A Study on Recombinant Botulinum Toxin Type A (YY001) for Injection in Multiple Treatments of Adult Upper Limb Spasticity

Официальное название

An Open-label, Multicenter Clinical Study on The Long-term Safety and Efficacy of Multiple Treatments With Recombinant Botulinum Toxin Type A (YY001) for Injection in Adult Upper Limb Spasticity (REHAB-2)

Обзор

This is an open-label, multicenter, phase III clinical study to evaluate the long-term safety and efficacy of multiple treatments with recombinant botulinum toxin type A (YY001) for injection in adult upper limb spasticity

Вмешательства

• Биопрепарат Recombinant botulinum toxin type A for injection (YY001)
  Prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), intramuscular injection, the total injection dose for single treatment is 200 to 400 U.

Первичные конечные точки

• Incidence of Adverse Events and Serious Adverse Events [Срок оценки: Up to 48 weeks]

Вторичные конечные точки (5)

• Physician's Global Assessment (PGA) Score [Срок оценки: Weeks 1, 4, 8, 12, 16, 20 and 24 after each treatment]
• Change From Baseline in MAS Score of Primary Target Clinical Pattern [Срок оценки: Weeks 1, 4, 8, 12, 16, 20 and 24 after each treatment]
• Response Rates on MAS Calculated for the Primary Target Clinical Pattern [Срок оценки: Weeks 1, 4, 8, 12, 16, 20 and 24 after each treatment]
• The Proportion with Disability Assessment Scale (DAS)- Principal Therapeutic Target Domain Score Reduction of ≥1 Point [Срок оценки: Weeks 1, 4, 8, 12, 16, 20 and 24 after each treatment]
• Incidence of Anti-drug Antibodies and Neutralizing Antibodies [Срок оценки: Up to 48 weeks]

Критерии участия

Критерии включения

• Age between 18 and 75 years old inclusive, at the time of signing the informed consent, regardless of gender.
• Subjects with unilateral hemiplegia due to stroke (with a time interval of ≥ 3 months from stroke onset to enrollment) exhibiting upper limb spasticity.
• Subjects with Disability Assessment Scale score of at least 2 on the Principal Target of Treatment (one of four functional domains: hygiene, dressing, limb position and pain).

Критерии исключения

• History of allergy to any component of the experimental drugs.
• Previous use of any botulinum toxin within 6 months prior to enrollment, or plan to use other botulinum toxins not specified in the study protocol during the study.
• Fixed contractures of the studied limb.
• Any medical condition that may increase the risk to the subject when using botulinum toxin type A.
• Need for treatment with drugs that interfere with neuromuscular function during the study.
• Plan or anticipate to use new antispasticity drugs during the study.
• History of epilepsy.
• Pregnant or breastfeeding women.
• Participation in other drug/device clinical trials within 1 month prior to enrollment.

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

Китай · 16 центров

• Peking Union Medical College Hospital — Пекин
• West China Hospital，Sichuan University — Чэнду
• Guangdong Provincial People's Hospital — Guangdong
• Sun Yat-sen Memorial Hospital — Гуанчжоу
• The Second People's Hospital of Hefei — Хэфэй
• Huai'an First Hospital Affiliated to Nanjing Medical University — Huai'an
• The First Affiliated Hospital of Henan University — Kaifeng
• The Second Affiliated Hospital of Kunming Medical University — Куньмин
• … и ещё 8 центров

Идентификаторы

NCT: NCT07478822 · YY001-002-CN02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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