An Open Label Clinical Trial to Evaluate the Efficacy and Safety of PRAX-628 in Adult Patients With Focal Onset or Primary Generalized Tonic-Clonic Seizures
An open label clinical trial to evaluate the efficacy and safety of PRAX-628 in adult patients with focal onset or primary generalized tonic-clonic seizures who can attest to concurrently taking at least 1, but no more than 3 acceptable anti-seizure medications.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Once daily oral
Praxis Research Site
Phoenix, Arizona, United States
RECRUITINGPraxis Research Site
Miami Lakes, Florida, United States
RECRUITINGTo evaluate the efficacy of PRAX-628 on seizure frequency in adults with FOS or PGTCS currently taking ASMs
Median percent change in monthly (28 days) seizure frequency from the Screening/Observation Period to the Treatment Period for PRAX-628
Time frame: 8 weeks
To evaluate the efficacy of PRAX 628 on seizure frequency in adults with FOS or PGTCS currently taking ASMs
• Proportion of participants experiencing a ≥50% reduction in monthly (28 days) seizure frequency from the Screening/Observation Period to the Treatment Period (Responder Rate) for PRAX-628.
Time frame: 8 weeks
To evaluate the efficacy of PRAX 628 on seizure frequency in adults with FOS or PGTCS currently taking ASMs
• Proportion of participants experiencing seizure freedom, 100% reduction in monthly (28 days) seizure frequency from the Screening/Observation Period to the Treatment Period for PRAX-628.
Time frame: 8 weeks
To evaluate the efficacy of PRAX 628 on seizure frequency in adults with FOS or PGTCS currently taking ASMs
• Number of days after the first administration of PRAX-628 to reach the same or higher number of monthly seizures from the Screening/Observation Period to the Treatment Period
Time frame: 8 weeks
CGI-S Change from Baseline
CGI-S assesses the clinician's impression of the participant's current illness state. The clinician should use his/her total clinical experience with this patient population and rate the current severity on a 7-point scale from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
Time frame: 8 weeks
PGI-S Change from Baseline
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Praxis Research Site
Bethesda, Maryland, United States
RECRUITINGPraxis Research Site
Chesterfield, Missouri, United States
RECRUITINGPraxis Research Site
Hackensack, New Jersey, United States
RECRUITINGPraxis Research Site
Middletown, New York, United States
RECRUITINGPraxis Research Site
Round Rock, Texas, United States
RECRUITINGPraxis Research Site
Seabrook, Texas, United States
RECRUITINGPraxis Research Site
Heidelberg, Australia
RECRUITINGPraxis Research Site
Melbourne, Australia
RECRUITING...and 1 more locations
PGI-S assesses the participants' impression of their current illness state. The participant is required to assess their condition on a 7-point scale from 1 (Not present) to 7 (extremely severe).
Time frame: 8 weeks
To assess the safety and tolerability of PRAX-628 in adults with FOS or PGTCS currently taking ASMs
The number of participants with Adverse Events (AE) will be reported by preferred term
Time frame: 8 weeks