BHV-7000 for Epilepsy

(SHINE Trial)

Recruiting at 102 trial locations

Overseen By Chief Medical Officer

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Recruiting

Sponsor: Biohaven Therapeutics Ltd.

Must be taking: Antiseizure medications

Disqualifiers: Status epilepticus, Repetitive 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 idiopathic generalized epilepsy with generalized tonic-clonic seizures and includes an additional open-label extension (OLE) phase.

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.

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

The drug BHV-7000 is unique because it targets the GABA system, which is involved 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}

Eligibility Criteria

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

I have generalized seizures with specific EEG patterns or a history of certain seizure types.

I am between 18 and 75 years old.

I have generalized seizures with a specific type of EEG result.

Exclusion Criteria

I have had a severe seizure lasting more than 5 minutes in the last 6 months.

Any condition that would interfere with and/or confound the interpretation of safety or efficacy data from the study, as judged by the Investigator

I've had uncountable seizures or unknown number of severe seizures recently.

Trial Timeline

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

Treatment Details

Interventions

• BHV-7000 (Anti-epileptic Drug)

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.

Participant Groups

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+

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 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 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 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. Netherlands pubmed.ncbi.nlm.nih.gov

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

4. 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]

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]