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Also known as sublingual riluzole
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 studied for Social Anxiety Disorder and Amyotrophic Lateral Sclerosis (ALS). It has been evaluated in clinical trials for these neurological conditions, though it remains in early-stage development and is not approved for any use.
BHV-0223 is being developed by Biohaven Ltd., a biopharmaceutical company traded on the New York Stock Exchange under the ticker BHVN. The company is conducting clinical research on this investigational small molecule for neurological indications.
BHV-0223 is in Phase 1 clinical development. One Phase 1 trial has been completed, and the drug is still investigational, meaning it has not been approved by regulatory authorities. It is being studied for Social Anxiety Disorder and Amyotrophic Lateral Sclerosis.
BHV-0223 has been studied in two completed trials. NCT03017508 evaluated acute anxiolytic effects of riluzole in subjects with Social Anxiety Disorder, and NCT03520517 was an open-label study of BHV-0223 in ALS. Both were conducted in the United States with 22 participants each.
BHV-0223 is a formulation of riluzole, as indicated by the trial NCT03017508, which studied acute anxiolytic effects of riluzole in Social Anxiety Disorder. However, BHV-0223 is a distinct investigational product being developed by Biohaven for neurological conditions.