BHV-7000 for Epilepsy

(RISE 2 Trial)

Recruiting at 135 trial locations

Overseen By Chief Medical Officer

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Biohaven Therapeutics Ltd.

Must be taking: Anti-seizure medications

Disqualifiers: Status epilepticus, Cluster seizures, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

390 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called BHV-7000 to determine its effectiveness for people with refractory focal epilepsy, a type of epilepsy difficult to control with standard medications. The study includes different groups receiving either the new drug at varying doses or a placebo (a pill with no active medicine). It targets individuals who have experienced focal epilepsy for at least a year without relief from other treatments. Participants should be capable of maintaining a detailed diary of their seizures. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that BHV-7000 is likely to be safe for humans?

Research has shown that BHV-7000 has a strong safety record from earlier studies. Tested at doses up to 120 mg daily for 15 days, it proved to be safe and well-tolerated. Importantly, it did not cause the common side effects often seen with other seizure medications, such as problems with the brain and spinal cord.

This means that people taking BHV-7000 reported fewer issues that usually affect the mind and body. Early results suggest that BHV-7000 is generally well-tolerated, and no harmful effects emerged that would prevent increasing the dose.

These findings are promising for those considering joining a trial, as they suggest a treatment that appears to be safe with fewer side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for epilepsy?

Researchers are excited about BHV-7000 for epilepsy because it brings a novel approach to managing seizures. While many traditional epilepsy treatments, such as valproate or lamotrigine, focus on stabilizing neuronal activity by modulating sodium or calcium channels, BHV-7000 works differently by targeting the Kv7 potassium channels, potentially offering a new way to control seizures. This new mechanism could provide relief for patients who don't respond well to existing medications. Additionally, BHV-7000 is being tested in two dosage forms, 25 mg and 50 mg, which allows researchers to fine-tune its effectiveness and safety, aiming to maximize benefits while minimizing side effects. This innovative approach is why there's buzz around BHV-7000 in the epilepsy community.

What evidence suggests that BHV-7000 might be an effective treatment for epilepsy?

Research has shown that BHV-7000 might help treat epilepsy, especially for people with hard-to-control seizures. In early animal studies, it effectively reduced seizures by activating certain channels in the brain, which can lessen seizure activity. Initial human studies found that patients were pleased with the treatment and noticed their seizures were less severe. Overall, BHV-7000 aims to help those who haven't found relief with other epilepsy treatments. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• BHV-7000

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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 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 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]

Citations

1. neurology.org neurology.org/doi/10.1212/WNL.0000000000206409

Phase 1 Study Evaluating the Safety and Tolerability of ... In preclinical studies, BHV-7000 showed minimal GABAA receptor activation and exhibited potent anti-seizure efficacy in the maximal electroshock ...

2. ir.biohaven.com ir.biohaven.com/news-releases/news-release-details/biohaven-presents-new-data-bhv-7000-once-daily-extended-release

Biohaven Presents New Data with BHV-7000 Once-Daily ... Reported expanded safety results from BHV-7000 Phase 1 multiple ascending dose studies, including the once-daily extended-release formulation being evaluated ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06132893

A Study to Determine if BHV-7000 is Effective and Safe in ... To compare the efficacy of each of 2 doses of BHV-7000 to placebo as an adjunctive therapy for refractory focal onset epilepsy as measured by the change from OP ...

4. aesnet.org aesnet.org/abstractslisting/a-first-in-human-phase-1-study-evaluating-the-safety-and-tolerability-of-bhv-7000-a-novel-selective-kv7-2-7-3-potassium-channel-activator-in-healthy-adults

Abstracts - American Epilepsy Society Patients reported satisfaction with treatment and improved cognitive effects after seizures and seizure severity.

5. neurologylive.com neurologylive.com/view/insights-biohaven-new-phase-2-3-trial-potassium-inhibitor-bhv-7000-treating-epilepsy

Insights on Biohaven's New Phase 2/3 Trial of Potassium ... Early research has shown BHV-7000 to be successful in treating seizures in animal models of epilepsy.

6. ir.biohaven.com ir.biohaven.com/news-releases/news-release-details/biohaven-presents-expanded-eeg-and-safety-data-bhv-7000-american

Press Release Details We are pleased to see favorable safety and tolerability with BHV-7000 dosed up to 120 mg daily for 15 days, without the CNS adverse effects ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06309966

NCT06309966 | Study to Determine if BHV-7000 is ... The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy. Official Title. A Phase 2/3 Multicenter, ...

8. prnewswire.com prnewswire.com/news-releases/biohaven-presents-new-data-with-bhv-7000-once-daily-extended-release-formulation-demonstrating-excellent-safety-profile-and-nonclinical-data-updates-at-american-epilepsy-society-2024-annual-meeting-302324613.html

Biohaven Presents New Data with BHV-7000 Once-Daily ... We are encouraged to see BHV-7000 continue to demonstrate favorable safety and tolerability without dose-limiting toxicities or CNS adverse ...