Trial Outcomes & Findings for Study of Pregabalin Versus Placebo in the Treatment of Nerve Pain Associated With HIV Neuropathy (NCT NCT00232141)

NCT ID: NCT00232141

Last Updated: 2021-02-09

Results Overview

Change from baseline in mean NRS-Pain scores at endpoint-LOCF. Daily pain scores were assessed on an 11-point numerical rating scale \<(NRS)-Pain\> ranging from 0 (no pain) to 10 (worst possible pain).

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 302 participants
• Primary outcome timeframe: Baseline, Week 14
• Results posted on: 2021-02-09

Participant Flow

43 centers in the United States; Study Initiation and Completion Dates: 6 October 2005 to 27 November 2007

A total of 472 subjects were screened for the study, and 302 subjects were randomized to study treatment.

Participant milestones

Measure	Pregabalin Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.	Placebo Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
Overall Study STARTED	151	151
Overall Study COMPLETED	120	125
Overall Study NOT COMPLETED	31	26

Reasons for withdrawal

Measure	Pregabalin Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.	Placebo Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
Overall Study Adverse Event	9	4
Overall Study Lack of Efficacy	0	3
Overall Study Lost to Follow-up	9	6
Overall Study Other	8	10
Overall Study Withdrawal by Subject	5	3

Baseline Characteristics

Study of Pregabalin Versus Placebo in the Treatment of Nerve Pain Associated With HIV Neuropathy

Baseline characteristics by cohort

Measure	Pregabalin n=151 Participants Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.	Placebo n=151 Participants Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.	Total n=302 Participants Total of all reporting groups
Age, Continuous	48.2 years STANDARD_DEVIATION 8.1 • n=93 Participants	46.8 years STANDARD_DEVIATION 7.5 • n=4 Participants	47.5 years STANDARD_DEVIATION 7.8 • n=27 Participants
Sex: Female, Male Female	26 Participants n=93 Participants	31 Participants n=4 Participants	57 Participants n=27 Participants
Sex: Female, Male Male	125 Participants n=93 Participants	120 Participants n=4 Participants	245 Participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline, Week 14

Population: ITT population (ie, full analysis set)=all randomized participants who took at least 1 dose \& had at least 1 post-randomization efficacy assessment. The endpoint-LOCF mean value was computed from last 7 diary entries (Day 2 up to and including the day after the last dose w/n Dose-Adjustment or Maintenance phase (up to Day 99).

Change from baseline in mean NRS-Pain scores at endpoint-LOCF. Daily pain scores were assessed on an 11-point numerical rating scale <(NRS)-Pain> ranging from 0 (no pain) to 10 (worst possible pain).

Outcome measures

Measure	Pregabalin n=141 Participants Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.	Placebo n=140 Participants Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
Change From Baseline for Numerical Rating Scale (NRS) Pain Scores at Endpoint-LOCF (Last Observation Carried Forward) Relative to Baseline	-2.88 score on scale Standard Error 0.21	-2.63 score on scale Standard Error 0.21

SECONDARY outcome

Timeframe: Baseline, Week 14

Population: ITT Population; n = number of participants with data for analysis (n=pregabalin, placebo).

Change from baseline in MOS-Sleep subscales & Sleep Problem Indices. Twelve item subject-rated questionnaire assessing sleep constructs. Scores range from 0 - 100 and higher scores reflect more impairment. Subscales "sleep adequacy", "quantity of sleep" and "optimal sleep" low scores reflect impairment.

Outcome measures

Measure	Pregabalin n=127 Participants Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.	Placebo n=128 Participants Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
Change From Baseline for MOS (Medical Outcomes Study)-Sleep Subscales and Sleep Problem Indices Disturbances (n=127,125)	-13.17 score on scale Standard Error 1.82	-14.71 score on scale Standard Error 1.83
Change From Baseline for MOS (Medical Outcomes Study)-Sleep Subscales and Sleep Problem Indices Quantity (n=123,122)	0.39 score on scale Standard Error 0.18	0.65 score on scale Standard Error 0.19
Change From Baseline for MOS (Medical Outcomes Study)-Sleep Subscales and Sleep Problem Indices Adequacy (n=126,128)	10.04 score on scale Standard Error 2.12	10.09 score on scale Standard Error 2.11
Change From Baseline for MOS (Medical Outcomes Study)-Sleep Subscales and Sleep Problem Indices Awaken Short of Breath or w/Headache (n=125,128)	-6.52 score on scale Standard Error 1.82	-7.93 score on scale Standard Error 1.80
Change From Baseline for MOS (Medical Outcomes Study)-Sleep Subscales and Sleep Problem Indices Somnolence (n=125,128)	-5.61 score on scale Standard Error 1.81	-7.01 score on scale Standard Error 1.79
Change From Baseline for MOS (Medical Outcomes Study)-Sleep Subscales and Sleep Problem Indices Snoring (n=122,126)	4.34 score on scale Standard Error 2.34	-5.00 score on scale Standard Error 2.29
Change From Baseline for MOS (Medical Outcomes Study)-Sleep Subscales and Sleep Problem Indices Sleep problems Index I (n=122,127)	-10.11 score on scale Standard Error 1.44	-11.18 score on scale Standard Error 1.41
Change From Baseline for MOS (Medical Outcomes Study)-Sleep Subscales and Sleep Problem Indices Sleep problems Index II (n=122,125)	-10.16 score on scale Standard Error 1.37	-11.59 score on scale Standard Error 1.35

SECONDARY outcome

Timeframe: Baseline, Week 14

Population: ITT population

Change from Baseline in scale at endpoint: normal (score 0) to severe (score 21).

Outcome measures

Measure	Pregabalin n=128 Participants Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.	Placebo n=128 Participants Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
Change From Baseline for Hospital Anxiety and Depression Scale (HADS) Subscales Anxiety	-1.33 score on scale Standard Error 0.28	-1.59 score on scale Standard Error 0.28
Change From Baseline for Hospital Anxiety and Depression Scale (HADS) Subscales Depression	-1.10 score on scale Standard Error 0.26	-1.52 score on scale Standard Error 0.26

SECONDARY outcome

Timeframe: Baseline, Week 14

Population: ITT Population; n = number of participants with data for analysis reported (n=pregabalin, placebo).

Change from baseline to endpoint in the mBPI-sf to assess pain severity and pain interference with functional activities: 11-point scale ranging from "no pain" (0) to "pain as bad as you can imagine" (10)

Outcome measures

Measure	Pregabalin n=148 Participants Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.	Placebo n=147 Participants Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
Change From Baseline for Modified Brief Pain Inventory-Short Form (mBPI-sf) Scores Pain Severity Index (n=148,147)	-2.42 score on scale Standard Error 0.19	-2.56 score on scale Standard Error 0.19
Change From Baseline for Modified Brief Pain Inventory-Short Form (mBPI-sf) Scores Pain Interference Index (n=146,146)	-2.32 score on scale Standard Error 0.18	-2.39 score on scale Standard Error 0.18

SECONDARY outcome

Timeframe: Baseline, Week 14

Population: ITT Population

11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain])

Outcome measures

Measure	Pregabalin n=140 Participants Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.	Placebo n=140 Participants Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
Change From Baseline for NRS-Sleep Interference Scores	-2.53 score on scale Standard Error 0.20	-2.34 score on scale Standard Error 0.20

SECONDARY outcome

Timeframe: Baseline, Week 14

Population: ITT Population

The PGIC is a participant-rated instrument that measures change in the participants overall status on a 7-point scale. Scores range from 1 (very much improved) to 7 (very much worse). PGIC was evaluated using 3 categories of Improvement (Scores 1-3), No Change (Score 4), and Worsening (Scores 5-7).

Outcome measures

Measure	Pregabalin n=149 Participants Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.	Placebo n=150 Participants Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
Categorized Patient Global Impression of Change (PGIC) Improved (scores 1-3)	106 participants	84 participants
Categorized Patient Global Impression of Change (PGIC) No Change (score 4)	17 participants	32 participants
Categorized Patient Global Impression of Change (PGIC) Worsened (scores 5-7)	5 participants	10 participants

SECONDARY outcome

Timeframe: Baseline, Week 14, Endpoint-LOCF

Population: ITT Population

PGIC is a participant-rated instrument that measures change in the participants overall status on a 7-point scale. Scores range from 1 (very much improved) to 7 (very much worse).

Outcome measures

Measure	Pregabalin n=149 Participants Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.	Placebo n=150 Participants Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
Patient Global Impression of Change (PGIC) Rating Very much improved (score 1)	27 participants	27 participants
Patient Global Impression of Change (PGIC) Rating Much improved (score 2)	41 participants	38 participants
Patient Global Impression of Change (PGIC) Rating Minimally improved (score 3)	38 participants	19 participants
Patient Global Impression of Change (PGIC) Rating No change (score 4)	17 participants	32 participants
Patient Global Impression of Change (PGIC) Rating Minimally worse (score 5)	2 participants	5 participants
Patient Global Impression of Change (PGIC) Rating Much worse (score 6)	3 participants	5 participants
Patient Global Impression of Change (PGIC) Rating Very much worse (score 7)	0 participants	0 participants

SECONDARY outcome

Timeframe: Baseline, Week 14

Population: ITT Population; n = number of participants with data for analysis (n=pregabalin, placebo).

Change in mean score NPSI, questionnaire evaluates symptoms of neuropathic pain. 10 pain descriptors questions answered on an 11-point scale 0 (no pain)-10 (most intense pain imaginable). 2 items related to temporal pain assessed on 5-point scales. The NPSI derives 5 pain subscores & a total intensity score calculated from the 5 pain subscores

Outcome measures

Measure	Pregabalin n=127 Participants Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.	Placebo n=128 Participants Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
Change in Neuropathic Pain Symptom Inventory (NPSI) Subscores and Total Intensity Scores Burning (n=127,126)	-0.19 score on scale Standard Error 0.02	-0.22 score on scale Standard Error 0.02
Change in Neuropathic Pain Symptom Inventory (NPSI) Subscores and Total Intensity Scores Pressing (n=125,126)	-0.17 score on scale Standard Error 0.02	-0.15 score on scale Standard Error 0.02
Change in Neuropathic Pain Symptom Inventory (NPSI) Subscores and Total Intensity Scores Paroxysmal (n=127,127)	-0.16 score on scale Standard Error 0.02	-0.17 score on scale Standard Error 0.02
Change in Neuropathic Pain Symptom Inventory (NPSI) Subscores and Total Intensity Scores Evoked (n=126,128)	-0.16 score on scale Standard Error 0.02	-0.15 score on scale Standard Error 0.02
Change in Neuropathic Pain Symptom Inventory (NPSI) Subscores and Total Intensity Scores Paresthesia/dysesthesia (n=126,128)	-0.19 score on scale Standard Error 0.02	-0.23 score on scale Standard Error 0.02
Change in Neuropathic Pain Symptom Inventory (NPSI) Subscores and Total Intensity Scores Total score (n=124,126)	-0.01 score on scale Standard Error 0	-0.01 score on scale Standard Error 0

SECONDARY outcome

Timeframe: Baseline, Week 14

Population: ITT Population; n = number of participants with data for analysis (n=pregabalin, placebo).

Change in a quantitative assessment of the participants' neuropathic pain were on an 11-point scale ranging from 0 (no pain) to 10 (most intense pain imaginable).

Outcome measures

Measure	Pregabalin n=120 Participants Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.	Placebo n=119 Participants Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
Change in Quantitative Assessment of Neuropathic Pain (QANeP) Static mechanical allodynia (n=120,119)	-1.11 score on scale Standard Error 0.21	-1.22 score on scale Standard Error 0.21
Change in Quantitative Assessment of Neuropathic Pain (QANeP) Dynamic mechanical allodynia (n=120,119)	-0.99 score on scale Standard Error 0.18	-0.77 score on scale Standard Error 0.18
Change in Quantitative Assessment of Neuropathic Pain (QANeP) Punctate hyperalgesia testing area (n=118,119)	-0.78 score on scale Standard Error 0.25	-0.68 score on scale Standard Error 0.26
Change in Quantitative Assessment of Neuropathic Pain (QANeP) Temporal summation to tactile stimuli (n=120,118)	-1.21 score on scale Standard Error 0.24	-1.04 score on scale Standard Error 0.24
Change in Quantitative Assessment of Neuropathic Pain (QANeP) Cold allodynia testing area (n=120,117)	-1.19 score on scale Standard Error 0.23	-0.90 score on scale Standard Error 0.24
Change in Quantitative Assessment of Neuropathic Pain (QANeP) Cold hyperalgesia testing area (n=117,112)	-0.82 score on scale Standard Error 0.27	-0.93 score on scale Standard Error 0.28

SECONDARY outcome

Timeframe: Baseline, Weeks 1-14

Population: ITT Population; n = number of participants with data for analysis (n=pregabalin, placebo).

Change in mean Pain-related sleep interference was assessed on an 11-point scale from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]). Weekly mean score was the sum of the daily diary scores divided by the number of diary entries during that week.

Outcome measures

Measure	Pregabalin n=135 Participants Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.	Placebo n=133 Participants Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
Change in NRS-Sleep Interference Scores Week 8 (n=109,111)	-2.98 score on scale Standard Error 0.21	-2.29 score on scale Standard Error 0.21
Change in NRS-Sleep Interference Scores Week 9 (n=105,111)	-2.73 score on scale Standard Error 0.22	-2.25 score on scale Standard Error 0.21
Change in NRS-Sleep Interference Scores Week 10 (n=104,114)	-2.79 score on scale Standard Error 0.22	-2.32 score on scale Standard Error 0.20
Change in NRS-Sleep Interference Scores Week 11 (n=100,106)	-2.76 score on scale Standard Error 0.22	-2.32 score on scale Standard Error 0.21
Change in NRS-Sleep Interference Scores Week 12 (n=94,105)	-2.83 score on scale Standard Error 0.24	-2.29 score on scale Standard Error 0.22
Change in NRS-Sleep Interference Scores Week 13 (n=94,105)	-2.95 score on scale Standard Error 0.24	-2.28 score on scale Standard Error 0.22
Change in NRS-Sleep Interference Scores Week 14 (n=90,94)	-2.93 score on scale Standard Error 0.25	-2.30 score on scale Standard Error 0.25
Change in NRS-Sleep Interference Scores Week 1 (n=135, 133)	-1.04 score on scale Standard Error 0.13	-0.68 score on scale Standard Error 0.13
Change in NRS-Sleep Interference Scores Week 2 (n=123,132)	-1.99 score on scale Standard Error 0.17	-1.36 score on scale Standard Error 0.16
Change in NRS-Sleep Interference Scores Week 3 (n=117,121)	-2.26 score on scale Standard Error 0.19	-1.68 score on scale Standard Error 0.19
Change in NRS-Sleep Interference Scores Week 4 (n=117,124)	-2.34 score on scale Standard Error 0.20	-2.01 score on scale Standard Error 0.19
Change in NRS-Sleep Interference Scores Week 5 (n=115,121)	-2.57 score on scale Standard Error 0.20	-2.22 score on scale Standard Error 0.19
Change in NRS-Sleep Interference Scores Week 6 (n=110,119)	-2.73 score on scale Standard Error 0.20	-2.18 score on scale Standard Error 0.19
Change in NRS-Sleep Interference Scores Week 7 (n=110,111)	-2.89 score on scale Standard Error 0.21	-2.28 score on scale Standard Error 0.21

SECONDARY outcome

Timeframe: Baseline, Week 14

Population: ITT Population

Anxiety subscale analyzes generalized anxiety (anxious mood,restlessness, anxious thoughts, panic attacks). The depression subscale focuses on the state of lost interest and diminished pleasure response. A score of Normal = 0-7, Mild = 8-10, Moderate = 11-14, Severe = 15-21.

Outcome measures

Measure	Pregabalin n=128 Participants Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.	Placebo n=128 Participants Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
Shift in Hospital Anxiety and Depression (HADS) Subscales Anxiety-normal (baseline&endpoint)	47 participants	55 participants
Shift in Hospital Anxiety and Depression (HADS) Subscales Anxiety-normal (baseline)& mild (endpoint)	7 participants	6 participants
Shift in Hospital Anxiety and Depression (HADS) Subscales Anxiety-normal (baseline)& moderate(endpoint)	2 participants	2 participants
Shift in Hospital Anxiety and Depression (HADS) Subscales Anxiety-normal(baseline)&severe(endpoint)	0 participants	0 participants
Shift in Hospital Anxiety and Depression (HADS) Subscales Anxiety-mild(baseline)& normal(endpoint)	23 participants	19 participants
Shift in Hospital Anxiety and Depression (HADS) Subscales Anxiety-mild(baseline)& mild(endpoint)	7 participants	6 participants
Shift in Hospital Anxiety and Depression (HADS) Subscales Anxiety-mild(baseline)& moderate(endpoint)	2 participants	6 participants
Shift in Hospital Anxiety and Depression (HADS) Subscales Anxiety-mild(baseline)& severe(endpoint)	2 participants	0 participants
Shift in Hospital Anxiety and Depression (HADS) Subscales Anxiety-moderate(baseline)& normal(endpoint)	11 participants	8 participants
Shift in Hospital Anxiety and Depression (HADS) Subscales Anxiety-moderate(baseline)& mild(endpoint)	6 participants	9 participants
Shift in Hospital Anxiety and Depression (HADS) Subscales Anxiety-moderate(baseline)& moderate(endpoint)	8 participants	5 participants
Shift in Hospital Anxiety and Depression (HADS) Subscales Anxiety-moderate(baseline)& severe(endpoint)	3 participants	1 participants
Shift in Hospital Anxiety and Depression (HADS) Subscales Anxiety-severe(baseline)& normal(endpoint)	0 participants	1 participants
Shift in Hospital Anxiety and Depression (HADS) Subscales Anxiety-severe(baseline)& mild(endpoint)	1 participants	2 participants
Shift in Hospital Anxiety and Depression (HADS) Subscales Anxiety-severe(baseline)& moderate(endpoint)	7 participants	6 participants
Shift in Hospital Anxiety and Depression (HADS) Subscales Anxiety-severe(baseline)&severe(endpoint)	2 participants	2 participants
Shift in Hospital Anxiety and Depression (HADS) Subscales Depression-normal (baseline&endpoint)	75 participants	69 participants
Shift in Hospital Anxiety and Depression (HADS) Subscales Depression-normal (baseline)&mild (endpoint)	8 participants	7 participants
Shift in Hospital Anxiety and Depression (HADS) Subscales Depression-normal (baseline)&moderate (endpoint)	2 participants	2 participants
Shift in Hospital Anxiety and Depression (HADS) Subscales Depression-normal (baseline)&severe (endpoint)	1 participants	0 participants
Shift in Hospital Anxiety and Depression (HADS) Subscales Depression-mild (baseline)&normal(endpoint)	19 participants	21 participants
Shift in Hospital Anxiety and Depression (HADS) Subscales Depression-mild (baseline)&mild(endpoint)	5 participants	5 participants
Shift in Hospital Anxiety and Depression (HADS) Subscales Depression-mild (baseline)&moderate(endpoint)	3 participants	2 participants
Shift in Hospital Anxiety and Depression (HADS) Subscales Depression-mild (baseline)&severe(endpoint)	0 participants	0 participants
Shift in Hospital Anxiety and Depression (HADS) Subscales Depression-moderate (baseline)&normal(endpoint)	5 participants	11 participants
Shift in Hospital Anxiety and Depression (HADS) Subscales Depression-moderate (baseline)&mild(endpoint)	6 participants	7 participants
Shift in Hospital Anxiety and Depression (HADS) Subscales Depression-moderate (baseline)&moderate(endpoint)	2 participants	2 participants
Shift in Hospital Anxiety and Depression (HADS) Subscales Depression-moderate (baseline)&severe(endpoint)	1 participants	1 participants
Shift in Hospital Anxiety and Depression (HADS) Subscales Depression-severe (baseline)&normal(endpoint)	0 participants	0 participants
Shift in Hospital Anxiety and Depression (HADS) Subscales Depression-severe (baseline)&mild(endpoint)	0 participants	0 participants
Shift in Hospital Anxiety and Depression (HADS) Subscales Depression-severe (baseline)&moderate(endpoint)	0 participants	0 participants
Shift in Hospital Anxiety and Depression (HADS) Subscales Depression-severe (baseline)&severe(endpoint)	1 participants	1 participants

SECONDARY outcome

Timeframe: Baseline, Weeks 1,2,6,10,14, Endpoint - LOCF

Population: ITT population; n = number of participants with data for analysis (n=pregabalin, placebo).

Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.

Outcome measures

Measure	Pregabalin n=148 Participants Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.	Placebo n=147 Participants Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
Change in Brief Pain Inventory-short Form (BPI-sf) Scores (The Worst Pain in the Past 24 Hours) Week 1 (n=145,147)	-1.52 score on scale Standard Error 0.17	-1.09 score on scale Standard Error 0.17
Change in Brief Pain Inventory-short Form (BPI-sf) Scores (The Worst Pain in the Past 24 Hours) Week 2 (n=139,143)	-2.18 score on scale Standard Error 0.20	-2.20 score on scale Standard Error 0.20
Change in Brief Pain Inventory-short Form (BPI-sf) Scores (The Worst Pain in the Past 24 Hours) Week 6 (n=132,134)	-3.08 score on scale Standard Error 0.21	-2.95 score on scale Standard Error 0.21
Change in Brief Pain Inventory-short Form (BPI-sf) Scores (The Worst Pain in the Past 24 Hours) Week 10 (n=126,128)	-3.02 score on scale Standard Error 0.21	-3.03 score on scale Standard Error 0.21
Change in Brief Pain Inventory-short Form (BPI-sf) Scores (The Worst Pain in the Past 24 Hours) Week 14 (n=116,120)	-2.97 score on scale Standard Error 0.24	-3.01 score on scale Standard Error 0.24
Change in Brief Pain Inventory-short Form (BPI-sf) Scores (The Worst Pain in the Past 24 Hours) Endpoint -LOCF (n=148,147)	-2.82 score on scale Standard Error 0.22	-2.88 score on scale Standard Error 0.22

SECONDARY outcome

Timeframe: Baseline, Weeks 1,2,6,10,14, Endpoint-LOCF

Population: ITT population; n = number of participants with data for analysis (n=pregabalin, placebo).

Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.

Outcome measures

Measure	Pregabalin n=148 Participants Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.	Placebo n=147 Participants Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
Change in Brief Pain Inventory-sf Scores (The Least Pain in the Past 24 Hours) Week 1 (n=145,147)	-0.84 score on scale Standard Error 0.18	-0.80 score on scale Standard Error 0.17
Change in Brief Pain Inventory-sf Scores (The Least Pain in the Past 24 Hours) Week 2 (n=139,143)	-1.49 score on scale Standard Error 0.19	-1.44 score on scale Standard Error 0.19
Change in Brief Pain Inventory-sf Scores (The Least Pain in the Past 24 Hours) Week 6 (n=132,134)	-2.37 score on scale Standard Error 0.19	-2.05 score on scale Standard Error 0.18
Change in Brief Pain Inventory-sf Scores (The Least Pain in the Past 24 Hours) Week 10 (n=126,128)	-2.32 score on scale Standard Error 0.20	-2.13 score on scale Standard Error 0.19
Change in Brief Pain Inventory-sf Scores (The Least Pain in the Past 24 Hours) Week 14 (n=116,120)	-2.27 score on scale Standard Error 0.20	-2.41 score on scale Standard Error 0.20
Change in Brief Pain Inventory-sf Scores (The Least Pain in the Past 24 Hours) Endpoint (n=148,147)	-2.07 score on scale Standard Error 0.19	-2.20 score on scale Standard Error 0.19

SECONDARY outcome

Timeframe: Baseline, Weeks 1,2,6,10,14 and Endpoint

Population: ITT population; n = number of participants with data for analysis (n=pregabalin, placebo).

Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.

Outcome measures

Measure	Pregabalin n=148 Participants Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.	Placebo n=147 Participants Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
Change in Brief Pain Inventory-sf Scores (Average Level of Pain in the Past 24 Hours) Week 2 (n=139,143)	-1.79 score on scale Standard Error 0.17	-1.77 score on scale Standard Error 0.17
Change in Brief Pain Inventory-sf Scores (Average Level of Pain in the Past 24 Hours) Week 6 (n=132,134)	-2.64 score on scale Standard Error 0.20	-2.55 score on scale Standard Error 0.19
Change in Brief Pain Inventory-sf Scores (Average Level of Pain in the Past 24 Hours) Week 10 (n=126,128)	-2.86 score on scale Standard Error 0.20	-2.61 score on scale Standard Error 0.19
Change in Brief Pain Inventory-sf Scores (Average Level of Pain in the Past 24 Hours) Week 1 (n=145,147)	-1.15 score on scale Standard Error 0.16	-0.90 score on scale Standard Error 0.16
Change in Brief Pain Inventory-sf Scores (Average Level of Pain in the Past 24 Hours) Week 14 (n=116,120)	-2.58 score on scale Standard Error 0.22	-2.71 score on scale Standard Error 0.22
Change in Brief Pain Inventory-sf Scores (Average Level of Pain in the Past 24 Hours) Endpoint (n=148,147)	-2.37 score on scale Standard Error 0.20	-2.60 score on scale Standard Error 0.20

SECONDARY outcome

Timeframe: Baseline, Weeks 1,2,6,10,14 and Endpoint

Population: ITT population; n = number of participants with data for analysis (n=pregabalin, placebo).

Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.

Outcome measures

Measure	Pregabalin n=148 Participants Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.	Placebo n=147 Participants Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
Change in Brief Pain Inventory-sf Scores (How Much Pain Are You Having Right Now) Week 1 (n=144,147)	-1.56 score on scale Standard Error 0.17	-1.01 score on scale Standard Error 0.17
Change in Brief Pain Inventory-sf Scores (How Much Pain Are You Having Right Now) Week 2 (n=139,143)	-2.02 score on scale Standard Error 0.19	-1.98 score on scale Standard Error 0.19
Change in Brief Pain Inventory-sf Scores (How Much Pain Are You Having Right Now) Week 6 (n=132,134)	-2.66 score on scale Standard Error 0.20	-2.66 score on scale Standard Error 0.20
Change in Brief Pain Inventory-sf Scores (How Much Pain Are You Having Right Now) Week 10 (n=126,128)	-2.72 score on scale Standard Error 0.20	-2.57 score on scale Standard Error 0.20
Change in Brief Pain Inventory-sf Scores (How Much Pain Are You Having Right Now) Week 14 (n=116, 120)	-2.43 score on scale Standard Error 0.23	-2.72 score on scale Standard Error 0.22
Change in Brief Pain Inventory-sf Scores (How Much Pain Are You Having Right Now) Endpoint (n=148,147)	-2.26 score on scale Standard Error 0.21	-2.57 score on scale Standard Error 0.21

SECONDARY outcome

Timeframe: Baseline, Weeks 1,2,6,10,14 and Endpoint

Population: ITT population; n = number of participants with data for analysis (n=pregabalin, placebo).

Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.

Outcome measures

Measure	Pregabalin n=148 Participants Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.	Placebo n=147 Participants Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your General Activity) Week 1 (n=145,147)	-1.35 score on scale Standard Error 0.19	-1.04 score on scale Standard Error 0.19
Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your General Activity) Week 2 (n=139,143)	-1.95 score on scale Standard Error 0.19	-1.87 score on scale Standard Error 0.19
Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your General Activity) Week 6 (n=132,134)	-2.37 score on scale Standard Error 0.19	-2.25 score on scale Standard Error 0.19
Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your General Activity) Week 10 (n=125,128)	-2.32 score on scale Standard Error 0.19	-2.26 score on scale Standard Error 0.19
Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your General Activity) Week 14 (n=116,120)	-2.16 score on scale Standard Error 0.22	-2.46 score on scale Standard Error 0.21
Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your General Activity) Endpoint (n=148,147)	-2.15 score on scale Standard Error 0.20	-2.23 score on scale Standard Error 0.20

SECONDARY outcome

Timeframe: Baseline, Weeks 1,2,6,10,14 and Endpoint

Population: ITT population; n = number of participants with data for analysis (n=pregabalin, placebo).

Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.

Outcome measures

Measure	Pregabalin n=147 Participants Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.	Placebo n=147 Participants Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Mood) Week 1 (n=144,147)	-1.58 score on scale Standard Error 0.21	-1.20 score on scale Standard Error 0.20
Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Mood) Week 2 (n=138,143)	-2.23 score on scale Standard Error 0.23	-2.06 score on scale Standard Error 0.22
Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Mood) Week 6 (n=131,134)	-2.60 score on scale Standard Error 0.20	-2.41 score on scale Standard Error 0.20
Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Mood) Week 10 (n=125,128)	-2.52 score on scale Standard Error 0.20	-2.37 score on scale Standard Error 0.20
Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Mood) Week 14 (n=115,120)	-2.53 score on scale Standard Error 0.22	-2.76 score on scale Standard Error 0.21
Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Mood) Endpoint (n=147,147)	-2.31 score on scale Standard Error 0.20	-2.46 score on scale Standard Error 0.20

SECONDARY outcome

Timeframe: Baseline, Weeks 1,2,6,10,14 and Endpoint

Population: ITT population; n = number of participants with data for analysis (n=pregabalin, placebo).

Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.

Outcome measures

Measure	Pregabalin n=148 Participants Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.	Placebo n=147 Participants Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Walking Ability) Week 1 (n=144,147)	-1.40 score on scale Standard Error 0.21	-1.23 score on scale Standard Error 0.20
Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Walking Ability) Week 2 (n=139,142)	-1.84 score on scale Standard Error 0.22	-1.84 score on scale Standard Error 0.21
Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Walking Ability) Week 6 (n=132,134)	-2.44 score on scale Standard Error 0.21	-2.33 score on scale Standard Error 0.20
Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Walking Ability) Week 10 (n=125,128)	-2.13 score on scale Standard Error 0.20	-2.33 score on scale Standard Error 0.20
Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Walking Ability) Week 14 (n=115,120)	-2.09 score on scale Standard Error 0.22	-2.54 score on scale Standard Error 0.22
Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Walking Ability) Endpoint (n=148,147)	-2.11 score on scale Standard Error 0.21	-2.42 score on scale Standard Error 0.21

SECONDARY outcome

Timeframe: Baseline, Weeks 1,2,6,10,14 and Endpoint

Population: ITT population; n = number of participants with data for analysis (n=pregabalin, placebo).

Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.

Outcome measures

Measure	Pregabalin n=147 Participants Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.	Placebo n=147 Participants Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Normal Work Including Both Work Outside the Home and Housework) Week 1 (n=144,147)	-1.47 score on scale Standard Error 0.19	-1.42 score on scale Standard Error 0.18
Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Normal Work Including Both Work Outside the Home and Housework) Week 2 (n=138,143)	-2.10 score on scale Standard Error 0.20	-1.99 score on scale Standard Error 0.20
Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Normal Work Including Both Work Outside the Home and Housework) Week 6 (n=130,134)	-2.54 score on scale Standard Error 0.19	-2.45 score on scale Standard Error 0.19
Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Normal Work Including Both Work Outside the Home and Housework) Week 10 (n=125,128)	-2.49 score on scale Standard Error 0.20	-2.36 score on scale Standard Error 0.20
Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Normal Work Including Both Work Outside the Home and Housework) Week 14 (n=114,120)	-2.21 score on scale Standard Error 0.23	-2.70 score on scale Standard Error 0.22
Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Normal Work Including Both Work Outside the Home and Housework) Endpoint (n=147,147)	-2.30 score on scale Standard Error 0.20	-2.61 score on scale Standard Error 0.20

SECONDARY outcome

Timeframe: Baseline, Weeks 1,2,6,10,14 and Endpoint

Population: ITT population; n = number of participants with data for analysis (n=pregabalin, placebo).

Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.

Outcome measures

Measure	Pregabalin n=148 Participants Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.	Placebo n=147 Participants Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Relations With Other People) Week 1 (n=145,147)	-1.06 score on scale Standard Error 0.21	-0.87 score on scale Standard Error 0.20
Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Relations With Other People) Week 2 (n=139,143)	-1.54 score on scale Standard Error 0.22	-1.39 score on scale Standard Error 0.21
Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Relations With Other People) Week 6 (n=132,134)	-1.91 score on scale Standard Error 0.19	-1.67 score on scale Standard Error 0.19
Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Relations With Other People) Week 10 (n=126,128)	-1.84 score on scale Standard Error 0.19	-1.91 score on scale Standard Error 0.19
Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Relations With Other People) Week 14 (n=115,120)	-2.08 score on scale Standard Error 0.20	-2.10 score on scale Standard Error 0.19
Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Relations With Other People) Endpoint (n=148,147)	-2.00 score on scale Standard Error 0.19	-1.99 score on scale Standard Error 0.19

SECONDARY outcome

Timeframe: Baseline, Weeks 1,2,6,10,14 and Endpoint

Population: ITT population; n = number of participants with data for analysis (n=pregabalin, placebo).

Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.

Outcome measures

Measure	Pregabalin n=148 Participants Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.	Placebo n=147 Participants Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Sleep) Week 1 (n=145,147)	-1.80 score on scale Standard Error 0.18	-1.12 score on scale Standard Error 0.18
Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Sleep) Week 2 (n=139,142)	-2.22 score on scale Standard Error 0.22	-1.86 score on scale Standard Error 0.21
Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Sleep) Week 6 (n=131,134)	-3.06 score on scale Standard Error 0.21	-2.68 score on scale Standard Error 0.21
Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Sleep) Week 10 (n=126,128)	-3.10 score on scale Standard Error 0.22	-2.71 score on scale Standard Error 0.21
Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Sleep) Week 14 (n=116,120)	-2.65 score on scale Standard Error 0.23	-2.90 score on scale Standard Error 0.23
Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Sleep) Endpoint (n=148,147)	-2.51 score on scale Standard Error 0.22	-2.74 score on scale Standard Error 0.21

SECONDARY outcome

Timeframe: Baseline, Weeks 1,2,6,10,14 and Endpoint

Population: ITT population; n = number of participants with data for analysis (n=pregabalin, placebo).

Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.

Outcome measures

Measure	Pregabalin n=148 Participants Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.	Placebo n=146 Participants Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Enjoyment of Life) Week 1 (n=145,146)	-1.52 score on scale Standard Error 0.20	-1.20 score on scale Standard Error 0.19
Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Enjoyment of Life) Week 2 (n=139,141)	-2.20 score on scale Standard Error 0.24	-2.13 score on scale Standard Error 0.23
Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Enjoyment of Life) Week 6 (n=132,131)	-2.69 score on scale Standard Error 0.21	-2.64 score on scale Standard Error 0.21
Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Enjoyment of Life) Week 10 (n=126,127)	-2.59 score on scale Standard Error 0.21	-2.45 score on scale Standard Error 0.21
Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Enjoyment of Life) Week 14 (n=116,119)	-2.78 score on scale Standard Error 0.22	-2.79 score on scale Standard Error 0.22
Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Enjoyment of Life) Endpoint (n=148,146)	-2.64 score on scale Standard Error 0.21	-2.60 score on scale Standard Error 0.21

SECONDARY outcome

Timeframe: Baseline-Week 14 (Endpoint)

Population: ITT Population

Number of subjects reporting duration of spontaneous pain. The NPSI includes the temporal item for assessment of duration of spontaneous, ongoing and paroxysmal pain. Assessed using a 5-point specific categorical scale and refers to the past 24 hours at endpoint.

Outcome measures

Measure	Pregabalin n=128 Participants Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.	Placebo n=126 Participants Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain Permanently (baseline&endpoint)	15 participants	21 participants
Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain Permanently (baseline), 8-12 hours (endpoint)	11 participants	5 participants
Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain Permanently (baseline), 4-7 hours (endpoint)	8 participants	6 participants
Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain Permanently (baseline), 1-3 hours (endpoint)	4 participants	5 participants
Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain Permanently (baseline), < 1 hr (endpoint)	4 participants	5 participants
Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain 8-12 hours (baseline), permanently (endpoint)	2 participants	7 participants
Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain 8-12 hrs (baseline), 8-12 hrs (endpoint)	10 participants	7 participants
Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain 8-12 hrs (baseline), 4-7 hrs (endpoint)	5 participants	9 participants
Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain 8-12 hrs (baseline), 1-3 hours (endpoint)	4 participants	4 participants
Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain 8-12 hrs (baseline), <1 hr (endpoint)	8 participants	5 participants
Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain 4-7 hrs (baseline), permanently (endpoint)	3 participants	3 participants
Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain 4-7 hrs (baseline), 8-12 hrs (endpoint)	7 participants	6 participants
Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain 4-7 hrs (baseline), 4-7 hrs (endpoint)	9 participants	9 participants
Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain 4-7 hrs (baseline), 1-3 hrs (endpoint)	3 participants	8 participants
Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain 4-7 hrs (baseline), < 1 hr (endpoint)	7 participants	8 participants
Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain 1-3 hrs (baseline), permanently (endpoint)	1 participants	0 participants
Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain 1-3 hrs (baseline), 8-12 hrs (endpoint)	2 participants	2 participants
Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain 1-3 hrs (baseline), 4-7 hrs (endpoint)	1 participants	5 participants
Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain 1-3 hrs (baseline), 1-3 hrs (endpoint)	6 participants	3 participants
Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain 1-3 hrs (baseline), <1 hr (endpoint)	9 participants	5 participants
Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain Less than 1 hr (baseline), permanently (endpoint)	0 participants	1 participants
Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain Less than 1 hr (baseline), 8-12 hrs (endpoint)	2 participants	0 participants
Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain Less than 1 hr (baseline), 4-7 hrs (endpoint)	0 participants	0 participants
Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain Less than 1 hr (baseline), 1-3 hrs (endpoint)	1 participants	2 participants
Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain <1 hr (baseline), <1 hr (endpoint)	6 participants	0 participants

SECONDARY outcome

Timeframe: Baseline-Week 14 (Endpoint)

Population: ITT Population

Number of subjects reporting pain attacks. The NPSI includes the temporal item for assessing the numbers of pain attacks. Assessed using a 5-point specific categorical scale and refers to the past 24 hours at endpoint.

Outcome measures

Measure	Pregabalin n=119 Participants Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.	Placebo n=119 Participants Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks >20 attacks (baseline & endpoint)	4 participants	6 participants
Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks >20 attacks (baseline), 11-20 attacks (endpoint)	2 participants	4 participants
Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks >20 attacks (baseline), 6-10 attacks (endpoint)	1 participants	4 participants
Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks >20 attacks (baseline), 1-5 attacks (endpoint)	3 participants	3 participants
Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks >20 attacks (baseline), no pain attacks (endpoint)	3 participants	2 participants
Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks 11-20 attacks (baseline), >20 attacks (endpoint)	2 participants	0 participants
Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks 11-20 attacks (baseline), 11-20 attacks (endpoint)	2 participants	2 participants
Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks 11-20 attacks (baseline), 6-10 attacks (endpoint)	7 participants	8 participants
Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks 11-20 attacks (baseline), 1-5 attacks (endpoint)	10 participants	8 participants
Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks 11-20 attacks (baseline), no attacks (endpoint)	9 participants	5 participants
Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks 6-10 attacks (baseline), >20 attacks (endpoint)	1 participants	7 participants
Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks 6-10 attacks (baseline), 11-20 attacks (endpoint)	2 participants	2 participants
Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks 6-10 attacks (baseline), 6-10 attacks (endpoint)	5 participants	8 participants
Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks 6-10 attacks (baseline), 1-5 attacks (endpoint)	14 participants	17 participants
Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks 6-10 attacks (baseline), no attacks (endpoint)	6 participants	4 participants
Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks 1-5 attacks (baseline), >20 attacks (endpoint)	3 participants	1 participants
Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks 1-5 attacks (baseline), 11-20 attacks (endpoint)	3 participants	2 participants
Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks 1-5 attacks (baseline), 6-10 attacks (endpoint)	7 participants	3 participants
Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks 1-5 attacks (baseline), 1-5 attacks (endpoint)	21 participants	15 participants
Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks 1-5 attacks (baseline), no attacks (endpoint)	10 participants	11 participants
Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks no attacks (baseline), >20 attacks (endpoint)	0 participants	2 participants
Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks no attacks (baseline), 11-20 attacks (endpoint)	0 participants	0 participants
Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks no attacks (baseline), 6-10 attacks (endpoint)	0 participants	1 participants
Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks no attacks (baseline), 1-5 attacks (endpoint)	1 participants	3 participants
Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks no attacks (baseline), no attacks (endpoint)	3 participants	1 participants

SECONDARY outcome

Timeframe: Baseline, Week 14

Population: ITT Population

Change from baseline in the number of pain attacks at endpoint. The NPSI includes the temporal item for assessing the numbers of pain attacks. Assessed using a 5-point specific categorical scale and refers to the past 24 hours at endpoint.

Outcome measures

Measure	Pregabalin n=119 Participants Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.	Placebo n=119 Participants Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
Change in Number of Pain Attacks Compared to Baseline - NPSI (Neuropathic Pain Symptom Inventory) Improved from baseline to endpoint	65 participants	66 participants
Change in Number of Pain Attacks Compared to Baseline - NPSI (Neuropathic Pain Symptom Inventory) No change from baseline to endpoint	35 participants	32 participants
Change in Number of Pain Attacks Compared to Baseline - NPSI (Neuropathic Pain Symptom Inventory) Worsened from baseline to endpoint	19 participants	21 participants

SECONDARY outcome

Timeframe: Baseline, Week 14

Population: ITT Population

Change from baseline to endpoint in the duration of spontaneous pain. The NPSI includes the temporal item for assessment of duration of spontaneous, ongoing and paroxysmal pain. Assessed using a 5-point specific categorical scale and refers to the past 24 hours at endpoint.

Outcome measures

Measure	Pregabalin n=128 Participants Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.	Placebo n=126 Participants Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
Duration of Spontaneous Pain-NPSI (Neuropathic Pain Symptom Inventory) Improved from baseline to endpoint	63 participants	60 participants
Duration of Spontaneous Pain-NPSI (Neuropathic Pain Symptom Inventory) No change from baseline to endpoint	46 participants	40 participants
Duration of Spontaneous Pain-NPSI (Neuropathic Pain Symptom Inventory) Worsened from baseline to endpoint	19 participants	26 participants

SECONDARY outcome

Timeframe: Week 14

Population: ITT Population

The modified Gracely Pain Scale is a 13-point verbal rating scale based on sensory pain descriptors ranked by severity from nothing (rank = 0) to extremely intense (rank = 15). Subjects selected the verbal descriptors that best matched their average neuropathic pain during the last 24 hours prior to assessment.

Outcome measures

Measure	Pregabalin n=128 Participants Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.	Placebo n=127 Participants Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
Gracely Pain Scale Score	-2.70 score on scale Standard Deviation 3.36	-2.76 score on scale Standard Deviation 3.19

SECONDARY outcome

Timeframe: Baseline-Week 14 (Endpoint)

Population: ITT Population; Pregabalin weight range- 3.61, 4.31, 4.56, 5.07, 6.65 and not perceived. Placebo weight range- 2.83, 3.61, 4.31, 4.56, 5.07, 6.65 and not perceived

Shift from baseline in maximum sensory thresholds (in grams representing the force equivalent of various sizes of von Frey filaments) as measured on QANeP. Improved - decrease in the maximum of the 3 trials at endpoint. Worsened - an increase. Note:Sensory Thresholds are the highest values of the 3 trials at baseline (Week=0) and endpoint (Week 14)

Outcome measures

Measure	Pregabalin n=149 Participants Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.	Placebo n=150 Participants Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
Quantitative Assessments of Neuropathic Pain (QANeP) Maximum Sensory Thresholds : Shift Table Weight 2.83 Improved	0 participants	0 participants
Quantitative Assessments of Neuropathic Pain (QANeP) Maximum Sensory Thresholds : Shift Table Weight 2.83 No Change	0 participants	1 participants
Quantitative Assessments of Neuropathic Pain (QANeP) Maximum Sensory Thresholds : Shift Table Weight 2.83 Worsened	0 participants	3 participants
Quantitative Assessments of Neuropathic Pain (QANeP) Maximum Sensory Thresholds : Shift Table Weight 3.61 Improved	1 participants	2 participants
Quantitative Assessments of Neuropathic Pain (QANeP) Maximum Sensory Thresholds : Shift Table Weight 3.61 No Change	3 participants	2 participants
Quantitative Assessments of Neuropathic Pain (QANeP) Maximum Sensory Thresholds : Shift Table Weight 3.61 Worsened	9 participants	4 participants
Quantitative Assessments of Neuropathic Pain (QANeP) Maximum Sensory Thresholds : Shift Table Weight 4.31 Improved	4 participants	12 participants
Quantitative Assessments of Neuropathic Pain (QANeP) Maximum Sensory Thresholds : Shift Table Weight 4.31 No Change	17 participants	13 participants
Quantitative Assessments of Neuropathic Pain (QANeP) Maximum Sensory Thresholds : Shift Table Weight 4.31 Worsened	8 participants	18 participants
Quantitative Assessments of Neuropathic Pain (QANeP) Maximum Sensory Thresholds : Shift Table Weight 4.56 Improved	5 participants	6 participants
Quantitative Assessments of Neuropathic Pain (QANeP) Maximum Sensory Thresholds : Shift Table Weight 4.56 No Change	4 participants	7 participants
Quantitative Assessments of Neuropathic Pain (QANeP) Maximum Sensory Thresholds : Shift Table Weight 4.56 Worsened	9 participants	8 participants
Quantitative Assessments of Neuropathic Pain (QANeP) Maximum Sensory Thresholds : Shift Table Weight 5.07 Improved	10 participants	15 participants
Quantitative Assessments of Neuropathic Pain (QANeP) Maximum Sensory Thresholds : Shift Table Weight 5.07 No Change	8 participants	3 participants
Quantitative Assessments of Neuropathic Pain (QANeP) Maximum Sensory Thresholds : Shift Table Weight 5.07 Worsened	10 participants	5 participants
Quantitative Assessments of Neuropathic Pain (QANeP) Maximum Sensory Thresholds : Shift Table Weight 6.65 Improved	12 participants	5 participants
Quantitative Assessments of Neuropathic Pain (QANeP) Maximum Sensory Thresholds : Shift Table Weight 6.65 No Change	7 participants	6 participants
Quantitative Assessments of Neuropathic Pain (QANeP) Maximum Sensory Thresholds : Shift Table Weight 6.65 Worsened	2 participants	0 participants
Quantitative Assessments of Neuropathic Pain (QANeP) Maximum Sensory Thresholds : Shift Table Not Perceived Improved	3 participants	4 participants
Quantitative Assessments of Neuropathic Pain (QANeP) Maximum Sensory Thresholds : Shift Table Not Perceived No Change	8 participants	5 participants
Quantitative Assessments of Neuropathic Pain (QANeP) Maximum Sensory Thresholds : Shift Table Not Perceived Worsened	0 participants	0 participants

SECONDARY outcome

Timeframe: Baseline-Week 14 (Endpoint)

Population: ITT Population

Shift from baseline in median sensory thresholds (designated as Weight) from 3 trials as measured on the QANeP. Improved - a decrease in the median of the three trials at endpoint. Worsened - an increase. Note: Sensory Thresholds are the highest values of the three Trials at both baseline (Week=0) and endpoint (Week 14).

Outcome measures

Measure	Pregabalin n=149 Participants Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.	Placebo n=150 Participants Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
Quantitative Assessments of Neuropathic Pain (QANeP) Median Sensory Thresholds : Shift Table Weight 2.83 Improved	0 participants	0 participants
Quantitative Assessments of Neuropathic Pain (QANeP) Median Sensory Thresholds : Shift Table Weight 2.83 No Change	1 participants	3 participants
Quantitative Assessments of Neuropathic Pain (QANeP) Median Sensory Thresholds : Shift Table Weight 2.83 Worsened	5 participants	3 participants
Quantitative Assessments of Neuropathic Pain (QANeP) Median Sensory Thresholds : Shift Table Weight 3.61 Improved	0 participants	2 participants
Quantitative Assessments of Neuropathic Pain (QANeP) Median Sensory Thresholds : Shift Table Weight 3.61 No Change	10 participants	9 participants
Quantitative Assessments of Neuropathic Pain (QANeP) Median Sensory Thresholds : Shift Table Weight 3.61 Worsened	10 participants	13 participants
Quantitative Assessments of Neuropathic Pain (QANeP) Median Sensory Thresholds : Shift Table Weight 4.31 Improved	12 participants	11 participants
Quantitative Assessments of Neuropathic Pain (QANeP) Median Sensory Thresholds : Shift Table Weight 4.31 No Change	7 participants	11 participants
Quantitative Assessments of Neuropathic Pain (QANeP) Median Sensory Thresholds : Shift Table Weight 4.31 Worsened	9 participants	12 participants
Quantitative Assessments of Neuropathic Pain (QANeP) Median Sensory Thresholds : Shift Table Weight 4.56 Improved	8 participants	7 participants
Quantitative Assessments of Neuropathic Pain (QANeP) Median Sensory Thresholds : Shift Table Weight 4.56 No Change	6 participants	8 participants
Quantitative Assessments of Neuropathic Pain (QANeP) Median Sensory Thresholds : Shift Table Weight 4.56 Worsened	5 participants	7 participants
Quantitative Assessments of Neuropathic Pain (QANeP) Median Sensory Thresholds : Shift Table Weight 5.07 Improved	16 participants	11 participants
Quantitative Assessments of Neuropathic Pain (QANeP) Median Sensory Thresholds : Shift Table Weight 5.07 No Change	5 participants	3 participants
Quantitative Assessments of Neuropathic Pain (QANeP) Median Sensory Thresholds : Shift Table Weight 5.07 Worsened	6 participants	1 participants
Quantitative Assessments of Neuropathic Pain (QANeP) Median Sensory Thresholds : Shift Table Weight 6.65 Improved	10 participants	8 participants
Quantitative Assessments of Neuropathic Pain (QANeP) Median Sensory Thresholds : Shift Table Weight 6.65 No Change	2 participants	3 participants
Quantitative Assessments of Neuropathic Pain (QANeP) Median Sensory Thresholds : Shift Table Weight 6.65 Worsened	0 participants	0 participants
Quantitative Assessments of Neuropathic Pain (QANeP) Median Sensory Thresholds : Shift Table Not Perceived Improved	2 participants	3 participants
Quantitative Assessments of Neuropathic Pain (QANeP) Median Sensory Thresholds : Shift Table Not Perceived No Change	6 participants	4 participants
Quantitative Assessments of Neuropathic Pain (QANeP) Median Sensory Thresholds : Shift Table Not Perceived Worsened	0 participants	0 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Weeks 1 - 14 and Endpoint-BOCF

Population: ITT population; n = number of participants with data for analysis reported per week per treatment group (n=pregabalin, placebo).

Change from baseline in mean NRS-Pain scores at endpoint-BOCF. Daily pain scores were assessed on an 11-point numerical rating scale <(NRS)-Pain> ranging from 0 (no pain) to 10 (worst possible pain). Change from baseline in mean weekly pain scores was analyzed using longitudinal models assuming data were missing at random (MAR)

Outcome measures

Measure	Pregabalin n=141 Participants Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.	Placebo n=140 Participants Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
Change in NRS-Pain Scores From Baseline to Endpoint-BOCF (Modified Baseline Observation Carried Forward) Week 1 (n=136,133)	-1.14 score on scale Standard Error 0.13	-0.69 score on scale Standard Error 0.13
Change in NRS-Pain Scores From Baseline to Endpoint-BOCF (Modified Baseline Observation Carried Forward) Week 2 (n=126,132)	-1.92 score on scale Standard Error 0.17	-1.43 score on scale Standard Error 0.17
Change in NRS-Pain Scores From Baseline to Endpoint-BOCF (Modified Baseline Observation Carried Forward) Week 3 (n=118,121)	-2.36 score on scale Standard Error 0.20	-1.83 score on scale Standard Error 0.20
Change in NRS-Pain Scores From Baseline to Endpoint-BOCF (Modified Baseline Observation Carried Forward) Week 4 (n=118,124)	-2.66 score on scale Standard Error 0.21	-2.24 score on scale Standard Error 0.20
Change in NRS-Pain Scores From Baseline to Endpoint-BOCF (Modified Baseline Observation Carried Forward) Week 5 (n=116,121)	-2.79 score on scale Standard Error 0.22	-2.50 score on scale Standard Error 0.21
Change in NRS-Pain Scores From Baseline to Endpoint-BOCF (Modified Baseline Observation Carried Forward) Week 6 (n=111,119)	-2.98 score on scale Standard Error 0.23	-2.45 score on scale Standard Error 0.22
Change in NRS-Pain Scores From Baseline to Endpoint-BOCF (Modified Baseline Observation Carried Forward) Week 7 (n=112,111)	-3.22 score on scale Standard Error 0.23	-2.53 score on scale Standard Error 0.23
Change in NRS-Pain Scores From Baseline to Endpoint-BOCF (Modified Baseline Observation Carried Forward) Week 8 (n=111,111)	-3.33 score on scale Standard Error 0.22	-2.58 score on scale Standard Error 0.22
Change in NRS-Pain Scores From Baseline to Endpoint-BOCF (Modified Baseline Observation Carried Forward) Week 9 (n=107,111)	-3.09 score on scale Standard Error 0.23	-2.56 score on scale Standard Error 0.23
Change in NRS-Pain Scores From Baseline to Endpoint-BOCF (Modified Baseline Observation Carried Forward) Week 10 (n=106,114)	-2.98 score on scale Standard Error 0.23	-2.66 score on scale Standard Error 0.22
Change in NRS-Pain Scores From Baseline to Endpoint-BOCF (Modified Baseline Observation Carried Forward) Week 11 (n=102,106)	-3.05 score on scale Standard Error 0.24	-2.61 score on scale Standard Error 0.24
Change in NRS-Pain Scores From Baseline to Endpoint-BOCF (Modified Baseline Observation Carried Forward) Week 12 (n=96,105)	-3.14 score on scale Standard Error 0.25	-2.59 score on scale Standard Error 0.24
Change in NRS-Pain Scores From Baseline to Endpoint-BOCF (Modified Baseline Observation Carried Forward) Week 13 (n=96, 105)	-3.21 score on scale Standard Error 0.25	-2.59 score on scale Standard Error 0.24
Change in NRS-Pain Scores From Baseline to Endpoint-BOCF (Modified Baseline Observation Carried Forward) Week 14 (n=92,94)	-3.19 score on scale Standard Error 0.26	-2.70 score on scale Standard Error 0.27
Change in NRS-Pain Scores From Baseline to Endpoint-BOCF (Modified Baseline Observation Carried Forward) Endpoint BOCF (n=142,140)	-2.72 score on scale Standard Error 0.21	-2.64 score on scale Standard Error 0.21

OTHER_PRE_SPECIFIED outcome

Timeframe: Weeks 1-14 Endpoint BOCF (modified baseline observation carried forward)

Population: ITT population; n = number of participants with data for analysis reported per week per treatment group (n=pregabalin, placebo), BOCF = modified baseline observation carried forward

Number of subjects that experienced at least a 50% decrease in mean weekly pain.

Outcome measures

Measure	Pregabalin n=146 Participants Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.	Placebo n=147 Participants Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
Responders- Decreases of at Least 50% in Mean Weekly Pain Score Week 1 (n=140,141)	13 participants	6 participants
Responders- Decreases of at Least 50% in Mean Weekly Pain Score Week 2 (n=136,139)	28 participants	23 participants
Responders- Decreases of at Least 50% in Mean Weekly Pain Score Week 3 (n=131,133)	35 participants	33 participants
Responders- Decreases of at Least 50% in Mean Weekly Pain Score Week 4 (n=126,132)	45 participants	41 participants
Responders- Decreases of at Least 50% in Mean Weekly Pain Score Week 5 (n=124,131)	48 participants	47 participants
Responders- Decreases of at Least 50% in Mean Weekly Pain Score Week 6 (n=124,130)	49 participants	47 participants
Responders- Decreases of at Least 50% in Mean Weekly Pain Score Week 7 (n=125,124)	53 participants	38 participants
Responders- Decreases of at Least 50% in Mean Weekly Pain Score Week 8 (n=120,119)	54 participants	43 participants
Responders- Decreases of at Least 50% in Mean Weekly Pain Score Week 9 (n=116,121)	50 participants	45 participants
Responders- Decreases of at Least 50% in Mean Weekly Pain Score Week 10 (n=116,121)	45 participants	49 participants
Responders- Decreases of at Least 50% in Mean Weekly Pain Score Week 11 (n=113,117)	43 participants	46 participants
Responders- Decreases of at Least 50% in Mean Weekly Pain Score Week 12 (n=107,115)	45 participants	46 participants
Responders- Decreases of at Least 50% in Mean Weekly Pain Score Week 13 (n=103,111)	45 participants	47 participants
Responders- Decreases of at Least 50% in Mean Weekly Pain Score Week 14 (n=101,108)	42 participants	44 participants
Responders- Decreases of at Least 50% in Mean Weekly Pain Score Endpoint-BOCF (n=146,147)	54 participants	62 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Weeks 1-14 endpoint BOCF

Population: ITT population; n = number of participants with data for analysis reported per week per treatment group (n=pregabalin, placebo); BOCF = modified baseline observation carried forward

Number of subjects that experienced at least 30% decrease in mean weekly pain.

Outcome measures

Measure	Pregabalin n=146 Participants Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.	Placebo n=147 Participants Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
Responders - Decreases of at Least 30% in Mean Weekly Pain Score Week 7 (n=125,124)	69 participants	64 participants
Responders - Decreases of at Least 30% in Mean Weekly Pain Score Week 1 (n=140,141)	33 participants	21 participants
Responders - Decreases of at Least 30% in Mean Weekly Pain Score Week 2 (n=136,139)	51 participants	46 participants
Responders - Decreases of at Least 30% in Mean Weekly Pain Score Week 3 (n=131,133)	63 participants	51 participants
Responders - Decreases of at Least 30% in Mean Weekly Pain Score Week 4 (n=126,132)	64 participants	60 participants
Responders - Decreases of at Least 30% in Mean Weekly Pain Score Week 5 (n=124,131)	65 participants	68 participants
Responders - Decreases of at Least 30% in Mean Weekly Pain Score Week 6 (n=124,130)	63 participants	70 participants
Responders - Decreases of at Least 30% in Mean Weekly Pain Score Week 8 (n=120,119)	75 participants	62 participants
Responders - Decreases of at Least 30% in Mean Weekly Pain Score Week 9 (n=116,121)	68 participants	65 participants
Responders - Decreases of at Least 30% in Mean Weekly Pain Score Week 10 (n=116,121)	64 participants	69 participants
Responders - Decreases of at Least 30% in Mean Weekly Pain Score Week 11 (n=113,117)	67 participants	63 participants
Responders - Decreases of at Least 30% in Mean Weekly Pain Score Week 12 (n=107,115)	65 participants	57 participants
Responders - Decreases of at Least 30% in Mean Weekly Pain Score Week 13 (n=103,111)	62 participants	62 participants
Responders - Decreases of at Least 30% in Mean Weekly Pain Score Week 14 (n=101,108)	58 participants	54 participants
Responders - Decreases of at Least 30% in Mean Weekly Pain Score Endpoint-BOCF (n=146,147)	77 participants	81 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Weekly: Week 1 - Week 14

Population: ITT Population

Duration Adjusted Average Change(DAAC) in NRS-Pain score = (mean at observation - mean at baseline)x(proportion of planned study duration that the subject completed).

Outcome measures

Measure	Pregabalin n=141 Participants Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.	Placebo n=140 Participants Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
Duration Adjusted Average Change From Baseline in NRS Pain Scores	-2.45 score on scale Standard Error 0.18	-2.07 score on scale Standard Error 0.18

Adverse Events

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: ClinicalTrials.govCallCenter@pfizer.com

Results disclosure agreements

• Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of \< 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), \< 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info other than study results.
• Publication restrictions are in place

Restriction type: OTHER