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Anti-epileptic Drug

BHV-7000 for Epilepsy (SHINE Trial)

Phase 2 & 3
Recruiting
Research Sponsored by Biohaven Therapeutics Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male and Female participants 18 to 75 years of age at time of consent
Accurate history of having at least 3 days with a GTC seizure evenly spread throughout the 16 weeks prior to the screening visit, such that a subject had at least 1 day with a GTC seizure during the first 8 weeks and at least 1 day with a GTC seizure during the second 8 weeks
Must not have
History of status epilepticus (convulsive status epilepticus for > 5 minutes or focal status epilepticus with impaired conscious for > 10 minutes) within the last 6 months prior to screening visit that is not consistent with the subject's habitual seizure
History of repetitive/cluster seizures (where individual seizures cannot be counted) within the last 6 months prior to screening visit, or having an unknown GTC seizure count during the screening phase
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 24 of double-blind treatment period
Awards & highlights

Summary

This trial aims to find out if BHV-7000 can effectively treat a type of epilepsy that causes seizures with loss of consciousness. The study also includes a phase where participants can continue treatment in an

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While the side effects of BHV-7000 are not detailed here, common side effects for antiepileptic drugs may include dizziness, fatigue, nausea, coordination problems, and potential skin reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 75 years old.
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I've had seizures on at least 3 different days in the last 16 weeks.
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My epilepsy hasn't improved after trying two different medications.
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I am currently on 1 to 3 seizure medications as part of up to 4 epilepsy treatments.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a severe seizure lasting more than 5 minutes in the last 6 months.
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I've had uncountable seizures or unknown number of severe seizures recently.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 24 of double-blind treatment period
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 24 of double-blind treatment period for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time to the Second Day with a Generalized Tonic Clonic (GTC) Seizure During the 24- week Double-blind Treatment Period
Secondary outcome measures
Number of Participants With Clinically Significant Laboratory Abnormalities
Number of Participants With Deaths, Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and moderate or severe AEs
Percentage of Participants with freedom of GTC seizures during DBT Phase

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: BHV-7000 75 mgActive Control1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

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Who is running the clinical trial?

Biohaven Therapeutics Ltd.Lead Sponsor
10 Previous Clinical Trials
3,910 Total Patients Enrolled
3 Trials studying Epilepsy
1,440 Patients Enrolled for Epilepsy
~161 spots leftby Jul 2026
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