Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BHV-0223 · 2 trials · 8 indications
Measure Description: In the Visual Analogue Scale (VAS) participants are presented with a straight horizontal line of 100 mm in length and asked to mark the placement that would best describe the intensity of the anxiety felt at that moment. The left end (0mm) represents "no anxiety" and the right end (100mm) represents "the worst anxiety ever felt" by the participant.The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks, generating a numerical score along a continuum
Incidence of treatment emergent adverse events (safety and tolerability) as measured through laboratory tests and physical exam findings.
| Arm | Type | Description |
|---|---|---|
| BHV-0223 (Sublingual Riluzole) | EXPERIMENTAL | Participants will be given one dose of BHV-0223 (sublingual riluzole) 35mg before performing a 10 minute speech task. Participants will then be assessed every hour for the next three hours. There will be 2 to 10 days of washout period between the randomly assigned arms of the study. |
| Placebo | PLACEBO_COMPARATOR | Participants will be given one dose of an identical looking sublingual placebo before performing a 10 minute speech task. Participants will then be assessed every hour for the next three hours. There will be 2 to 10 days of washout period between the randomly assigned arms of the study. |
| BHV-0223 | EXPERIMENTAL | riluzole 40 mg sublingual tablet |
| Name | Type | Description |
|---|---|---|
| BHV-0223 | DRUG | 35mg of sublingual riluzole before performing an anxiety provoking speech task. Participants will then be clinically assessed every hour for 3 hours. |
| Placebo | DRUG | a sublingual tablet identical to the active drug will be given before performing an anxiety provoking speech task. Participants will then be clinically assessed every hour for three hours. |
Inclusion Criteria: 1. Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control, including complete abstinence, during the testing period) between the age of 18 and 65 yrs. 2. Meet DSM-5 criteria for social an...
BHV-0223 is an investigational small molecule being developed for amyotrophic lateral sclerosis (ALS) and social anxiety disorder. It is in clinical development for these neurological conditions, with studies conducted in the United States.
BHV-0223 is a small molecule being studied for its effects in amyotrophic lateral sclerosis and social anxiety disorder. Its specific molecular target has not been disclosed in available clinical trial information.
BHV-0223 is being developed by Biohaven Ltd., a biopharmaceutical company. The company is conducting clinical trials to evaluate the drug's safety and efficacy in neurological conditions.
BHV-0223 is in Phase 1 clinical development. A Phase 1 study evaluating its safety, tolerability, and pharmacokinetics in ALS has been completed, and it remains an investigational drug not yet approved.
BHV-0223 has been studied in two completed clinical trials. NCT03520517 was a Phase 1 open-label study in ALS, and NCT03017508 was a Phase 2 study of acute anxiolytic effects in social anxiety disorder. Both enrolled 22 participants.
BHV-0223 is a small molecule being studied for ALS and social anxiety disorder. A clinical trial NCT03017508 examined acute anxiolytic effects of riluzole in social anxiety disorder, but BHV-0223 is a distinct investigational compound.