## Protocol Section
### Identification Module
**NCT ID:** NCT06425159

**Acronym:** SHINE

**Brief Title:** A Study to Determine if BHV-7000 is Effective and Safe in Adults With Idiopathic Generalized Epilepsy With Generalized Tonic-clonic Seizures

**Official Title:** A Phase 2/3 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of BHV-7000 as Adjunctive Therapy in Subjects With Idiopathic Generalized Epilepsy With Generalized Tonic-clonic Seizures, With Open-label Extension

#### Organization Study ID Info
**ID:** BHV7000-304
#### Organization
**Class:** INDUSTRY
**Full Name:** Biohaven Pharmaceuticals, Inc.
#### Secondary ID Infos
**Domain:** EU CTR
**ID:** 2023-508812-45-00
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2027-07

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-17

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-07

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Biohaven Therapeutics Ltd.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** 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.

### Conditions Module

**Conditions:**

- Generalized Epilepsy

**Keywords:**

- Idiopathic Generalized Epilepsy

- Generalized

- Epilepsy

- tonic-clonic

- generalized tonic-clonic

- tonic

- clonic

- seizure

- refractory epilepsy

- generalized tonic-clonic alone

- juvenile myoclonic epilepsy

- juvenile absence epilepsy

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 242

**Type:** ESTIMATED

**Phases:**

- PHASE2

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: BHV-7000

**Label:** BHV-7000 75 mg

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Intervention Names:**

- Drug: Placebo

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- BHV-7000 75 mg

**Description:** BHV-7000 75mg. Participants will take blinded investigational product (IP) once daily

**Name:** BHV-7000

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Placebo

**Description:** Matching placebo taken once daily

**Name:** Placebo

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** To compare the efficacy of BHV-7000 to placebo as adjunctive therapy for subjects with idiopathic generalized epilepsy with generalized tonic-clonic (GTC) seizures as measured by the time to the second day with a GTC seizure during the double-blind phase

**Measure:** Time to the Second Day with a Generalized Tonic Clonic (GTC) Seizure During the 24- week Double-blind Treatment Period

**Time Frame:** Baseline to Week 24 of Double-Blind Treatment Period

#### Secondary Outcomes

**Description:** To compare the efficacy of BHV-7000 to placebo in terms of the proportion of subjects that are free of GTC seizures as measured by the proportion of subjects with GTC seizure freedom during the 24-week DBP, estimated using Kaplan- Meier methods.

**Measure:** Percentage of Participants with freedom of GTC seizures during DBT Phase

**Time Frame:** Baseline to Week 24 of Double-Blind Treatment Period

**Description:** To assess the safety and tolerability of BHV-7000 as measured by the number of unique subjects with deaths, SAEs, AEs leading to discontinuation, and moderate and severe AEs

**Measure:** Number of Participants With Deaths, Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and moderate or severe AEs

**Time Frame:** Baseline to Week 24 of Double-Blind Treatment Period

**Description:** To assess the safety and tolerability of BHV-7000 as measured by the number of unique subjects with grade 3 and grade 4 laboratory abnormalities.

**Measure:** Number of Participants With Clinically Significant Laboratory Abnormalities

**Time Frame:** Baseline to Week 24 of Double-Blind Treatment Period

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Male and Female participants 18 to 75 years of age at time of consent.
* Diagnosis of Idiopathic Generalized Epilepsy at least 6 months prior to the screening visit, defined by 2017 International League Against Epilepsy (ILAE) Classification and based on requirements of Epilepsy Adjudication criteria.

  1. Subject has probable GTC seizures in the setting of IGE, meaning GTC seizures and either classic 3-4 Hz generalized spike-wave (GSW) or 4-6 Hz polyspike-wave on EEG and no focal abnormality (asymmetric spike-wave fragment is allowed) AND/OR a clear history of absence seizures or myoclonic jerks
  2. Subjects with possible GTC seizures in the setting of IGE, meaning GTC and either Normal EEG OR Generalized epileptiform EEG abnormality with atypical spike-wave and no focal abnormality (asymmetric spike-wave fragment is allowed).
* Subject meets the 2009 ILAE definition of drug resistant epilepsy, failure of adequate trials of two tolerated and appropriately chosen and used ASM schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom.
* Ability of subject or caregiver to keep accurate seizure diaries
* Current treatment with at least 1 to 3 ASMs as part of no more than 4 epilepsy treatments in total (e.g., 3 ASMs + 1 diet regimen; 2 ASMs + 1 diet regimen + 1 device, etc.).
* 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.

Exclusion Criteria:

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

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** clinicaltrials@biohavenpharma.com

**Name:** Chief Medical Officer

**Phone:** 203-404-0410

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Jacksonville

**Contacts:**

***Contact 1:***

- **Email:** yasmeen.shabbir@jax.ufl.edu

- **Name:** Yasmeen Shabbir

- **Phone:** 904-244-9856

- **Role:** CONTACT

**Country:** United States

**Facility:** University of Florida (Jacksonville)

**State:** Florida

**Zip:** 32209

**Location 2:**

**City:** Orlando

**Contacts:**

***Contact 1:***

- **Email:** michelle@researchinstituteoforlando.com

- **Name:** Michelle Clevenger

- **Phone:** 407-652-6011

- **Role:** CONTACT

**Country:** United States

**Facility:** Research Institute of Orlando

**State:** Florida

**Zip:** 32806

**Location 3:**

**City:** Weston

**Contacts:**

***Contact 1:***

- **Email:** abarreiro@encoremedicalresearch.com

- **Name:** Antonio Barreiro

- **Phone:** 954-777-8827

- **Role:** CONTACT

**Country:** United States

**Facility:** Encore Medical Research of Weston LLC.

**State:** Florida

**Zip:** 33331

**Location 4:**

**City:** Elgin

**Contacts:**

***Contact 1:***

- **Email:** Afatima@rev-research.com

- **Name:** Ayesha Fatima

- **Phone:** 847-497-0421

- **Role:** CONTACT

**Country:** United States

**Facility:** Revive Research Institute, Inc.

**State:** Illinois

**Zip:** 60123

**Location 5:**

**City:** Lexington

**Contacts:**

***Contact 1:***

- **Email:** morgan.medley@commonspirit.org

- **Name:** Morgan Medley

- **Phone:** 859-313-4989

- **Role:** CONTACT

**Country:** United States

**Facility:** Bluegrass Epilepsy Research

**State:** Kentucky

**Zip:** 40504

**Location 6:**

**City:** Baton Rouge

**Contacts:**

***Contact 1:***

- **Email:** joanne.hollingsworth@fmolhs.org

- **Name:** JoAnne Hollingsworth

- **Phone:** 225-765-7659

- **Role:** CONTACT

**Country:** United States

**Facility:** OLOLRMC

**State:** Louisiana

**Zip:** 70808

**Location 7:**

**City:** Livingston

**Contacts:**

***Contact 1:***

- **Email:** mmalik@inst-neuro.com

- **Name:** Munazza Malik

- **Phone:** 973-322-7425

- **Role:** CONTACT

**Country:** United States

**Facility:** Inst of Neurology

**State:** New Jersey

**Zip:** 07039

**Location 8:**

**City:** Amherst

**Contacts:**

***Contact 1:***

- **Email:** hpearson@dentinstitute.com

- **Name:** Hailley Pearson

- **Phone:** 716-250-7002

- **Role:** CONTACT

**Country:** United States

**Facility:** Dent Neurosciences Research Center

**State:** New York

**Zip:** 14226

**Location 9:**

**City:** Chattanooga

**Contacts:**

***Contact 1:***

- **Email:** aerskine@wakeresearch.com

- **Name:** Arlann Erskine

- **Phone:** 423-698-4584

- **Role:** CONTACT

**Country:** United States

**Facility:** WR-ClinSearch

**State:** Tennessee

**Zip:** 37421

**Location 10:**

**City:** Nashville

**Contacts:**

***Contact 1:***

- **Email:** melissa.osborn@vumc.org

- **Name:** Melissa Osborn

- **Phone:** 615-322-8817

- **Role:** CONTACT

**Country:** United States

**Facility:** Vanderbilt University Medical Center

**State:** Tennessee

**Zip:** 37232

**Location 11:**

**City:** Dallas

**Contacts:**

***Contact 1:***

- **Email:** jchowell@neurologydallas.com

- **Name:** J. Christina Howell

- **Phone:** 214-750-9977

- **Phone Ext:** 293

- **Role:** CONTACT

**Country:** United States

**Facility:** Neurology Consultants of Dallas, PA

**State:** Texas

**Zip:** 75243

**Location 12:**

**City:** Houston

**Contacts:**

***Contact 1:***

- **Email:** saad.ahmad@uth.tmc.edu

- **Name:** Saad Ahmad

- **Phone:** 713-500-7894

- **Role:** CONTACT

**Country:** United States

**Facility:** UTHealth Houston

**State:** Texas

**Zip:** 77030

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000009461

- Term: Neurologic Manifestations

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M7983

- Name: Epilepsy

- Relevance: HIGH

- As Found: Epilepsy

- ID: M369

- Name: Drug Resistant Epilepsy

- Relevance: LOW

- As Found: Unknown

- ID: M15452

- Name: Seizures

- Relevance: HIGH

- As Found: Generalized Tonic-Clonic Seizures

- ID: M7985

- Name: Epilepsy, Generalized

- Relevance: HIGH

- As Found: Generalized Epilepsy

- ID: M7987

- Name: Epilepsies, Myoclonic

- Relevance: LOW

- As Found: Unknown

- ID: M7988

- Name: Epilepsy, Absence

- Relevance: LOW

- As Found: Unknown

- ID: M22018

- Name: Myoclonic Epilepsy, Juvenile

- Relevance: LOW

- As Found: Unknown

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: T2109

- Name: Epilepsy Juvenile Absence

- Relevance: LOW

- As Found: Unknown

- ID: T4008

- Name: Myoclonus Epilepsy

- Relevance: LOW

- As Found: Unknown

- ID: T3175

- Name: Juvenile Myoclonic Epilepsy

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000004827

- Term: Epilepsy

- ID: D000012640

- Term: Seizures

- ID: D000004829

- Term: Epilepsy, Generalized

### Misc Info Module

- Version Holder: 2024-05-31
