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Also known as BHV-700, opakalim
BHV-7000 · 8 trials · 6 indications
Safety and tolerability of BHV-7000 as assessed by frequency of unique subjects with SAEs; AEs leading to discontinuation; AEs judged to be related to study medication
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.
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.
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.
The YMRS is a clinician administered scale that consists of 11 items used to assess the subject's symptoms of mania (total scores range from 0 to 60). The higher the YMRS score, the more severe the subject's symptoms of mania.
The MADRS is a clinician- rated scale to assess depressive symptoms which consists of 10 items. Each item is scored on 7-point scale (0 \[absence of symptoms\] to 6 \[severe\]). A higher score represents a higher severity of the level of depression (total scores range from 0 to 60).
To compare the efficacy of 75mg of BHV-7000 to placebo as an adjunctive therapy for refractory focal onset epilepsy as measured by the change from OP (observational phase) in 28-day average seizure frequency. The primary objective will be measured by comparing the observation phase (8 weeks) to the 8-week double-blind treatment phase.
To compare the efficacy of each of 2 doses of BHV-7000 to placebo as an adjunctive therapy for refractory focal onset epilepsy as measured by the change from OP (observational phase) in 28-day average seizure frequency. The primary objective will be measured by comparing the observation phase (8 weeks) to the 12-week double-blind treatment phase.
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.
To assess the safety and tolerability of BHV-7000. This objective will be measured by assessing the number of unique subjects with grade 3 and 4 laboratory abnormalities.
Per-participant percentage reduction in patient-specific seizure surrogate rate in the treatment period relative to retrospective baseline.
Per-participant percentage reduction in seizure onset pattern rate in the treatment period relative to retrospective baseline.
Per-participant reduction in long episode rate during the treatment period relative to the retrospective baseline.
Per-participant reduction in saturation rate during the treatment period relative to the retrospective baseline, for those patients who have saturations.
Participants will be asked to record peak (worst) pain experienced in the previous 2 hours using an 11-point Likert scale (0-10) where 0=no pain and 10=worst possible pain
| Arm | Type | Description |
|---|---|---|
| BHV-7000 | EXPERIMENTAL | - |
| BHV-7000 50 mg | EXPERIMENTAL | - |
| BHV-7000 75 mg | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| BHV-7000 25 mg Part A | EXPERIMENTAL | - |
| BHV-7000 50 mg Part A | EXPERIMENTAL | - |
| Placebo Part A | PLACEBO_COMPARATOR | - |
| BHV-7000 75 mg Part B | EXPERIMENTAL | - |
| Placebo Part B | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| BHV-7000 | DRUG | BHV-7000 75 mg taken once daily |
| Placebo | DRUG | Matching placebo taken once daily for 21 days |
| BHV-700 | DRUG | 75 mg daily for the 4-week treatment period (dose which may be adjusted based on tolerability) |
Key Inclusion Criteria: 1. Eligible subjects should have successfully completed the Treatment/Randomization Phase of parent studies. 2. WOCBP must have a negative urine pregnancy test at Baseline Visit. 3. WOCBP must not be breastfeeding or lactating at Baseline Visit or at any point during the stu...
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BHV-7000 is an investigational small molecule being developed by Biohaven Ltd. for neurological and psychiatric conditions. It is in Phase 2 clinical development and is being studied in bipolar disorder, epilepsy, familial erythromelalgia, focal epilepsy, and major depressive disorder. It has not been approved by the FDA.
BHV-7000 targets Kv7.2/7.3, a potassium channel. By acting on this potassium channel target, the drug is designed to modulate neuronal excitability, which is the basis for its study in seizure disorders and mood disorders such as bipolar disorder and major depressive disorder.
Biohaven Ltd. is developing BHV-7000. Biohaven Ltd. trades on the New York Stock Exchange under the ticker BHVN. The company is running the clinical development program for the drug across epilepsy, mood disorders, and familial erythromelalgia indications.
BHV-7000 is in Phase 2 clinical development. It is investigational and has not been approved by the FDA. The program includes Phase 1 and Phase 2 studies, with a completed Phase 2 long-term safety study in major depressive disorder and an ongoing Phase 2 long-term safety study in focal epilepsy.
BHV-7000 trials include NCT06443463, a Phase 2 long-term safety and tolerability study in focal epilepsy enrolling 660 participants across many countries, and NCT06423781, a completed Phase 2 long-term safety study in major depressive disorder with 233 participants. Earlier studies include NCT07262268 in familial erythromelalgia and NCT07125261 in epilepsy.
Yes, BHV-7000 and BHV-700 refer to the same investigational drug from Biohaven Ltd. BHV-700 is an alternative name used for BHV-7000, so search results and publications using either name describe the same Kv7.2/7.3 potassium channel compound in clinical development.