BHV-7000 for Epilepsy

Enrolling by invitation at 300 trial locations

Overseen By Chief Medical Officer

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Biohaven Therapeutics Ltd.

Disqualifiers: Ongoing adverse events, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if BHV-7000 is safe and tolerable for adults with refractory focal onset epilepsy, where seizures begin in one brain area and resist typical treatments. Participants will receive either 50 mg or 75 mg of BHV-7000 to assess the effects of different doses. This trial suits those who have participated in specific previous studies and do not have conditions that might interfere with the trial. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

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

Research has shown that BHV-7000 is safe, based on earlier studies. Participants tolerated the treatment well, even at doses up to 120 mg daily. Unlike other anti-seizure drugs, BHV-7000 did not cause the usual side effects often seen with similar treatments. This suggests it could be a promising option for people with epilepsy. ^{1 2 3 4 5}

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

Unlike the standard epilepsy treatments that typically involve antiepileptic drugs like levetiracetam or valproate, BHV-7000 is unique because it targets epilepsy through a potentially novel mechanism of action. BHV-7000 may offer a new approach by modulating specific ion channels, which could lead to better seizure control with fewer side effects. Researchers are excited about BHV-7000 because it comes in different dosages, 50 mg and 75 mg, allowing for flexible treatment options that could be tailored to individual patient needs. This flexibility and the potential for improved efficacy make BHV-7000 a promising candidate in the fight against epilepsy.

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

Research has shown that BHV-7000 may help treat epilepsy. In early studies, it effectively reduced seizures without causing the usual side effects linked to certain brain receptors. Previous research found that BHV-7000 was safe and did not cause common issues like drowsiness. Patients reported satisfaction with their treatment, noting improved cognitive abilities and fewer severe seizures. These results suggest that BHV-7000 could be useful for managing difficult-to-treat focal onset epilepsy. Participants in this trial will receive either a 50 mg or 75 mg dose of BHV-7000 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 who have finished the double-blind phase of previous BHV-7000 studies. Women able to bear children must test negative for pregnancy before starting.

Inclusion Criteria

I am a woman able to have children and have a negative pregnancy test.

I completed the double-blind phase of the BHV7000-302 or BHV7000-303 study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BHV-7000 to assess safety and tolerability

52 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 long-term safety and tolerability of a medication called BHV-7000 in individuals with difficult-to-treat epilepsy that starts in one area of the brain.

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

Who Is Running the Clinical Trial?

Biohaven Therapeutics Ltd.

Lead Sponsor

Trials

13

Recruited

4,800+

Published Research Related to This Trial

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 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 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]

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]

Citations

1. 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 ...

2. 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 ...

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. 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.

5. 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.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06443463

Long-term Safety and Tolerability of BHV-7000 A Phase 2, Global, Multicenter, Long-term Safety Study Designed to Assess the Safety and Tolerability of BHV-7000 in Subjects With Refractory Focal Onset ...

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 ...