BHV-7000 for Epilepsy

(RISE 2 Trial)

Recruiting in Palo Alto (17 mi)

+116 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Recruiting

Sponsor: Biohaven Therapeutics Ltd.

Must be taking: Anti-seizure medications

Disqualifiers: Status epilepticus, Cluster seizures, others

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but it mentions that participants should be on at least 1 and up to 3 anti-seizure medications. It seems like you can continue your current treatment.

How does the drug BHV-7000 differ from other epilepsy treatments?

BHV-7000 is unique because it targets the GABA system, which plays a crucial role in controlling brain activity, and aims to develop more innovative therapies for epilepsy by focusing on this system. This approach is different from many existing treatments that also target GABA but may not be as innovative in their mechanisms. ^{1 2 3 4 5}

Research Team

Eligibility Criteria

This trial is for adults aged 18-75 with refractory focal onset epilepsy, who have tried at least two anti-seizure medications without success. Participants should be able to track their seizures and may be on up to three anti-seizure meds plus one additional treatment like a diet regimen or device.

Inclusion Criteria

You have been diagnosed with Focal Epilepsy

I was diagnosed with Focal Onset Epilepsy over a year ago.

My epilepsy is drug-resistant according to the 2009 ILAE definition.

Exclusion Criteria

Participation in any other investigational clinical trial while participating in this clinical trial.

Subjects who are detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Observation

Participants are observed to establish baseline seizure frequency

8 weeks

Treatment

Participants receive BHV-7000 or placebo in a double-blind manner

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• BHV-7000 (Anti-epileptic Drug)

Trial Overview The study is testing the effectiveness and safety of BHV-7000 compared to a placebo in treating refractory focal epilepsy. Patients will either receive BHV-7000 or an inactive substance (placebo) without knowing which one they are taking.

Participant Groups

Group I: BHV-7000 50 mg Experimental Treatment 1 Intervention

Group II: BHV-7000 25 mg Experimental Treatment 1 Intervention

Group III: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Biohaven Therapeutics Ltd.

Lead Sponsor

Trials

13

Recruited

4,800+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New GABA-Targeting Therapies for the Treatment of Seizures and Epilepsy: II. Treatments in Clinical Development. Perucca, E., White, HS., Bialer, M.[2023]

The Sixteenth Eilat Conference on New Antiepileptic Drugs and Devices showcased advancements in epilepsy treatment, with 157 delegates discussing five investigational compounds, highlighting a focus on novel molecular targets and treatments for rare epilepsy syndromes.

The conference emphasized the importance of both pharmacological treatments and device-based therapies, reflecting a broader approach to managing epilepsy beyond traditional medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Progress report on new antiepileptic drugs: A summary of the Sixteenth Eilat Conference on New Antiepileptic Drugs and Devices (EILAT XVI): I. Drugs in preclinical and early clinical development. Bialer, M., Johannessen, SI., Koepp, MJ., et al.[2022]

The Eilat XIII Conference highlighted significant advancements in antiepileptic drugs (AEDs), including the approval of brivaracetam in 2016 and 12 other drugs currently in various phases of clinical development, indicating a strong focus on improving treatment options for epilepsy.

Many of the new AEDs discussed show innovative mechanisms of action and have demonstrated promising results in patients with difficult-to-treat epilepsy, particularly in rare and severe epilepsy syndromes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Progress report on new antiepileptic drugs: A summary of the Thirteenth Eilat Conference on New Antiepileptic Drugs and Devices (EILAT XIII). Bialer, M., Johannessen, SI., Levy, RH., et al.[2018]

The Eilat VII conference highlighted advancements in the development of new antiepileptic drugs (AEDs), including promising candidates like brivaracetam and eslicarbazepine acetate, which may offer new treatment options for epilepsy.

The conference also provided updates on existing AEDs and treatment strategies, emphasizing the importance of evidence-based guidelines and the potential role of neurostimulation in managing refractory epilepsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Progress report on new antiepileptic drugs: a summary of the Eigth Eilat Conference (EILAT VIII). Bialer, M., Johannessen, SI., Kupferberg, HJ., et al.[2018]

The antisense oligonucleotide STK-001 effectively increases NaV1.1 protein expression and reduces seizures in a mouse model of Dravet Syndrome, demonstrating its potential as a targeted treatment.

STK-001 treatment not only reduces seizures and improves survival but also restores the excitability of parvalbumin-positive inhibitory interneurons to normal levels, addressing a core mechanism of the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeted Augmentation of Nuclear Gene Output (TANGO) of Scn1a rescues parvalbumin interneuron excitability and reduces seizures in a mouse model of Dravet Syndrome. Wengert, ER., Wagley, PK., Strohm, SM., et al.[2022]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

New GABA-Targeting Therapies for the Treatment of Seizures and Epilepsy: II. Treatments in Clinical Development. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Progress report on new antiepileptic drugs: A summary of the Sixteenth Eilat Conference on New Antiepileptic Drugs and Devices (EILAT XVI): I. Drugs in preclinical and early clinical development. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Progress report on new antiepileptic drugs: A summary of the Thirteenth Eilat Conference on New Antiepileptic Drugs and Devices (EILAT XIII). [2018]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Progress report on new antiepileptic drugs: a summary of the Eigth Eilat Conference (EILAT VIII). [2018]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Targeted Augmentation of Nuclear Gene Output (TANGO) of Scn1a rescues parvalbumin interneuron excitability and reduces seizures in a mouse model of Dravet Syndrome. [2022]