A Multicenter, Open-label Trial to Assess the Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Diabetic Neuropathy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 371
- 主要终点
- Percentage of Subjects With Adverse Events (AE) Reported Spontaneously by the Subject or Observed by the Investigator
研究概览
简要总结
The purpose of this study is to determine if lacosamide (SPM 927) is safe if taken for a longer period of time and whether it continues to work well to treat pain.
Subjects will receive lacosamide at a dose that will be individually determined to be the one that provides most pain relief with the least side effects. The maximum dose will be 600mg/day. Subjects may participate in this trial until October 2007. This time may be extended to allow them to participate until lacosamide is commercially available.
If a subject meet the requirements for the study at Visit 1 and after a two weeks phase without trial medication, s/he enters a Titration Phase to determine the personal optimal dose of lacosamide. When this dose is reached s/he will enter the Maintenance Phase and will be asked to return for visits every 4 weeks for the first 24 weeks and every 12 weeks thereafter.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria:
- •Painful diabetic neuropathy
排除标准
- •no clinically relevant liver enzyme abnormalities and impaired renal function, no cardiac abnormalities, no pregnant or nursing females
- •Exclusion Criteria:
研究组 & 干预措施
Lacosamide (LCM)
Open label active treatment
干预措施: Lacosamide (Drug)
结局指标
主要结局
Percentage of Subjects With Adverse Events (AE) Reported Spontaneously by the Subject or Observed by the Investigator
时间窗: From Screening until Safety Follow up Visit (up to 140 weeks)
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
Percentage of Subjects With Marked Abnormalities in Hematology Parameters After Start of Treatment During the Maintenance Period
时间窗: During the maintenance period (up to 136 weeks)
Changes in hematology parameters is reported as incidence of marked abnormalities in - Hematocrit (\<=.85x Lower Limit Normal \[LLN\] or \>= 1.15x Upper Limit Normal \[ULN\] - Hemoglobin (\<=.85x LLN or \>=1.15x ULN) - White Blood Cell (WBC) Count (\<=3.0 or \>=16.0 G/l) - Basophils (\>=5.0%) - Eosinophils (\>=10%) - Monocytes (\>=20%) - Platelet Count (\<=100 or \>=600 G/l)
Number of Subjects With Urine White Blood Cell Count 'Negative' at Baseline, Categorized by Urine White Blood Cell Count at Last Visit
时间窗: Baseline, Last Visit (up to 140 weeks)
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace, positive +, positive ++, positive +++, not done (data not available). Positive categories (+,++,+++) indicate worsening from Baseline.
Number of Subjects With Urine White Blood Cell Count 'Trace' at Baseline, Categorized by Urine White Blood Cell Count at Last Visit
时间窗: Baseline, Last Visit (up to 140 weeks)
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace, positive +, positive ++, positive +++, not done (data not available). Positive categories (+,++,+++) indicate worsening from Baseline.
Percentage of Subjects With Marked Abnormalities Clinical Chemistry Parameters After Start of Treatment During the Titration Period
时间窗: During the titration period (up to Week 8)
Changes in clinical chemistry parameters is reported as incidence of marked abnormalities in - Alanine aminotransferase (\[ALT\] 3x ULN) - Alanine aminotransferase (\[ALT\] 5x ULN) - Alanine aminotransferase \[(ALT\] 10x ULN) - Aspartate aminotransferase (\[AST\] 3x ULN) - Aspartate aminotransferase (\[AST\] 5x ULN) - Aspartate aminotransferase (\[AST\] 10x ULN) - Alkaline Phosphatase (3x ULN) - Gamma-glutamyltransferase (\[GGT\] 3x ULN) - Total Bilirubin (2x ULN) - Albumin (\<26 g/l) - Blood Urea Nitrogen (\>=14.28 mmol/l) - Creatinine (\>=2.0 mg/dl) - Calcium (\<=7.6 or \>=11.0 mg/dl) - Chloride (\<=90 or \>=112 mmol/l) - Phosphorus (\<=2.0 or \>=6.0 mg/dl) - Potassium (\<=3.0 or \>=6.0 mmol/l) - Sodium (\<127 or \>151 mmol/l) - Glucose (\<50 or \>=200 mg/dl) - Total Cholesterol (\>6.5 mmol/l) - Uric Acid (\>565.06 umol/l)
Number of Subjects With Urine pH= 7.0 at Baseline, Categorized by Urine pH at Last Visit
时间窗: Baseline, Last Visit (up to 140 weeks)
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: pH= 5.0, pH= 6.0, pH= 6.5, pH= 7.0, pH= 7.5, pH= 8.0, pH= 8.5, not done (data not available). Baseline value taken at Visit 2 or at screening for parameters not collected at Visit 2. Last visit is the last post-baseline visit observed under exposure of trial medication, including unscheduled visits.
Number of Subjects With Urine Nitrite Status 'Positive' at Baseline, Categorized by Urine Nitrite Status at Last Visit
时间窗: Baseline, Last Visit (up to 140 weeks)
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, positive, not done (data not available). Positive category indicate worsening from Baseline.
Number of Subjects With Urine pH= 7.5 at Baseline, Categorized by Urine pH at Last Visit
时间窗: Baseline, Last Visit (up to 140 weeks)
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: pH= 5.0, pH= 6.0, pH= 6.5, pH= 7.0, pH= 7.5, pH= 8.0, pH= 8.5, not done (data not available). Baseline value taken at Visit 2 or at screening for parameters not collected at Visit 2. Last visit is the last post-baseline visit observed under exposure of trial medication, including unscheduled visits.
Number of Subjects With Urine pH= 8.0 at Baseline, Categorized by Urine pH at Last Visit
时间窗: Baseline, Last Visit (up to 140 weeks)
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: pH= 5.0, pH= 6.0, pH= 6.5, pH= 7.0, pH= 7.5, pH= 8.0, pH= 8.5, not done (data not available). Baseline value taken at Visit 2 or at screening for parameters not collected at Visit 2. Last visit is the last post-baseline visit observed under exposure of trial medication, including unscheduled visits.
Number of Subjects With Urine pH= 6.0 at Baseline, Categorized by Urine pH at Last Visit
时间窗: Baseline, Last Visit (up to 140 weeks)
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: pH= 5.0, pH= 6.0, pH= 6.5, pH= 7.0, pH= 7.5, pH= 8.0, pH= 8.5, not done (data not available). Baseline value taken at Visit 2 or at screening for parameters not collected at Visit 2. Last visit is the last post-baseline visit observed under exposure of trial medication, including unscheduled visits.
Number of Subjects With Urine White Blood Cell Count 'Positive ++' at Baseline, Categorized by Urine White Blood Cell Count at Last Visit
时间窗: Baseline, Last Visit (up to 140 weeks)
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace, positive +, positive ++, positive +++, not done (data not available). Positive categories (+,++,+++) indicate worsening from Baseline.
Percentage of Subjects With Marked Abnormalities in Hematology Parameters After Start of Treatment During the Titration Period
时间窗: During the titration period (up to Week 8)
Changes in hematology parameters is reported as incidence of marked abnormalities in - Hematocrit (\<=.85x Lower Limit Normal \[LLN\] or \>= 1.15x Upper Limit Normal \[ULN\] - Hemoglobin (\<=.85x LLN or \>=1.15x ULN) - White Blood Cell (WBC) Count (\<=3.0 or \>=16.0 G/l) - Basophils (\>=5.0%) - Eosinophils (\>=10%) - Monocytes (\>=20%) - Platelet Count (\<=100 or \>=600 G/l)
Number of Subjects With Urine Protein Status 'Negative' at Baseline, Categorized by Urine Protein Status at Last Visit
时间窗: Baseline, Last Visit (up to 140 weeks)
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace, positive +, positive ++, positive +++, not done (data not available). Positive categories (+,++,+++) indicate worsening from Baseline.
Number of Subjects With Urine Urobilinogen Value 66 µmol/l at Baseline, Categorized by Urine Urobilinogen Value at Last Visit
时间窗: Baseline, Last Visit (up to 140 weeks)
Categories are as following: 3 µmol/l, 16 µmol/l, 33 µmol/l, 66 µmol/l, not done (data not available).
Percentage of Subjects With Marked Abnormalities Clinical Chemistry Parameters After Start of Treatment During the Maintenance Period
时间窗: During the maintenance period (up to 136 weeks)
Changes in clinical chemistry parameters is reported as incidence of marked abnormalities in - Alanine aminotransferase (\[ALT\] 3x ULN) - Alanine aminotransferase (\[ALT\] 5x ULN) - Alanine aminotransferase \[(ALT\] 10x ULN) - Aspartate aminotransferase (\[AST\] 3x ULN) - Aspartate aminotransferase (\[AST\] 5x ULN) - Aspartate aminotransferase (\[AST\] 10x ULN) - Alkaline Phosphatase (3x ULN) - Gamma-glutamyltransferase (\[GGT\] 3x ULN) - Total Bilirubin (2x ULN) - Albumin (\<26 g/l) - Blood Urea Nitrogen (\>=14.28 mmol/l) - Creatinine (\>=2.0 mg/dl) - Calcium (\<=7.6 or \>=11.0 mg/dl) - Chloride (\<=90 or \>=112 mmol/l) - Phosphorus (\<=2.0 or \>=6.0 mg/dl) - Potassium (\<=3.0 or \>=6.0 mmol/l) - Sodium (\<127 or \>151 mmol/l) - Glucose (\<50 or \>=200 mg/dl) - Total Cholesterol (\>6.5 mmol/l) - Uric Acid (\>565.06 umol/l)
Number of Subjects With Urine pH= 5.0 at Baseline, Categorized by Urine pH at Last Visit
时间窗: Baseline, Last Visit (up to 140 weeks)
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: pH= 5.0, pH= 6.0, pH= 6.5, pH= 7.0, pH= 7.5, pH= 8.0, pH= 8.5, not done (data not available). Baseline value taken at Visit 2 or at screening for parameters not collected at Visit 2. Last visit is the last post-baseline visit observed under exposure of trial medication, including unscheduled visits.
Number of Subjects With Urine pH= 6.5 at Baseline, Categorized by Urine pH at Last Visit
时间窗: Baseline, Last Visit (up to 140 weeks)
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: pH= 5.0, pH= 6.0, pH= 6.5, pH= 7.0, pH= 7.5, pH= 8.0, pH= 8.5, not done (data not available). Baseline value taken at Visit 2 or at screening for parameters not collected at Visit 2. Last visit is the last post-baseline visit observed under exposure of trial medication, including unscheduled visits.
Number of Subjects With Urine Nitrite Status 'Negative' at Baseline, Categorized by Urine Nitrite Status at Last Visit
时间窗: Baseline, Last Visit (up to 140 weeks)
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, positive, not done (data not available). Positive category indicate worsening from Baseline.
Number of Subjects With Urine Urobilinogen Value 3 µmol/l at Baseline, Categorized by Urine Urobilinogen Value at Last Visit
时间窗: Baseline, Last Visit (up to 140 weeks)
Categories are as following: 3 µmol/l, 16 µmol/l, 33 µmol/l, 66 µmol/l, not done (data not available).
Number of Subjects With Urine Urobilinogen Value 16 µmol/l at Baseline, Categorized by Urine Urobilinogen Value at Last Visit
时间窗: Baseline, Last Visit (up to 140 weeks)
Categories are as following: 3 µmol/l, 16 µmol/l, 33 µmol/l, 66 µmol/l, not done (data not available).
Number of Subjects With Urine Blood Status 'Negative' at Baseline, Categorized by Urine Blood Status at Last Visit
时间窗: Baseline, Last Visit (up to 140 weeks)
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace (N), trace (H), positive +, positive ++, positive +++, not done (data not available). Positive category (+, ++, +++) indicate worsening from Baseline.
Number of Subjects With Urine Blood Status 'Trace (N)' at Baseline, Categorized by Urine Blood Status at Last Visit
时间窗: Baseline, Last Visit (up to 140 weeks)
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace (N), trace (H), positive +, positive ++, positive +++, not done (data not available). Positive category (+, ++, +++) indicate worsening from Baseline.
Number of Subjects With Urine Blood Status 'Trace (H)' at Baseline, Categorized by Urine Blood Status at Last Visit
时间窗: Baseline, Last Visit (up to 140 weeks)
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace (N), trace (H), positive +, positive ++, positive +++, not done (data not available). Positive category (+, ++, +++) indicate worsening from Baseline.
Number of Subjects With Urine Glucose Value 'Negative' at Baseline, Categorized by Urine Glucose Value at Last Visit
时间窗: Baseline, Last Visit (up to 140 weeks)
Categories are as following: negative, 5.5 mmol/l, 14 mmol/l, 28 mmol/l, 55 mmol/l, \>= 111 mmol/l, not done (data not available).
Number of Subjects With Urine Glucose Value 5.5 mmol/l at Baseline, Categorized by Urine Glucose Value at Last Visit
时间窗: Baseline, Last Visit (up to 140 weeks)
Categories are as following: negative, 5.5 mmol/l, 14 mmol/l, 28 mmol/l, 55 mmol/l, \>= 111 mmol/l, not done (data not available).
Number of Subjects With Urine White Blood Cell Count 'Positive +' at Baseline, Categorized by Urine White Blood Cell Count at Last Visit
时间窗: Baseline, Last Visit (up to 140 weeks)
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace, positive +, positive ++, positive +++, not done (data not available). Positive categories (+,++,+++) indicate worsening from Baseline.
Number of Subjects With Urine Protein Status 'Trace' at Baseline, Categorized by Urine Protein Status at Last Visit
时间窗: Baseline, Last Visit (up to 140 weeks)
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace, positive +, positive ++, positive +++, not done (data not available). Positive category (+, ++, +++) indicate worsening from Baseline.
Number of Subjects With Urine Protein Status 'Positive +' at Baseline, Categorized by Urine Protein Status at Last Visit
时间窗: Baseline, Last Visit (up to 140 weeks)
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace, positive +, positive ++, positive +++, not done (data not available). Positive category (+, ++, +++) indicate worsening from Baseline.
Number of Subjects With Urine Protein Status 'Positive ++' at Baseline, Categorized by Urine Protein Status at Last Visit
时间窗: Baseline, Last Visit (up to 140 weeks)
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace, positive +, positive ++, positive +++, not done (data not available). Positive category (+, ++, +++) indicate worsening from Baseline.
Number of Subjects With Urine Blood Status 'Positive +' at Baseline, Categorized by Urine Blood Status at Last Visit
时间窗: Baseline, Last Visit (up to 140 weeks)
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace (N), trace (H), positive +, positive ++, positive +++, not done (data not available). Positive category (+, ++, +++) indicate worsening from Baseline.
Number of Subjects With Urine Blood Status 'Positive ++' at Baseline, Categorized by Urine Blood Status at Last Visit
时间窗: Baseline, Last Visit (up to 140 weeks)
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace (N), trace (H), positive +, positive ++, positive +++, not done (data not available). Positive category (+, ++, +++) indicate worsening from Baseline.
Number of Subjects With Urine Ketone Status 'Negative' at Baseline, Categorized by Urine Ketone Status at Last Visit
时间窗: Baseline, Last Visit (up to 140 weeks)
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace (N), trace, small, moderate, not done (data not available).
Number of Subjects With Urine Ketone Status 'Trace' at Baseline, Categorized by Urine Ketone Status at Last Visit
时间窗: Baseline, Last Visit (up to 140 weeks)
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace (N), trace, small, moderate, not done (data not available).
Number of Subjects With Urine Ketone Status 'Moderate' at Baseline, Categorized by Urine Ketone Status at Last Visit
时间窗: Baseline, Last Visit (up to 140 weeks)
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace (N), trace, small, moderate, not done (data not available).
Percentage of Subjects With Marked Abnormalities in Neurological Examination Findings After Start of Treatment
时间窗: Last Visit (up to 140 weeks)
Changes in neurological examination findings is reported as percentage of subjects with marked abnormalities in following categories: - General - Cranial Nerves - Reflexes - Muscle Strength and Tone - Coordination and Cerebellar Function - Motor System - Sensation: Upper Extremities - Sensation: Lower Extremities The percentages are based on the number of subjects with examinations done at last visit for each category or parameter.
Number of Subjects With Urine Protein Status 'Positive +++' at Baseline, Categorized by Urine Protein Status at Last Visit
时间窗: Last Visit (up to 140 weeks)
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace, positive +, positive ++, positive +++, not done (data not available). Positive category (+, ++, +++) indicate worsening from Baseline.
Number of Subjects With Urine Ketone Status 'Small' at Baseline, Categorized by Urine Ketone Status at Last Visit
时间窗: Baseline, Last Visit (up to 140 weeks)
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace (N), trace, small, moderate, not done (data not available).
Number of Subjects With Urine Bilirubin Status 'Negative' at Baseline, Categorized by Urine Bilirubin Status at Last Visit
时间窗: Baseline, Last Visit (up to 140 weeks)
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, positive +, positive ++, not done (data not available). Positive category (+, ++) indicate worsening from Baseline.
Number of Subjects With Urine Bilirubin Status 'Positive +' at Baseline, Categorized by Urine Bilirubin Status at Last Visit
时间窗: Baseline, Last Visit (up to 140 weeks)
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, positive +, positive ++, not done (data not available). Positive category (+, ++) indicate worsening from Baseline.
Number of Subjects With Urine Bilirubin Status 'Positive ++' at Baseline, Categorized by Urine Bilirubin Status at Last Visit
时间窗: Baseline, Last Visit (up to 140 weeks)
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, positive +, positive ++, not done (data not available). Positive category (+, ++) indicate worsening from Baseline.
Number of Subjects With Urine Glucose Value 14 mmol/l at Baseline, Categorized by Urine Glucose Value at Last Visit
时间窗: Baseline, Last Visit (up to 140 weeks)
Categories are as following: negative, 5.5 mmol/l, 14 mmol/l, 28 mmol/l, 55 mmol/l, \>= 111 mmol/l, not done (data not available).
Number of Subjects With Urine Glucose Value 28 mmol/l at Baseline, Categorized by Urine Glucose Value at Last Visit
时间窗: Baseline, Last Visit (up to 140 weeks)
Categories are as following: negative, 5.5 mmol/l, 14 mmol/l, 28 mmol/l, 55 mmol/l, \>= 111 mmol/l, not done (data not available).
Number of Subjects With Urine Glucose Value 55 mmol/l at Baseline, Categorized by Urine Glucose Value at Last Visit
时间窗: Baseline, Last Visit (up to 140 weeks)
Categories are as following: negative, 5.5 mmol/l, 14 mmol/l, 28 mmol/l, 55 mmol/l, \>= 111 mmol/l, not done (data not available).
Number of Subjects With Urine Glucose Value >=111 mmol/l at Baseline, Categorized by Urine Glucose Value at Last Visit
时间窗: Baseline, Last Visit (up to 140 weeks)
Categories are as following: negative, 5.5 mmol/l, 14 mmol/l, 28 mmol/l, 55 mmol/l, \>= 111 mmol/l, not done (data not available).
Percentage of Subjects With Marked Abnormalities in Vital Signs After Start of Treatment
时间窗: During study period (up to 140 weeks)
Changes in vital signs examination findings is reported as percentage of subjects with marked abnormalities in - Systolic Blood Pressure (SBP) \>=180 mmHg and increase of \>=20 mmHg - Systolic Blood Pressure \>=90 mmHg and decrease of \>=20 mmHg - Diastolic Blood Pressure (DBP) \>=105 mmHg and increase of \>=15 mmHg - Diastolic Blood Pressure \>=50 mmHg and decrease of \>=15 mmHg - Pulse Rate (PR) \>=120 beats/min and increase of \>=15 beats/min - Pulse Rate \>=50 beats/min and decrease of \>=15 beats/min
Percentage of Subjects With Marked Abnormalities in Physical Examination Findings After Start of Treatment.
时间窗: Last Visit (up to 140 weeks)
Changes in physical examination findings is reported as percentage of subjects with marked abnormalities in following categories: - Ears, Eyes, Nose, Mouth, Throat - Cardiovascular - Peripheral vascular - Pulmonary - Musculoskeletal - Hepato- / Gastrointestinal - Renal / Genitourological - Neurological - Metabolic / Endocrine - Psychiatric - Hematological / Lymphatic Nodes - Dermatological - Other The percentages are based on the number of subjects with examinations done at each visit for each body system.
Percentage of Subjects With Abnormal Electrocardiogram (ECG) Findings
时间窗: Last Visit (up to 140 weeks)
Changes in 12-lead ECGs is reported as percentage of subjects with abnormal ECG findings categorized in 'Abnormal, possibly insignificant' and 'Abnormal, possibly significant' based on the alert criterion by the ECG vendor and not on the investigator's assessment.
Percentage of Subjects Who Withdrew Due to Adverse Events (AEs)
时间窗: During the study period (up to 140 weeks)
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
次要结局
- Change in Average Pain Interference With Sleep From the Baseline Week to the 7 Days Prior to Each Visit(Baseline, Visit 2.1, Visit 2.2, Visit 2.4, Visit 2.5, Visit 3, Visit 4, Visit 5, Visit 6, Visit 7, Visit 8, Visit 9.0, Visit 9.1, Visit 9.2, Visit 9.3, Visit 9.4, Visit 9.5, Visit 9.6, Visit 9.7, Visit 9.8, Visit 9.9)
- Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 6(Visit 6)
- Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.0(Visit 9.0)
- Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.4(Visit 9.4)
- Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.5(Visit 9.5)
- Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.1(Visit 9.1)
- Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.7(Visit 9.7)
- Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.8(Visit 9.8)
- Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 4(Baseline, Visit 4)
- Change in Average Pain Interference With General Activity From the Baseline Week to the 7 Days Prior to Each Visit(Baseline, Visit 2.1, Visit 2.2, Visit 2.4, Visit 2.5, Visit 3, Visit 4, Visit 5, Visit 6, Visit 7, Visit 8, Visit 9.0, Visit 9.1, Visit 9.2, Visit 9.3, Visit 9.4, Visit 9.5, Visit 9.6, Visit 9.7, Visit 9.8, Visit 9.9)
- Change in Current Pain From Visit 2 (Baseline) to Each Subsequent Visit as Measured by a 100 mm Visual Analogue Scale (VAS)(Baseline, Visit 2.1, Visit 2.2, Visit 2.4, Visit 2.5, Visit 3, Visit 4, Visit 5, Visit 6, Visit 7, Visit 8, Visit 9.0, Visit 9.1, Visit 9.2, Visit 9.3, Visit 9.4, Visit 9.5, Visit 9.6, Visit 9.7, Visit 9.8, Visit 9.9)
- Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.3(Visit 9.3)
- Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.0(Baseline, Visit 9.0)
- Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.1(Baseline, Visit 9.1)
- Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.4(Baseline, Visit 9.4)
- Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.5(Baseline, Visit 9.5)
- Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.6(Baseline, Visit 9.6)
- Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 4(Visit 4)
- Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.2(Visit 9.2)
- Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.3(Baseline, Visit 9.3)
- Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.7(Baseline, Visit 9.7)
- Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.8(Baseline, Visit 9.8)
- Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 2 (Baseline)(Visit 2 (Baseline))
- Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.6(Visit 9.6)
- Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 6(Visit 6)
- Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.0(Visit 9.0)
- Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.2(Visit 9.2)
- Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.3(Visit 9.3)
- Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.4(Visit 9.4)
- Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.5(Visit 9.5)
- Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Termination Visit(Termination Visit (last treatment visit))
- Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 6(Baseline, Visit 6)
- Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.2(Baseline, Visit 9.2)
- Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.2(Visit 9.2)
- Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.7(Visit 9.7)
- Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.8(Visit 9.8)
- Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 4(Visit 4)
- Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Termination Visit(Baseline, Termination Visit (last treatment visit))
- Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 4(Visit 4)
- Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.1(Visit 9.1)
- Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.6(Visit 9.6)
- Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Termination Visit(Termination Visit (last treatment visit))
- Change in Quality of Life From Visit 2 (Baseline) to Visit 6(Baseline, Visit 6)
- Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 6(Visit 6)
- Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.0(Visit 9.0)
- Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.3(Visit 9.3)
- Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.4(Visit 9.4)
- Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.5(Visit 9.5)
- Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.6(Visit 9.6)
- Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.7(Visit 9.7)
- Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.8(Visit 9.8)
- Change in Quality of Life From Visit 2 (Baseline) to Visit 9.8(Baseline, Visit 9.8)
- Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Termination Visit(Termination Visit (last treatment visit))
- Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 2 (Baseline)(Visit 2 (Baseline))
- Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.1(Visit 9.1)
- Change in Quality of Life From Visit 2 (Baseline) to Visit 9.4(Baseline, Visit 9.4)
- Change in Quality of Life From Visit 2 (Baseline) to Visit 9.5(Baseline, Visit 9.5)
- Change in Quality of Life From Visit 2 (Baseline) to Visit 9.6(Baseline, Visit 9.6)
- Change in Quality of Life From Visit 2 (Baseline) to Termination Visit(Baseline, Termination Visit (last treatment visit))
- Change in Quality of Life From Visit 2 (Baseline) to Visit 4(Baseline, Visit 4)
- Change in Quality of Life From Visit 2 (Baseline) to Visit 9.3(Baseline, Visit 9.3)
- Change in Quality of Life From Visit 2 (Baseline) to Visit 9.7(Baseline, Visit 9.7)
- Change in Quality of Life From Visit 2 (Baseline) to Visit 9.0(Baseline, Visit 9.0)
- Change in Quality of Life From Visit 2 (Baseline) to Visit 9.1(Baseline, Visit 9.1)
- Change in Quality of Life From Visit 2 (Baseline) to Visit 9.2(Baseline, Visit 9.2)