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An Open Label Trial to Evaluate the Efficacy and Safety of PRAX-628 in Adults With Focal Onset or Tonic-Clonic Seizures

ConditionsFocal Onset SeizurePrimary Generalized Epilepsy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorPraxis Precision Medicines

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 of allowable ASMs (a minimum of 1 and a maximum of 3 ASMs).

Participant and/or caregiver (if applicable) self-reports at least 2 countable focal onset seizures per month for focal onset patients, or 1 countable generalized tonic-clonic seizure per month in the 3 months immediately prior to the Screening/Observation Period for PGTCS patients.

Disqualifiers

History of pseudo or psychogenic seizures, or cluster seizures only, within the 12-month period preceding study entry where the individual seizures cannot be counted, or an episode of convulsive status epilepticus requiring hospitalization and intubation in the 12 months prior to Screening.

Planned epilepsy surgery during the course of the clinical trial.

History of neurosurgery for seizures <1 year prior to enrollment, or radiosurgery <2 years prior to enrollment.

Schizophrenia and obsessive-compulsive disorder, or other serious mental health disorders.

Trial design

Design model

Single group

Treatments tested in this trial

  • 30mg PRAX-628

    Drug

    Once daily oral

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Open-label 30mg/day PRAX-628 for 8 weeksExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

To 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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Praxis Precision Medicines

Lead sponsor

Source ClinicalTrials.gov
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