NCT06443463Enrolling By Invitation2 期
A Phase 2, Global, Multicenter, Long-term Safety Study Designed to Assess the Safety and Tolerability of BHV-7000 in Subjects With Refractory Focal Onset Epilepsy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 入组人数
- 660
- 试验地点
- 338
- 主要终点
- Number of Participants With Deaths, Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and moderate or severe AEs
研究概览
简要总结
A study to determine if BHV- 7000 is safe and tolerable in adults with refractory focal onset epilepsy
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who completed the double-blind phase (DBP) of prior parent study, BHV7000-302 or BHV7000-
- •(FOCBP) Females of Child Bearing Potential must have a negative urine pregnancy test at the Baseline/Day 0 visit
排除标准
- •Any condition, such as an ongoing AE with/without sequelae, or is poorly tolerating IP in the double-blind phase of the parent study, that would interfere with the subject's ability to comply with study instructions, place the subject at unacceptable risk, and/or confound the interpretation of safety or efficacy data from the study, as judged by the Investigator.
- •Any medical condition, based on the judgement of the Investigator, that would confound the ability to adequately assess safety and efficacy outcome measures
研究组 & 干预措施
BHV-7000 50 mg
Experimental
干预措施: BHV-7000 (Drug)
BHV-7000 75 mg
Experimental
干预措施: BHV-7000 (Drug)
结局指标
主要结局
Number of Participants With Deaths, Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and moderate or severe AEs
时间窗: Up to 104 weeks
To assess the safety and tolerability of BHV-7000. This objective will be measured by assessing the number of unique subjects with deaths, SAEs, AEs leading to discontinuation, and moderate and severe AEs.
Number of Participants With Deaths, Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and moderate or severe AEs
时间窗: Up to 104 weeks
To assess the safety and tolerability of BHV-7000. This objective will be measured by assessing the number of unique subjects with deaths, SAEs, AEs leading to discontinuation, and moderate and severe AEs.
Number of Subjects with Clinically Significant Laboratory Abnormalities
时间窗: Up to 104 weeks
To assess the safety and tolerability of BHV-7000. This objective will be measured by assessing the number of unique subjects with grade 3 or 4 laboratory abnormalities.
次要结局
未报告次要终点
研究者
研究点 (338)
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相关资讯
FDA Places Partial Clinical Hold on Biohaven's Epilepsy Candidate Opakalim, Pausing New Enrollment in Pivotal Program- The FDA issued a partial clinical hold on Biohaven's opakalim (BHV-7000) after nonclinical rodent studies flagged a metabolite with uncertain relevance to human safety.
- New patient enrollment is paused across the focal epilepsy program, though dosing continues for more than 600 already-randomized patients, including the fully enrolled RISE-3 study.
- Biohaven expects RISE-3 topline data in the second half of 2026, with the hold not affecting that timeline, while enrollment resumption timing remains uncertain.
- The hold arrives days after Biohaven licensed global rights to opakalim to SK Biopharmaceuticals for $350 million upfront in a deal worth up to $795 million.6 days agoSK Biopharm licenses Biohaven's Kv7 activator Opakalim in $795M deal, targeting 2029 US launch- SK Biopharm signed a licensing-in agreement worth up to $795 million to acquire worldwide exclusive rights to Opakalim (BHV-7000), a Kv7 potassium channel activator for epilepsy, from Biohaven.
- Opakalim's novel mechanism selectively activates Kv7.2/7.3 channels, offering a significantly reduced risk of CNS side effects such as drowsiness and dizziness compared with existing epilepsy treatments.
- A global Phase 2/3 trial (RISE3) in adult patients with partial-onset seizures is underway, with first top-line results expected by year-end and a US launch targeted as early as 2029.
- SK Biopharm plans to leverage its US subsidiary SK Life Science's 150-strong sales force and neurologist network built through Xcopri to commercialize the drug.21 days agoBiohaven's Opakalim Shows Promise in Epilepsy Trials with Superior Tolerability Profile- Biohaven's selective Kv7.2/7.3 channel activator opakalim demonstrated a 3-fold prolongation in time to second generalized tonic-clonic seizure compared to placebo in idiopathic generalized epilepsy patients.
- In focal epilepsy studies, 54% of patients achieved at least 50% reduction in seizure frequency over six months, with remarkably low rates of central nervous system adverse events.
- The drug showed zero cases of somnolence, dizziness, fatigue, or memory impairment in the IGE study, contrasting sharply with double-digit adverse event rates reported for other investigational Kv7 activators.
- Biohaven is on track to receive top-line results from pivotal Phase 2/3 studies in refractory focal epilepsy in the second half of 2026 to support registration.3 months ago