Trial Outcomes & Findings for Treatment of Pain Associated With Fibromyalgia (NCT NCT02187471)

Last Updated: 2020-11-09

Results Overview

Average daily pain scores (ADPS) reported by the participant that best describes his or her worst pain over the previous 24 hours. A daily pain score has a scale where 0 = no pain to 10 = worst possible pain. Higher scores indicate a worse outcome. For participants with no Week 13 data, the baseline observation was carried forward (BOCF). The mean (multiple imputation estimate) and standard error (multiple imputation) are reported.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1301 participants

Primary outcome timeframe

Baseline up to Week 13 postdose

Results posted on

2020-11-09

Participant Flow

A total of 2526 participants who met all inclusion criteria and no exclusion criteria were enrolled from 16 Jan 2015 to 12 Jan 2017 at 182 sites. Of the 2526 participants enrolled, 1301 were randomized to treatment.

Eligible participants were randomized 1:1:1:1 to either DS-5565 15 mg every day (QD) given orally, DS-5565 15 mg twice daily (BID) given orally, placebo given orally as pregabalin placebo and DS-5565 placebo BID, or pregabalin 150 mg BID.

Participant milestones

Participant milestones
Measure	Placebo Participants who received oral DS-5565 placebo and pregabalin placebo in the morning and evening.	Pregabalin 150 mg BID Participants who received oral DS-5565 placebo and pregabalin 150 mg BID in the morning and evening.	DS-5565 15 mg QD Participants who received oral DS-5565 placebo and pregabalin placebo in the morning and DS-5565 15 mg and pregabalin placebo in the evening.	DS-5565 15 mg BID Participants who received oral DS-5565 15 mg and pregabalin placebo in the morning and evening.
Overall Study STARTED	325	324	326	326
Overall Study COMPLETED	249	242	240	246
Overall Study NOT COMPLETED	76	82	86	80

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants who received oral DS-5565 placebo and pregabalin placebo in the morning and evening.	Pregabalin 150 mg BID Participants who received oral DS-5565 placebo and pregabalin 150 mg BID in the morning and evening.	DS-5565 15 mg QD Participants who received oral DS-5565 placebo and pregabalin placebo in the morning and DS-5565 15 mg and pregabalin placebo in the evening.	DS-5565 15 mg BID Participants who received oral DS-5565 15 mg and pregabalin placebo in the morning and evening.
Overall Study Protocol Violation	4	5	4	4
Overall Study Missing	0	0	0	1
Overall Study Lack of Efficacy	18	9	13	11
Overall Study Adverse Event	24	34	44	36
Overall Study Withdrawal by Subject	23	29	22	24
Overall Study Other	7	5	3	4

Baseline Characteristics

Treatment of Pain Associated With Fibromyalgia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=325 Participants Participants who received oral DS-5565 placebo and pregabalin placebo in the morning and evening.	Pregabalin 150 mg BID n=324 Participants Participants who received oral DS-5565 placebo and pregabalin 150 mg BID in the morning and evening.	DS-5565 15 mg QD n=326 Participants Participants who received oral DS-5565 placebo and pregabalin placebo in the morning and DS-5565 15 mg and pregabalin placebo in the evening.	DS-5565 15 mg BID n=326 Participants Participants who received oral DS-5565 15 mg and pregabalin placebo in the morning and evening.	Total n=1301 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Age, Categorical Between 18 and 65 years	296 Participants n=93 Participants	294 Participants n=4 Participants	294 Participants n=27 Participants	290 Participants n=483 Participants	1174 Participants n=36 Participants
Age, Categorical >=65 years	29 Participants n=93 Participants	30 Participants n=4 Participants	32 Participants n=27 Participants	36 Participants n=483 Participants	127 Participants n=36 Participants
Age, Continuous	48.9 years STANDARD_DEVIATION 11.16 • n=93 Participants	49.9 years STANDARD_DEVIATION 12.02 • n=4 Participants	50.1 years STANDARD_DEVIATION 11.22 • n=27 Participants	49.0 years STANDARD_DEVIATION 12.03 • n=483 Participants	49.5 years STANDARD_DEVIATION 11.62 • n=36 Participants
Sex: Female, Male Female	303 Participants n=93 Participants	302 Participants n=4 Participants	302 Participants n=27 Participants	296 Participants n=483 Participants	1203 Participants n=36 Participants
Sex: Female, Male Male	22 Participants n=93 Participants	22 Participants n=4 Participants	24 Participants n=27 Participants	30 Participants n=483 Participants	98 Participants n=36 Participants
Region of Enrollment Colombia	0 participants n=93 Participants	0 participants n=4 Participants	1 participants n=27 Participants	0 participants n=483 Participants	1 participants n=36 Participants
Region of Enrollment Argentina	25 participants n=93 Participants	25 participants n=4 Participants	19 participants n=27 Participants	19 participants n=483 Participants	88 participants n=36 Participants
Region of Enrollment United States	190 participants n=93 Participants	190 participants n=4 Participants	190 participants n=27 Participants	190 participants n=483 Participants	760 participants n=36 Participants
Region of Enrollment Belarus	5 participants n=93 Participants	2 participants n=4 Participants	2 participants n=27 Participants	3 participants n=483 Participants	12 participants n=36 Participants
Region of Enrollment Portugal	8 participants n=93 Participants	8 participants n=4 Participants	1 participants n=27 Participants	5 participants n=483 Participants	22 participants n=36 Participants
Region of Enrollment Switzerland	0 participants n=93 Participants	0 participants n=4 Participants	1 participants n=27 Participants	0 participants n=483 Participants	1 participants n=36 Participants
Region of Enrollment Spain	25 participants n=93 Participants	25 participants n=4 Participants	27 participants n=27 Participants	24 participants n=483 Participants	101 participants n=36 Participants
Region of Enrollment Austria	4 participants n=93 Participants	4 participants n=4 Participants	10 participants n=27 Participants	11 participants n=483 Participants	29 participants n=36 Participants
Region of Enrollment Belgium	5 participants n=93 Participants	5 participants n=4 Participants	3 participants n=27 Participants	2 participants n=483 Participants	15 participants n=36 Participants
Region of Enrollment Poland	20 participants n=93 Participants	21 participants n=4 Participants	23 participants n=27 Participants	22 participants n=483 Participants	86 participants n=36 Participants
Region of Enrollment Mexico	9 participants n=93 Participants	4 participants n=4 Participants	9 participants n=27 Participants	7 participants n=483 Participants	29 participants n=36 Participants
Region of Enrollment Slovenia	4 participants n=93 Participants	2 participants n=4 Participants	4 participants n=27 Participants	1 participants n=483 Participants	11 participants n=36 Participants
Region of Enrollment Chile	7 participants n=93 Participants	11 participants n=4 Participants	12 participants n=27 Participants	15 participants n=483 Participants	45 participants n=36 Participants
Region of Enrollment Russia	7 participants n=93 Participants	7 participants n=4 Participants	6 participants n=27 Participants	7 participants n=483 Participants	27 participants n=36 Participants
Region of Enrollment Ukraine	16 participants n=93 Participants	20 participants n=4 Participants	18 participants n=27 Participants	20 participants n=483 Participants	74 participants n=36 Participants

PRIMARY outcome

Timeframe: Baseline up to Week 13 postdose

Population: This outcome was assessed using the modified intent-to-treat analysis set.

Outcome measures

Outcome measures
Measure	Placebo n=323 Participants Participants who received oral DS-5565 placebo and pregabalin placebo in the morning and evening.	Pregabalin 150 mg BID n=319 Participants Participants who received oral DS-5565 placebo and pregabalin 150 mg BID in the morning and evening.	DS-5565 15 mg QD n=324 Participants Participants who received oral DS-5565 placebo and pregabalin placebo in the morning and DS-5565 15 mg and pregabalin placebo in the evening.	DS-5565 15 mg BID n=322 Participants Participants who received oral DS-5565 15 mg and pregabalin placebo in the morning and evening.
Change From Baseline to Week 13 in Average Daily Pain Score (ADPS) Among Participants Receiving DS-5565, Pregabalin, or Placebo	-1.90 units on a scale Standard Error 0.135	-2.64 units on a scale Standard Error 0.137	-2.04 units on a scale Standard Error 0.138	-2.30 units on a scale Standard Error 0.136

SECONDARY outcome

Timeframe: Baseline up to Week 13 postdose

Population: This outcome was assessed using the modified intent-to-treat analysis set.

Patient global impression of change (PGIC) on a 7-point categorical scale, where 1 = very much improved and 7 = very much worse. Higher scores indicate worse outcomes. The number of participants with 'much improved or better' status (≤2) is being reported.

Outcome measures

Outcome measures
Measure	Placebo n=324 Participants Participants who received oral DS-5565 placebo and pregabalin placebo in the morning and evening.	Pregabalin 150 mg BID n=319 Participants Participants who received oral DS-5565 placebo and pregabalin 150 mg BID in the morning and evening.	DS-5565 15 mg QD n=324 Participants Participants who received oral DS-5565 placebo and pregabalin placebo in the morning and DS-5565 15 mg and pregabalin placebo in the evening.	DS-5565 15 mg BID n=323 Participants Participants who received oral DS-5565 15 mg and pregabalin placebo in the morning and evening.
Number of Participants Who Answered "Much Improved or Better" in Patient Global Impression of Change at Week 13 Receiving DS-5565, Pregabalin, or Placebo	88 Participants	145 Participants	127 Participants	134 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 13 postdose

Population: This outcome was assessed using the modified intent-to-treat analysis set.

The total FIQ score is composed of 10 items, with a maximum possible score of 100. The first item contains 11 questions related to physical functioning and are rated on a 4-point Likert-type scale, where 0 indicates 'always' and 3 indicates 'never'. The overall impact items are rated on a 0-7 scale for the number of days that the patient felt well and the number of days they were unable to work (including housework) because of fibromyalgia symptoms. The symptoms items are rated on visual analog scales (0-10 cm), with higher numbers indicated greater symptomatology. Final scores range from 0 (no impairment) to 10 (maximum impairment), where higher scores indicate worse outcome. For this outcome, the change in total FIQ score from baseline is being reported. Negative values indicate improvement from baseline in impairment.

Outcome measures

Outcome measures
Measure	Placebo n=322 Participants Participants who received oral DS-5565 placebo and pregabalin placebo in the morning and evening.	Pregabalin 150 mg BID n=318 Participants Participants who received oral DS-5565 placebo and pregabalin 150 mg BID in the morning and evening.	DS-5565 15 mg QD n=323 Participants Participants who received oral DS-5565 placebo and pregabalin placebo in the morning and DS-5565 15 mg and pregabalin placebo in the evening.	DS-5565 15 mg BID n=320 Participants Participants who received oral DS-5565 15 mg and pregabalin placebo in the morning and evening.
Change From Baseline to Week 13 in Average Score on the Fibromyalgia Index Questionnaire (FIQ) in Participants Receiving DS-5565, Pregabalin, or Placebo	-15.02 units on a scale Standard Error 1.198	-19.42 units on a scale Standard Error 1.222	-16.61 units on a scale Standard Error 1.215	-20.44 units on a scale Standard Error 1.209

SECONDARY outcome

Timeframe: Week 13 postdose

Population: This outcome was assessed using the modified intent-to-treat analysis set.

The ADPS responder rate was defined a priori as the proportion of participants who met the clinically relevant reductions (ie, ≥30% and ≥50%) in ADPS at Week 13 (baseline observation carried forward) compared to Baseline.

Outcome measures

Outcome measures
Measure	Placebo n=324 Participants Participants who received oral DS-5565 placebo and pregabalin placebo in the morning and evening.	Pregabalin 150 mg BID n=319 Participants Participants who received oral DS-5565 placebo and pregabalin 150 mg BID in the morning and evening.	DS-5565 15 mg QD n=324 Participants Participants who received oral DS-5565 placebo and pregabalin placebo in the morning and DS-5565 15 mg and pregabalin placebo in the evening.	DS-5565 15 mg BID n=323 Participants Participants who received oral DS-5565 15 mg and pregabalin placebo in the morning and evening.
Number of Participants Classified As Responders at Week 13 Among Participants Receiving DS-5565, Pregabalin, or Placebo 30% Responders	122 Participants	144 Participants	121 Participants	125 Participants
Number of Participants Classified As Responders at Week 13 Among Participants Receiving DS-5565, Pregabalin, or Placebo 50% Responders	68 Participants	95 Participants	77 Participants	89 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 13 postdose

Population: MFI-20 was assessed in the modified intent-to-treat population.

MFI is a validated 20-item, self-reported instrument designed to measure fatigue in the following dimensions: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. The respondent is asked to mark an 'X' in 1 of 5 boxes arranged linearly where 1 is 'Yes, that is true' and 5 is 'No, that is not true.' Each subscale consists of 4 items, 2 indicative for fatigue and 2 contraindicative. For the indicative questions, a high score indicates a high fatigue level and low scores indicate a low fatigue levels. Conversely, for the contraindicative questions a high score indicates a low fatigue level and a low score indicates a high fatigue level. Overall, respondents are rated on a scale of 0 (no fatigue) to 7 (high fatigue). For this outcome, the change from baseline in MFI-20 general fatigue subscale score is being reported. Negative values indicate an improvement in fatigue.

Outcome measures

Outcome measures
Measure	Placebo n=307 Participants Participants who received oral DS-5565 placebo and pregabalin placebo in the morning and evening.	Pregabalin 150 mg BID n=299 Participants Participants who received oral DS-5565 placebo and pregabalin 150 mg BID in the morning and evening.	DS-5565 15 mg QD n=301 Participants Participants who received oral DS-5565 placebo and pregabalin placebo in the morning and DS-5565 15 mg and pregabalin placebo in the evening.	DS-5565 15 mg BID n=300 Participants Participants who received oral DS-5565 15 mg and pregabalin placebo in the morning and evening.
Change From Baseline to Week 13 in Multidimensional Fatigue Inventory (MFI-20) General Fatigue Score Among Participants Receiving DS-5565, Pregabalin, or Placebo	-1.6 units on a scale Standard Deviation 3.55	-2.6 units on a scale Standard Deviation 4.00	-2.4 units on a scale Standard Deviation 3.91	-3.4 units on a scale Standard Deviation 4.54

SECONDARY outcome

Timeframe: Baseline up to Week 13 postdose

Population: This outcome was assessed in the modified intent-to-treat analysis set.

The HADS questionnaire is a reliable, widely-used self-assessment scale to assess symptoms of anxiety and depression. The instrument consists of 7 questions related to anxiety and 7 related to depression, each rated on a 4-point scale (score of 0 to 3). Scores for anxiety and depression are independently summed to compute HADS-Anxiety and HADS-Depression subscale scores, with ranges from 0 to 21, where higher scores indicate greater severity.

Outcome measures

Outcome measures
Measure	Placebo n=324 Participants Participants who received oral DS-5565 placebo and pregabalin placebo in the morning and evening.	Pregabalin 150 mg BID n=299 Participants Participants who received oral DS-5565 placebo and pregabalin 150 mg BID in the morning and evening.	DS-5565 15 mg QD n=324 Participants Participants who received oral DS-5565 placebo and pregabalin placebo in the morning and DS-5565 15 mg and pregabalin placebo in the evening.	DS-5565 15 mg BID n=323 Participants Participants who received oral DS-5565 15 mg and pregabalin placebo in the morning and evening.
Change From Baseline to Week 13 in Hospital Anxiety and Depression Scale (HADS) Measure Among Participants Receiving DS-5565, Pregabalin, or Placebo Change from baseline at Week 13: Anxiety	-1.0 units on a scale Standard Deviation 3.58	-0.9 units on a scale Standard Deviation 3.81	-1.0 units on a scale Standard Deviation 3.78	-1.0 units on a scale Standard Deviation 4.10
Change From Baseline to Week 13 in Hospital Anxiety and Depression Scale (HADS) Measure Among Participants Receiving DS-5565, Pregabalin, or Placebo Change from baseline at Week 13: Depression	-0.8 units on a scale Standard Deviation 3.67	-1.0 units on a scale Standard Deviation 4.07	-1.0 units on a scale Standard Deviation 3.80	-1.2 units on a scale Standard Deviation 3.69

SECONDARY outcome

Timeframe: Baseline up to Week 13 postdose

Population: This outcome was assessed in the modified intent-to-treat analysis set.

The SF-36 is a generic health survey that asks 36 questions to measure functional health and well-being from the patient's point of view. The SF-36 provides scores for 8 health domains (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health) as well as psychometrically-based physical component summary (PCS) and mental component summary (MCS) scores. Each scale is transformed into a 0-100 scale with each question carrying the same weight. The lower the score indicates more disability (ie, worse outcome).

Outcome measures

Outcome measures
Measure	Placebo n=324 Participants Participants who received oral DS-5565 placebo and pregabalin placebo in the morning and evening.	Pregabalin 150 mg BID n=319 Participants Participants who received oral DS-5565 placebo and pregabalin 150 mg BID in the morning and evening.	DS-5565 15 mg QD n=324 Participants Participants who received oral DS-5565 placebo and pregabalin placebo in the morning and DS-5565 15 mg and pregabalin placebo in the evening.	DS-5565 15 mg BID n=323 Participants Participants who received oral DS-5565 15 mg and pregabalin placebo in the morning and evening.
Change From Baseline to Week 13 in Short Form 36 (SF-36) Measure Among Participants Receiving DS-5565, Pregabalin, or Placebo Change from baseline to Week 13:Physical Component	3.78 units on a scale Standard Deviation 7.22	6.46 units on a scale Standard Deviation 8.32	5.94 units on a scale Standard Deviation 8.06	6.22 units on a scale Standard Deviation 8.46
Change From Baseline to Week 13 in Short Form 36 (SF-36) Measure Among Participants Receiving DS-5565, Pregabalin, or Placebo Change from baseline to Week 13: Mental Component	2.23 units on a scale Standard Deviation 9.54	1.97 units on a scale Standard Deviation 10.53	1.56 units on a scale Standard Deviation 10.19	2.71 units on a scale Standard Deviation 9.67

SECONDARY outcome

Timeframe: Baseline up to Week 13 postdose

Population: This outcome was assessed in the modified intent-to-treat analysis set.

The EQ-5D is an instrument that shows high construct validity and responsiveness in patients with chronic pain and has been used specifically in fibromyalgia. The EQ-5D includes a descriptive section with 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each with a scale that ranges from 0 (no problems) to 5 (extreme problems). These 5 dimensions are combined into an overall health utilities index, and an numeric rating scale (100 mm visual analog scale) that measures perception of overall health, with 0 indicating worst health and 100 representing best imaginable health. A summary index with a maximum total score of 1 can be derived from these five dimensions by conversion with a table of scores. The maximum total score of 1 indicates the best health outcome. For this outcome, the change from baseline in total EQ-5D score is being reported. Positive values indicate an improvement in health.

Outcome measures

Outcome measures
Measure	Placebo n=307 Participants Participants who received oral DS-5565 placebo and pregabalin placebo in the morning and evening.	Pregabalin 150 mg BID n=299 Participants Participants who received oral DS-5565 placebo and pregabalin 150 mg BID in the morning and evening.	DS-5565 15 mg QD n=301 Participants Participants who received oral DS-5565 placebo and pregabalin placebo in the morning and DS-5565 15 mg and pregabalin placebo in the evening.	DS-5565 15 mg BID n=300 Participants Participants who received oral DS-5565 15 mg and pregabalin placebo in the morning and evening.
Change From Baseline to Week 13 in EuroQol Five Dimensions Questionnaire (EQ-5D) Measure Among Participants Receiving DS-5565, Pregabalin, or Placebo	0.09 units on a scale Standard Deviation 0.19	0.1274 units on a scale Standard Deviation 0.20	0.10 units on a scale Standard Deviation 0.19	0.11 units on a scale Standard Deviation 0.21

SECONDARY outcome

Timeframe: Baseline up to Week 13 postdose

Population: This outcome was assessed using the modified intent-to-treat analysis set.

Pain-associated sleep interference will be assessed using the Average Daily Sleep Interference Score that utilize electronic daily diaries with an 11-point numeric rating scale (NRS) for pain, ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep, unable to sleep). Higher scores indicate worse outcomes.

Outcome measures

Outcome measures
Measure	Placebo n=324 Participants Participants who received oral DS-5565 placebo and pregabalin placebo in the morning and evening.	Pregabalin 150 mg BID n=319 Participants Participants who received oral DS-5565 placebo and pregabalin 150 mg BID in the morning and evening.	DS-5565 15 mg QD n=324 Participants Participants who received oral DS-5565 placebo and pregabalin placebo in the morning and DS-5565 15 mg and pregabalin placebo in the evening.	DS-5565 15 mg BID n=323 Participants Participants who received oral DS-5565 15 mg and pregabalin placebo in the morning and evening.
Change From Baseline to Week 13 in Average Daily Sleep Interference Score (ADSIS) Among Participants Receiving DS-5565, Pregabalin, or Placebo	-1.76 units on a scale Standard Deviation 0.116	-2.71 units on a scale Standard Deviation 0.116	-2.31 units on a scale Standard Deviation 0.117	-2.64 units on a scale Standard Deviation 0.116

SECONDARY outcome

Timeframe: Week 13 postdose

Population: This outcome was assessed using the modified intent-to-treat analysis set.

The MOS Sleep Scale is a 12-item questionnaire from which the following subscales were derived: sleep disturbance (4 items), quantity of sleep/optimal sleep (1 item), snoring (1 item), awakening due to shortness of breath or due to headache (1 item), sleep adequacy (2 items), and somnolence (3 items). In addition, values for sleep disturbances index (9 items), optimal sleep scale (1 item), and sleep quantity scale (1 item) were determined. Most subscales range from 0 to 100, where higher scores indicate more of the concept begin measured (eg., higher sleep disturbance scores indicate greater sleep disturbances).

Outcome measures

Outcome measures
Measure	Placebo n=324 Participants Participants who received oral DS-5565 placebo and pregabalin placebo in the morning and evening.	Pregabalin 150 mg BID n=319 Participants Participants who received oral DS-5565 placebo and pregabalin 150 mg BID in the morning and evening.	DS-5565 15 mg QD n=324 Participants Participants who received oral DS-5565 placebo and pregabalin placebo in the morning and DS-5565 15 mg and pregabalin placebo in the evening.	DS-5565 15 mg BID n=323 Participants Participants who received oral DS-5565 15 mg and pregabalin placebo in the morning and evening.
Number of Participants Reporting Optimal Sleep at Week 13 on the Medical Outcomes Study (MOS) Sleep Scale Among Participants Receiving DS-5565, Pregabalin, or Placebo	78 Participants	107 Participants	102 Participants	119 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 13 postdose

Population: This outcome was assessed using the modified intent-to-treat analysis set.

The BPI-SF measures pain severity and interference within the past 24 hours. Items are rated on an 11-point NRS from 0 to 10, where 0 indicates does not interfere and 10 indicates completely interferes. Severity score is the average of the responses to the 4 pain intensity items that assess the Worst/Least/Average pain in the last 24 hours and the Pain Right Now. The individual items being reported (using the same scale as noted above) are Severity, General Activity, Mood, Walking Ability, Normal Work, Relations With Other People, Sleep, and Enjoyment of Life. Percentage relief of treatment pain scale ranges from 100% (complete pain relief) to 0% (no pain relief) and higher percentages indicate better outcome. Interference % is the average of responses for General activity, Mood, Walking ability, Normal work, Relations with other people, Sleep, Enjoyment of life where 0% (no interference) to 100% (completely interferes) and negative (ie. lower) percentages indicate better outcomes.

Outcome measures

Outcome measures
Measure	Placebo n=324 Participants Participants who received oral DS-5565 placebo and pregabalin placebo in the morning and evening.	Pregabalin 150 mg BID n=319 Participants Participants who received oral DS-5565 placebo and pregabalin 150 mg BID in the morning and evening.	DS-5565 15 mg QD n=324 Participants Participants who received oral DS-5565 placebo and pregabalin placebo in the morning and DS-5565 15 mg and pregabalin placebo in the evening.	DS-5565 15 mg BID n=323 Participants Participants who received oral DS-5565 15 mg and pregabalin placebo in the morning and evening.
Change From Baseline at Week 13 in the Brief Pain Inventory Short Form (BPI-SF) Measure Among Participants Receiving DS-5565, Pregabalin, or Placebo Worst pain	-1.9 units on a scale Standard Deviation 2.26	-2.7 units on a scale Standard Deviation 2.78	-2.2 units on a scale Standard Deviation 2.48	-2.7 units on a scale Standard Deviation 2.52
Change From Baseline at Week 13 in the Brief Pain Inventory Short Form (BPI-SF) Measure Among Participants Receiving DS-5565, Pregabalin, or Placebo Least pain	-1.5 units on a scale Standard Deviation 2.48	-2.3 units on a scale Standard Deviation 2.58	-2.0 units on a scale Standard Deviation 2.43	-2.1 units on a scale Standard Deviation 2.53
Change From Baseline at Week 13 in the Brief Pain Inventory Short Form (BPI-SF) Measure Among Participants Receiving DS-5565, Pregabalin, or Placebo Average pain	-1.5 units on a scale Standard Deviation 2.11	-2.3 units on a scale Standard Deviation 2.27	-2.0 units on a scale Standard Deviation 2.28	-2.3 units on a scale Standard Deviation 2.39
Change From Baseline at Week 13 in the Brief Pain Inventory Short Form (BPI-SF) Measure Among Participants Receiving DS-5565, Pregabalin, or Placebo Pain right now	-2.1 units on a scale Standard Deviation 2.44	-2.8 units on a scale Standard Deviation 2.74	-2.5 units on a scale Standard Deviation 2.50	-2.9 units on a scale Standard Deviation 2.72
Change From Baseline at Week 13 in the Brief Pain Inventory Short Form (BPI-SF) Measure Among Participants Receiving DS-5565, Pregabalin, or Placebo Severity score	-1.75 units on a scale Standard Deviation 2.05	-2.55 units on a scale Standard Deviation 2.35	-2.16 units on a scale Standard Deviation 2.13	-2.51 units on a scale Standard Deviation 2.26
Change From Baseline at Week 13 in the Brief Pain Inventory Short Form (BPI-SF) Measure Among Participants Receiving DS-5565, Pregabalin, or Placebo Percentage of relief by treatment of pain	23.1 units on a scale Standard Deviation 31.93	32.6 units on a scale Standard Deviation 35.39	31.8 units on a scale Standard Deviation 32.28	36.0 units on a scale Standard Deviation 34.68
Change From Baseline at Week 13 in the Brief Pain Inventory Short Form (BPI-SF) Measure Among Participants Receiving DS-5565, Pregabalin, or Placebo Interference (%)	-16.19 units on a scale Standard Deviation 21.83	-23.55 units on a scale Standard Deviation 23.60	-21.66 units on a scale Standard Deviation 22.29	-25.97 units on a scale Standard Deviation 23.38
Change From Baseline at Week 13 in the Brief Pain Inventory Short Form (BPI-SF) Measure Among Participants Receiving DS-5565, Pregabalin, or Placebo General activity	-1.7 units on a scale Standard Deviation 2.60	-2.5 units on a scale Standard Deviation 2.87	-2.3 units on a scale Standard Deviation 2.69	-2.6 units on a scale Standard Deviation 2.82
Change From Baseline at Week 13 in the Brief Pain Inventory Short Form (BPI-SF) Measure Among Participants Receiving DS-5565, Pregabalin, or Placebo Mood	-1.6 units on a scale Standard Deviation 2.83	-2.1 units on a scale Standard Deviation 2.92	-1.9 units on a scale Standard Deviation 2.95	-2.4 units on a scale Standard Deviation 2.95
Change From Baseline at Week 13 in the Brief Pain Inventory Short Form (BPI-SF) Measure Among Participants Receiving DS-5565, Pregabalin, or Placebo Walking ability	-1.4 units on a scale Standard Deviation 2.66	-1.7 units on a scale Standard Deviation 2.96	-1.8 units on a scale Standard Deviation 2.73	-2.1 units on a scale Standard Deviation 2.66
Change From Baseline at Week 13 in the Brief Pain Inventory Short Form (BPI-SF) Measure Among Participants Receiving DS-5565, Pregabalin, or Placebo Normal work	-1.6 units on a scale Standard Deviation 2.52	-2.3 units on a scale Standard Deviation 2.93	-2.1 units on a scale Standard Deviation 2.63	-2.7 units on a scale Standard Deviation 2.73
Change From Baseline at Week 13 in the Brief Pain Inventory Short Form (BPI-SF) Measure Among Participants Receiving DS-5565, Pregabalin, or Placebo Relations with other people	-1.3 units on a scale Standard Deviation 2.89	-1.9 units on a scale Standard Deviation 3.03	-1.6 units on a scale Standard Deviation 2.95	-2.0 units on a scale Standard Deviation 2.97
Change From Baseline at Week 13 in the Brief Pain Inventory Short Form (BPI-SF) Measure Among Participants Receiving DS-5565, Pregabalin, or Placebo Sleep	-2.1 units on a scale Standard Deviation 3.13	-3.6 units on a scale Standard Deviation 3.13	-3.1 units on a scale Standard Deviation 3.06	-3.9 units on a scale Standard Deviation 3.08
Change From Baseline at Week 13 in the Brief Pain Inventory Short Form (BPI-SF) Measure Among Participants Receiving DS-5565, Pregabalin, or Placebo Enjoyment of life	-1.6 units on a scale Standard Deviation 2.94	-2.4 units on a scale Standard Deviation 3.06	-2.3 units on a scale Standard Deviation 2.95	-2.4 units on a scale Standard Deviation 3.27

SECONDARY outcome

Timeframe: Week 1 to Week 13 postdose

Population: This outcome was assessed using the modified intent-to-treat analysis set.

Proportion of days with rescue medication intake during the double-blind treatment period equals number of days with rescue medication intake/(date of last study drug administration in the double-blind treatment period) - (date of first study drug administration + 1).

Outcome measures

Outcome measures
Measure	Placebo n=324 Participants Participants who received oral DS-5565 placebo and pregabalin placebo in the morning and evening.	Pregabalin 150 mg BID n=319 Participants Participants who received oral DS-5565 placebo and pregabalin 150 mg BID in the morning and evening.	DS-5565 15 mg QD n=324 Participants Participants who received oral DS-5565 placebo and pregabalin placebo in the morning and DS-5565 15 mg and pregabalin placebo in the evening.	DS-5565 15 mg BID n=323 Participants Participants who received oral DS-5565 15 mg and pregabalin placebo in the morning and evening.
Proportion of Days a Rescue Medication Was Used Among Participants Receiving DS-5565, Pregabalin, or Placebo	0.23 proportion of days Standard Deviation 0.32	0.15 proportion of days Standard Deviation 0.25	0.21 proportion of days Standard Deviation 0.31	0.16 proportion of days Standard Deviation 0.26

Adverse Events

Placebo

Serious events: 9 serious events

Other events: 171 other events

Deaths: 0 deaths

Pregabalin 150 mg BID

Serious events: 2 serious events

Other events: 289 other events

Deaths: 0 deaths

DS-5565 15 mg QD

Serious events: 5 serious events

Other events: 258 other events

Deaths: 0 deaths

DS-5565 15 mg BID

Serious events: 5 serious events

Other events: 247 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Placebo n=324 participants at risk Participants who received oral DS-5565 placebo and pregabalin placebo in the morning and evening.	Pregabalin 150 mg BID n=319 participants at risk Participants who received oral DS-5565 placebo and pregabalin 150 mg BID in the morning and evening.	DS-5565 15 mg QD n=324 participants at risk Participants who received oral DS-5565 placebo and pregabalin placebo in the morning and DS-5565 15 mg and pregabalin placebo in the evening.	DS-5565 15 mg BID n=323 participants at risk Participants who received oral DS-5565 15 mg and pregabalin placebo in the morning and evening.
Investigations Weight increased	6.8% 22/324 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last dose of study medication, up to 2 years 3 months. A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.	15.4% 49/319 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last dose of study medication, up to 2 years 3 months. A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.	8.0% 26/324 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last dose of study medication, up to 2 years 3 months. A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.	10.5% 34/323 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last dose of study medication, up to 2 years 3 months. A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
Nervous system disorders Dizziness	5.2% 17/324 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last dose of study medication, up to 2 years 3 months. A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.	17.6% 56/319 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last dose of study medication, up to 2 years 3 months. A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.	14.5% 47/324 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last dose of study medication, up to 2 years 3 months. A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.	11.1% 36/323 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last dose of study medication, up to 2 years 3 months. A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
Nervous system disorders Headache	15.4% 50/324 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last dose of study medication, up to 2 years 3 months. A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.	12.9% 41/319 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last dose of study medication, up to 2 years 3 months. A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.	12.0% 39/324 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last dose of study medication, up to 2 years 3 months. A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.	9.6% 31/323 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last dose of study medication, up to 2 years 3 months. A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
Nervous system disorders Somnolence	2.8% 9/324 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last dose of study medication, up to 2 years 3 months. A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.	12.5% 40/319 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last dose of study medication, up to 2 years 3 months. A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.	9.0% 29/324 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last dose of study medication, up to 2 years 3 months. A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.	12.1% 39/323 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last dose of study medication, up to 2 years 3 months. A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
General disorders Drug withdrawal syndrome	3.1% 10/324 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last dose of study medication, up to 2 years 3 months. A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.	3.8% 12/319 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last dose of study medication, up to 2 years 3 months. A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.	4.6% 15/324 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last dose of study medication, up to 2 years 3 months. A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.	6.5% 21/323 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last dose of study medication, up to 2 years 3 months. A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
General disorders Oedema peripheral	1.2% 4/324 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last dose of study medication, up to 2 years 3 months. A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.	5.6% 18/319 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last dose of study medication, up to 2 years 3 months. A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.	3.4% 11/324 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last dose of study medication, up to 2 years 3 months. A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.	4.6% 15/323 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last dose of study medication, up to 2 years 3 months. A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
Gastrointestinal disorders Nausea	3.4% 11/324 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last dose of study medication, up to 2 years 3 months. A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.	5.6% 18/319 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last dose of study medication, up to 2 years 3 months. A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.	7.7% 25/324 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last dose of study medication, up to 2 years 3 months. A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.	6.2% 20/323 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last dose of study medication, up to 2 years 3 months. A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
Musculoskeletal and connective tissue disorders Back pain	3.4% 11/324 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last dose of study medication, up to 2 years 3 months. A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.	3.4% 11/319 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last dose of study medication, up to 2 years 3 months. A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.	5.6% 18/324 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last dose of study medication, up to 2 years 3 months. A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.	2.2% 7/323 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last dose of study medication, up to 2 years 3 months. A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
Infections and infestations Urinary tract infection	4.3% 14/324 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last dose of study medication, up to 2 years 3 months. A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.	3.1% 10/319 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last dose of study medication, up to 2 years 3 months. A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.	6.2% 20/324 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last dose of study medication, up to 2 years 3 months. A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.	5.0% 16/323 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last dose of study medication, up to 2 years 3 months. A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
Infections and infestations Nasopharyngitis	4.0% 13/324 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last dose of study medication, up to 2 years 3 months. A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.	6.0% 19/319 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last dose of study medication, up to 2 years 3 months. A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.	4.0% 13/324 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last dose of study medication, up to 2 years 3 months. A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.	4.3% 14/323 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last dose of study medication, up to 2 years 3 months. A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
General disorders Fatigue	3.1% 10/324 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last dose of study medication, up to 2 years 3 months. A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.	4.7% 15/319 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last dose of study medication, up to 2 years 3 months. A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.	4.6% 15/324 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last dose of study medication, up to 2 years 3 months. A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.	4.3% 14/323 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last dose of study medication, up to 2 years 3 months. A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.

Additional Information

Daiichi Sankyo US Contact for Clinical Trial Results

Daiichi Sankyo, Inc.

Phone: 1-908-992-6400

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place