Study to Assess the Safety of 3 mg/mL Gablofen® (Baclofen Injection) Delivered by Intrathecal Administration Using the Synchromed® II Programmable Infusion System
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 153
- 试验地点
- 13
- 主要终点
- The rate of inflammatory granulomas in patients given 3 mg/mL Gablofen® (baclofen injection) 3mg/mL by the intrathecal route of administration.
研究概览
简要总结
Safety study to assess the 3 mg/mL baclofen injection (intrathecal) using a programmable pump
详细描述
This is a prospective 36-month Phase IIIb/IV clinical safety trial that will be conducted at clinical trial sites that are experienced with the use of intrathecal baclofen. All patients will be entered after signing an IRB approved informed consent. Patients will be followed for the duration of their treatment with Gablofen® (baclofen injection) 3 mg/mL using the SynchroMed® II Programmable Pump or until the study is terminated. Patients will be evaluated for clinical complications associated with the use of intrathecal baclofen that are considered signs and symptoms of an inflammatory granuloma, specifically new radicular pain at the level of the catheter tip, and/or spinal cord compression. An MRI scan with and without infusion will be performed (with consent of the patient) to evaluate the potential presence of an inflammatory granuloma if clinical signs exist. Events that may be related to an inflammatory granuloma will be classified as a definite granuloma, possible granuloma, other catheter related problem (confirmed not caused by a granuloma), or other clinical sequelae caused by the underlying disease or other infusion system related event.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •4 years of age or older
- •Subjects must be clinically diagnosed with sever spasticity and be receiving intrathecal baclofen
- •Subjects must have a SynchroMed® II Pump already implanted
- •Current treatment with intrathecal baclofen should be at the 2 mg/mL concentration
- •Life expectancy greater than or equal to 12 months
- •Signed written informed consent
- •Ability and willingness to comply with the study protocol for the duration of the study and with follow-up procedures
排除标准
- •History or presence of malignancy, with the exception of adequately treated localized skin cancer (basal cell or squamous cell carcinoma) or carcinoma in-situ of the cervix, which is allowed
- •History of any allergic reaction to baclofen
- •History of inflammatory granulomas with an intrathecal infusion pump
- •Any previous history of neuroleptic malignant syndrome or malignant hyperthermia
- •As a result of medical review and physical examination, the Investigator considers the subject unfit for the study
研究组 & 干预措施
Gablofen 3 mg/mL (baclofen Injection)
3 mg/mL Gablofen (baclofen Injection)
干预措施: Gablofen® 3 mg/mL (baclofen injection) (Drug)
Gablofen 3 mg/mL (baclofen Injection)
3 mg/mL Gablofen (baclofen Injection)
干预措施: SynchroMed® II Programmable Pump (Device)
结局指标
主要结局
The rate of inflammatory granulomas in patients given 3 mg/mL Gablofen® (baclofen injection) 3mg/mL by the intrathecal route of administration.
时间窗: 36-months
The rate of inflammatory granulomas in patients given 3 mg/mL Gablofen® (baclofen injection) 3mg/mL by the intrathecal route of administration.
次要结局
- Overall safety of 3 mg/mL Gablofen® (baclofen injection) given by the intrathecal route of administration(36-months)