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Also known as 30mg PRAX-628
PRAX-628 · 2 trials · 3 indications
Median percent change in monthly (28 days) seizure frequency from the Screening/Observation Period to the Treatment Period for PRAX-628
Geometric mean ratio (90% CI) for maximum observed plasma concentration (Cmax)
| Arm | Type | Description |
|---|---|---|
| Open-label 30mg/day PRAX-628 for 8 weeks | EXPERIMENTAL | Participants who meet all eligibility criteria will receive 30mg of PRAX-628 for 8 weeks. |
| Single Oral Dose 40mg PRAX-628 tablet then 4x10mg PRAX-628 capsules | EXPERIMENTAL | 40 mg PRAX-628 tablet followed by 4×10 mg PRAX-628 capsules administered orally. |
| Single Oral Dose 4x10mg PRAX-628 capsules then 40mg PRAX-628 tablet | EXPERIMENTAL | 4×10 mg PRAX-628 capsules followed by 40 mg PRAX-628 tablet administered orally. |
| Name | Type | Description |
|---|---|---|
| 30mg PRAX-628 | DRUG | Once daily oral |
| PRAX-628 | DRUG | Once daily oral |
Inclusion Criteria: * A diagnosis of focal onset seizures or idiopathic generalized tonic clonic seizures. * Evidence by computed tomography (CT) or magnetic resonance imaging (MRI) in the past that has ruled out a progressive cause of epilepsy. * Participant must have been receiving stable doses o...
PRAX-628 is an investigational small molecule being developed by Praxis Precision Medicines, Inc. for the treatment of focal onset seizures and primary generalized epilepsy. It is currently being evaluated in a Phase 2 open-label clinical trial in adults with these conditions. The drug is also being studied in healthy volunteers for bioavailability purposes.
PRAX-628 targets sodium channels, which are ion channels involved in the generation and propagation of electrical signals in neurons. By modulating these channels, the drug is intended to reduce abnormal neuronal activity that leads to seizures. This mechanism is being investigated for its potential to treat focal onset seizures and primary generalized epilepsy.
PRAX-628 is being developed by Praxis Precision Medicines, Inc., a biopharmaceutical company focused on neurological diseases. The company's stock is listed under the ticker symbol PRAX. Praxis is conducting clinical trials to evaluate the safety, efficacy, and bioavailability of PRAX-628 in patients with seizure disorders.
PRAX-628 is currently in Phase 2 clinical development for the treatment of focal onset seizures and primary generalized epilepsy. A Phase 2 open-label trial is actively recruiting participants to evaluate the efficacy and safety of the drug in adults. Additionally, a Phase 1 trial has been completed to assess its relative bioavailability in healthy volunteers.
PRAX-628 is being studied in two clinical trials. The first, NCT06840925, is a completed Phase 1 trial in healthy volunteers to evaluate relative bioavailability. The second, NCT06908356, is an actively recruiting Phase 2 open-label trial in adults with focal onset seizures or primary generalized epilepsy, conducted in the United States, Australia, and Spain.
Yes, PRAX-628 is also known as 30mg PRAX-628, which refers to a specific dosage strength of the drug. This alternative name may be used in clinical contexts to specify the dose being administered. The drug is being developed by Praxis Precision Medicines under the primary name PRAX-628.