Ziconotide for Non-cancer Pain by Intrathecal Administration
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 85
- 试验地点
- 14
- 主要终点
- Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: medical history
研究概览
简要总结
Although ziconotide's marketing authorization does not restrict its use to a given type of pain, the drug has been used mainly in cancer patients. Most data on ziconotide-based intrathecal (IT) treatment has therefore been obtained in this population, for whom the drug's place is clearly documented (national and international recommendations).
In contrast the management of non-cancer pain is less straightforward, partly because of the very large range of possible clinical conditions, and the utilization of ziconotide is poorly documented, mainly described in single-centre small series.
Due to the lack of data, physicians are often reluctant to undertake this type of treatment, which may represent a loss of opportunity for patients.
This registry aims at providing information on patients suffering from non-cancer pain refractory to standard therapy, treated by ziconotide-based intrathecal analgesia.
Patients suffering from all types of non-malignant pain will be eligible for the study, including but not limited to spinal cord injury, radiculopathy, failed back surgery, diabetic neuropathy, central pain syndrome, complex regional pain syndrome, chemotherapy-induced neuropathy, fibromyalgia.
The collected data will cover the first 2 years of treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years,
- •Chronic non-cancer pain requiring interventional techniques, and eligible to ziconotide-containing intrathecal therapy,
- •Having received information on and not opposed to data collection,
- •Inclusion criteria specific for the retrospective cohort:
- •Currently treated by ziconotide-based ITA according to SmPC whatever the duration of treatment
- •Inclusion criteria specific for the prospective cohort:
- •Naïve of ITA and candidate to ziconotide-based ITA or already treated by IT route without ziconotide, scheduled for addition of ziconotide in the pump
排除标准
- •Contraindication to intrathecal therapy or to ziconotide
- •Any condition that may jeopardize appropriate follow-up of the treatment
- •Patient under guardianship or deprived of liberty by a judicial or administrative decision or unable to express opposition to data collection.
研究组 & 干预措施
Patients treated by ziconotide-based intrathecal analgesia (ITA)
Patients followed during 2 years after an initiation of ziconotide. These patients will be recruited retrospectively or prospectively.
干预措施: Ziconotide [Prialt] (Drug)
结局指标
主要结局
Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: medical history
时间窗: Baseline (treatment initiation)
Relevant medical history, including history of psychiatric disorders
Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: pain intensity
时间窗: Baseline (treatment initiation)
Numerical Rating Scale score for pain (graduated from 0: absence of pain to 10: worst possible pain) analgesic treatment (administered when decision of ziconotide treatment is made)
Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: demographic characteristics
时间窗: Baseline (treatment initiation)
Patient's demographic characteristics
Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: neuro-psychiatric condition
时间窗: Baseline (treatment initiation)
NPI-ES score (NeuroPsychiatric Inventory of An inventory of 12 of the most frequent symptoms of Alzheimer's disease and related disorders, assessing their frequency and severity, as well as the impact on the caregiver or professional), or score of another type or neuropsychological evaluation questionnaire)
Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: disability condition
时间窗: Baseline (treatment initiation)
Owestry disability index score: patient-completed questionnaire which gives a subjective percentage score of level of function (disability) in 10 activities of daily living
Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: anxiety and depression disorders
时间窗: Baseline (treatment initiation)
Hospital Anxiety and Depression Scale (HADS) score: patient-completed questionnaire with 14 items assessing anxiety and depressive disorders
Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: indication for intrathecal ziconotide
时间窗: Baseline (treatment initiation)
Indication for ziconotide initiation (mechanism of pain and etiology)
Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: starting date of pain
时间窗: Baseline (treatment initiation)
Starting date of severe/disabling pain
Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: reasons for initiating ziconotide
时间窗: Baseline (treatment initiation)
Reasons for initiating ziconotide (process of medical decision)
Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: history of pain management
时间窗: Baseline (treatment initiation)
History of pain management including prior interventional techniques and current analgesic treatment (administered when decision of ziconotide treatment is made)
Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: planned modification of the current intrathecal treatment
时间窗: Baseline (treatment initiation)
Planned modification of the current intrathecal treatment
次要结局
- Describe the modalities of ziconotide therapy during follow-up(2 years follow-up)
- Describe the effect of treatment on anxiety and depression(3 months, 1 year and 2 years.)
- Describe the effect of treatment on pain evolution(2 years follow-up)
- Describe the effect of treatment on disability(3 months, 1 year and 2 years.)
- Describe the modalities of ziconotide therapy at ziconotide initiation(Baseline (treatment initiation))
- Describe the patient's care pathway and treatment management(2 years follow-up)
- Describe the safety and tolerability of treatment(From treatment initiation to 2 years of follow-up)