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New treatment option for Focal Epilepsy
Official title A Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy
ClinicalTrials.gov ID: NCT06132893
What this study is testing
What is BHV-7000?
BHV-7000 is an investigational medicine, given as an once-daily, being studied as a potential treatment for focal epilepsy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Male and Female participants 18 to 75 years of age at time of consent.
- Diagnosis of Focal Onset Epilepsy at least 1 year prior to screening visit defined by 2017 International League Against Epilepsy (ILAE)...
- Subject meets the 2009 ILAE definition of drug resistant epilepsy, failure of adequate trials of two tolerated and appropriately chosen and used...
- Ability to keep accurate seizure diaries
- Current treatment with at least 1 and up to 3 ASMs and 4 epilepsy treatments in total Key
You likely can't join if
- History of status epilepticus (convulsive status epilepticus for \> 5 minutes or focal status epilepticus with impaired consciousness for \> 10...
- History of repetitive/cluster seizures (where individual seizures cannot be counted) within the last 6 months prior to screening visit and during...
- Resection neurosurgery for seizures \<4 months prior to the screening visit.
- Radiosurgery performed \<2 years prior to the screening visit.
- people with only focal aware nonmotor seizures which involve subjective sensory or psychic phenomena only, without impairment of consciousness or...
- Any condition that would interfere with the subject's ability to comply with study instructions, place the subject at unacceptable risk, and/or...
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Tucson, Arizona, United States
- Little Rock, Arkansas, United States
- Rogers, Arkansas, United States
- La Jolla, California, United States
- Los Angeles, California, United States
- Palo Alto, California, United States
- Pasadena, California, United States
- Aurora, Colorado, United States
- New Haven, Connecticut, United States
- Boca Raton, Florida, United States
- Bradenton, Florida, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Orlando, Florida, United States
- Port Charlotte, Florida, United States
- Tampa, Florida, United States
- Weston, Florida, United States
- Winter Park, Florida, United States
- Augusta, Georgia, United States
+ 88 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Tucson, Arizona, United States; Little Rock, Arkansas, United States; Rogers, Arkansas, United States; La Jolla, California, United States; Los Angeles, California, United States and 102 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.