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Идёт набор NCT07734103

Lumateperone in the Treatment of Stuttering, Childhood Onset Fluency Disorder

Фаза II С лечением Stuttering, Adult

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: Lumateperone (ITI-007), Placebo Tablet or Capsule.
Кому может быть актуально
Состояния в реестре: Stuttering, Adult. 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
США
Следующий шаг
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Официальное название

A Single-Center, Double-Blind, Placebo-Controlled, Study to Evaluate Lumateperone, Flexible Doses of 21mg or 42mg in Patients With Moderate to Severe Childhood Onset Fluency Disorder, Stuttering.

Обзор

The primary objective of this study is to evaluate the efficacy and tolerability of Lumateperone in reducing stuttering symptoms. The following scales and samples will be collected for clinical and functional outcomes. • MLGSSS • SSS • Stuttering Severity Instrument (SSI-IV) • PHQ-9 • Barnes Akathisia • SAS • AIMS • CGI-I • CGI-S

Подробное описание

This is a double-blind, placebo-controlled trial of Lumateperone in adults who suffer from developmental stuttering. Subjects with moderate to severe stuttering as measure by MLGSS scale will be enrolled. We anticipate screening a total of 30 subjects in anticipation of enrolling 24 suitable subjects for the trial. The subjects will be adults between the ages of 18-65, who have the capacity to consent for themselves. After providing written informed consent, potential subjects will undergo a thorough clinical screening.

Вмешательства

  • Препарат Lumateperone (ITI-007)
    This medication is a tablet that is taken once daily
  • Препарат Placebo Tablet or Capsule
    Matching Placebo

Первичные конечные точки

  • Comprehensive Brief Stuttering Assessment-SR (CBSA-SR) previously know as Maguire-Leal-Garibaldi Self rated Stuttering Scale (MLGSSS) [Срок оценки: last seven days, previous week (Minimum score 0 to Maximum score 100)]
  • Clinical Global Impression - Severity (CGI-S) [Срок оценки: Based primarily on symptoms and functioning over the past 7 days]
Вторичные конечные точки (1)
  • Clinical Global Impression - Improvement (CGI-I) [Срок оценки: Rating for patients illness the past 7 days and measuring if symptoms and functioning have improved or worsened relative to their initial baseline]

Критерии участия

Критерии включения

Subjects will be included in the study only if they meet all the following criteria:

  • Subject must satisfy DSM-V criteria for childhood onset fluency disorder (stuttering).
  • The nature of stuttering must be developmental in origin with the onset prior to 8 years of age.
  • Subject must have a score of moderate or higher on the MLGSSS.
  • Subject agrees to use an acceptable method of contraception for the duration of the study.
  • Subject must be able to speak English.
  • Subjects must be adults between the ages of 18 - 65.

Критерии исключения

Subjects will be excluded from the study if they meet one or more of the following criteria:

  • Subject has an unstable neurologic, psychiatric, or medical condition in the judgement of the investigator.
  • Subject (female) is pregnant.
  • Subject has evidence of moderate or severe renal or hepatic impairment at Screening.
  • Subjects currently taking any moderate or strong CYP3A4 inhibitor medications.
  • Subject who meets the DSM-5 criteria for moderate to severe substance use disorder within twelve months prior to study inclusion.
  • Subject has a positive pregnancy test at screening or on Day 1 prior to the start of study drug.
  • Subject that is lactating at screening or Day 1, prior to the start of study drug and does not agree to cease giving breast milk to child(ren), donating breast milk and/or providing breast milk to anyone for consumption, from Day 1 until 14 days after the last dose of study medication.
  • Any history of neuroleptic malignant syndrome (NMS).
  • Subject with a glycosylate hemoglobin (A1c) of greater than 6.4 percent.

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

США · 1 центр
  • CSTrials — Costa Mesa

Публикации

  • Maguire GA, Yoo BR, SheikhBahaei S. Investigation of Risperidone Treatment Associated With Enhanced Brain Activity in Patients Who Stutter. Front Neurosci. 2021 Feb 12;15:598949. doi: 10.3389/fnins.2021.598949. eCollection 2021. PMID 33642973
  • Charoensook J, Maguire GA. A case series on the effectiveness of lurasidone in patients with stuttering. Ann Clin Psychiatry. 2017 Aug;29(3):191-194. PMID 28738099
  • Maguire GA, LaSalle L, Hoffmeyer D, Nelson M, Lochhead JD, Davis K, Burris A, Yaruss JS. Ecopipam as a pharmacologic treatment of stuttering. Ann Clin Psychiatry. 2019 Aug;31(3):164-168. PMID 31369655

Идентификаторы

NCT: NCT07734103 · ITI-IIT-001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗