52 Participants Needed

NBI-921352 for Epilepsy

Recruiting at 11 trial locations
NM
Overseen ByNeurocrine Medical Information Call Center
Age: < 65
Sex: Any
Trial Phase: Phase 2
Sponsor: Neurocrine Biosciences
Must be taking: Antiseizure medications
Stay on Your Current MedsYou can continue your current medications while participating
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The objective of this study is to assess the efficacy, safety, and pharmacokinetics of NBI-921352 as adjunctive therapy for seizures in subjects with SCN8A Developmental and Epileptic Encephalopathy Syndrome (SCN8A-DEE).

Do I have to stop taking my current medications for this trial?

The trial does not specify that you need to stop taking your current medications. In fact, you must be on at least one other antiseizure medication to participate. However, you cannot be on systemic steroids or certain cannabinoids unless approved by the Sponsor.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must be on at least one other antiseizure medication. You cannot take systemic steroids or certain cannabinoids, except Epidiolex, during the study.

What safety data is available for NBI-921352 (Zandatrigine) in epilepsy treatment?

The provided research does not contain specific safety data for NBI-921352, also known as Zandatrigine. The studies mentioned focus on other antiepileptic drugs like lamotrigine and perampanel, as well as chemogenetic techniques for seizure suppression. Therefore, no direct safety data for NBI-921352 is available in the given research.12345

Is the drug NBI-921352 a promising treatment for epilepsy?

The drug NBI-921352 is considered promising for epilepsy because new antiepileptic drugs are being developed to improve treatment options. These drugs aim to be more effective and have fewer side effects than older ones. Some new drugs target specific brain receptors involved in seizures, which can help control epilepsy better. Overall, the development of new drugs like NBI-921352 offers hope for better management of epilepsy.46789

How does the drug NBI-921352 differ from other epilepsy drugs?

NBI-921352 is unique because it may target specific neurotransmitter systems in the brain, potentially offering a new mechanism of action compared to conventional epilepsy drugs, which often have limitations in effectiveness and side effects.46789

What data supports the idea that NBI-921352 for Epilepsy is an effective drug?

The available research does not provide specific data on the effectiveness of NBI-921352 for Epilepsy. Instead, it discusses other drugs and treatments for epilepsy, such as lamotrigine, which showed a modest reduction in seizures compared to a placebo in a study. However, there is no direct comparison or data on NBI-921352 in the provided information.410111213

Who Is on the Research Team?

CD

Clinical Development Lead

Principal Investigator

Neurocrine Biosciences

Are You a Good Fit for This Trial?

This trial is for children and young adults aged 2 to 21 with SCN8A Developmental and Epileptic Encephalopathy Syndrome. Participants must weigh at least 10 kg, have frequent seizures despite taking up to four antiseizure medications, and not be seizure-free for over 20 days.

Inclusion Criteria

I am currently taking 1 to 4 medications for seizures.
I have at least one noticeable seizure every week and haven't been seizure-free for more than 20 days in a row.
I am between 2 and 21 years old.
See 6 more

Exclusion Criteria

Participated in an interventional clinical trial < 30 days prior to screening
I have symptoms similar to Dravet syndrome.
I have had a serious head injury or disease affecting my brain.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Titration

Participants receive increasing doses of NBI-921352 based on weight

6 weeks

Maintenance

Participants receive treatment at their final tolerated dose

10 weeks

Taper

Participants receive decreasing doses of NBI-921352

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • NBI-921352
  • Placebo
Trial Overview The study tests NBI-921352 as an additional treatment alongside existing antiseizure medications in patients with SCN8A-DEE. It aims to evaluate the drug's effectiveness in reducing seizures compared to a placebo (a substance with no therapeutic effect).
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: NBI-921352Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Neurocrine Biosciences

Lead Sponsor

Trials
78
Recruited
6,600+

Kyle W. Gano

Neurocrine Biosciences

Chief Executive Officer since 2024

PhD in Pharmacology

Dr. Sanjay Keswani

Neurocrine Biosciences

Chief Medical Officer

MD

Published Research Related to This Trial

Recent studies have highlighted the efficacy and tolerability of various epilepsy treatments, including both new drugs like vigabatrin and established therapies such as lamotrigine and gabapentin, although comparisons between them remain limited.
Encouragingly, new double-blinded placebo-controlled trials are now including children and the elderly, which helps address gaps in research for these often-overlooked patient groups.
New antiepileptic drugs and non-pharmacological treatments.Ben-Menachem, E.[2019]
A meta-analysis of 29 trials involving 4,091 patients showed that all six add-on treatments for refractory epilepsy (gabapentin, lamotrigine, tiagabine, topiramate, vigabatrin, and zonisamide) were significantly more effective than placebo in reducing seizure frequency by at least 50%.
While there were no definitive differences in efficacy or tolerability among the drugs, topiramate and vigabatrin showed the highest odds of response and discontinuation, indicating they may be the most effective but also potentially the least tolerable options.
The new antiepileptic drugs: a systematic review of their efficacy and tolerability.Marson, AG., Kadir, ZA., Hutton, JL., et al.[2022]
GABA plays a crucial role in controlling neuronal excitability, and many current antiseizure medications enhance GABA transmission, highlighting the need for innovative therapies targeting this system.
Several promising treatments are in development, including repurposed drugs like Staccato® alprazolam for acute seizures and novel therapies like GABAergic interneurons and gene therapies aimed at restoring GABA function, though more clinical data is needed to evaluate their effectiveness.
New GABA-Targeting Therapies for the Treatment of Seizures and Epilepsy: II. Treatments in Clinical Development.Perucca, E., White, HS., Bialer, M.[2023]

Citations

New antiepileptic drugs and non-pharmacological treatments. [2019]
The new antiepileptic drugs: a systematic review of their efficacy and tolerability. [2022]
New GABA-Targeting Therapies for the Treatment of Seizures and Epilepsy: II. Treatments in Clinical Development. [2023]
A study of the effects of lamotrigine on mice using two convulsive tests. [2020]
Double-blind crossover trial of lamotrigine (Lamictal) as add-on therapy in intractable epilepsy. [2019]
Perampanel Study 207: long-term open-label evaluation in patients with epilepsy. [2021]
Chemogenetic Recruitment of Specific Interneurons Suppresses Seizure Activity. [2022]
Human safety of lamotrigine. [2019]
Bioequivalence and switchability of generic antiseizure medications (ASMs): A re-appraisal based on analysis of generic ASM products approved in Europe. [2021]
The clinical pharmacology of the new antiepileptic drugs. [2015]
Targeting NMDA Receptor Complex in Management of Epilepsy. [2022]
12.United Statespubmed.ncbi.nlm.nih.gov
The NMDA receptor complex as a therapeutic target in epilepsy: a review. [2022]
13.United Statespubmed.ncbi.nlm.nih.gov
Antiepileptic drugs in development: prospects for the near future. [2019]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security