Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Amisulpride · 1 trial · 1 indication
Defined as no vomiting/retching (absence of PONV) and no use of anti-emetic rescue medication, during the first 24 hours after completion of surgery. Subjects will be questioned and assessed.
| Arm | Type | Description |
|---|---|---|
| Stage 1 - Group 1: IV amisulpride 0.035 mg/kg + IV dexamethasone | EXPERIMENTAL | Stage 1 - Group 1: IV amisulpride 0.035 mg/kg + IV dexamethasone |
| Stage 1 - Group 2: IV amisulpride 0.07 mg/kg + IV dexamethasone | EXPERIMENTAL | Stage 1 - Group 2: IV amisulpride 0.07 mg/kg + IV dexamethasone |
| Name | Type | Description |
|---|---|---|
| Amisulpride Injection | DRUG | Dose finding treatment for continuation to phase 3 |
| Dexamethasone | DRUG | Standard of care treatment |
Inclusion Criteria: 1. Male or female patients aged from full-term birth to 17 years of age 2. Signed informed consent form and/or assent and willingness of patient and parents to participate in the trial 3. Patients undergoing non-emergency surgery, preferentially eye surgery, adenotonsillectomy o...
Amisulpride is an investigational small molecule being studied for the prophylaxis of postoperative nausea and vomiting (PONV), specifically in pediatric patients. It is administered intravenously. The drug is currently in Phase 2 clinical development and is not yet approved by the FDA.
Amisulpride is being developed by Amicus Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol FOLD. The company is conducting clinical trials to evaluate the drug's safety and efficacy for preventing postoperative nausea and vomiting in pediatric patients.
Amisulpride is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied for the prophylaxis of postoperative nausea and vomiting in pediatric patients, with one completed Phase 2 trial.
Amisulpride has one completed clinical trial, NCT05546359, which studied intravenous amisulpride for prophylaxis of postoperative nausea and vomiting in pediatric patients. This Phase 2 trial enrolled 453 participants across the United States, Canada, France, and Germany, and included patients as young as 2 months old.
Amisulpride is a small molecule that acts as a dopamine receptor antagonist. By blocking dopamine receptors, it helps prevent nausea and vomiting. The drug is being evaluated for its ability to prevent postoperative nausea and vomiting when given intravenously to pediatric patients.