EUCTR2012-000043-27-DE进行中（未招募）1 期
BOTOX® Treatment in Pediatric Upper Limb Spasticity: Open-label Study
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
- 412
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
- •Rollover patients:
- •Eligible patients who successfully completed Allergan Study 191622-101 without major protocol deviations (eg, noncompliance to protocol-required procedures) and who, in the investigator’s clinical judgment, did not experience an adverse event that may indicate an unacceptable safety risk for additional BOTOX treatments
- •Stable medical condition in the investigator’s opinion
- •Written informed consent has been obtained from parent/legally authorized representative
- •Written minor assent has been obtained in accordance with local laws and institutional review board (IRB)/independent ethics committee (IEC) requirements
- •Written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable (eg, Written Authorization for Use and Release of Health and Research Study Information for United States [US] sites and written Data Protection consent for European Union [EU] sites)
- •Negative urine pregnancy test at day 1 visit (for females of childbearing potential, defined as females post menarche)
- •De novo patients:
- •Male or female, 2 to 16 years and 11 months of age (prior to 17th birthday) at the day 1 visit
- •Minimum weight of 10 kg at the screening and day 1visits
- •Upper limb monoplegic, hemiplegic, or triplegic spasticity (spasticity confirmed by Hypertonia Assessment Tool [HAT]) with single-arm sparing (only 1 arm requiring botulinum toxin treatment for spasticity during the study) resulting from cerebral palsy, or post-stroke with onset prior to age 2 and at least 12 months prior to the day 1 visit
- •Patient’s spasticity meets at least one of the conditions below at the screening and day 1 visits:
- •a) Elbow flexor tone of 2 or greater as measured by the Modified Ashworth Scale – Bohannon (MAS-B) AND elbow flexor muscle contracture of no more than 30 degrees, and/or
- •b) Wrist flexor tone of 2 or greater as measured by the MAS-B AND at least neutral position for wrist with fingers at maximum extension
- •Gross Motor Function Classification System – Expanded and Revised (GMFCS-E&R) level I to IV at the screening visit
- •Manual Ability Classification System (MACS) level I to IV at the screening visit
- •Patients who are on anti-spastic medications or muscle relaxants (eg, oral baclofen, tizanidine, dantrolene, scopolamine [oral or patch], vigabatrin, or benzodiazepine therapy) must be on a stable dose
- •and regimen for at least 30 days prior to the day 1 visit
- •Patients who are on anti-epileptic medications must be on a stable dose and regimen for at least 30 days prior to the day 1 visit
- •Written informed consent has been obtained from parent/legally authorized representative
- •Written minor assent has been obtained in accordance with local laws and IRB/IEC requirements
- •Written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable (eg, Written Authorization for Use and Release of Health and Research Study Information for US sites and written Data Protection consent for EU sites)
- •Negative urine pregnancy test at the screening and day 1 visits (for females of childbearing potential, defined as females post menarche)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 412
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Any uncontrolled clinically significant medical condition other than the condition under study
- •Any medical condition that may put the patient at increased risk with exposure to Botulinum Toxin Type A Purified Neurotoxin Complex, including diagnosed muscular dystrophy (eg, Duchenne’s muscular dystrophy), myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, mitochondrial disease, or any other significant disease that might interfere with neuromuscular function
- •Fixed contracture of the principal muscle group (elbow or wrist) for the study limb
- •Uncontrolled epilepsy defined as more than 1 generalized seizure per month within 3 months prior to the day 1 visit or history of prolonged seizures or repetitive seizure activity requiring administration of a rescue benzodiazepine (oral, rectal, etc) more than once a month, seizures lasting more than 10 minutes, status epilepticus, or epilepsy with autonomic involvement within 9 months prior to the day 1 visit
- •Patients with presence or history of aspiration pneumonia, recurrent lower respiratory tract infections, uncontrolled asthma, or compromised respiratory function within 12 months prior to the day 1 visit that may indicate a vulnerable respiratory state per investigator’s clinical judgment
- •Patients with presence or history (within 12 months prior to the day 1 visit) of aspiration or a condition(s) that, in the investigator’s opinion, may put the patient at an increased risk for aspiration (eg, significant drooling, chronic dysphagia [difficulty swallowing] requiring changes in diet, or clinically significant gastroesophageal reflux disease)
- •Patients previously exposed to botulinum toxin therapy of any serotype who have a history of allergy or sensitivity to the toxin or its components or other significant adverse experiences that, in the investigator’s opinion, may put the patient at an unacceptable risk
- •Botulinum toxin therapy of any serotype for any condition within 3 months prior to the day 1 visit (de novo patients only)
- •History of treatment with phenol or alcohol block in the study upper limb within 6 months prior to the day 1 visit (de novo patients only) or planned treatment with phenol or alcohol block in the study upper limb during the study
- •History of or planned treatment during the study with selective dorsal rhizotomy or deep brain stimulation
- •History of surgical intervention of the study upper limb within 12 months prior to the day 1 visit (de novo patients only) or planned surgical intervention of any limb(s) during the study
- •Females who are pregnant, nursing, or planning a pregnancy during the study
- •Females of childbearing potential (defined as females post menarche) not using reliable means of contraception (see Section 4.5.1.1 for acceptable contraceptive methods)
研究者
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