An Open-Label Long-Term Study Of Pregabalin For The Treatment Of Central Neuropathic Pain (Post Spinal Cord Injury Pain, Post Stroke Pain, And Multiple Sclerosis Pain)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 26
- 主要终点
- Number of Participants With Peripheral Edema
研究概览
简要总结
The purpose of this study is to assess the safety of the long-term use of pregabalin at doses up to 600 mg/day in patients with central neuropathic pain (post spinal cord injury pain, post stroke pain, and multiple sclerosis pain).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Inclusion criteria for subjects to be shifted from Study A0081107
- •Subjects who completed the 18-week study period in Study A0081107 conducted for chronic neuropathic pain after spinal cord injury;
- •Subjects who completed assessments of all efficacy endpoints until the end of the treatment phase of the preceding Study A0081107 (V7);
- •Inclusion criteria for subjects to be new participants in this study
- •Subjects with central neuropathic pain after stroke or multiple sclerosis;
- •At least 6 months have passed after the onset of central neuropathic pain;
- •Pain VAS at least 40mm in Visit 1 and Visit 2;
排除标准
- •Creatinine clearance < 60 mL/min;
- •Platelet count < 100 × 103/mm3 ; White blood cell (WBC) count < 2500 / mm3; Neutrophil count < 1500/ mm3;
- •Subjects who are expected to require surgery during the trial;
研究组 & 干预措施
Pregabalin
Flexible dosing in 4 weeks followed by 48 weeks maintenance and one week taper period
干预措施: pregabalin (Drug)
结局指标
主要结局
Number of Participants With Peripheral Edema
时间窗: Baseline, Weeks 4, 20, 36, 52, and 53
Number of participants who had peripheral edema in lower extremities. Edema was categorized as follows: trace, pitting 1 (lower leg), 2 (lower leg to knee), and 3 (above knee and /or presacral edema).
Number of Participants With Pitting Edema Related to Deep Vein Thrombosis (DVT)
时间窗: Baseline, Weeks 4, 20, 36, 52, and 53
DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe.
Number of Participants With Visual Field Deteriorated
时间窗: 53 weeks
Number of participants who had normal visual field at baseline and showed abnormal result after the study treatment, assessed by confrontational visual field test (neurological examination).
Number of Participants With Facial/Periorbital Edema
时间窗: Baseline, Weeks 4, 20, 36, 52, and 53
Number of participants who had facial or periorbital edema.
Number of Participants With Localized Tenderness Related to Deep Vein Thrombosis (DVT)
时间窗: Baseline, Weeks 4, 20, 36, 52, and 53
DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe.
Number of Participants With Generalized or Abdominal Edema
时间窗: Baseline, Weeks 4, 20, 36, 52, and 53
Number of participants who had generalized or abdominal edema.
Number of Participants With Localized Pain Related to Deep Vein Thrombosis (DVT)
时间窗: Baseline, Weeks 4, 20, 36, 52, and 53
DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe.
Number of Participants With Swelling Related to Deep Vein Thrombosis (DVT)
时间窗: Baseline, Weeks 4, 20, 36, 52, and 53
DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe.
Number of Participants With Collateral Superficial Veins (Non-varicose) Related to Deep Vein Thrombosis (DVT)
时间窗: Baseline, Weeks 4, 20, 36, 52, and 53
DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe.
Number of Participants With Skin Redness Related to Deep Vein Thrombosis (DVT)
时间窗: Baseline, Weeks 4, 20, 36, 52, and 53
DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe.
Number of Participants With Deterioration in Neurological Examination Findings
时间窗: 53 weeks
Worsening of the condition relative to baseline was reported as deteriorated. Assessment categories are as follows: normal or abnormal for Cranial Nerve Function, Mental State, and Coordination; normal, mild, moderate, or severe ataxia for Gait; none/absent, normal, or hyper-reflexic for Deep Tendon Reflexes; absent or present for Abnormal Reflexes; normal, mild, moderate, or severe weakness for Muscle Strength; slight, more marked, or considerable increase, or affected parts rigid in flexion or extension for Muscle Tone; absent or present for Sensory Function.
Number of Participants With Suicidal Ideation According to Sheehan Suicidality Tracking Scale (Sheehan-STS)
时间窗: Baseline, Weeks 2, 4, 8, 12, 20, 28, 36, 44, and 52
The Sheehan-STS is an 8-item prospective rating scale that tracks treatment-emergent suicidal ideation and behaviors. Participants who reported a score of ≥1 (5-point scale ranging from 0: not at all to 4: extremely) for Item 2, 3, 4 or 5 of the Sheehan-STS prognostic scale is considered to have suicidal ideation as the scores are mapped to Category 4 (suicide ideation) of the Columbia Classification Algorithm of Suicide Assessment.
次要结局
- Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Affective Scores(Baseline, Weeks 2, 4, 8, 12, 20, 28, 36, 44, and 52)
- Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Total Scores(Baseline, Weeks 2, 4, 8, 12, 20, 28, 36, 44, and 52)
- Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Sensory Scores(Baseline, Weeks 2, 4, 8, 12, 20, 28, 36, 44, and 52)
- Change From Baseline in the Modified Brief Pain Inventory (10 Item) (mBPI-10)Total Scores at Last Evaluation Score(Baseline, Week 52)