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Набор скоро начнётся NCT05179577

A Study to Investigate Arbaclofen ER Tablets for the Treatment of Spasticity in Patients With Multiple Sclerosis

Фаза III С лечением Spasticity

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Arbaclofen, Placebo.
Кому может быть актуально
Состояния в реестре: Spasticity. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Randomized, Double-Blind, Placebo-Controlled Parallel Group Study to Investigate the Safety and Efficacy of Arbaclofen Extended-Release Tablets for the Treatment of Spasticity in Patients With Multiple Sclerosis (Study OS440-3006)

Обзор

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of oral arbaclofen ER tablets in MS patients with spasticity. Arbaclofen ER will be compared with placebo.

Подробное описание

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of oral arbaclofen ER tablets (80 mg/day) in MS patients with spasticity. Arbaclofen ER will be compared with placebo. The treatment groups will be randomized in a 1:1 ratio. There will be a 49-day dose escalation period, followed by a 84-day maintenance treatment period, followed by a 21-day taper period.

Вмешательства

  • Препарат Arbaclofen
    Arbaclofen Extended Release Tablets
  • Препарат Placebo
    Placebo tablets

Первичные конечные точки

  • Change from Baseline to Maintenance Treatment Period for Total Numeric-Transformed Modified Ashworth Scale Most Affected Limb (TNmAS-MAL) [Срок оценки: Maintenance Treatment Period: Visit 5 (day 77), Visit 6 (day 105), and Visit 7 (day 133)]
  • Responder Analysis of Ashworth Scale Score (AS-MAL-R) for Maintenance Treatment Period [Срок оценки: Maintenance Treatment Period: Visit 5 (day 77), Visit 6 (day 105), and Visit 7 (day 133)]
Вторичные конечные точки (4)
  • Change from Baseline to Maintenance Treatment Period for Total Numeric-Transformed Modified Ashworth Scale Total Limbs (TNmAS-TL) [Срок оценки: Maintenance Treatment Period: Visit 5 (day 77), Visit 6 (day 105), and Visit 7 (day 133)]
  • Clinician's global impression of change (CGIC) for Maintenance Treatment Period [Срок оценки: Maintenance Treatment Period: Visit 5 (day 77), Visit 6 (day 105), and Visit 7 (day 133)]
  • Numeric Rating Scale of Spasticity (NRS-S) for Maintenance Treatment Period [Срок оценки: Maintenance Treatment Period: Visit 5 (day 77), Visit 6 (day 105), and Visit 7 (day 133)]
  • Expanded Disability Status Scale (EDSS) for Maintenance Treatment Period [Срок оценки: Maintenance Treatment Period: Visit 5 (day 77), Visit 6 (day 105), and Visit 7 (day 133)]

Критерии участия

Критерии включения

  • Subjects 18 to 65 years of age, inclusive
  • An established diagnosis per McDonald Criteria (Polman et al 2011) of MS (either RR or SP course) that manifests a documented history of spasticity for at least 6 months prior to screening
  • Spasticity due to MS as shown by a TNmAS-MAL score ≥ 2
  • Expanded Disability Status Scale (EDSS) score greater than or equal to (≥) 3.0 and less than or equal to (≤) 7.0
  • Absence of infections, peripheral vascular disease, painful contractures, advanced arthritis, or other conditions that hinder evaluation of joint movement
  • Use of a medically highly effective form of birth control (see Section 7.8) during the study and for 3 months thereafter for women of child-bearing potential (including female subjects and female partners of non-sterile male subjects)
  • Willing to sign the informed consent form (ICF)

Критерии исключения

  • Any concomitant disease or disorder that has symptoms of spasticity or that may influence the subject's level of spasticity
  • In the opinion of the investigator, the patient is unable to rate their level of spasticity or distinguish it from other MS symptoms
  • Concomitant use of medications that would potentially interfere with the actions of the study medication or outcome variables
  • Pregnancy, lactation, or planned pregnancy during the course of the study and for 3 months after the final study visit
  • Current significant cognitive deficit, severe or untreated anxiety, severe or untreated depression
  • Current malignancy or history of malignancy that has not been in remission for more than 5 years, except effectively treated basal cell skin carcinoma
  • Any other significant disease, disorder, or significant laboratory finding which, in the opinion of the investigator, puts the subject at risk because of participation, influences the result of the study, or affects the subject's ability to participate

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Четверное слепое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT05179577 · OS440-3006

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗