BHV-7000 for Epilepsy

(SHINE Trial)

Recruiting at 89 trial locations

Overseen By Chief Medical Officer

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Biohaven Therapeutics Ltd.

Must be taking: Antiseizure medications

Disqualifiers: Status epilepticus, Repetitive seizures, others

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

Compensation: Varies

Number of Visits: Unknown

242 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, a potential drug for people with a type of epilepsy known for causing generalized tonic-clonic seizures, which are severe and involve convulsions. The trial includes two groups: one will receive the actual treatment, while the other will get a placebo (a harmless pill with no effect) for comparison. Suitable participants have drug-resistant epilepsy, experience convulsive seizures regularly for at least 16 weeks, and currently take 1 to 3 epilepsy medications. The goal is to determine if BHV-7000 can effectively reduce seizures and improve life for those with this condition. As a Phase 2 trial, this research measures how well the treatment works in an initial, smaller group, offering participants a chance to contribute to important advancements in epilepsy care.

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 1 to 3 anti-seizure medications (ASMs) as part of no more than 4 epilepsy treatments in total. It seems you can continue your current epilepsy treatments if they fit within these guidelines.

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

Research has shown that BHV-7000 is generally safe for people. Studies have found that this treatment is well-tolerated at doses up to 120 mg per day. In earlier research, patients taking BHV-7000 did not experience the common side effects often seen with other anti-seizure medications, suggesting that BHV-7000 might be safer. While these findings are encouraging, discussing trial participation with a healthcare provider is important to understand the potential risks and benefits. ^{1 2 3 4 5}

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

Unlike standard epilepsy treatments, which often focus on stabilizing electrical activity in the brain, BHV-7000 represents a novel approach by targeting specific ion channels involved in neuron excitability. This innovative mechanism could potentially lead to more precise control of seizures with fewer side effects. Researchers are particularly excited about BHV-7000 because it offers a new avenue for those who may not respond well to current medications, such as sodium channel blockers or GABA enhancers.

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

Research has shown that BHV-7000 may help treat epilepsy. Early studies demonstrated its effectiveness in stopping seizures, particularly generalized tonic-clonic seizures. Participants in these studies reported satisfaction, improved cognitive abilities, and less severe seizures. Importantly, BHV-7000 proved safe and did not cause common side effects like drowsiness, which many other seizure medications do. These results suggest that BHV-7000 could be a promising treatment option for people with epilepsy. Participants in this trial will receive either BHV-7000 or a placebo to further evaluate its effectiveness and safety. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults with idiopathic generalized epilepsy who frequently experience generalized tonic-clonic seizures. Participants must be diagnosed according to specific criteria and have a certain number of seizures within a defined period before the study starts.

Inclusion Criteria

Have you had more than 4 seizures in the last 4 weeks?

Have you been on a stable does of 1 to 3 medications for you seizures?

Exclusion Criteria

Do you currently use marijuana?

Have you ever had brain surgery or vagus-nerve stimulations?

Do you have a history of serious liver, kidney, or heart problems?

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Double-blind Treatment

Participants receive either BHV-7000 or placebo to evaluate efficacy and safety in treating idiopathic generalized epilepsy with generalized tonic-clonic seizures

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label Extension

Participants may opt into continuation of treatment with BHV-7000 long-term

What Are the Treatments Tested in This Trial?

Interventions

• BHV-7000

Trial Overview The effectiveness and safety of BHV-7000 in treating idiopathic generalized epilepsy are being tested. The study includes an initial phase where participants receive either BHV-7000 or a placebo, followed by an open-label extension where all participants can receive BHV-7000.

How Is the Trial Designed?

Group I: BHV-7000 75 mg Active Control 1 Intervention

Group II: 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

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 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 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]

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. 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 ...

7. 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 ...