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

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Препарат 30mg PRAX-628
  Once daily oral

Первичные конечные точки

• To evaluate the efficacy of PRAX-628 on seizure frequency in adults with FOS or PGTCS currently taking ASMs [Срок оценки: 8 weeks]

Вторичные конечные точки (6)

• To evaluate the efficacy of PRAX 628 on seizure frequency in adults with FOS or PGTCS currently taking ASMs [Срок оценки: 8 weeks]
• To evaluate the efficacy of PRAX 628 on seizure frequency in adults with FOS or PGTCS currently taking ASMs [Срок оценки: 8 weeks]
• To evaluate the efficacy of PRAX 628 on seizure frequency in adults with FOS or PGTCS currently taking ASMs [Срок оценки: 8 weeks]
• CGI-S Change from Baseline [Срок оценки: 8 weeks]
• PGI-S Change from Baseline [Срок оценки: 8 weeks]
• To assess the safety and tolerability of PRAX-628 in adults with FOS or PGTCS currently taking ASMs [Срок оценки: 8 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.
• Active suicidal plan/intent in the past 6 months, or a history of suicide attempt in the last 2 years, or more than 1 lifetime suicide attempt.
• Participants with a history of malignancy, myeloproliferative or lymphoproliferative disorders within the past 5 years are excluded.
• History of cardiac disease(s)/cardiac conduction disorders/or cardiac structural abnormality(ies).
• Is pregnant or breastfeeding at the time of Screening, or has a positive serum pregnancy test at Screening or is planning to become pregnant during the clinical trial or within 14 days of the last study drug dose.
• Has received any other experimental or investigational drug, device or other therapy within 30 days or 5 half-lives (whichever is longer) prior to Screening, or any prior use of gene therapy.
• Vigabatrin: Use in the last 5 years without stable visual fields tested twice over the 12 months after the last dose of vigabatrin.
• Felbamate: If used as a concomitant ASM, patients must be on felbamate for at least 2 years, with a stable dose for 2 months prior to Screening. If a patient received felbamate in the past, it must have been discontinued 2 months prior to Screening.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 8 центров

• Praxis Research Site — Phoenix
• Praxis Research Site — Miami Lakes
• Praxis Research Site — Bethesda
• Praxis Research Site — Chesterfield
• Praxis Research Site — Hackensack
• Praxis Research Site — Middletown
• Praxis Research Site — Round Rock
• Praxis Research Site — Seabrook

Австралия · 2 центра

• Praxis Research Site — Heidelberg
• Praxis Research Site — Melbourne

Испания · 1 центр

• Praxis Research Site — Madrid

Идентификаторы

NCT: NCT06908356 · PRAX-628-212

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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