EUCTR2008-008339-27-CZ进行中（未招募）不适用
A 17-WEEK, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, MULTI-CENTER TRIAL OF PREGABALIN FOR THE TREATMENT OF CHRONIC CENTRAL NEUROPATHIC PAIN AFTER SPINAL CORD INJURY
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
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
- •1. Subjects who are able and willing to provide informed consent; 2. Male and non-pregnant, non-lactating, postmenopausal, or surgically sterilized female subjects at least 18 years of age, of any ethnic origin; males and females of childbearing potential must use of contraception; all females must have a confirmed negative serum pregnancy test prior to randomization;3. Subjects deemed to comply with study schedule, procedures and medications as specified by the protocol; 4. Subjects with a documented diagnosis of spinal cord injury (SCI) including all of the
- •following: - Outpatient or inpatient subjects; SCI resulting from accident (examples include motor vehicle, fall, gunshot, electric shock); SCI from diving; SCI due to spinal cord ischemia, Post-surgical SCI after benign tumor (except meningiomas and fibromas) has been removed and the level of injury has been stable for at least 6 months. 5. Complete or incomplete SCI of at least 12 months duration: Complete SCI: Grade A on the American Spinal Injury Association (ASIA); Impairment Scale - No sensory or motor function is preserved in the sacral segments S4-S5; Incomplete SCI: Grade B - Sensory but no motor function is preserved below the neurological level and includes the sacral segments S4-S5; Incomplete SCI: Grade C - Motor function is preserved below the neurological level, and more than half of key muscles below the neurological level have a muscle grade less than 3 (0 to 2); Incomplete SCI: Grade D - Motor function is preserved below the neurological level,and at least half ot key muscles below the neurological level have a muscle grade greater than or equal to 3 (3 to 5). 6. Neurological examination findings consistent with SCI and/or appropriate radiographic/imaging studies (such as X-ray, CT, myelogram, MRI) demonstrating a corresponding anatomical lesion documented by present or past medical records; 7. The Neurological Level of Injury (NLI) must be from C2-T12 inclusive (the NLI is defined as the most caudal segment of the spinal cord with normal sensory and motor function). C2 and C3 lesions are permitted as long as the subject is able to breathe without assistance. Low thoracic NLI (T11-T12) are allowed as long as the subject does not have radicular pain; 8. Subjects may also be included if they have the following conditions as long as all other entry criteria are met: Central cord syndrome, Brown-Sequard syndrome and anterior cord syndrome; Pain Inclusion Criteria - Definitions:-
- •Neurological Level of Injury (NLI) is defined as the most caudal segment of the
- •spinal cord with normal sensory and motor function; Below-level” pain is defined as more than two dermatomes below the NLI; At-level”pain is defined as within two dermatomes either above or below the NLI; Above-level”pain is defined as more than two dermatomes above the NLI; ASIA is American Spinal Injury Association; information and the dermatome chart/worksheet to help with assessment can be found at www.asiaspinalinjury.org, under Publications. 9. For the purpose of this study, the pain is chronic central neuropathic pain, defined as: Pain can be experienced unilaterally or bilaterally, and must have started after the spinal cord injury and persisted continuously for at least 3 months or with remissions and relapses for at least 6 months; Below-level neuropathic pain according to the Bryce-Ragnarsson SCI pain taxonomy type 14 or 15(to the power of 47). Type 14. SCI below level central pain is neuropathic pa
排除标准
- •1. Pregnant or lactating females or females of childbearing potential not practicing an
- •effective method of contraception;
- •2. Neurologic disorders unrelated to spinal cord injury that may confound the assessment of the central neuropathic pain due to spinal cord injury (including but not limited to pain due to hereditary neuropathies; compression-related neuropathies, ie, leprosy; diabetic peripheral neuropathy; traumatic neuropathy; metabolic abnormalities such as hypothyroidism; vascular, inflammatory, malignancy-mediated, and immune-mediated neuropathies;
- •3. Preexisting myelopathy due to other causes;
- •4. Congenital canal stenosis with trauma-induced spinal cord injury;
- •5. Presence of severe pain associated with conditions other than spinal cord injury that could confound the assessment or self-evaluation of pain due to spinal cord injury; 6. Specific systemic diseases or other medical conditions that would interfere with the evaluation of the therapeutic response or safety of the study drug
- •7.Abuse or dependence of drugs or alcohol within the past 12 months according to the Diagnostic and statistical manual of mental disorders criteria (DSM-IV);
- •8. Previous or current participation in another clinical study of pregabalin; intolerance
- •to doses of pregabalin (150 to 600mg/day); pregabalin use within 60 days prior to
- •9. Concurrent or previous participation in another clinical trial within 30 days prior to
- •10. A previous history of intolerance or hypersensitivity to gabapentin or drugs with
- •similar chemical structures;
- •11. Anticipated need for surgery during the course of the study;
- •12. Malignancy within the past year, with the exception of basal cell carcinoma, which
- •is not exclusionary;
- •13. Clinically significant or unstable medical condition that, in the opinion of the
- •investigator, would compromise participation in the study;
- •14. Mental or psychological condition rendering the subject unable to understand the
- •requirements of participation in the study and risks/benefits thereof, and/or evidence
- •of an uncooperative attitude in the judgment of the investigator;
- •15. Significant psychiatric disorder, recurrent episodes of severe depression (any pharmacologic treatment or hospitalization for the illness within 1 year prior to Screening), or subjects with serious suicidal risk per criteria. A risk assessment should be done by a qualified mental health professional (MHP) to assess whether it is safe for the subject to participate in the trial if at least one of the following three conditions are met: Subject’s responses on the Sheehan-Suicidality Tracking Scale (Sheehan-STS, Lifetime Assessment version) Appendix 13 items 1a, 1b, 3 and 4, 5, 6, or 8 is positive (score = 1); or, Subject’s total Patient Health Questionnaire-8 (PHQ-8) Appendix 11 score = 15; or, Presence of any current major psychiatric disorder that is not explicitly permitted in the inclusion/exclusion criteria.The Sheehan-STS and PHQ-8 criteria are described in the Section 7 of the protocol. Subjects with mild, chronic depression without recent hospitalization who are being maintained on a stable dose of a single antidepressant are acceptable;
- •16. Pending civil litigation or disability claims pertinent to the subjects spinal cord
- •injury, current involvement in out-of-court settlements for claims pertinent to the
- •subjects spinal cord injury, or other legal complications related to the spinal cord
- •injury that could confound assessments;
- •17. Likelihood
研究者
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