Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Zonisamide · 1 trial · 1 indication
Difference between groups in the number of total standard drinks per week over 8 weeks (weeks 9-16, the weeks on the target dose) performed using a mixed models longitudinal analysis.
| Arm | Type | Description |
|---|---|---|
| Zonisamide | EXPERIMENTAL | Subjects will receive zonisamide titrated to a target dose of 500mg orally, daily, double-blind (Titration of dose to 500mg oral, daily, over 7 weeks, then 9 weeks of treatment at that dose). Subjects may increase their dose to 600mg daily during the target treatment period if it is thought to be beneficial. |
| Placebo | PLACEBO_COMPARATOR | Patients will receive placebo pills that are made to match the zonisamide medication (via over-encapsulation, double-blind, subjects will receive same number of capsules as the active medication group) |
| Name | Type | Description |
|---|---|---|
| Zonisamide | DRUG | Titration of dose to 500mg oral, daily, over 8 weeks, then 7 weeks of treatment at that dose |
| Placebo | DRUG | Placebo |
Inclusion Criteria: * Female/male aged 21-70 years * Regular heavy drinkers as defined by averaging 2 heavy drinking days per week over 90 days baseline pre-treatment timeline follow-back (TLFB), and current DSM-IV-TR alcohol dependence that recognize a need to reduce or stop drinking (Note: heavy ...
Zonisamide is an investigational small molecule being studied for the treatment of Alcohol Use Disorder. It is currently in Phase 3 clinical development, though the single completed trial has not led to regulatory approval. The drug is being evaluated for its efficacy and mechanism of action in reducing alcohol use.
Zonisamide is a small molecule being studied for Alcohol Use Disorder. While its precise molecular target in this condition is not specified, the Phase 3 trial was designed to evaluate both efficacy and mechanism of action. The drug's anticonvulsant properties are thought to be relevant to its potential effects on alcohol use.
Zonisamide is being developed by National Healthcare Corp. (ticker: NHC). The company is conducting clinical research on the drug for Alcohol Use Disorder, with one completed Phase 3 trial involving 156 participants in the United States.
Zonisamide is in Phase 3 clinical development for Alcohol Use Disorder. The drug is investigational and has not been approved by regulatory authorities. One Phase 3 trial has been completed, but no active trials are currently listed for this indication.
Zonisamide has one completed Phase 3 trial, NCT02900352, titled 'Zonisamide Treatment of Alcohol Use Disorder: an Evaluation of Efficacy and Mechanism of Action.' This randomized, double-blind, placebo-controlled study enrolled 156 adults aged 21 and older in the United States, with biomarker selection.
Zonisamide is a distinct small molecule being investigated for Alcohol Use Disorder. It is not identified as the same as any other named treatment in the available data. Its development is focused on evaluating its efficacy and mechanism of action in this condition.