Diabetic Peripheral Neuropathy
Conditions
Keywords
Keywords: pain, diabetes, neuropathy
Brief summary
The purpose of this study is to evaluate the safety, tolerability and effectiveness of DS-5565 compared to placebo (inactive substance) and pregabalin in diabetic subjects with DPN.
Detailed description
Diabetic peripheral neuropathy (DPN) affects up to 50% of patients who have diabetes for at least 25 years. Up to 26% of all patients with DPN experience neuropathic pain. DPN pain contributes to sleep disorders, depression, and anxiety, which together may have an impact on a patient's well-being and quality of life. There are currently several drugs used to treat painful DPN. For example, Lyrica® (pregabalin) is approved by the United States Food and Drug Administration (FDA) to treat neuropathic pain associated with DPN and is commonly prescribed. The dosage of the FDA-approved drugs is limited by side-effects such as dizziness, sleepiness, weight gain and swelling of the hands, legs, and feet. As a result, many patients suffering from DPN pain do not get satisfactory pain relief.
Interventions
DRUGPlacebo tablet
DRUGplacebo capsule
DRUGDS-5565 tablet
5mg and 10mg tablets
75mg and 150mg over-encapsulated
Sponsors
Daiichi Sankyo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age \> 18 years of age 2. Able to give informed consent and willing to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures 3. Type 1 or type 2 diabetes with a hemoglobin A1c (HbA1c) ≤ 10% at Screening and on a stable antidiabetic medication regimen for at least 30 days prior to Screening (insulin therapy is acceptable) 4. Painful distal symmetrical sensorimotor polyneuropathy (as per American Society of Pain Educators guidelines ) diagnosed for at least 6 months, based on neurological history and/or examination; diagnosis includes absent or reduced deep tendon reflexes at both ankles 5. At Screening, a pain score of ≥ 40 mm on the SF-MPQ VAS 6. At Randomization, a pain score of ≥ 40 mm on the SF-MPQ VAS and an ADPS of ≥ 4 on the 11-point NRS, the latter calculated from a minimum of 4 pain ratings in daily diaries obtained during the 1-week Baseline Period (prior to randomization) 7. Creatinine clearance \> 60 mL/min (estimated using the Cockcroft-Gault equation) 8. Antidiabetic and other medications anticipated to remain stable and constant during the study period 9. Women of child bearing potential (WOCBP) must be using an adequate method of contraception as detailed in the protocol to avoid pregnancy during the study and for 4 weeks after study completion
Exclusion criteria
1. Diagnosis of mononeuropathy 2. Use of concomitant medications that may confound assessments of efficacy and/or safety (see Section 5.2) 3. Major psychiatric disorders 4. Have had a malignancy other than basal cell carcinoma within the past 2 years 5. At Visit 1, have a white blood cell count \< 2500/mm3, neutrophil count \< 1500/mm3, or platelet count \< 100 x 103/mm3 6. Clinically significant unstable diabetes mellitus, unstable hepatic, respiratory, or hematologic illness, unstable cardiovascular disease (including myocardial infarction in the 3 months prior to Visit 1), or symptomatic peripheral vascular disease 7. Clinically significant findings on the Screening ECG 8. History of pernicious anemia, untreated hypothyroidism, chronic hepatitis B, hepatitis B within the past 3 months, or human immunodeficiency virus infection 9. Amputations of body parts other than toes 10. Prior therapeutic failure of pregabalin or gabapentin (considered unresponsive or intolerant to treatment); therapeutic failure implies lack of efficacy following full titration to effective doses (eg, 300 mg/day for pregabalin) 11. Known hypersensitivity to pregabalin or gabapentin 12. Requirement for concomitant anticonvulsant and antidepressant therapy, with the exception of stable doses of SSRIs 13. Neurologic disorders unrelated to DPN that may confound the assessment of pain associated with DPN 14. Skin conditions that could alter sensation 15. Other sources of pain that may confound assessment or self-evaluation of the pain due to DPN 16. Abuse of prescription medications, street drugs or alcohol (including alcohol dependence) within the last 1 year 17. Current enrollment in another investigational study, participation in another investigational study with the past 30 days, or other current or recent use of any investigational drug 18. Pregnancy (as based on lab test results) or breast feeding 19. Laboratory values exceeding limits listed in Table 4.1 of the protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline to Week 5 in Average Daily Pain Score (ADPS) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Baseline up to Week 5 postdose, up to 10 months total follow up | Average daily pain score (ADPS) is a participant-reported instrument that measures pain intensity using an 11-point numeric rating scale (NRS) where 0 is defined as no pain and 10 is defined as worst possible pain. Higher scores indicate worse pain intensity level. The change from baseline to Week 5 is reported where a negative value is considered an improvement in pain intensity. A minimally meaningful effect was defined as a decrease of at least 1.0 point \[scale of 0 to 10\] versus placebo). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average Daily Pain Score Responder Rates Based on ≥30% and ≥50% Decrease From Baseline at Endpoint) Following Treatment With DS-5565 or Placebo Compared to Pregabalin | Baseline up to Week 5 postdose, up to 10 months total follow up | Average daily pain score (ADPS) is a participant-reported instrument that measures pain intensity using an 11-point numeric rating scale (NRS) where 0 is defined as no pain and 10 is defined as worst possible pain. Higher scores indicate worse pain intensity level. |
| Mean Change From Baseline to End-of-Treatment in Average Daily Sleep Interference Score Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Baseline up to Week 5 postdose, up to 10 months total follow up | Average Daily Sleep Interference Score (ADSIS) is the weekly average of patient-reported sleep interference (rated every morning on a numerical scale of 0 = pain did not interfere with sleep to 10 = pain completely interfered with sleep over the past 24 h), where higher scores indicate worse outcome.The change from baseline to Week 5 in ADSIS is being reported as the average of the last 7 available daily scores. The greater the negative value, the greater the improvement in sleep. |
| Short-Form McGill Pain Questionnaire (SF-MPQ) Sensory and Affective Scores Change From Baseline to Endpoint Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Baseline up to Week 5 postdose, up to 10 months total follow up | The SF-MPQ sensory score is the sum of 11 pain descriptors each scored from 0 to 3: throbbing, shooting, stabbing, sharp cramping, gnawing, hot-burning, aching, heavy, tender, and splitting. Thus, the SF-MPQ sensory score ranges from 0 to 33, where lower scores indicate a better outcome. The SF-MPQ affective score is the sum of four pain descriptors each scored from 0 to 3: tiring-exhausting, sickening, fearful, and punishing cruel. Thus, SF-MPQ affective score ranges from 0 to 12, where lower scores indicate a better outcome. The change from baseline to Week 5 in SF-MPQ sensory and affective scores are being reported. The greater the negative value, the greater the improvement in sensory and affective scores. |
| Short-Form McGill Pain Questionnaire (SF-MPQ) Total Score and Visual Analog Scale Change From Baseline to Endpoint Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Baseline up to Week 5 postdose, up to 10 months total follow up | The SF-MPQ sensory score is the sum of 11 pain descriptors each scored from 0 to 3: throbbing, shooting, stabbing, sharp cramping, gnawing, hot-burning, aching, heavy, tender, and splitting. Thus, the SF-MPQ sensory score ranges from 0 to 33, where lower scores indicate a better outcome. The SF-MPQ affective score is the sum of four pain descriptors each scored from 0 to 3: tiring-exhausting, sickening, fearful, and punishing cruel. Thus, SF-MPQ affective score ranges from 0 to 12, where lower scores indicate a better outcome. The SF-MPQ total score comprises the sum of the sensory and affective scores. The SF-MPQ VAS ranges from 0 (no pain) to 100 (worst possible pain), where lower scores indicate a better outcome. The change from baseline to Week 5 in SF-MPQ total score and VAS are being reported. The greater the negative value, the greater the improvement in total score (sensory and affective scores) and VAS pain. |
| Short-Form McGill Pain Questionnaire (SF-MPQ) Present Pain Intensity Change From Baseline to Endpoint Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Baseline up to Week 5 postdose, up to 10 months total follow up | The SF-MPQ present pain intensity ranges from 0 (no pain) to 5 (excruciating), where lower scores indicate a better outcome. The change from baseline to Week 5 in SF-MPQ present pain intensity is being reported. The greater the negative value, the greater the improvement in present pain intensity. |
| Least Square Means of Average Daily Pain Score by Week Mixed Effects Model for Repeated Measures (MMRM) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Baseline up to Week 5 postdose, up to 10 months total follow up | Average daily pain score (ADPS) is a participant-reported instrument that measures pain intensity using an 11-point numeric rating scale (NRS) where 0 is defined as no pain and 10 is defined as worst possible pain. Higher scores indicate worse pain intensity level. The least square means of ADPS (assessed by MMRM) are reported where a negative value is considered an improvement in pain intensity. A minimally meaningful effect was defined as a decrease of at least 1.0 point \[scale of 0 to 10\] versus placebo). |
| Mean Change From Baseline to Endpoint of Modified BPI Subscales, Worst, Least and Average Pain Intensity, Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Baseline up to Week 5 postdose, up to 10 months total follow up | The Modified Brief Pain Inventory (BPI) includes Interference with Daily Functions Subscale, Worst Pain Intensity, Least Pain Intensity, Average Pain Intensity, Pain Right Now, and Relief From Pain. The range of worst pain intensity in the last 24 hours is 0-10, where lower scores indicate a better outcome. The range of least pain intensity in the last 24 hours is 0-10, where lower scores indicate a better outcome. The range of average pain intensity in the last 24 hours is 0-10, where lower scores indicate a better outcome. The change from baseline to Week 5 in Modified Brief Pain Inventory is being reported. The greater the negative value, the greater the improvement in worst, least, and average pain intensity. |
| Mean Change From Baseline to Endpoint of Modified BPI Subscale, Pain Right Now, Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Baseline up to Week 5 postdose, up to 10 months total follow up | The Modified Brief Pain Inventory (BPI) includes Interference with Daily Functions Subscale, Worst Pain Intensity, Least Pain Intensity, Average Pain Intensity, Pain Right Now, and Relief From Pain. The range of pain right now is 0-10, where lower scores indicate a better outcome. The change from baseline to Week 5 in Modified Brief Pain Inventory is being reported. For pain right now, the greater the negative value, the greater the improvement. |
| Mean Change From Baseline to Endpoint of Modified BPI Subscale, Relief From Pain, Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Baseline up to Week 5 postdose, up to 10 months total follow up | The Modified Brief Pain Inventory (BPI) includes Interference with Daily Functions Subscale, Worst Pain Intensity, Least Pain Intensity, Average Pain Intensity, Pain Right Now, and Relief From Pain. The range of % relief from pain is 0-100, where higher scores indicate a better outcome. The change from baseline to Week 5 in Modified Brief Pain Inventory is being reported. For relief from pain, the higher the score, the greater the improvement in pain relief. |
| Patient Global Impression of Change at End-of-Treatment or Early Termination Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Baseline up to Week 5 postdose, up to 10 months total follow up | Patient Global Impression of Change (PGIC) has a range of 7 possible responses for overall status since start of the study, where 0 was defined as 'Very much improved' and 7 was defined as 'Very much worse'. Lower scores indicate a better outcome. PGIC was analyzed based on the following definitions: Participant's overall status was minimally improved or better (ie, score ≤3) or Participant's overall status was much improved or better (ie, score ≤ 2). |
| Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | From the time of signing the informed consent form (ICF) up to 10 months postdose | Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug. Drug-related TEAEs included AEs that were considered related to the study drug as judged by the Investigator. TEAEs were classified according to MedDRA 14.1. |
| Mean Change From Baseline to Endpoint of Modified Brief Pain Inventory (BPI) Subscale, Interference With Daily Functions, Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Baseline up to Week 5 postdose, up to 10 months total follow up | The Modified Brief Pain Inventory (BPI) includes Interference with Daily Functions Subscale, Worst Pain Intensity, Least Pain Intensity, Average Pain Intensity, Pain Right Now, and Relief From Pain. The range of interference subscale is 0-10, where lower scores indicate a better outcome. The change from baseline to Week 5 in Modified Brief Pain Inventory is being reported. The greater the negative value, the greater the improvement in interference with daily functions. |
Countries
United States
Participant flow
Recruitment details
A total of 452 participants who met all inclusion criteria and no exclusion criteria were enrolled and randomized in the study at 80 clinic sites in the United States.
Pre-assignment details
Participants were randomized to 1 of 7 treatment groups which included placebo, pregabalin 150 mg BID, DS-5565 5 mg QD, DS-5565 10 mg QD, DS-5565 15 mg QD, DS-5565 10 mg BID, and DS-5565 15 mg BID.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants who were randomized to placebo. | 112 |
| Pregabalin 150 mg BID Participants who were randomized to pregabalin 150 mg twice daily (BID). | 56 |
| DS-5565 5mg QD Participants who were randomized to DS-5565 5 mg every day (QD). | 57 |
| DS-5565 10 mg QD Participants who were randomized to DS-5565 10 mg every day (QD). | 57 |
| DS-5565 15 mg QD Participants who were randomized to DS-5565 15 mg every day (QD). | 57 |
| DS-5565 10 mg BID Participants who were randomized to DS-5565 10 mg twice daily (BID). | 56 |
| DS-5565 15 mg BID Participants who were randomized to DS-5565 15 mg twice daily (BID). | 57 |
| Total | 452 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 3 | 3 | 2 | 5 | 6 | 4 |
| Overall Study | Lack of Efficacy | 1 | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 | 0 | 0 | 2 | 0 | 0 |
| Overall Study | Other | 4 | 4 | 2 | 1 | 3 | 0 | 1 |
| Overall Study | Protocol Violation | 2 | 1 | 1 | 0 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 6 | 6 | 0 | 1 | 3 | 2 | 1 |
Baseline characteristics
| Characteristic | Placebo | Total | DS-5565 15 mg BID | DS-5565 10 mg BID | DS-5565 15 mg QD | DS-5565 10 mg QD | DS-5565 5mg QD | Pregabalin 150 mg BID |
|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 60.2 years STANDARD_DEVIATION 9.57 | 60.1 years STANDARD_DEVIATION 9.26 | 59.3 years STANDARD_DEVIATION 8.54 | 60.4 years STANDARD_DEVIATION 8.59 | 61.4 years STANDARD_DEVIATION 8.7 | 60.9 years STANDARD_DEVIATION 9.92 | 58.9 years STANDARD_DEVIATION 9.85 | 59.5 years STANDARD_DEVIATION 9.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 11 Participants | 1 Participants | 1 Participants | 1 Participants | 4 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 27 Participants | 94 Participants | 8 Participants | 10 Participants | 12 Participants | 9 Participants | 11 Participants | 17 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 4 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 81 Participants | 339 Participants | 46 Participants | 44 Participants | 44 Participants | 43 Participants | 45 Participants | 36 Participants |
| Region of Enrollment United States | 112 participants | 452 participants | 57 participants | 56 participants | 57 participants | 57 participants | 57 participants | 56 participants |
| Sex: Female, Male Female | 56 Participants | 210 Participants | 25 Participants | 24 Participants | 23 Participants | 28 Participants | 30 Participants | 24 Participants |
| Sex: Female, Male Male | 56 Participants | 242 Participants | 32 Participants | 32 Participants | 34 Participants | 29 Participants | 27 Participants | 32 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 | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 108 | 0 / 50 | 0 / 55 | 0 / 56 | 0 / 53 | 0 / 56 | 0 / 57 |
| other Total, other adverse events | 48 / 108 | 30 / 50 | 29 / 55 | 28 / 56 | 30 / 53 | 33 / 56 | 36 / 57 |
| serious Total, serious adverse events | 1 / 108 | 0 / 50 | 2 / 55 | 3 / 56 | 2 / 53 | 1 / 56 | 0 / 57 |
Outcome results
Primary
Mean Change From Baseline to Week 5 in Average Daily Pain Score (ADPS) Following Treatment With DS-5565 Compared to Pregabalin and Placebo
Average daily pain score (ADPS) is a participant-reported instrument that measures pain intensity using an 11-point numeric rating scale (NRS) where 0 is defined as no pain and 10 is defined as worst possible pain. Higher scores indicate worse pain intensity level. The change from baseline to Week 5 is reported where a negative value is considered an improvement in pain intensity. A minimally meaningful effect was defined as a decrease of at least 1.0 point \[scale of 0 to 10\] versus placebo).
Time frame: Baseline up to Week 5 postdose, up to 10 months total follow up
Population: ADPS was assessed in the Full Analysis Set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline to Week 5 in Average Daily Pain Score (ADPS) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | -1.86 units on a scale | Standard Deviation 2.18 |
| Pregabalin 150 mg BID | Mean Change From Baseline to Week 5 in Average Daily Pain Score (ADPS) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | -1.79 units on a scale | Standard Deviation 2.27 |
| DS-5565 5mg QD | Mean Change From Baseline to Week 5 in Average Daily Pain Score (ADPS) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | -2.04 units on a scale | Standard Deviation 2.22 |
| DS-5565 10 mg QD | Mean Change From Baseline to Week 5 in Average Daily Pain Score (ADPS) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | -2.32 units on a scale | Standard Deviation 2.17 |
| DS-5565 15 mg QD | Mean Change From Baseline to Week 5 in Average Daily Pain Score (ADPS) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | -2.66 units on a scale | Standard Deviation 2.37 |
| DS-5565 10 mg BID | Mean Change From Baseline to Week 5 in Average Daily Pain Score (ADPS) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | -2.64 units on a scale | Standard Deviation 2.45 |
| DS-5565 15 mg BID | Mean Change From Baseline to Week 5 in Average Daily Pain Score (ADPS) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | -2.79 units on a scale | Standard Deviation 2.43 |
p-value: 0.891695% CI: [-0.81, 0.7]ANCOVA
p-value: 0.556995% CI: [-0.95, 0.51]ANCOVA
p-value: 0.154495% CI: [-1.25, 0.2]ANCOVA
p-value: 0.013795% CI: [-1.69, -0.19]ANCOVA
p-value: 0.017195% CI: [-1.61, 0.16]ANCOVA
p-value: 0.00695% CI: [-1.74, -0.29]ANCOVA
p-value: 0.705195% CI: [-1.03, 0.69]ANCOVA
p-value: 0.277295% CI: [-1.33, 0.38]ANCOVA
p-value: 0.045895% CI: [-1.77, -0.02]ANCOVA
p-value: 0.056995% CI: [-1.69, 0.02]ANCOVA
p-value: 0.027195% CI: [-1.81, -0.11]ANCOVA
Secondary
Average Daily Pain Score Responder Rates Based on ≥30% and ≥50% Decrease From Baseline at Endpoint) Following Treatment With DS-5565 or Placebo Compared to Pregabalin
Average daily pain score (ADPS) is a participant-reported instrument that measures pain intensity using an 11-point numeric rating scale (NRS) where 0 is defined as no pain and 10 is defined as worst possible pain. Higher scores indicate worse pain intensity level.
Time frame: Baseline up to Week 5 postdose, up to 10 months total follow up
Population: ADPS was assessed in the Full Analysis Set.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Placebo | Average Daily Pain Score Responder Rates Based on ≥30% and ≥50% Decrease From Baseline at Endpoint) Following Treatment With DS-5565 or Placebo Compared to Pregabalin | Responder rate: ≥30% decrease from baseline | Yes | 45 Participants |
| Placebo | Average Daily Pain Score Responder Rates Based on ≥30% and ≥50% Decrease From Baseline at Endpoint) Following Treatment With DS-5565 or Placebo Compared to Pregabalin | Responder rate: ≥30% decrease from baseline | No | 63 Participants |
| Placebo | Average Daily Pain Score Responder Rates Based on ≥30% and ≥50% Decrease From Baseline at Endpoint) Following Treatment With DS-5565 or Placebo Compared to Pregabalin | Responder Rate: ≥50% decrease from baseline | Yes | 26 Participants |
| Placebo | Average Daily Pain Score Responder Rates Based on ≥30% and ≥50% Decrease From Baseline at Endpoint) Following Treatment With DS-5565 or Placebo Compared to Pregabalin | Responder Rate: ≥50% decrease from baseline | No | 82 Participants |
| Pregabalin 150 mg BID | Average Daily Pain Score Responder Rates Based on ≥30% and ≥50% Decrease From Baseline at Endpoint) Following Treatment With DS-5565 or Placebo Compared to Pregabalin | Responder Rate: ≥50% decrease from baseline | No | 36 Participants |
| Pregabalin 150 mg BID | Average Daily Pain Score Responder Rates Based on ≥30% and ≥50% Decrease From Baseline at Endpoint) Following Treatment With DS-5565 or Placebo Compared to Pregabalin | Responder Rate: ≥50% decrease from baseline | Yes | 14 Participants |
| Pregabalin 150 mg BID | Average Daily Pain Score Responder Rates Based on ≥30% and ≥50% Decrease From Baseline at Endpoint) Following Treatment With DS-5565 or Placebo Compared to Pregabalin | Responder rate: ≥30% decrease from baseline | Yes | 19 Participants |
| Pregabalin 150 mg BID | Average Daily Pain Score Responder Rates Based on ≥30% and ≥50% Decrease From Baseline at Endpoint) Following Treatment With DS-5565 or Placebo Compared to Pregabalin | Responder rate: ≥30% decrease from baseline | No | 31 Participants |
| DS-5565 5mg QD | Average Daily Pain Score Responder Rates Based on ≥30% and ≥50% Decrease From Baseline at Endpoint) Following Treatment With DS-5565 or Placebo Compared to Pregabalin | Responder Rate: ≥50% decrease from baseline | Yes | 11 Participants |
| DS-5565 5mg QD | Average Daily Pain Score Responder Rates Based on ≥30% and ≥50% Decrease From Baseline at Endpoint) Following Treatment With DS-5565 or Placebo Compared to Pregabalin | Responder rate: ≥30% decrease from baseline | No | 33 Participants |
| DS-5565 5mg QD | Average Daily Pain Score Responder Rates Based on ≥30% and ≥50% Decrease From Baseline at Endpoint) Following Treatment With DS-5565 or Placebo Compared to Pregabalin | Responder rate: ≥30% decrease from baseline | Yes | 22 Participants |
| DS-5565 5mg QD | Average Daily Pain Score Responder Rates Based on ≥30% and ≥50% Decrease From Baseline at Endpoint) Following Treatment With DS-5565 or Placebo Compared to Pregabalin | Responder Rate: ≥50% decrease from baseline | No | 44 Participants |
| DS-5565 10 mg QD | Average Daily Pain Score Responder Rates Based on ≥30% and ≥50% Decrease From Baseline at Endpoint) Following Treatment With DS-5565 or Placebo Compared to Pregabalin | Responder rate: ≥30% decrease from baseline | Yes | 32 Participants |
| DS-5565 10 mg QD | Average Daily Pain Score Responder Rates Based on ≥30% and ≥50% Decrease From Baseline at Endpoint) Following Treatment With DS-5565 or Placebo Compared to Pregabalin | Responder rate: ≥30% decrease from baseline | No | 24 Participants |
| DS-5565 10 mg QD | Average Daily Pain Score Responder Rates Based on ≥30% and ≥50% Decrease From Baseline at Endpoint) Following Treatment With DS-5565 or Placebo Compared to Pregabalin | Responder Rate: ≥50% decrease from baseline | Yes | 16 Participants |
| DS-5565 10 mg QD | Average Daily Pain Score Responder Rates Based on ≥30% and ≥50% Decrease From Baseline at Endpoint) Following Treatment With DS-5565 or Placebo Compared to Pregabalin | Responder Rate: ≥50% decrease from baseline | No | 40 Participants |
| DS-5565 15 mg QD | Average Daily Pain Score Responder Rates Based on ≥30% and ≥50% Decrease From Baseline at Endpoint) Following Treatment With DS-5565 or Placebo Compared to Pregabalin | Responder rate: ≥30% decrease from baseline | Yes | 34 Participants |
| DS-5565 15 mg QD | Average Daily Pain Score Responder Rates Based on ≥30% and ≥50% Decrease From Baseline at Endpoint) Following Treatment With DS-5565 or Placebo Compared to Pregabalin | Responder Rate: ≥50% decrease from baseline | No | 31 Participants |
| DS-5565 15 mg QD | Average Daily Pain Score Responder Rates Based on ≥30% and ≥50% Decrease From Baseline at Endpoint) Following Treatment With DS-5565 or Placebo Compared to Pregabalin | Responder rate: ≥30% decrease from baseline | No | 17 Participants |
| DS-5565 15 mg QD | Average Daily Pain Score Responder Rates Based on ≥30% and ≥50% Decrease From Baseline at Endpoint) Following Treatment With DS-5565 or Placebo Compared to Pregabalin | Responder Rate: ≥50% decrease from baseline | Yes | 20 Participants |
| DS-5565 10 mg BID | Average Daily Pain Score Responder Rates Based on ≥30% and ≥50% Decrease From Baseline at Endpoint) Following Treatment With DS-5565 or Placebo Compared to Pregabalin | Responder rate: ≥30% decrease from baseline | No | 22 Participants |
| DS-5565 10 mg BID | Average Daily Pain Score Responder Rates Based on ≥30% and ≥50% Decrease From Baseline at Endpoint) Following Treatment With DS-5565 or Placebo Compared to Pregabalin | Responder rate: ≥30% decrease from baseline | Yes | 34 Participants |
| DS-5565 10 mg BID | Average Daily Pain Score Responder Rates Based on ≥30% and ≥50% Decrease From Baseline at Endpoint) Following Treatment With DS-5565 or Placebo Compared to Pregabalin | Responder Rate: ≥50% decrease from baseline | Yes | 24 Participants |
| DS-5565 10 mg BID | Average Daily Pain Score Responder Rates Based on ≥30% and ≥50% Decrease From Baseline at Endpoint) Following Treatment With DS-5565 or Placebo Compared to Pregabalin | Responder Rate: ≥50% decrease from baseline | No | 32 Participants |
| DS-5565 15 mg BID | Average Daily Pain Score Responder Rates Based on ≥30% and ≥50% Decrease From Baseline at Endpoint) Following Treatment With DS-5565 or Placebo Compared to Pregabalin | Responder Rate: ≥50% decrease from baseline | Yes | 25 Participants |
| DS-5565 15 mg BID | Average Daily Pain Score Responder Rates Based on ≥30% and ≥50% Decrease From Baseline at Endpoint) Following Treatment With DS-5565 or Placebo Compared to Pregabalin | Responder rate: ≥30% decrease from baseline | Yes | 32 Participants |
| DS-5565 15 mg BID | Average Daily Pain Score Responder Rates Based on ≥30% and ≥50% Decrease From Baseline at Endpoint) Following Treatment With DS-5565 or Placebo Compared to Pregabalin | Responder rate: ≥30% decrease from baseline | No | 25 Participants |
| DS-5565 15 mg BID | Average Daily Pain Score Responder Rates Based on ≥30% and ≥50% Decrease From Baseline at Endpoint) Following Treatment With DS-5565 or Placebo Compared to Pregabalin | Responder Rate: ≥50% decrease from baseline | No | 32 Participants |
Secondary
Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug. Drug-related TEAEs included AEs that were considered related to the study drug as judged by the Investigator. TEAEs were classified according to MedDRA 14.1.
Time frame: From the time of signing the informed consent form (ICF) up to 10 months postdose
Population: Safety events were assessed in the Safety Analysis Set.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Fatigue | 1 Participants |
| Placebo | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | General Disorders & Administration Site Conditions | 4 Participants |
| Placebo | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Amnesia | 0 Participants |
| Placebo | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Balance disorder | 0 Participants |
| Placebo | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Erectile dysfunction | 0 Participants |
| Placebo | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Reproductive System and Breast Disorders | 0 Participants |
| Placebo | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Dizziness | 1 Participants |
| Placebo | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Nervous System Disorders | 3 Participants |
| Placebo | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Vision blurred | 2 Participants |
| Placebo | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Eye Disorders | 2 Participants |
| Placebo | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Blood creatinine phosphokinase increased | 2 Participants |
| Placebo | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Weight increased | 1 Participants |
| Placebo | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Investigations | 4 Participants |
| Placebo | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Somnolence | 1 Participants |
| Placebo | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Participants with ≥1 drug-related TEAEs | 20 Participants |
| Placebo | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Insomnia | 1 Participants |
| Placebo | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Psychiatric Disorders | 3 Participants |
| Placebo | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Dry mouth | 0 Participants |
| Placebo | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Constipation | 1 Participants |
| Placebo | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Nausea | 1 Participants |
| Placebo | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Headache | 1 Participants |
| Placebo | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Drug-related TEAEs | 31 Participants |
| Placebo | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Gastrointestinal Disorders | 5 Participants |
| Placebo | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Oedema peripheral | 0 Participants |
| Pregabalin 150 mg BID | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Investigations | 2 Participants |
| Pregabalin 150 mg BID | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Dizziness | 1 Participants |
| Pregabalin 150 mg BID | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Somnolence | 4 Participants |
| Pregabalin 150 mg BID | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Headache | 0 Participants |
| Pregabalin 150 mg BID | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Balance disorder | 2 Participants |
| Pregabalin 150 mg BID | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Amnesia | 0 Participants |
| Pregabalin 150 mg BID | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | General Disorders & Administration Site Conditions | 4 Participants |
| Pregabalin 150 mg BID | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Fatigue | 2 Participants |
| Pregabalin 150 mg BID | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Oedema peripheral | 2 Participants |
| Pregabalin 150 mg BID | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Gastrointestinal Disorders | 2 Participants |
| Pregabalin 150 mg BID | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Nausea | 0 Participants |
| Pregabalin 150 mg BID | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Constipation | 0 Participants |
| Pregabalin 150 mg BID | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Dry mouth | 1 Participants |
| Pregabalin 150 mg BID | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Psychiatric Disorders | 5 Participants |
| Pregabalin 150 mg BID | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Insomnia | 1 Participants |
| Pregabalin 150 mg BID | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Nervous System Disorders | 7 Participants |
| Pregabalin 150 mg BID | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Weight increased | 0 Participants |
| Pregabalin 150 mg BID | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Blood creatinine phosphokinase increased | 1 Participants |
| Pregabalin 150 mg BID | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Eye Disorders | 1 Participants |
| Pregabalin 150 mg BID | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Vision blurred | 1 Participants |
| Pregabalin 150 mg BID | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Reproductive System and Breast Disorders | 0 Participants |
| Pregabalin 150 mg BID | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Erectile dysfunction | 0 Participants |
| Pregabalin 150 mg BID | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Drug-related TEAEs | 35 Participants |
| Pregabalin 150 mg BID | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Participants with ≥1 drug-related TEAEs | 14 Participants |
| DS-5565 5mg QD | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Somnolence | 1 Participants |
| DS-5565 5mg QD | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | General Disorders & Administration Site Conditions | 2 Participants |
| DS-5565 5mg QD | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Fatigue | 0 Participants |
| DS-5565 5mg QD | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Vision blurred | 1 Participants |
| DS-5565 5mg QD | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Nervous System Disorders | 4 Participants |
| DS-5565 5mg QD | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Drug-related TEAEs | 24 Participants |
| DS-5565 5mg QD | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Constipation | 0 Participants |
| DS-5565 5mg QD | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Headache | 3 Participants |
| DS-5565 5mg QD | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Blood creatinine phosphokinase increased | 1 Participants |
| DS-5565 5mg QD | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Dizziness | 0 Participants |
| DS-5565 5mg QD | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Gastrointestinal Disorders | 3 Participants |
| DS-5565 5mg QD | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Weight increased | 0 Participants |
| DS-5565 5mg QD | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Insomnia | 0 Participants |
| DS-5565 5mg QD | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Dry mouth | 1 Participants |
| DS-5565 5mg QD | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Balance disorder | 0 Participants |
| DS-5565 5mg QD | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Amnesia | 0 Participants |
| DS-5565 5mg QD | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Eye Disorders | 1 Participants |
| DS-5565 5mg QD | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Participants with ≥1 drug-related TEAEs | 13 Participants |
| DS-5565 5mg QD | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Erectile dysfunction | 0 Participants |
| DS-5565 5mg QD | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Oedema peripheral | 2 Participants |
| DS-5565 5mg QD | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Psychiatric Disorders | 2 Participants |
| DS-5565 5mg QD | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Investigations | 1 Participants |
| DS-5565 5mg QD | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Reproductive System and Breast Disorders | 0 Participants |
| DS-5565 5mg QD | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Nausea | 2 Participants |
| DS-5565 10 mg QD | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Dizziness | 5 Participants |
| DS-5565 10 mg QD | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Insomnia | 0 Participants |
| DS-5565 10 mg QD | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Weight increased | 1 Participants |
| DS-5565 10 mg QD | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Nervous System Disorders | 7 Participants |
| DS-5565 10 mg QD | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Investigations | 2 Participants |
| DS-5565 10 mg QD | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Erectile dysfunction | 0 Participants |
| DS-5565 10 mg QD | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Balance disorder | 0 Participants |
| DS-5565 10 mg QD | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Fatigue | 1 Participants |
| DS-5565 10 mg QD | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Gastrointestinal Disorders | 3 Participants |
| DS-5565 10 mg QD | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | General Disorders & Administration Site Conditions | 1 Participants |
| DS-5565 10 mg QD | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Reproductive System and Breast Disorders | 0 Participants |
| DS-5565 10 mg QD | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Nausea | 1 Participants |
| DS-5565 10 mg QD | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Vision blurred | 0 Participants |
| DS-5565 10 mg QD | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Participants with ≥1 drug-related TEAEs | 12 Participants |
| DS-5565 10 mg QD | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Constipation | 2 Participants |
| DS-5565 10 mg QD | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Amnesia | 0 Participants |
| DS-5565 10 mg QD | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Eye Disorders | 0 Participants |
| DS-5565 10 mg QD | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Headache | 3 Participants |
| DS-5565 10 mg QD | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Drug-related TEAEs | 21 Participants |
| DS-5565 10 mg QD | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Dry mouth | 0 Participants |
| DS-5565 10 mg QD | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Somnolence | 1 Participants |
| DS-5565 10 mg QD | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Psychiatric Disorders | 2 Participants |
| DS-5565 10 mg QD | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Oedema peripheral | 0 Participants |
| DS-5565 10 mg QD | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Blood creatinine phosphokinase increased | 0 Participants |
| DS-5565 15 mg QD | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Nervous System Disorders | 9 Participants |
| DS-5565 15 mg QD | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Fatigue | 2 Participants |
| DS-5565 15 mg QD | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Oedema peripheral | 1 Participants |
| DS-5565 15 mg QD | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Headache | 0 Participants |
| DS-5565 15 mg QD | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Gastrointestinal Disorders | 5 Participants |
| DS-5565 15 mg QD | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Nausea | 1 Participants |
| DS-5565 15 mg QD | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Constipation | 1 Participants |
| DS-5565 15 mg QD | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Somnolence | 3 Participants |
| DS-5565 15 mg QD | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Dry mouth | 2 Participants |
| DS-5565 15 mg QD | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Drug-related TEAEs | 40 Participants |
| DS-5565 15 mg QD | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Psychiatric Disorders | 3 Participants |
| DS-5565 15 mg QD | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Insomnia | 2 Participants |
| DS-5565 15 mg QD | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Investigations | 3 Participants |
| DS-5565 15 mg QD | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Weight increased | 0 Participants |
| DS-5565 15 mg QD | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Dizziness | 5 Participants |
| DS-5565 15 mg QD | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Blood creatinine phosphokinase increased | 0 Participants |
| DS-5565 15 mg QD | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Eye Disorders | 2 Participants |
| DS-5565 15 mg QD | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Vision blurred | 2 Participants |
| DS-5565 15 mg QD | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Participants with ≥1 drug-related TEAEs | 17 Participants |
| DS-5565 15 mg QD | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Reproductive System and Breast Disorders | 2 Participants |
| DS-5565 15 mg QD | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Balance disorder | 1 Participants |
| DS-5565 15 mg QD | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Amnesia | 0 Participants |
| DS-5565 15 mg QD | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Erectile dysfunction | 2 Participants |
| DS-5565 15 mg QD | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | General Disorders & Administration Site Conditions | 6 Participants |
| DS-5565 10 mg BID | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Drug-related TEAEs | 34 Participants |
| DS-5565 10 mg BID | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Amnesia | 0 Participants |
| DS-5565 10 mg BID | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Blood creatinine phosphokinase increased | 0 Participants |
| DS-5565 10 mg BID | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Psychiatric Disorders | 1 Participants |
| DS-5565 10 mg BID | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Dry mouth | 0 Participants |
| DS-5565 10 mg BID | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Eye Disorders | 1 Participants |
| DS-5565 10 mg BID | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Constipation | 0 Participants |
| DS-5565 10 mg BID | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Somnolence | 5 Participants |
| DS-5565 10 mg BID | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Nausea | 2 Participants |
| DS-5565 10 mg BID | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Headache | 2 Participants |
| DS-5565 10 mg BID | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Vision blurred | 0 Participants |
| DS-5565 10 mg BID | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | General Disorders & Administration Site Conditions | 4 Participants |
| DS-5565 10 mg BID | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Fatigue | 2 Participants |
| DS-5565 10 mg BID | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Reproductive System and Breast Disorders | 1 Participants |
| DS-5565 10 mg BID | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Nervous System Disorders | 14 Participants |
| DS-5565 10 mg BID | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Participants with ≥1 drug-related TEAEs | 18 Participants |
| DS-5565 10 mg BID | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Gastrointestinal Disorders | 2 Participants |
| DS-5565 10 mg BID | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Erectile dysfunction | 1 Participants |
| DS-5565 10 mg BID | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Balance disorder | 3 Participants |
| DS-5565 10 mg BID | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Oedema peripheral | 2 Participants |
| DS-5565 10 mg BID | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Investigations | 2 Participants |
| DS-5565 10 mg BID | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Dizziness | 4 Participants |
| DS-5565 10 mg BID | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Weight increased | 2 Participants |
| DS-5565 10 mg BID | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Insomnia | 0 Participants |
| DS-5565 15 mg BID | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | General Disorders & Administration Site Conditions | 6 Participants |
| DS-5565 15 mg BID | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Psychiatric Disorders | 5 Participants |
| DS-5565 15 mg BID | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Reproductive System and Breast Disorders | 1 Participants |
| DS-5565 15 mg BID | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Investigations | 2 Participants |
| DS-5565 15 mg BID | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Blood creatinine phosphokinase increased | 0 Participants |
| DS-5565 15 mg BID | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Weight increased | 1 Participants |
| DS-5565 15 mg BID | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Dry mouth | 0 Participants |
| DS-5565 15 mg BID | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Gastrointestinal Disorders | 2 Participants |
| DS-5565 15 mg BID | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Constipation | 2 Participants |
| DS-5565 15 mg BID | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Amnesia | 2 Participants |
| DS-5565 15 mg BID | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Drug-related TEAEs | 37 Participants |
| DS-5565 15 mg BID | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Eye Disorders | 2 Participants |
| DS-5565 15 mg BID | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Oedema peripheral | 1 Participants |
| DS-5565 15 mg BID | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Dizziness | 7 Participants |
| DS-5565 15 mg BID | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Nausea | 1 Participants |
| DS-5565 15 mg BID | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Insomnia | 1 Participants |
| DS-5565 15 mg BID | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Balance disorder | 2 Participants |
| DS-5565 15 mg BID | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Headache | 1 Participants |
| DS-5565 15 mg BID | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Vision blurred | 2 Participants |
| DS-5565 15 mg BID | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Nervous System Disorders | 13 Participants |
| DS-5565 15 mg BID | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Fatigue | 2 Participants |
| DS-5565 15 mg BID | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Participants with ≥1 drug-related TEAEs | 19 Participants |
| DS-5565 15 mg BID | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Somnolence | 4 Participants |
| DS-5565 15 mg BID | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Erectile dysfunction | 1 Participants |
Secondary
Least Square Means of Average Daily Pain Score by Week Mixed Effects Model for Repeated Measures (MMRM) Following Treatment With DS-5565 Compared to Pregabalin and Placebo
Average daily pain score (ADPS) is a participant-reported instrument that measures pain intensity using an 11-point numeric rating scale (NRS) where 0 is defined as no pain and 10 is defined as worst possible pain. Higher scores indicate worse pain intensity level. The least square means of ADPS (assessed by MMRM) are reported where a negative value is considered an improvement in pain intensity. A minimally meaningful effect was defined as a decrease of at least 1.0 point \[scale of 0 to 10\] versus placebo).
Time frame: Baseline up to Week 5 postdose, up to 10 months total follow up
Population: ADPS was assessed in the Full Analysis Set.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo | Least Square Means of Average Daily Pain Score by Week Mixed Effects Model for Repeated Measures (MMRM) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Week 3 | -1.47 units on a scale |
| Placebo | Least Square Means of Average Daily Pain Score by Week Mixed Effects Model for Repeated Measures (MMRM) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Week 1 | -0.55 units on a scale |
| Placebo | Least Square Means of Average Daily Pain Score by Week Mixed Effects Model for Repeated Measures (MMRM) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | End of treatment | -1.91 units on a scale |
| Placebo | Least Square Means of Average Daily Pain Score by Week Mixed Effects Model for Repeated Measures (MMRM) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Week 2 | -1.12 units on a scale |
| Placebo | Least Square Means of Average Daily Pain Score by Week Mixed Effects Model for Repeated Measures (MMRM) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Week 4 | -1.67 units on a scale |
| Pregabalin 150 mg BID | Least Square Means of Average Daily Pain Score by Week Mixed Effects Model for Repeated Measures (MMRM) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Week 3 | -1.79 units on a scale |
| Pregabalin 150 mg BID | Least Square Means of Average Daily Pain Score by Week Mixed Effects Model for Repeated Measures (MMRM) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Week 2 | -1.75 units on a scale |
| Pregabalin 150 mg BID | Least Square Means of Average Daily Pain Score by Week Mixed Effects Model for Repeated Measures (MMRM) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Week 4 | -1.83 units on a scale |
| Pregabalin 150 mg BID | Least Square Means of Average Daily Pain Score by Week Mixed Effects Model for Repeated Measures (MMRM) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Week 1 | -1.10 units on a scale |
| Pregabalin 150 mg BID | Least Square Means of Average Daily Pain Score by Week Mixed Effects Model for Repeated Measures (MMRM) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | End of treatment | -1.87 units on a scale |
| DS-5565 5mg QD | Least Square Means of Average Daily Pain Score by Week Mixed Effects Model for Repeated Measures (MMRM) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | End of treatment | -2.05 units on a scale |
| DS-5565 5mg QD | Least Square Means of Average Daily Pain Score by Week Mixed Effects Model for Repeated Measures (MMRM) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Week 2 | -1.38 units on a scale |
| DS-5565 5mg QD | Least Square Means of Average Daily Pain Score by Week Mixed Effects Model for Repeated Measures (MMRM) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Week 1 | -0.68 units on a scale |
| DS-5565 5mg QD | Least Square Means of Average Daily Pain Score by Week Mixed Effects Model for Repeated Measures (MMRM) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Week 3 | -1.62 units on a scale |
| DS-5565 5mg QD | Least Square Means of Average Daily Pain Score by Week Mixed Effects Model for Repeated Measures (MMRM) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Week 4 | -2.01 units on a scale |
| DS-5565 10 mg QD | Least Square Means of Average Daily Pain Score by Week Mixed Effects Model for Repeated Measures (MMRM) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Week 3 | -1.78 units on a scale |
| DS-5565 10 mg QD | Least Square Means of Average Daily Pain Score by Week Mixed Effects Model for Repeated Measures (MMRM) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Week 1 | -0.95 units on a scale |
| DS-5565 10 mg QD | Least Square Means of Average Daily Pain Score by Week Mixed Effects Model for Repeated Measures (MMRM) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Week 2 | -1.56 units on a scale |
| DS-5565 10 mg QD | Least Square Means of Average Daily Pain Score by Week Mixed Effects Model for Repeated Measures (MMRM) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Week 4 | -2.41 units on a scale |
| DS-5565 10 mg QD | Least Square Means of Average Daily Pain Score by Week Mixed Effects Model for Repeated Measures (MMRM) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | End of treatment | -2.40 units on a scale |
| DS-5565 15 mg QD | Least Square Means of Average Daily Pain Score by Week Mixed Effects Model for Repeated Measures (MMRM) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Week 1 | -1.13 units on a scale |
| DS-5565 15 mg QD | Least Square Means of Average Daily Pain Score by Week Mixed Effects Model for Repeated Measures (MMRM) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | End of treatment | -2.90 units on a scale |
| DS-5565 15 mg QD | Least Square Means of Average Daily Pain Score by Week Mixed Effects Model for Repeated Measures (MMRM) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Week 3 | -2.30 units on a scale |
| DS-5565 15 mg QD | Least Square Means of Average Daily Pain Score by Week Mixed Effects Model for Repeated Measures (MMRM) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Week 4 | -2.46 units on a scale |
| DS-5565 15 mg QD | Least Square Means of Average Daily Pain Score by Week Mixed Effects Model for Repeated Measures (MMRM) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Week 2 | -1.76 units on a scale |
| DS-5565 10 mg BID | Least Square Means of Average Daily Pain Score by Week Mixed Effects Model for Repeated Measures (MMRM) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Week 1 | -1.26 units on a scale |
| DS-5565 10 mg BID | Least Square Means of Average Daily Pain Score by Week Mixed Effects Model for Repeated Measures (MMRM) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | End of treatment | -2.87 units on a scale |
| DS-5565 10 mg BID | Least Square Means of Average Daily Pain Score by Week Mixed Effects Model for Repeated Measures (MMRM) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Week 4 | -2.68 units on a scale |
| DS-5565 10 mg BID | Least Square Means of Average Daily Pain Score by Week Mixed Effects Model for Repeated Measures (MMRM) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Week 2 | -1.72 units on a scale |
| DS-5565 10 mg BID | Least Square Means of Average Daily Pain Score by Week Mixed Effects Model for Repeated Measures (MMRM) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Week 3 | -2.38 units on a scale |
| DS-5565 15 mg BID | Least Square Means of Average Daily Pain Score by Week Mixed Effects Model for Repeated Measures (MMRM) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Week 4 | -2.72 units on a scale |
| DS-5565 15 mg BID | Least Square Means of Average Daily Pain Score by Week Mixed Effects Model for Repeated Measures (MMRM) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Week 2 | -2.33 units on a scale |
| DS-5565 15 mg BID | Least Square Means of Average Daily Pain Score by Week Mixed Effects Model for Repeated Measures (MMRM) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Week 3 | -2.55 units on a scale |
| DS-5565 15 mg BID | Least Square Means of Average Daily Pain Score by Week Mixed Effects Model for Repeated Measures (MMRM) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Week 1 | -1.40 units on a scale |
| DS-5565 15 mg BID | Least Square Means of Average Daily Pain Score by Week Mixed Effects Model for Repeated Measures (MMRM) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | End of treatment | -2.79 units on a scale |
Secondary
Mean Change From Baseline to End-of-Treatment in Average Daily Sleep Interference Score Following Treatment With DS-5565 Compared to Pregabalin and Placebo
Average Daily Sleep Interference Score (ADSIS) is the weekly average of patient-reported sleep interference (rated every morning on a numerical scale of 0 = pain did not interfere with sleep to 10 = pain completely interfered with sleep over the past 24 h), where higher scores indicate worse outcome.The change from baseline to Week 5 in ADSIS is being reported as the average of the last 7 available daily scores. The greater the negative value, the greater the improvement in sleep.
Time frame: Baseline up to Week 5 postdose, up to 10 months total follow up
Population: ADSIS was assessed in the Full Analysis Set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline to End-of-Treatment in Average Daily Sleep Interference Score Following Treatment With DS-5565 Compared to Pregabalin and Placebo | -1.98 units on a scale | Standard Deviation 2.38 |
| Pregabalin 150 mg BID | Mean Change From Baseline to End-of-Treatment in Average Daily Sleep Interference Score Following Treatment With DS-5565 Compared to Pregabalin and Placebo | -1.94 units on a scale | Standard Deviation 2.08 |
| DS-5565 5mg QD | Mean Change From Baseline to End-of-Treatment in Average Daily Sleep Interference Score Following Treatment With DS-5565 Compared to Pregabalin and Placebo | -2.19 units on a scale | Standard Deviation 2.35 |
| DS-5565 10 mg QD | Mean Change From Baseline to End-of-Treatment in Average Daily Sleep Interference Score Following Treatment With DS-5565 Compared to Pregabalin and Placebo | -2.35 units on a scale | Standard Deviation 2.31 |
| DS-5565 15 mg QD | Mean Change From Baseline to End-of-Treatment in Average Daily Sleep Interference Score Following Treatment With DS-5565 Compared to Pregabalin and Placebo | -2.97 units on a scale | Standard Deviation 2.57 |
| DS-5565 10 mg BID | Mean Change From Baseline to End-of-Treatment in Average Daily Sleep Interference Score Following Treatment With DS-5565 Compared to Pregabalin and Placebo | -2.52 units on a scale | Standard Deviation 2.89 |
| DS-5565 15 mg BID | Mean Change From Baseline to End-of-Treatment in Average Daily Sleep Interference Score Following Treatment With DS-5565 Compared to Pregabalin and Placebo | -2.69 units on a scale | Standard Deviation 2.43 |
Secondary
Mean Change From Baseline to Endpoint of Modified BPI Subscale, Pain Right Now, Following Treatment With DS-5565 Compared to Pregabalin and Placebo
The Modified Brief Pain Inventory (BPI) includes Interference with Daily Functions Subscale, Worst Pain Intensity, Least Pain Intensity, Average Pain Intensity, Pain Right Now, and Relief From Pain. The range of pain right now is 0-10, where lower scores indicate a better outcome. The change from baseline to Week 5 in Modified Brief Pain Inventory is being reported. For pain right now, the greater the negative value, the greater the improvement.
Time frame: Baseline up to Week 5 postdose, up to 10 months total follow up
Population: Modified BPI was assessed in the Full Analysis Set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline to Endpoint of Modified BPI Subscale, Pain Right Now, Following Treatment With DS-5565 Compared to Pregabalin and Placebo | -2.0 units on a scale | Standard Deviation 2.35 |
| Pregabalin 150 mg BID | Mean Change From Baseline to Endpoint of Modified BPI Subscale, Pain Right Now, Following Treatment With DS-5565 Compared to Pregabalin and Placebo | -1.8 units on a scale | Standard Deviation 1.94 |
| DS-5565 5mg QD | Mean Change From Baseline to Endpoint of Modified BPI Subscale, Pain Right Now, Following Treatment With DS-5565 Compared to Pregabalin and Placebo | -2.0 units on a scale | Standard Deviation 2.13 |
| DS-5565 10 mg QD | Mean Change From Baseline to Endpoint of Modified BPI Subscale, Pain Right Now, Following Treatment With DS-5565 Compared to Pregabalin and Placebo | -2.5 units on a scale | Standard Deviation 2.44 |
| DS-5565 15 mg QD | Mean Change From Baseline to Endpoint of Modified BPI Subscale, Pain Right Now, Following Treatment With DS-5565 Compared to Pregabalin and Placebo | -2.5 units on a scale | Standard Deviation 2.36 |
| DS-5565 10 mg BID | Mean Change From Baseline to Endpoint of Modified BPI Subscale, Pain Right Now, Following Treatment With DS-5565 Compared to Pregabalin and Placebo | -2.0 units on a scale | Standard Deviation 3.09 |
| DS-5565 15 mg BID | Mean Change From Baseline to Endpoint of Modified BPI Subscale, Pain Right Now, Following Treatment With DS-5565 Compared to Pregabalin and Placebo | -2.5 units on a scale | Standard Deviation 2.75 |
Secondary
Mean Change From Baseline to Endpoint of Modified BPI Subscale, Relief From Pain, Following Treatment With DS-5565 Compared to Pregabalin and Placebo
The Modified Brief Pain Inventory (BPI) includes Interference with Daily Functions Subscale, Worst Pain Intensity, Least Pain Intensity, Average Pain Intensity, Pain Right Now, and Relief From Pain. The range of % relief from pain is 0-100, where higher scores indicate a better outcome. The change from baseline to Week 5 in Modified Brief Pain Inventory is being reported. For relief from pain, the higher the score, the greater the improvement in pain relief.
Time frame: Baseline up to Week 5 postdose, up to 10 months total follow up
Population: Modified BPI was assessed in the Full Analysis Set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline to Endpoint of Modified BPI Subscale, Relief From Pain, Following Treatment With DS-5565 Compared to Pregabalin and Placebo | 26.4 score on a scale | Standard Deviation 37.67 |
| Pregabalin 150 mg BID | Mean Change From Baseline to Endpoint of Modified BPI Subscale, Relief From Pain, Following Treatment With DS-5565 Compared to Pregabalin and Placebo | 20.4 score on a scale | Standard Deviation 31.06 |
| DS-5565 5mg QD | Mean Change From Baseline to Endpoint of Modified BPI Subscale, Relief From Pain, Following Treatment With DS-5565 Compared to Pregabalin and Placebo | 31.5 score on a scale | Standard Deviation 34.72 |
| DS-5565 10 mg QD | Mean Change From Baseline to Endpoint of Modified BPI Subscale, Relief From Pain, Following Treatment With DS-5565 Compared to Pregabalin and Placebo | 32.0 score on a scale | Standard Deviation 36.33 |
| DS-5565 15 mg QD | Mean Change From Baseline to Endpoint of Modified BPI Subscale, Relief From Pain, Following Treatment With DS-5565 Compared to Pregabalin and Placebo | 23.0 score on a scale | Standard Deviation 37.39 |
| DS-5565 10 mg BID | Mean Change From Baseline to Endpoint of Modified BPI Subscale, Relief From Pain, Following Treatment With DS-5565 Compared to Pregabalin and Placebo | 35.3 score on a scale | Standard Deviation 33.13 |
| DS-5565 15 mg BID | Mean Change From Baseline to Endpoint of Modified BPI Subscale, Relief From Pain, Following Treatment With DS-5565 Compared to Pregabalin and Placebo | 33.0 score on a scale | Standard Deviation 43.52 |
Secondary
Mean Change From Baseline to Endpoint of Modified BPI Subscales, Worst, Least and Average Pain Intensity, Following Treatment With DS-5565 Compared to Pregabalin and Placebo
The Modified Brief Pain Inventory (BPI) includes Interference with Daily Functions Subscale, Worst Pain Intensity, Least Pain Intensity, Average Pain Intensity, Pain Right Now, and Relief From Pain. The range of worst pain intensity in the last 24 hours is 0-10, where lower scores indicate a better outcome. The range of least pain intensity in the last 24 hours is 0-10, where lower scores indicate a better outcome. The range of average pain intensity in the last 24 hours is 0-10, where lower scores indicate a better outcome. The change from baseline to Week 5 in Modified Brief Pain Inventory is being reported. The greater the negative value, the greater the improvement in worst, least, and average pain intensity.
Time frame: Baseline up to Week 5 postdose, up to 10 months total follow up
Population: Modified BPI was assessed in the Full Analysis Set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Baseline to Endpoint of Modified BPI Subscales, Worst, Least and Average Pain Intensity, Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Average Pain Intensity | -1.7 units on a scale | Standard Deviation 2.16 |
| Placebo | Mean Change From Baseline to Endpoint of Modified BPI Subscales, Worst, Least and Average Pain Intensity, Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Least Pain Intensity | -1.3 units on a scale | Standard Deviation 2.37 |
| Placebo | Mean Change From Baseline to Endpoint of Modified BPI Subscales, Worst, Least and Average Pain Intensity, Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Worst Pain Intensity | -2.1 units on a scale | Standard Deviation 2.53 |
| Pregabalin 150 mg BID | Mean Change From Baseline to Endpoint of Modified BPI Subscales, Worst, Least and Average Pain Intensity, Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Least Pain Intensity | -0.9 units on a scale | Standard Deviation 1.98 |
| Pregabalin 150 mg BID | Mean Change From Baseline to Endpoint of Modified BPI Subscales, Worst, Least and Average Pain Intensity, Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Worst Pain Intensity | -1.9 units on a scale | Standard Deviation 2.61 |
| Pregabalin 150 mg BID | Mean Change From Baseline to Endpoint of Modified BPI Subscales, Worst, Least and Average Pain Intensity, Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Average Pain Intensity | -1.5 units on a scale | Standard Deviation 1.95 |
| DS-5565 5mg QD | Mean Change From Baseline to Endpoint of Modified BPI Subscales, Worst, Least and Average Pain Intensity, Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Average Pain Intensity | -1.7 units on a scale | Standard Deviation 2.18 |
| DS-5565 5mg QD | Mean Change From Baseline to Endpoint of Modified BPI Subscales, Worst, Least and Average Pain Intensity, Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Worst Pain Intensity | -2.0 units on a scale | Standard Deviation 2.26 |
| DS-5565 5mg QD | Mean Change From Baseline to Endpoint of Modified BPI Subscales, Worst, Least and Average Pain Intensity, Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Least Pain Intensity | -1.6 units on a scale | Standard Deviation 2.55 |
| DS-5565 10 mg QD | Mean Change From Baseline to Endpoint of Modified BPI Subscales, Worst, Least and Average Pain Intensity, Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Least Pain Intensity | -1.7 units on a scale | Standard Deviation 2.69 |
| DS-5565 10 mg QD | Mean Change From Baseline to Endpoint of Modified BPI Subscales, Worst, Least and Average Pain Intensity, Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Worst Pain Intensity | -2.6 units on a scale | Standard Deviation 2.53 |
| DS-5565 10 mg QD | Mean Change From Baseline to Endpoint of Modified BPI Subscales, Worst, Least and Average Pain Intensity, Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Average Pain Intensity | -2.3 units on a scale | Standard Deviation 2.31 |
| DS-5565 15 mg QD | Mean Change From Baseline to Endpoint of Modified BPI Subscales, Worst, Least and Average Pain Intensity, Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Least Pain Intensity | -2.0 units on a scale | Standard Deviation 2.31 |
| DS-5565 15 mg QD | Mean Change From Baseline to Endpoint of Modified BPI Subscales, Worst, Least and Average Pain Intensity, Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Worst Pain Intensity | -2.7 units on a scale | Standard Deviation 2.71 |
| DS-5565 15 mg QD | Mean Change From Baseline to Endpoint of Modified BPI Subscales, Worst, Least and Average Pain Intensity, Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Average Pain Intensity | -2.0 units on a scale | Standard Deviation 2.34 |
| DS-5565 10 mg BID | Mean Change From Baseline to Endpoint of Modified BPI Subscales, Worst, Least and Average Pain Intensity, Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Worst Pain Intensity | -2.3 units on a scale | Standard Deviation 3.06 |
| DS-5565 10 mg BID | Mean Change From Baseline to Endpoint of Modified BPI Subscales, Worst, Least and Average Pain Intensity, Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Average Pain Intensity | -1.8 units on a scale | Standard Deviation 2.72 |
| DS-5565 10 mg BID | Mean Change From Baseline to Endpoint of Modified BPI Subscales, Worst, Least and Average Pain Intensity, Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Least Pain Intensity | -1.0 units on a scale | Standard Deviation 2.58 |
| DS-5565 15 mg BID | Mean Change From Baseline to Endpoint of Modified BPI Subscales, Worst, Least and Average Pain Intensity, Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Average Pain Intensity | -2.3 units on a scale | Standard Deviation 2.22 |
| DS-5565 15 mg BID | Mean Change From Baseline to Endpoint of Modified BPI Subscales, Worst, Least and Average Pain Intensity, Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Least Pain Intensity | -1.9 units on a scale | Standard Deviation 2.2 |
| DS-5565 15 mg BID | Mean Change From Baseline to Endpoint of Modified BPI Subscales, Worst, Least and Average Pain Intensity, Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Worst Pain Intensity | -3.0 units on a scale | Standard Deviation 3.09 |
Secondary
Mean Change From Baseline to Endpoint of Modified Brief Pain Inventory (BPI) Subscale, Interference With Daily Functions, Following Treatment With DS-5565 Compared to Pregabalin and Placebo
The Modified Brief Pain Inventory (BPI) includes Interference with Daily Functions Subscale, Worst Pain Intensity, Least Pain Intensity, Average Pain Intensity, Pain Right Now, and Relief From Pain. The range of interference subscale is 0-10, where lower scores indicate a better outcome. The change from baseline to Week 5 in Modified Brief Pain Inventory is being reported. The greater the negative value, the greater the improvement in interference with daily functions.
Time frame: Baseline up to Week 5 postdose, up to 10 months total follow up
Population: Modified BPI was assessed in the Full Analysis Set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline to Endpoint of Modified Brief Pain Inventory (BPI) Subscale, Interference With Daily Functions, Following Treatment With DS-5565 Compared to Pregabalin and Placebo | -1.5 units on a scale | Standard Deviation 2.11 |
| Pregabalin 150 mg BID | Mean Change From Baseline to Endpoint of Modified Brief Pain Inventory (BPI) Subscale, Interference With Daily Functions, Following Treatment With DS-5565 Compared to Pregabalin and Placebo | -1.7 units on a scale | Standard Deviation 1.83 |
| DS-5565 5mg QD | Mean Change From Baseline to Endpoint of Modified Brief Pain Inventory (BPI) Subscale, Interference With Daily Functions, Following Treatment With DS-5565 Compared to Pregabalin and Placebo | -1.6 units on a scale | Standard Deviation 1.97 |
| DS-5565 10 mg QD | Mean Change From Baseline to Endpoint of Modified Brief Pain Inventory (BPI) Subscale, Interference With Daily Functions, Following Treatment With DS-5565 Compared to Pregabalin and Placebo | -2.5 units on a scale | Standard Deviation 2.11 |
| DS-5565 15 mg QD | Mean Change From Baseline to Endpoint of Modified Brief Pain Inventory (BPI) Subscale, Interference With Daily Functions, Following Treatment With DS-5565 Compared to Pregabalin and Placebo | -2.4 units on a scale | Standard Deviation 2.35 |
| DS-5565 10 mg BID | Mean Change From Baseline to Endpoint of Modified Brief Pain Inventory (BPI) Subscale, Interference With Daily Functions, Following Treatment With DS-5565 Compared to Pregabalin and Placebo | -2.1 units on a scale | Standard Deviation 2.51 |
| DS-5565 15 mg BID | Mean Change From Baseline to Endpoint of Modified Brief Pain Inventory (BPI) Subscale, Interference With Daily Functions, Following Treatment With DS-5565 Compared to Pregabalin and Placebo | -2.6 units on a scale | Standard Deviation 2.34 |
Secondary
Patient Global Impression of Change at End-of-Treatment or Early Termination Following Treatment With DS-5565 Compared to Pregabalin and Placebo
Patient Global Impression of Change (PGIC) has a range of 7 possible responses for overall status since start of the study, where 0 was defined as 'Very much improved' and 7 was defined as 'Very much worse'. Lower scores indicate a better outcome. PGIC was analyzed based on the following definitions: Participant's overall status was minimally improved or better (ie, score ≤3) or Participant's overall status was much improved or better (ie, score ≤ 2).
Time frame: Baseline up to Week 5 postdose, up to 10 months total follow up
Population: PGIC was assessed in the Full Analysis Set.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Placebo | Patient Global Impression of Change at End-of-Treatment or Early Termination Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Overall status is much improved or better (score ≤2) | Yes | 33 Participants |
| Placebo | Patient Global Impression of Change at End-of-Treatment or Early Termination Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Overall status is much improved or better (score ≤2) | No | 73 Participants |
| Placebo | Patient Global Impression of Change at End-of-Treatment or Early Termination Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Overall status is minimally improved or better (score ≤3) | Yes | 66 Participants |
| Placebo | Patient Global Impression of Change at End-of-Treatment or Early Termination Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Overall status is minimally improved or better (score ≤3) | No | 40 Participants |
| Pregabalin 150 mg BID | Patient Global Impression of Change at End-of-Treatment or Early Termination Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Overall status is minimally improved or better (score ≤3) | No | 17 Participants |
| Pregabalin 150 mg BID | Patient Global Impression of Change at End-of-Treatment or Early Termination Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Overall status is minimally improved or better (score ≤3) | Yes | 33 Participants |
| Pregabalin 150 mg BID | Patient Global Impression of Change at End-of-Treatment or Early Termination Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Overall status is much improved or better (score ≤2) | Yes | 19 Participants |
| Pregabalin 150 mg BID | Patient Global Impression of Change at End-of-Treatment or Early Termination Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Overall status is much improved or better (score ≤2) | No | 31 Participants |
| DS-5565 5mg QD | Patient Global Impression of Change at End-of-Treatment or Early Termination Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Overall status is minimally improved or better (score ≤3) | Yes | 45 Participants |
| DS-5565 5mg QD | Patient Global Impression of Change at End-of-Treatment or Early Termination Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Overall status is much improved or better (score ≤2) | No | 28 Participants |
| DS-5565 5mg QD | Patient Global Impression of Change at End-of-Treatment or Early Termination Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Overall status is much improved or better (score ≤2) | Yes | 27 Participants |
| DS-5565 5mg QD | Patient Global Impression of Change at End-of-Treatment or Early Termination Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Overall status is minimally improved or better (score ≤3) | No | 10 Participants |
| DS-5565 10 mg QD | Patient Global Impression of Change at End-of-Treatment or Early Termination Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Overall status is much improved or better (score ≤2) | Yes | 30 Participants |
| DS-5565 10 mg QD | Patient Global Impression of Change at End-of-Treatment or Early Termination Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Overall status is much improved or better (score ≤2) | No | 25 Participants |
| DS-5565 10 mg QD | Patient Global Impression of Change at End-of-Treatment or Early Termination Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Overall status is minimally improved or better (score ≤3) | Yes | 46 Participants |
| DS-5565 10 mg QD | Patient Global Impression of Change at End-of-Treatment or Early Termination Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Overall status is minimally improved or better (score ≤3) | No | 9 Participants |
| DS-5565 15 mg QD | Patient Global Impression of Change at End-of-Treatment or Early Termination Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Overall status is much improved or better (score ≤2) | Yes | 24 Participants |
| DS-5565 15 mg QD | Patient Global Impression of Change at End-of-Treatment or Early Termination Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Overall status is minimally improved or better (score ≤3) | No | 13 Participants |
| DS-5565 15 mg QD | Patient Global Impression of Change at End-of-Treatment or Early Termination Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Overall status is much improved or better (score ≤2) | No | 26 Participants |
| DS-5565 15 mg QD | Patient Global Impression of Change at End-of-Treatment or Early Termination Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Overall status is minimally improved or better (score ≤3) | Yes | 37 Participants |
| DS-5565 10 mg BID | Patient Global Impression of Change at End-of-Treatment or Early Termination Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Overall status is much improved or better (score ≤2) | No | 27 Participants |
| DS-5565 10 mg BID | Patient Global Impression of Change at End-of-Treatment or Early Termination Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Overall status is much improved or better (score ≤2) | Yes | 25 Participants |
| DS-5565 10 mg BID | Patient Global Impression of Change at End-of-Treatment or Early Termination Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Overall status is minimally improved or better (score ≤3) | Yes | 38 Participants |
| DS-5565 10 mg BID | Patient Global Impression of Change at End-of-Treatment or Early Termination Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Overall status is minimally improved or better (score ≤3) | No | 14 Participants |
| DS-5565 15 mg BID | Patient Global Impression of Change at End-of-Treatment or Early Termination Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Overall status is minimally improved or better (score ≤3) | Yes | 44 Participants |
| DS-5565 15 mg BID | Patient Global Impression of Change at End-of-Treatment or Early Termination Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Overall status is much improved or better (score ≤2) | Yes | 28 Participants |
| DS-5565 15 mg BID | Patient Global Impression of Change at End-of-Treatment or Early Termination Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Overall status is much improved or better (score ≤2) | No | 28 Participants |
| DS-5565 15 mg BID | Patient Global Impression of Change at End-of-Treatment or Early Termination Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Overall status is minimally improved or better (score ≤3) | No | 12 Participants |
Secondary
Short-Form McGill Pain Questionnaire (SF-MPQ) Present Pain Intensity Change From Baseline to Endpoint Following Treatment With DS-5565 Compared to Pregabalin and Placebo
The SF-MPQ present pain intensity ranges from 0 (no pain) to 5 (excruciating), where lower scores indicate a better outcome. The change from baseline to Week 5 in SF-MPQ present pain intensity is being reported. The greater the negative value, the greater the improvement in present pain intensity.
Time frame: Baseline up to Week 5 postdose, up to 10 months total follow up
Population: SF-MPQ present pain intensity was assessed in the Full Analysis Set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Short-Form McGill Pain Questionnaire (SF-MPQ) Present Pain Intensity Change From Baseline to Endpoint Following Treatment With DS-5565 Compared to Pregabalin and Placebo | -0.85 units on a scale | Standard Deviation 1.21 |
| Pregabalin 150 mg BID | Short-Form McGill Pain Questionnaire (SF-MPQ) Present Pain Intensity Change From Baseline to Endpoint Following Treatment With DS-5565 Compared to Pregabalin and Placebo | -0.84 units on a scale | Standard Deviation 0.96 |
| DS-5565 5mg QD | Short-Form McGill Pain Questionnaire (SF-MPQ) Present Pain Intensity Change From Baseline to Endpoint Following Treatment With DS-5565 Compared to Pregabalin and Placebo | -1.00 units on a scale | Standard Deviation 0.86 |
| DS-5565 10 mg QD | Short-Form McGill Pain Questionnaire (SF-MPQ) Present Pain Intensity Change From Baseline to Endpoint Following Treatment With DS-5565 Compared to Pregabalin and Placebo | -1.04 units on a scale | Standard Deviation 1.23 |
| DS-5565 15 mg QD | Short-Form McGill Pain Questionnaire (SF-MPQ) Present Pain Intensity Change From Baseline to Endpoint Following Treatment With DS-5565 Compared to Pregabalin and Placebo | -0.90 units on a scale | Standard Deviation 1.03 |
| DS-5565 10 mg BID | Short-Form McGill Pain Questionnaire (SF-MPQ) Present Pain Intensity Change From Baseline to Endpoint Following Treatment With DS-5565 Compared to Pregabalin and Placebo | -0.73 units on a scale | Standard Deviation 1.34 |
| DS-5565 15 mg BID | Short-Form McGill Pain Questionnaire (SF-MPQ) Present Pain Intensity Change From Baseline to Endpoint Following Treatment With DS-5565 Compared to Pregabalin and Placebo | -1.02 units on a scale | Standard Deviation 1.15 |
Secondary
Short-Form McGill Pain Questionnaire (SF-MPQ) Sensory and Affective Scores Change From Baseline to Endpoint Following Treatment With DS-5565 Compared to Pregabalin and Placebo
The SF-MPQ sensory score is the sum of 11 pain descriptors each scored from 0 to 3: throbbing, shooting, stabbing, sharp cramping, gnawing, hot-burning, aching, heavy, tender, and splitting. Thus, the SF-MPQ sensory score ranges from 0 to 33, where lower scores indicate a better outcome. The SF-MPQ affective score is the sum of four pain descriptors each scored from 0 to 3: tiring-exhausting, sickening, fearful, and punishing cruel. Thus, SF-MPQ affective score ranges from 0 to 12, where lower scores indicate a better outcome. The change from baseline to Week 5 in SF-MPQ sensory and affective scores are being reported. The greater the negative value, the greater the improvement in sensory and affective scores.
Time frame: Baseline up to Week 5 postdose, up to 10 months total follow up
Population: SF-MPQ sensory and affective scores were assessed in the Full Analysis Set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Short-Form McGill Pain Questionnaire (SF-MPQ) Sensory and Affective Scores Change From Baseline to Endpoint Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Sensory score | -6.29 units on a scale | Standard Deviation 6.77 |
| Placebo | Short-Form McGill Pain Questionnaire (SF-MPQ) Sensory and Affective Scores Change From Baseline to Endpoint Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Affective score | -2.10 units on a scale | Standard Deviation 2.93 |
| Pregabalin 150 mg BID | Short-Form McGill Pain Questionnaire (SF-MPQ) Sensory and Affective Scores Change From Baseline to Endpoint Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Sensory score | -5.94 units on a scale | Standard Deviation 7.32 |
| Pregabalin 150 mg BID | Short-Form McGill Pain Questionnaire (SF-MPQ) Sensory and Affective Scores Change From Baseline to Endpoint Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Affective score | -1.98 units on a scale | Standard Deviation 3.19 |
| DS-5565 5mg QD | Short-Form McGill Pain Questionnaire (SF-MPQ) Sensory and Affective Scores Change From Baseline to Endpoint Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Sensory score | -8.02 units on a scale | Standard Deviation 6.62 |
| DS-5565 5mg QD | Short-Form McGill Pain Questionnaire (SF-MPQ) Sensory and Affective Scores Change From Baseline to Endpoint Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Affective score | -2.35 units on a scale | Standard Deviation 2.8 |
| DS-5565 10 mg QD | Short-Form McGill Pain Questionnaire (SF-MPQ) Sensory and Affective Scores Change From Baseline to Endpoint Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Sensory score | -8.73 units on a scale | Standard Deviation 6.7 |
| DS-5565 10 mg QD | Short-Form McGill Pain Questionnaire (SF-MPQ) Sensory and Affective Scores Change From Baseline to Endpoint Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Affective score | -2.44 units on a scale | Standard Deviation 3.07 |
| DS-5565 15 mg QD | Short-Form McGill Pain Questionnaire (SF-MPQ) Sensory and Affective Scores Change From Baseline to Endpoint Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Sensory score | -6.86 units on a scale | Standard Deviation 6.77 |
| DS-5565 15 mg QD | Short-Form McGill Pain Questionnaire (SF-MPQ) Sensory and Affective Scores Change From Baseline to Endpoint Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Affective score | -1.84 units on a scale | Standard Deviation 2.28 |
| DS-5565 10 mg BID | Short-Form McGill Pain Questionnaire (SF-MPQ) Sensory and Affective Scores Change From Baseline to Endpoint Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Sensory score | -6.56 units on a scale | Standard Deviation 7.42 |
| DS-5565 10 mg BID | Short-Form McGill Pain Questionnaire (SF-MPQ) Sensory and Affective Scores Change From Baseline to Endpoint Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Affective score | -1.40 units on a scale | Standard Deviation 3.19 |
| DS-5565 15 mg BID | Short-Form McGill Pain Questionnaire (SF-MPQ) Sensory and Affective Scores Change From Baseline to Endpoint Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Sensory score | -8.55 units on a scale | Standard Deviation 6.84 |
| DS-5565 15 mg BID | Short-Form McGill Pain Questionnaire (SF-MPQ) Sensory and Affective Scores Change From Baseline to Endpoint Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Affective score | -2.23 units on a scale | Standard Deviation 2.74 |
Secondary
Short-Form McGill Pain Questionnaire (SF-MPQ) Total Score and Visual Analog Scale Change From Baseline to Endpoint Following Treatment With DS-5565 Compared to Pregabalin and Placebo
The SF-MPQ sensory score is the sum of 11 pain descriptors each scored from 0 to 3: throbbing, shooting, stabbing, sharp cramping, gnawing, hot-burning, aching, heavy, tender, and splitting. Thus, the SF-MPQ sensory score ranges from 0 to 33, where lower scores indicate a better outcome. The SF-MPQ affective score is the sum of four pain descriptors each scored from 0 to 3: tiring-exhausting, sickening, fearful, and punishing cruel. Thus, SF-MPQ affective score ranges from 0 to 12, where lower scores indicate a better outcome. The SF-MPQ total score comprises the sum of the sensory and affective scores. The SF-MPQ VAS ranges from 0 (no pain) to 100 (worst possible pain), where lower scores indicate a better outcome. The change from baseline to Week 5 in SF-MPQ total score and VAS are being reported. The greater the negative value, the greater the improvement in total score (sensory and affective scores) and VAS pain.
Time frame: Baseline up to Week 5 postdose, up to 10 months total follow up
Population: SF-MPQ total score and VAS pain were assessed in the Full Analysis Set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Short-Form McGill Pain Questionnaire (SF-MPQ) Total Score and Visual Analog Scale Change From Baseline to Endpoint Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Total score | -8.39 units on a scale | Standard Deviation 8.91 |
| Placebo | Short-Form McGill Pain Questionnaire (SF-MPQ) Total Score and Visual Analog Scale Change From Baseline to Endpoint Following Treatment With DS-5565 Compared to Pregabalin and Placebo | VAS pain | -20.84 units on a scale | Standard Deviation 25.12 |
| Pregabalin 150 mg BID | Short-Form McGill Pain Questionnaire (SF-MPQ) Total Score and Visual Analog Scale Change From Baseline to Endpoint Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Total score | -7.92 units on a scale | Standard Deviation 9.89 |
| Pregabalin 150 mg BID | Short-Form McGill Pain Questionnaire (SF-MPQ) Total Score and Visual Analog Scale Change From Baseline to Endpoint Following Treatment With DS-5565 Compared to Pregabalin and Placebo | VAS pain | -19.28 units on a scale | Standard Deviation 24.27 |
| DS-5565 5mg QD | Short-Form McGill Pain Questionnaire (SF-MPQ) Total Score and Visual Analog Scale Change From Baseline to Endpoint Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Total score | -10.36 units on a scale | Standard Deviation 8.54 |
| DS-5565 5mg QD | Short-Form McGill Pain Questionnaire (SF-MPQ) Total Score and Visual Analog Scale Change From Baseline to Endpoint Following Treatment With DS-5565 Compared to Pregabalin and Placebo | VAS pain | -27.40 units on a scale | Standard Deviation 22.52 |
| DS-5565 10 mg QD | Short-Form McGill Pain Questionnaire (SF-MPQ) Total Score and Visual Analog Scale Change From Baseline to Endpoint Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Total score | -11.16 units on a scale | Standard Deviation 9.29 |
| DS-5565 10 mg QD | Short-Form McGill Pain Questionnaire (SF-MPQ) Total Score and Visual Analog Scale Change From Baseline to Endpoint Following Treatment With DS-5565 Compared to Pregabalin and Placebo | VAS pain | -28.56 units on a scale | Standard Deviation 23.67 |
| DS-5565 15 mg QD | Short-Form McGill Pain Questionnaire (SF-MPQ) Total Score and Visual Analog Scale Change From Baseline to Endpoint Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Total score | -8.71 units on a scale | Standard Deviation 8.11 |
| DS-5565 15 mg QD | Short-Form McGill Pain Questionnaire (SF-MPQ) Total Score and Visual Analog Scale Change From Baseline to Endpoint Following Treatment With DS-5565 Compared to Pregabalin and Placebo | VAS pain | -28.73 units on a scale | Standard Deviation 26.73 |
| DS-5565 10 mg BID | Short-Form McGill Pain Questionnaire (SF-MPQ) Total Score and Visual Analog Scale Change From Baseline to Endpoint Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Total score | -7.96 units on a scale | Standard Deviation 9.77 |
| DS-5565 10 mg BID | Short-Form McGill Pain Questionnaire (SF-MPQ) Total Score and Visual Analog Scale Change From Baseline to Endpoint Following Treatment With DS-5565 Compared to Pregabalin and Placebo | VAS pain | -25.45 units on a scale | Standard Deviation 25.46 |
| DS-5565 15 mg BID | Short-Form McGill Pain Questionnaire (SF-MPQ) Total Score and Visual Analog Scale Change From Baseline to Endpoint Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Total score | -10.79 units on a scale | Standard Deviation 8.94 |
| DS-5565 15 mg BID | Short-Form McGill Pain Questionnaire (SF-MPQ) Total Score and Visual Analog Scale Change From Baseline to Endpoint Following Treatment With DS-5565 Compared to Pregabalin and Placebo | VAS pain | -32.82 units on a scale | Standard Deviation 26.97 |