BHV-7000 for Epilepsy

(RISE 3 Trial)

Recruiting at 170 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

390 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new medication, BHV-7000, to determine its effectiveness for people with epilepsy who continue to have seizures despite other treatments. The trial compares two different doses of BHV-7000 to a placebo (a "sugar pill" with no active medicine). It seeks participants diagnosed with focal epilepsy for at least a year who still experience seizures after trying at least two other seizure medications. Participants should be able to maintain a diary of their seizures. As a Phase 2 trial, this research measures how well BHV-7000 works 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 underwent safety testing in earlier studies. These studies found BHV-7000 to be generally safe and well-tolerated. Participants did not experience the usual side effects common with other anti-seizure medications. The data also indicated that even at doses up to 120 mg daily, BHV-7000 remained well-tolerated. This suggests the treatment is likely safe for humans. ^{1 2 3 4 5}

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

Most treatments for epilepsy focus on preventing seizures by stabilizing electrical activity in the brain, often using medications like valproate, lamotrigine, or carbamazepine. However, BHV-7000 works differently, as it targets specific ion channels that play a role in nerve signaling, potentially offering a more precise approach. Researchers are excited about BHV-7000 because it might offer improved seizure control with fewer side effects, providing a new hope for those who don't respond well to current medications. This unique mechanism could lead to better quality of life for epilepsy patients.

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

Early research has shown that BHV-7000 effectively reduces seizures, particularly in tests simulating seizure conditions. This treatment uniquely targets specific potassium channels that help control brain activity. Previous users of this treatment reported feeling better after seizures. It has also proven safe and well-tolerated, without causing the drowsiness common with other anti-seizure medications. These findings suggest that BHV-7000 could effectively treat hard-to-control focal epilepsy. Participants in this trial will receive either BHV-7000 at varying dosages or a placebo to further evaluate its effectiveness and safety. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults with refractory focal onset epilepsy, which means their seizures aren't well-controlled by current medications. Specific eligibility details are not provided, but typically participants must meet certain health standards and may be excluded based on other medical conditions or treatments.

Inclusion Criteria

I am currently on 1-3 seizure medications and have tried up to 4 treatments in total.

Ability to keep accurate seizure diaries

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

Exclusion Criteria

I have had a severe seizure not typical for me in the last 6 months.

I had brain surgery for seizures less than 4 months ago.

I had radiosurgery less than 2 years ago.

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

Double-Blind Treatment

Participants receive either BHV-7000 or placebo to evaluate efficacy and safety

8 weeks

Regular visits for monitoring and assessment

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 a medication called BHV-7000 in treating refractory focal epilepsy. Participants will either receive BHV-7000 or a placebo to compare outcomes between the two groups.

How Is the Trial Designed?

Group I: BHV-7000 75 mg Experimental Treatment 1 Intervention

Group II: BHV-7000 50 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 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]

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 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]

Citations

1. 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 ...

2. 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.

3. neurology.org neurology.org/doi/10.1212/WNL.0000000000211240

A Modern Design for a Phase 2/3 Randomized, Double- ... In phase 1 studies, BHV-7000 was safe and well tolerated without CNS adverse effects typical of ASMs, such as somnolence.

4. 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 ...

5. 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 ...

6. 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, ...

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

Press Release Details Biohaven reported full results from the BHV-7000 Phase 1 study examining doses up to 120 mg daily, demonstrating BHV-7000 was well-tolerated ...

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 ... Reported expanded safety results from BHV-7000 Phase 1 multiple ascending dose studies, including the once-daily extended-release formulation ...