Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BHV-7000 · 7 trials · 4 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.
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 |
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...
BHV-7000 is an investigational small molecule being developed for Familial Erythromelalgia, Major Depressive Disorder, Bipolar Disorder, and Focal Epilepsy. It is currently in Phase 2 clinical development for psychiatric and neurological conditions, with studies conducted in the United States.
BHV-7000 targets the Kv7.2/7.3 potassium channel. This target is involved in regulating neuronal excitability, and modulating it may help in conditions like depression, bipolar disorder, and epilepsy. The drug is designed to act on this channel to potentially stabilize abnormal electrical activity in the brain.
BHV-7000 is being developed by Biohaven Ltd., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol BHVN. Biohaven is conducting clinical trials for this drug across multiple indications in the United States.
BHV-7000 is in Phase 2 clinical development. It has completed Phase 2 trials for bipolar mania and major depressive disorder, and a long-term safety study in MDD. A Phase 1b study is enrolling for Familial Erythromelalgia. It is not yet FDA approved.
BHV-7000 has several clinical trials. NCT06419582 is a completed Phase 2 study for bipolar mania. NCT06419608 is a completed Phase 2 monotherapy study for major depression. NCT06423781 is a completed long-term safety study in MDD. NCT07262268 is a Phase 1b study enrolling for inherited erythromelalgia.
BHV-7000 is the primary name used in clinical trials and development. No alternative names have been reported for this drug. It is a distinct investigational compound being studied by Biohaven for multiple psychiatric and neurological conditions.