An Observational Post-Marketing Safety Registry Of Patients Who Have Been Prescribed Sativex®
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 978
- 主要终点
- Incidence rates of adverse events.
研究概览
简要总结
The purpose of this registry is to monitor safety outcomes of patients who are receiving Sativex® for Multiple Sclerosis (MS) spasticity and for off-label indications in the United Kingdom (UK), Germany and Sweden.
详细描述
The objectives of this multi-centre, observational program are to evaluate the long-term safety of Sativex® with special regard to the following:
- The potential for addiction, abuse and misuse for illegal purposes
- The potential for long-term psychiatric effects including suicidality and psychosis
- The potential for mood changes / psychological effects (such as confusion / disorientation)
- The potential for memory impairment
- The effect on driving ability
- The potential for falls
- The use of MS concomitant medications
All physicians who are prescribing Sativex® in the UK and those from specialist neurology centres in Germany and Sweden will be invited to participate in the registry and will be provided with information regarding the background and objectives of the study. The prescribing physician will be asked to enter the following information via electronic Case Report Forms (CRF) at 6 monthly intervals for up to 24 months for any one patient:
Sativex® Use:
- Was Sativex® prescribed for Spasticity in MS? (Yes/No). If no, specify then indication for prescribing Sativex®
- Year of Spasticity diagnosis (Germany/Sweden only)
- Sativex® start date
- Sativex® daily dose (average, minimum and maximum)
- Date of last prescription
- Is Sativex® providing worthwhile benefit? (Yes/ No/ Don't Know)
- Has Sativex® been stopped permanently? (Yes /No). If yes, reason for stopping is to be provided.
- Sativex® stop date
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients who are prescribed Sativex® in the UK
- •Patients who are prescribed Sativex® from selected specialist neurology centres in Germany and Sweden.
排除标准
- 未提供
研究组 & 干预措施
Sativex® users
UK: All patients and who are prescribed Sativex®. Germany and Sweden: Patients who are prescribed Sativex® from selected specialist neurology centres.
干预措施: Sativex® (Drug)
结局指标
主要结局
Incidence rates of adverse events.
时间窗: Participants will be followed for the duration of Sativex treatment, an expected average of 2 years.
The number of treatment-emergent adverse events was recorded. The incidence rate (number of patients divided by the total patient-years exposure to Sativex®) for each adverse event is presented.
次要结局
- Average daily number of sprays of Sativex® used.(Participants will be followed for the duration of Sativex treatment, an expected average of 2 years.)
- Number of patients experiencing fall-related injuries requiring medical attention.(Participants will be followed for the duration of Sativex treatment, an expected average of 2 years.)
- Number of patients experiencing a change in driving ability.(Participants will be followed for the duration of Sativex treatment, an expected average of 2 years.)
- Number of patients experiencing suicidal thoughts or attempts.(Participants will be followed for the duration of Sativex treatment, an expected average of 2 years.)
- Incidence of patient deaths.(Participants will be followed for the duration of Sativex treatment, an expected average of 2 years.)
- Number of MS patients discontinuing medications for MS symptoms other than anti-spasticity medications.(Participants will be followed for the duration of Sativex treatment, an expected average of 2 years.)
- Number of patients experiencing significant psychiatric or psychotic events other than suicidality.(Participants will be followed for the duration of Sativex treatment, an expected average of 2 years.)
- Number of MS patients discontinuing anti-spasticity medications.(Participants will be followed for the duration of Sativex treatment, an expected average of 2 years.)
- Number of patients receiving worthwhile benefit from Sativex®.(Participants will be followed for the duration of Sativex treatment, an expected average of 2 years.)