizures at 3, 6, and 12 months was 60%, 63.8%, and 65.9%, respectively. The ...
3.
cureepilepsy.org
cureepilepsy.org/news/study-efficacy-of-antiepileptic-drugs-in-the-adjunctive-treatment-of-refractory-partial-onset-seizures-meta-analysis-of-pivotal-trials/Study: Efficacy of Antiepileptic Drugs in the Adjunctive ...
Outcomes analyzed: 1) 50% responder rate (?50% reduction from baseline in seizure frequency); 2) seizure freedom (proportion of seizure-free ...
Efficacy and safety of add‐on antiseizure medications for focal ...
The primary efficacy outcomes were the proportion of participants achieving response rates of ≥50%, ≥75%, and seizure freedom from baseline seizure frequency, ...
5.
neurologyadvisor.com
neurologyadvisor.com/news/seizure-frequency-improves-over-time-in-treatment-resistant-epilepsy/Seizure Frequency Improves Over Time in Treatment ...
The researchers found that in 86 participants (68.3 percent), seizure frequency was reduced in the second half of the study compared with the ...
Chinese Clinical Trial Register (ChiCTR)
Exploring the Efficacy and Safety of Monoclonal Antibody SIF001 in the Treatment of Drug-Resistant Epilepsy ... Data and Safety Monitoring ...
Epilepsy (DBCOND0017557)
A Study to Investigate the Safety and Efficacy of Lacosamide Added to the Patients Current Therapy in Patients Aged 1 Month to Less Than 18 Years Old With ...
SIF001 for Epilepsy · Recruiting Participants for Phase ...
This Phase 1 medical study run by Suninflam Inc is evaluating whether SIF001 will have tolerable side effects & efficacy for patients with Epilepsy, ...
Epilepsy Paid Clinical Trials in Florida - Policy Lab
The purpose of the study is to investigate the long-term safety and tolerability of brivaracetam in study participants with childhood absence epilepsy or ...
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