A Clinical Study on Recombinant Botulinum Toxin Type A (YY001) for Injection in The Treatment of Upper Limb Spasticity in Adults

Официальное название

A Clinical Study to Evaluate the Efficacy and Safety of Recombinant Botulinum Toxin Type A (YY001) for Injection in The Treatment of Upper Limb Spasticity in Adults (REHAB-1)

Обзор

This is a randomized, double-blind, multi-center phase II/III study to evaluate the efficacy and safety of Recombinant Botulinum Toxin Type A (YY001) for injection in the treatment of upper limb spasticity in adults

Вмешательства

• Биопрепарат Recombinant Botulinum Toxin Type A for injection (YY001)
  Single treatment, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), intramuscular injection, the total injection dose is 200-400 U.
• Биопрепарат BOTOX®
  Single treatment, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), intramuscular injection, the total injection dose is 200 U.
• Биопрепарат Placebo
  Single treatment, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), intramuscular injection.

Первичные конечные точки

• Change From Baseline in Modified Ashworth Scale (MAS) Score of Primary Target Clinical Pattern at Week 4 [Срок оценки: Week 4 after treatment]

Вторичные конечные точки (6)

• Physician's Global Assessment (PGA) Score at Week 1, Week 4, Week 8 and Week 12 [Срок оценки: Week 1, Week 4, Week 8 and Week 12 after treatment]
• Change From Baseline in MAS Score of Primary Target Clinical Pattern at Week 1, Week 8, Week 12 [Срок оценки: Week 1, Week 8 and Week 12 after treatment]
• Response Rates on MAS Calculated for the Primary Target Clinical Pattern at Week 1, Week 4, Week 8 and Week 12 [Срок оценки: Week 1, Week 4, Week 8 and Week 12 after treatment]
• Changes From Baseline in Disability Assessment Scale (DAS)- Principal Therapeutic Target Domain at Week 1, Week 4, Week 8 and Week 12 [Срок оценки: Week 1, Week 4, Week 8 and Week 12 after treatment]
• Incidence of Adverse Events and Serious Adverse Events [Срок оценки: Within 12 weeks of treatment]
• Incidence of Anti-drug Antibodies and Neutralizing Antibodies [Срок оценки: Within 12 weeks of treatment]

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 randomized 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).
• If taking oral antispasticity, the dosage must be stable for at least 1 month prior to randomized enrollment.
• If the study limb receives physical therapy or occupational therapy, the frequency, type, and intensity must be stable for at least 3 weeks prior to randomized enrollment.

Критерии исключения

• History of allergy to any component of the experimental drugs.
• Previous use of any botulinum toxin within 6 months prior to randomized 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 randomized enrollment.

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

Китай · 24 центра

• Anhui Provincial Hospital — Хэфэй
• The Second People's Hospital of Hefei — Хэфэй
• Peking Union Medical College Hospital — Пекин
• Chongqing Traditional Chinese Medicine Hospital — Чунцин
• The First Affiliated Hospital of Chongqing Medical University — Чунцин
• Guangdong Provincial People's Hospital — Гуанчжоу
• Sun Yat-sen Memorial Hospital — Гуанчжоу
• Shenzhen Second People's Hospital — Шэньчжэнь
• … и ещё 16 центров

Идентификаторы

NCT: NCT06783114 · YY001-002-CN01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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