EUCTR2015-000095-10-SE进行中（未招募）1 期
Botulinum toxin-A as a treatment for chronic muscle-related pain in adults with spastic cerebral palsy: a randomized controlled trial.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 48
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Age = 18 years.
- •- Spastic Cerebral palsy, according to SCPE guidelines 1
- •- Chronic pain, with pain localization related to regional spastic muscle. Chronic pain defined as:
- •* Recurring regional pain for at least three (3) months.
- •* Pain intensity on average for the last 24 hours =3 on Numerical Rating Scale.
- •- Signed Informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 43
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •For reasons of safety:
- •- Allergy/hypersensitivity to Dysport® or any of its components.
- •- Pregnancy. All women not passed menopause or not previously surgically sterilized, will need to perform a urine pregnancy test at Visit 2, before treatment.
- •- Women who breastfeed their children.
- •For reasons of study consistency:
- •- Treatment with BoNT-A within the last 5 months.
- •- If there has been dose changes in any muscle-tone altering medication within two (2) weeks of Screening visit.
- •- A clear degenerative cause behind the pain as elucidated by the clinical examination (i.e. history of osteoarthritis).
- •- Intellectual disability and/or communication impairment that disable the individual from answering the questionnaires and giving informed consent.
研究者
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