Post-Herpetic Neuralgia
Conditions
Keywords
Post-Herpetic Neuralgia, Developmental Phase III
Brief summary
Investigate the efficacy and safety of DS-5565 in subjects with Post-Herpetic Neuralgia (PHN) in comparison to placebo
Detailed description
\[Double Blind Phase\] The primary objective is to compare change in the Average Daily Pain Score (ADPS) from baseline to Week 14 in Asian subjects with PHN receiving DS-5565 versus placebo. \[Open Extension Phase\] The objective is to assess the long-term safety and efficacy of DS-5565 in subjects with PHN.
Interventions
DRUGPlacebo
Placebo
DRUGDS-5565
Sponsors
SRL Medisearch Inc.
Quintiles, Inc.
Daiichi Sankyo Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* PHN defined as pain present for more than 3 months after herpes zoster skin rash at screening * At screening, a pain scale of ≥ 40 mm
Exclusion criteria
* Previous use of neurolytic block
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Oral Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Baseline to Week 14 | Each participant recorded a pain score in the electronic patient diary once daily from the day after the screening visit (Visit 1) to the end of treatment/early termination visit (Visit 10). Prior to taking the study drug each morning, the participant selected the number that best described his or her pain over the past 24 hours on a scale of 0 (no pain) to 10 (worst possible pain). Higher ADPS scores indicated worse outcome. ADPS was the weekly average pain score based on the pain scores from the electronic patient diaries (Pain diary). In this outcome, the change from baseline in ADPS is being reported with negative values representing improvements in average daily pain. The larger the negative value (ie. improvement), the greater the improvement in average daily pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Visual Analog Scale (VAS) Pain From Baseline (Week 14) to Week 66 Following Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | From baseline (Week 14) to Week 66 | Visual Analog Scale (VAS) pain is a 10-point assessment tool to measure pain levels, where 0 is defined as 'no pain' and 10 is defined as 'worst possible pain'. Higher VAS pain scores indicate worse outcome. In this outcome, the change from baseline in VAS pain is being reported with negative values representing improvements in pain intensity. The larger the negative value (ie. improvement), the greater the improvement in pain intensity. |
Countries
Japan
Participant flow
Recruitment details
A total of 765 participants who met all inclusion and no exclusion criteria were enrolled in the study; 763 participants received treatment in the double-blind phase. A total of 239 participants received treatment in the open-label extension phase.
Pre-assignment details
This study included a double-blind phase where participants received DS-5565 (15 mg, 20 mg, or 30 mg) or placebo and an open-label extension phase where participants received DS-5565 (starting dose 5 mg).
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants who received placebo for 14 weeks. | 304 |
| DS-5565 15 mg Participants who received oral administration of DS-5565 15 mg with a 2 week titration and 12 weeks fixed dose treatment period. | 153 |
| DS-5565 20 mg Participants who received oral administration of DS-5565 20 mg with a 1 week titration and 13 weeks fixed dose treatment period. | 153 |
| DS-5565 30 mg Participants who received oral administration of DS-5565 30 mg with a 2 week titration and 12 weeks fixed dose treatment period. | 155 |
| Total | 765 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Double-blind Phase | Adverse Event | 7 | 6 | 12 | 4 | 0 |
| Double-blind Phase | Lack of Efficacy | 5 | 0 | 1 | 1 | 0 |
| Double-blind Phase | Other | 1 | 2 | 0 | 0 | 0 |
| Double-blind Phase | Protocol Violation | 0 | 1 | 3 | 0 | 0 |
| Double-blind Phase | Withdrawal by Subject | 25 | 7 | 9 | 10 | 0 |
| Open-label Extension Phase | Adverse Event | 0 | 0 | 0 | 0 | 15 |
| Open-label Extension Phase | Death | 0 | 0 | 0 | 0 | 1 |
| Open-label Extension Phase | Lack of Efficacy | 0 | 0 | 0 | 0 | 1 |
| Open-label Extension Phase | Other | 0 | 0 | 0 | 0 | 7 |
| Open-label Extension Phase | Withdrawal by Subject | 0 | 0 | 0 | 0 | 31 |
Baseline characteristics
| Characteristic | DS-5565 15 mg | DS-5565 20 mg | DS-5565 30 mg | Placebo | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 106 Participants | 114 Participants | 91 Participants | 202 Participants | 513 Participants |
| Age, Categorical Between 18 and 65 years | 47 Participants | 39 Participants | 64 Participants | 102 Participants | 252 Participants |
| Age, Continuous | 66.6 years STANDARD_DEVIATION 8.97 | 68.9 years STANDARD_DEVIATION 9.19 | 64.5 years STANDARD_DEVIATION 10.74 | 66.2 years STANDARD_DEVIATION 10.13 | 66.5 years STANDARD_DEVIATION 9.94 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 153 Participants | 153 Participants | 155 Participants | 304 Participants | 765 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Japan | 153 participants | 153 participants | 155 participants | 304 participants | 765 participants |
| Sex: Female, Male Female | 56 Participants | 62 Participants | 59 Participants | 127 Participants | 304 Participants |
| Sex: Female, Male Male | 97 Participants | 91 Participants | 96 Participants | 177 Participants | 461 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 303 | 0 / 152 | 0 / 153 | 0 / 155 | 1 / 237 |
| other Total, other adverse events | 45 / 303 | 44 / 152 | 53 / 153 | 72 / 155 | 99 / 237 |
| serious Total, serious adverse events | 0 / 303 | 0 / 152 | 0 / 153 | 0 / 155 | 20 / 237 |
Outcome results
Primary
Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Oral Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia
Each participant recorded a pain score in the electronic patient diary once daily from the day after the screening visit (Visit 1) to the end of treatment/early termination visit (Visit 10). Prior to taking the study drug each morning, the participant selected the number that best described his or her pain over the past 24 hours on a scale of 0 (no pain) to 10 (worst possible pain). Higher ADPS scores indicated worse outcome. ADPS was the weekly average pain score based on the pain scores from the electronic patient diaries (Pain diary). In this outcome, the change from baseline in ADPS is being reported with negative values representing improvements in average daily pain. The larger the negative value (ie. improvement), the greater the improvement in average daily pain.
Time frame: Baseline to Week 14
Population: Average daily pain score (ADPS) was assessed in the modified Intent-to-Treat Analysis Set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Oral Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Week 12 | -1.21 units on a scale | Standard Deviation 1.614 |
| Placebo | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Oral Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Week 10 | -1.15 units on a scale | Standard Deviation 1.547 |
| Placebo | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Oral Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Week 9 | -1.09 units on a scale | Standard Deviation 1.478 |
| Placebo | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Oral Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Week 8 | -1.03 units on a scale | Standard Deviation 1.466 |
| Placebo | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Oral Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Week 11 | -1.22 units on a scale | Standard Deviation 1.601 |
| Placebo | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Oral Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Week 7 | -0.96 units on a scale | Standard Deviation 1.399 |
| Placebo | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Oral Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Week 5 | -0.74 units on a scale | Standard Deviation 1.215 |
| Placebo | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Oral Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Week 4 | -0.64 units on a scale | Standard Deviation 1.163 |
| Placebo | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Oral Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Week 3 | -0.48 units on a scale | Standard Deviation 1.03 |
| Placebo | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Oral Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Week 2 | -0.33 units on a scale | Standard Deviation 0.902 |
| Placebo | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Oral Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Week 6 | -0.81 units on a scale | Standard Deviation 1.329 |
| Placebo | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Oral Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Week 14 | -1.31 units on a scale | Standard Deviation 1.71 |
| Placebo | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Oral Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Week 1 | -0.10 units on a scale | Standard Deviation 0.743 |
| Placebo | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Oral Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Week 13 | -1.25 units on a scale | Standard Deviation 1.665 |
| DS-5565 15 mg/Day | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Oral Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Week 7 | -1.32 units on a scale | Standard Deviation 1.409 |
| DS-5565 15 mg/Day | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Oral Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Week 4 | -1.08 units on a scale | Standard Deviation 1.283 |
| DS-5565 15 mg/Day | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Oral Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Week 5 | -1.17 units on a scale | Standard Deviation 1.351 |
| DS-5565 15 mg/Day | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Oral Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Week 6 | -1.29 units on a scale | Standard Deviation 1.412 |
| DS-5565 15 mg/Day | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Oral Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Week 8 | -1.39 units on a scale | Standard Deviation 1.509 |
| DS-5565 15 mg/Day | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Oral Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Week 9 | -1.44 units on a scale | Standard Deviation 1.574 |
| DS-5565 15 mg/Day | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Oral Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Week 10 | -1.49 units on a scale | Standard Deviation 1.632 |
| DS-5565 15 mg/Day | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Oral Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Week 12 | -1.59 units on a scale | Standard Deviation 1.727 |
| DS-5565 15 mg/Day | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Oral Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Week 13 | -1.63 units on a scale | Standard Deviation 1.769 |
| DS-5565 15 mg/Day | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Oral Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Week 14 | -1.67 units on a scale | Standard Deviation 1.717 |
| DS-5565 15 mg/Day | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Oral Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Week 1 | -0.39 units on a scale | Standard Deviation 0.787 |
| DS-5565 15 mg/Day | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Oral Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Week 2 | -0.72 units on a scale | Standard Deviation 1.036 |
| DS-5565 15 mg/Day | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Oral Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Week 3 | -0.96 units on a scale | Standard Deviation 1.195 |
| DS-5565 15 mg/Day | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Oral Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Week 11 | -1.53 units on a scale | Standard Deviation 1.647 |
| DS-5565 20 mg/Day | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Oral Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Week 14 | -1.73 units on a scale | Standard Deviation 1.715 |
| DS-5565 20 mg/Day | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Oral Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Week 11 | -1.60 units on a scale | Standard Deviation 1.576 |
| DS-5565 20 mg/Day | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Oral Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Week 2 | -1.06 units on a scale | Standard Deviation 0.998 |
| DS-5565 20 mg/Day | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Oral Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Week 5 | -1.36 units on a scale | Standard Deviation 1.233 |
| DS-5565 20 mg/Day | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Oral Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Week 12 | -1.63 units on a scale | Standard Deviation 1.624 |
| DS-5565 20 mg/Day | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Oral Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Week 8 | -1.40 units on a scale | Standard Deviation 1.455 |
| DS-5565 20 mg/Day | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Oral Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Week 9 | -1.42 units on a scale | Standard Deviation 1.48 |
| DS-5565 20 mg/Day | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Oral Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Week 6 | -1.44 units on a scale | Standard Deviation 1.337 |
| DS-5565 20 mg/Day | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Oral Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Week 3 | -1.16 units on a scale | Standard Deviation 1.122 |
| DS-5565 20 mg/Day | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Oral Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Week 7 | -1.45 units on a scale | Standard Deviation 1.382 |
| DS-5565 20 mg/Day | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Oral Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Week 13 | -1.68 units on a scale | Standard Deviation 1.643 |
| DS-5565 20 mg/Day | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Oral Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Week 10 | -1.51 units on a scale | Standard Deviation 1.564 |
| DS-5565 20 mg/Day | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Oral Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Week 4 | -1.24 units on a scale | Standard Deviation 1.192 |
| DS-5565 20 mg/Day | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Oral Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Week 1 | -0.54 units on a scale | Standard Deviation 0.783 |
| DS-5565 30 mg/Day | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Oral Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Week 11 | -1.84 units on a scale | Standard Deviation 1.473 |
| DS-5565 30 mg/Day | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Oral Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Week 4 | -1.33 units on a scale | Standard Deviation 1.236 |
| DS-5565 30 mg/Day | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Oral Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Week 12 | -1.89 units on a scale | Standard Deviation 1.519 |
| DS-5565 30 mg/Day | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Oral Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Week 6 | -1.55 units on a scale | Standard Deviation 1.277 |
| DS-5565 30 mg/Day | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Oral Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Week 9 | -1.72 units on a scale | Standard Deviation 1.431 |
| DS-5565 30 mg/Day | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Oral Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Week 14 | -1.96 units on a scale | Standard Deviation 1.501 |
| DS-5565 30 mg/Day | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Oral Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Week 2 | -0.95 units on a scale | Standard Deviation 1.003 |
| DS-5565 30 mg/Day | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Oral Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Week 1 | -0.46 units on a scale | Standard Deviation 0.693 |
| DS-5565 30 mg/Day | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Oral Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Week 5 | -1.49 units on a scale | Standard Deviation 1.275 |
| DS-5565 30 mg/Day | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Oral Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Week 13 | -1.95 units on a scale | Standard Deviation 1.486 |
| DS-5565 30 mg/Day | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Oral Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Week 8 | -1.62 units on a scale | Standard Deviation 1.375 |
| DS-5565 30 mg/Day | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Oral Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Week 7 | -1.67 units on a scale | Standard Deviation 1.346 |
| DS-5565 30 mg/Day | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Oral Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Week 3 | -1.20 units on a scale | Standard Deviation 1.188 |
| DS-5565 30 mg/Day | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Oral Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Week 10 | -1.81 units on a scale | Standard Deviation 1.486 |
Comparison: Placebo vs DS-5565 15 mg/day at Week 14p-value: 0.01795% CI: [-0.74, -0.07]Mixed Models Analysis
Comparison: Placebo vs DS-5565 20 mg/day at Week 14p-value: 0.005895% CI: [-0.81, -0.14]Mixed Models Analysis
Comparison: Placebo vs DS-5565 30 mg/day at Week 14p-value: <0.000195% CI: [-1.1, -0.44]Mixed Models Analysis
Secondary
Change in Visual Analog Scale (VAS) Pain From Baseline (Week 14) to Week 66 Following Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia
Visual Analog Scale (VAS) pain is a 10-point assessment tool to measure pain levels, where 0 is defined as 'no pain' and 10 is defined as 'worst possible pain'. Higher VAS pain scores indicate worse outcome. In this outcome, the change from baseline in VAS pain is being reported with negative values representing improvements in pain intensity. The larger the negative value (ie. improvement), the greater the improvement in pain intensity.
Time frame: From baseline (Week 14) to Week 66
Population: Visual analog scale (VAS) was assessed in the modified Intent-to-Treat Analysis Set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change in Visual Analog Scale (VAS) Pain From Baseline (Week 14) to Week 66 Following Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Week 16 | -0.70 units on a scale | Standard Deviation 9.53 |
| Placebo | Change in Visual Analog Scale (VAS) Pain From Baseline (Week 14) to Week 66 Following Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Week 18 | 4.60 units on a scale | Standard Deviation 9.85 |
| Placebo | Change in Visual Analog Scale (VAS) Pain From Baseline (Week 14) to Week 66 Following Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Week 42 | -11.20 units on a scale | Standard Deviation 13.93 |
| Placebo | Change in Visual Analog Scale (VAS) Pain From Baseline (Week 14) to Week 66 Following Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Week 46 | -12.00 units on a scale | Standard Deviation 13.89 |
| Placebo | Change in Visual Analog Scale (VAS) Pain From Baseline (Week 14) to Week 66 Following Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Week 50 | -12.60 units on a scale | Standard Deviation 14.53 |
| Placebo | Change in Visual Analog Scale (VAS) Pain From Baseline (Week 14) to Week 66 Following Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Week 22 | -8.30 units on a scale | Standard Deviation 12.07 |
| Placebo | Change in Visual Analog Scale (VAS) Pain From Baseline (Week 14) to Week 66 Following Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Week 26 | -8.60 units on a scale | Standard Deviation 12.03 |
| Placebo | Change in Visual Analog Scale (VAS) Pain From Baseline (Week 14) to Week 66 Following Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Week 30 | -8.70 units on a scale | Standard Deviation 13.67 |
| Placebo | Change in Visual Analog Scale (VAS) Pain From Baseline (Week 14) to Week 66 Following Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Week 34 | -10.00 units on a scale | Standard Deviation 14.26 |
| Placebo | Change in Visual Analog Scale (VAS) Pain From Baseline (Week 14) to Week 66 Following Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Week 38 | -10.40 units on a scale | Standard Deviation 14.45 |
| Placebo | Change in Visual Analog Scale (VAS) Pain From Baseline (Week 14) to Week 66 Following Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Week 54 | -12.50 units on a scale | Standard Deviation 14.76 |
| Placebo | Change in Visual Analog Scale (VAS) Pain From Baseline (Week 14) to Week 66 Following Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Week 58 | -12.90 units on a scale | Standard Deviation 15.25 |
| Placebo | Change in Visual Analog Scale (VAS) Pain From Baseline (Week 14) to Week 66 Following Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Week 62 | -14.00 units on a scale | Standard Deviation 16.79 |
| Placebo | Change in Visual Analog Scale (VAS) Pain From Baseline (Week 14) to Week 66 Following Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Week 66 | -14.70 units on a scale | Standard Deviation 15.27 |