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Идёт набор NCT07432958

A Study to Evaluate the Effectiveness of Two Doses of AP-472 as Adjunctive Therapy to Levodopa in Parkinson's Disease (PD) Participants With Motor Fluctuations

Фаза II С лечением Parkinson Disease

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: AP-472, Placebo.
Кому может быть актуально
Состояния в реестре: Parkinson Disease. Базовые параметры: 30 лет — 80 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Phase 2, Double-blind, Placebo-controlled Study to Evaluate the Effectiveness of Two Doses of AP-472 as Adjunctive Therapy to Levodopa in Parkinson's Disease (PD) Participants With Motor Fluctuations

Обзор

This is a Phase 2 study in people with Parkinson's disease who experience motor fluctuations while taking levodopa. The study will evaluate how effective two different doses of the study drug AP-472 are when added to levodopa treatment, compared with a placebo. The study will last about 12 weeks. Participants will be randomly assigned to receive one of the two doses of AP-472 or a placebo. Neither the participants nor the study staff will know which treatment is given. The study includes a screening period, a 4-week period during which Parkinson's medications must remain stable, and an 8-week treatment period. During the treatment period, limited adjustments to levodopa are allowed if needed.

Вмешательства

  • Препарат AP-472
    Oral tablet
  • Другое Placebo
    Oral tablet

Первичные конечные точки

  • Change from Baseline in average daily OFF time on motor diaries for AP-472 compared to placebo (normalized to 16-hour awake time) [Срок оценки: Week 12]
Вторичные конечные точки (5)
  • Change from baseline in ON time without troublesome dyskinesia (normalized to 16 hours) [Срок оценки: Week 12]
  • Change from baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part 2 (Motor Experiences of Daily Living (M-EDL)) score [Срок оценки: Week 12]
  • Change from baseline in Parkinson's Disease Questionnaire-39 (PDQ-39) summary index [Срок оценки: Week 12]
  • Change from baseline in MDS-UPDRS Part III (Motor Examination) score in the best ON state [Срок оценки: Week 12]
  • Change from baseline in Epworth Sleepiness Scale (ESS) total score [Срок оценки: Week 12]

Критерии участия

Критерии включения

Participants must meet all of the following criteria to take part in the study:

  • Be a man or woman between 30 and 80 years of age at the time of screening.
  • Have a diagnosis of Parkinson's disease, confirmed using standard medical criteria, including slowness of movement and symptoms that affect one side of the body more than the other.
  • Have mild to moderate Parkinson's disease, defined as stage 3 or lower on the Hoehn and Yahr scale when medications are working ("ON" state).
  • Experience an average of at least 3 hours of OFF time per day, based on home symptom diaries, with at least 2.5 hours of OFF time each day during the baseline period.
  • Have a Montreal Cognitive Assessment (MoCA) score of 24 or higher at screening.
  • Be able to walk independently, with or without the use of a walking aid.
  • Be able to swallow oral medication.
  • Have been on a stable Parkinson's medication regimen for at least 4 weeks before screening. Medications known as MAO-B inhibitors must have been stable for at least 12 weeks.
  • Be taking levodopa at least four times daily (immediate- or controlled-release formulations) or three times daily (extended-release formulations such as Rytary or Crexont).

Критерии исключения

Participants cannot take part in the study if any of the following apply:

  • Have a form of parkinsonism that is not typical Parkinson's disease, such as secondary or atypical parkinsonism.
  • Have previously received, or plan to receive during the study, advanced Parkinson's therapies such as continuous levodopa or dopamine delivery systems, or Parkinson's disease-related brain surgery.
  • Have dyskinesias (involuntary movements) that are severe enough, in the study doctor's opinion, to interfere with participation.
  • Have a history of only certain types of dyskinesias (such as OFF-state, diphasic, myoclonic, or dystonic dyskinesias) without typical peak-dose dyskinesias.
  • Are currently taking medications that block dopamine, except for low-dose quetiapine (up to 50 mg per day) used for insomnia.
  • Routinely use on-demand "rescue" Parkinson's medications more than three times per week.

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
Двойное слепое
Основная цель
Лечение

Центры проведения

США · 30 центров
  • University of Arkansas for Medical Sciences (Site #208) — Little Rock
  • Profound Research LLC (Site #222) — Carlsbad
  • Collaborative Neuroscience Network - Los Alamitos- CenExel - PPDS (Site #217) — Los Alamitos
  • Keck Medicine of USC - USC Healthcare Center 2 (Site #221) — Los Angeles
  • Parkinson's Research Centers of America (Site #218) — Palo Alto
  • Rocky Mountain Clinical Research - CenExel - PPDS (Site #215) — Englewood
  • Parkinson's Disease & Movement Disorders Center of Boca Raton (Site #227) — Boca Raton
  • UM-UHealth at Boca Raton (Site #226) — Boca Raton
  • … и ещё 22 центра

Идентификаторы

NCT: NCT07432958 · APLO-1201

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗