Neuralgia
Conditions
Keywords
Phase 4, post-traumatic neuropathic pain, neuropathic pain, Nep, post surgical pain, nerve injury, phantom limb pain, international
Brief summary
To evaluate the efficacy of pregabalin compared to placebo in the treatment of posttraumatic peripheral neuropathic pain
Interventions
DRUGpregabalin
pregabalin
DRUGPlacebo
placebo
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of Posttraumatic Peripheral Neuropathic Pain (NeP) syndrome, including post-surgical NeP, NeP due to peripheral nerve injury, and phantom limb pain, confirmed by a qualified pain specialist and persisting for a minimum of 3 months following the traumatic event
Exclusion criteria
* Subjects whose posttraumatic neuropathic pain is due to Complex Regional Pain Syndrome (CRPS, Type I or Type II) * NeP not due to trauma, and not peripheral pain
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weekly Mean Pain Score at End of Treatment (Week 8) From Daily Pain Diary | each day of Week 8 | Daily Pain Diary scale : mean score from 11-point numerical scale of pain; range: 0 (no pain) to 10 (worst possible pain). Endpoint weekly mean pain score: mean of the last 7 available pain scores from a daily pain diary during double blind treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital Anxiety and Depression Scale (HADS) Depression Score | Week 8 | Hospital Anxiety and Depression Scale Depression Score (HADS-D) consists of 7 items that are assessed by a score of 0 = no depression to 3 = severe feeling of depression. The depression subscale focuses on the state of lost interest and diminished pleasure response (lowering of hedonic tone). Score range = 0 to 21; higher scores indicate a greater intensity of depression |
| Hospital Anxiety and Depression Scale (HADS) Anxiety Score - FAS Subset With Moderate/Severe Baseline Scores | Week 8 | Hospital Anxiety and Depression Scale Anxiety Score (HADS-A) consists of 7 items that are assessed by a score of 0 = no anxiety to 3 = severe feeling of anxiety. The anxiety subscale determines a state of generalized anxiety (including anxious mood, restlessness, anxious thoughts, panic attacks). Score range = 0 to 21; higher scores indicate a greater intensity of anxiety. |
| Hospital Anxiety and Depression Scale (HADS) Depression Score - FAS Subset With Moderate/Severe Baseline Scores | Week 8 | Hospital Anxiety and Depression Scale (HADS-D) consists of 7 items that are assessed by a score of 0 = no depression to 3 = severe feeling of depression. The depression subscale focuses on the state of lost interest and diminished pleasure response (lowering of hedonic tone). Score range = 0 to 21; higher scores indicate a greater intensity of depression |
| Weekly Mean Pain Score From Daily Pain Diary | Baseline through Week 8 | Daily Pain Diary scale : mean score from 11-point numerical scale of pain; range:0 (no pain) to 10 (worst possible pain). Mean of scores available for each week. |
| Number of Subjects With 30% and 50% Response in Weekly Mean Daily Pain Rating Score (DPRS) From Baseline Until Endpoint (Week 8) | Baseline, Week 8 | Based on weekly mean daily pain rating score (DPRS), responders were defined as subjects with a \>= 30% and \>=50% reduction in weekly mean scores from baseline until endpoint (Week 8). Endpoint was calculated as the mean of the last 7 available pain scores from the daily pain diary while in the double-blind treatment phase. |
| Weekly Mean Sleep Interference Score | Week 8 | 11-point numerical scale with which the patient describes pain interference with sleep over past 24 hours; range: 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep). Endpoint weekly mean score: mean of last 7 available scores from daily sleep interference diary during double-blind treatment. |
| Medical Outcome Study (MOS) Sleep Subscales | Week 8 | Medical Outcome Study (MOS) is a patient-rated questionnaire consisting of 12 items that assess key constructs of sleep (7 subscales as well as a 9-item overall sleep problems index. MOS-Sleep Scale is scored from 0 to 100. A higher score indicates more disturbance. |
| Medical Outcome Study (MOS) Optimal Sleep | Week 8 | Number of subjects responding to have had optimal sleep. Optimal sleep is 1 item in the Medical Outcome Study (MOS)sleep scale, a patient-reported measure consisting of twelve items that assess the key constructs of sleep. Subjects were asked to recall sleep-related activities over the past week. |
| Patient Global Impression of Change (PGIC) | Week 8 | Patient Global Impression of Change (PGIC): a patient-rated instrument that measures change in patient's overall status on a 7-point scale; range: 1 Very Much Improved to 7 Very Much Worse. |
| Clinical Global Impression of Change (CGIC) | Week 8 | Clinical Global Impression of Change (CGIC): clinician's judgment of overall change in the patient's condition over a defined period on a 7-point scale; range: 1 Very Much Improved to 7 Very Much Worse. |
| Pain Treatment Satisfaction Scale (PTSS): Impact of Current Pain Medication | Screening, Week 8 | Pain Treatment Satisfaction Scale (PTSS); Impact of Current Pain Medication: measure of patient satisfaction with treatment for acute or chronic pain. Response range: 1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment. |
| Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication | Screening, Week 8 | Pain Treatment Satisfaction Scale (PTSS); Satisfaction with Current Pain Medication: measure of patient satisfaction with treatment for acute or chronic pain. Response range:1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment. |
| Hospital Anxiety and Depression Scale (HADS) Anxiety Score | Week 8 | Hospital Anxiety and Depression Scale Anxiety Score (HADS-A) consists of 7 items that are assessed by a score of 0 = no anxiety to 3 = severe feeling of anxiety. The anxiety subscale determines a state of generalized anxiety (including anxious mood, restlessness, anxious thoughts, panic attacks). Score range = 0 to 21; higher scores indicate a greater intensity of anxiety |
| Pain Treatment Satisfaction Scale (PTSS): Efficacy | Screening, Week 8 | Pain Treatment Satisfaction Scale (PTSS); Efficacy: measure of patient satisfaction with treatment for acute or chronic pain. Response range: 1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment. |
| Modified Brief Pain Inventory Short Form (m-BPI-sf) | Baseline, Week 8 | Modified Brief Pain Inventory Short Form (m-BPI-sf): self-administered questionnaire to assess severity of pain (measured by 4 items)and impact of pain on daily functions (measured by 7 items)in past 24 hours. Items are rated on an 11-point scale ranging from 0 to 10, with higher scores indicating greater pain and/or interference due to pain. |
| Neuropathic Pain Symptom Inventory (NPSI) Total Intensity Score | Week 8 | Neuropathic Pain Symptom Inventory (NPSI) includes 10 descriptors (scale 0-10) of different pain symptoms & 2 temporal items assessing the duration of spontaneous ongoing and paroxysmal pain. A total intensity score is calculated by sub grouping the questions into five pain dimensions, summing the five sub groups, and converting into a percentage. |
| Medical Outcome Study Cognitive Subscale (MOS-Cog); Reasoning | Baseline, Week 8 | The number of subjects' responses to each of the 6 questions on the Medical Outcome Study Cognitive (MOS-Cog) subscale were summarized at baseline and Week 8. Category range: all of the time to none of the time. No formal statistical modeling was used. |
| Medical Outcome Study Cognitive Subscale (MOS-Cog); Concentration | Baseline, Week 8 | The number of subjects' responses to each of the 6 questions on the Medical Outcome Study Cognitive (MOS-Cog) subscale were summarized at baseline and Week 8. Category range: all of the time to none of the time. No formal statistical modeling was used. |
| Medical Outcome Study Cognitive Subscale (MOS-Cog); Confusion | Baseline, Week 8 | The number of subjects' responses to each of the 6 questions on the Medical Outcome Study Cognitive (MOS-Cog) subscale were summarized at baseline and Week 8. Category range: all of the time to none of the time. No formal statistical modeling was used. |
| Medical Outcome Study Cognitive Subscale (MOS-Cog); Memory | Baseline, Week 8 | The number of subjects' responses to each of the 6 questions on the Medical Outcome Study Cognitive (MOS-Cog) subscale were summarized at baseline and Week 8. Category range: all of the time to none of the time. No formal statistical modeling was used. |
| Medical Outcome Study Cognitive Subscale (MOS-Cog); Attention | Baseline, Week 8 | The number of subjects' responses to each of the 6 questions on the Medical Outcome Study Cognitive (MOS-Cog) subscale were summarized at baseline and Week 8. Category range: all of the time to none of the time. No formal statistical modeling was used. |
| Medical Outcome Study Cognitive Subscale (MOS-Cog); Thinking | Baseline, Week 8 | The number of subjects' responses to each of the 6 questions on the Medical Outcome Study Cognitive (MOS-Cog) subscale were summarized at baseline and Week 8. Category range: all of the time to none of the time. No formal statistical modeling was used. |
| Davidson Trauma Scale (DTS): Severity | Baseline, Week 8 | Self-rated instrument to measure symptom severity and treatment outcome in post traumatic stress disorder (PTSD). Scale of 17 PTSD symptoms over previous week; frequency scale: 0 (not at all) to 4 (every day), and severity 0 (not at all distressing) to 4(extremely distressing). The total Davidson Trauma Scale score ranges from 0 to 136. |
| Davidson Trauma Scale (DTS): Frequency | Baseline, Week 8 | Self-rated instrument to measure symptom severity and treatment outcome in post traumatic stress disorder (PTSD). Scale of 17 PTSD symptoms over previous week; frequency scale: 0 (not at all) to 4 (every day), and severity 0 (not at all distressing) to 4(extremely distressing). The total Davidson Trauma Scale score ranges from 0 to 136. |
| Davidson Trauma Scale (DTS): Total Score | Baseline, Week 8 | Self-rated instrument to measure symptom severity and treatment outcome in post traumatic stress disorder (PTSD). Scale of 17 PTSD symptoms over previous week; frequency scale: 0 (not at all) to 4 (every day), and severity 0 (not at all distressing) to 4(extremely distressing). The total Davidson Trauma Scale score ranges from 0 to 136. |
| Pain Treatment Satisfaction Scale (PTSS): Medication Characteristics | Screening, Week 8 | Pain Treatment Satisfaction Scale (PTSS); Medication Characteristics: measure of patient satisfaction with treatment for acute or chronic pain. Response range: 1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment. |
Countries
Belgium, Canada, Denmark, Finland, Italy, Netherlands, Portugal, Romania, Sweden, Switzerland, United Kingdom
Participant flow
Pre-assignment details
2-week screening period and single-blind washout and placebo run-in phase followed by a 4-week randomized, dose adjustment, double-blind treatment phase
Participants by arm
| Arm | Count |
|---|---|
| Pregabalin Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).
At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day). | 127 |
| Placebo Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase. | 127 |
| Total | 254 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Double-Blind | Adverse Event | 0 | 25 | 9 |
| Double-Blind | Laboratory Abnormality | 0 | 0 | 1 |
| Double-Blind | Lack of Efficacy | 0 | 2 | 12 |
| Double-Blind | Lost to Follow-up | 0 | 1 | 0 |
| Double-Blind | Other | 0 | 3 | 4 |
| Double-Blind | Withdrawal by Subject | 0 | 0 | 3 |
| Single-Blind | Adverse Event | 14 | 0 | 0 |
| Single-Blind | Did not receive treatment | 1 | 0 | 0 |
| Single-Blind | Laboratory Abnormality | 5 | 0 | 0 |
| Single-Blind | Lack of Efficacy | 2 | 0 | 0 |
| Single-Blind | Lost to Follow-up | 3 | 0 | 0 |
| Single-Blind | Other | 77 | 0 | 0 |
| Single-Blind | Withdrawal by Subject | 12 | 0 | 0 |
Baseline characteristics
| Characteristic | Pregabalin | Placebo | Total |
|---|---|---|---|
| Age, Customized 18-44 years | 38 participants | 42 participants | 80 participants |
| Age, Customized 45-64 years | 60 participants | 60 participants | 120 participants |
| Age, Customized ≥65 years | 29 participants | 25 participants | 54 participants |
| Sex: Female, Male Female | 77 Participants | 52 Participants | 129 Participants |
| Sex: Female, Male Male | 50 Participants | 75 Participants | 125 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 77 / — | 109 / — | 73 / — |
| serious Total, serious adverse events | 2 / — | 4 / — | 2 / — |
Outcome results
Primary
Weekly Mean Pain Score at End of Treatment (Week 8) From Daily Pain Diary
Daily Pain Diary scale : mean score from 11-point numerical scale of pain; range: 0 (no pain) to 10 (worst possible pain). Endpoint weekly mean pain score: mean of the last 7 available pain scores from a daily pain diary during double blind treatment.
Time frame: each day of Week 8
Population: Full Analysis Set (FAS): all randomized subjects who received \>= 1 dose study drug \& have post-randomization efficacy data. Last Observation Carried Forward (LOCF).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin | Weekly Mean Pain Score at End of Treatment (Week 8) From Daily Pain Diary | 4.61 score on a scale | Standard Error 0.18 |
| Placebo | Weekly Mean Pain Score at End of Treatment (Week 8) From Daily Pain Diary | 5.23 score on a scale | Standard Error 0.18 |
Comparison: The study is powered to detect a clinically significant difference of 1 between treatment groups in the weekly mean pain score. Null hypothesis was that there was no difference in weekly mean pain scores between pregabalin and placebo.p-value: 0.0195% CI: [-1.09, -0.15]ANCOVA
Secondary
Clinical Global Impression of Change (CGIC)
Clinical Global Impression of Change (CGIC): clinician's judgment of overall change in the patient's condition over a defined period on a 7-point scale; range: 1 Very Much Improved to 7 Very Much Worse.
Time frame: Week 8
Population: FAS, LOCF
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Clinical Global Impression of Change (CGIC) | very much worse | 1 participants |
| Pregabalin | Clinical Global Impression of Change (CGIC) | very much improved | 11 participants |
| Pregabalin | Clinical Global Impression of Change (CGIC) | much improved | 33 participants |
| Pregabalin | Clinical Global Impression of Change (CGIC) | minimally improved | 36 participants |
| Pregabalin | Clinical Global Impression of Change (CGIC) | no change | 33 participants |
| Pregabalin | Clinical Global Impression of Change (CGIC) | minimally worse | 5 participants |
| Pregabalin | Clinical Global Impression of Change (CGIC) | much worse | 4 participants |
| Placebo | Clinical Global Impression of Change (CGIC) | very much worse | 1 participants |
| Placebo | Clinical Global Impression of Change (CGIC) | no change | 61 participants |
| Placebo | Clinical Global Impression of Change (CGIC) | very much improved | 6 participants |
| Placebo | Clinical Global Impression of Change (CGIC) | much worse | 3 participants |
| Placebo | Clinical Global Impression of Change (CGIC) | much improved | 18 participants |
| Placebo | Clinical Global Impression of Change (CGIC) | minimally worse | 9 participants |
| Placebo | Clinical Global Impression of Change (CGIC) | minimally improved | 26 participants |
Secondary
Davidson Trauma Scale (DTS): Frequency
Self-rated instrument to measure symptom severity and treatment outcome in post traumatic stress disorder (PTSD). Scale of 17 PTSD symptoms over previous week; frequency scale: 0 (not at all) to 4 (every day), and severity 0 (not at all distressing) to 4(extremely distressing). The total Davidson Trauma Scale score ranges from 0 to 136.
Time frame: Baseline, Week 8
Population: FAS, LOCF. Number of subjects with evaluable data: (n=pregabalin, placebo), respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Davidson Trauma Scale (DTS): Frequency | Baseline (n=124, 124) | 18.27 score on scale | Standard Deviation 13.98 |
| Pregabalin | Davidson Trauma Scale (DTS): Frequency | Week 8 (n=118, 120) | 14.16 score on scale | Standard Deviation 12.67 |
| Placebo | Davidson Trauma Scale (DTS): Frequency | Baseline (n=124, 124) | 20.90 score on scale | Standard Deviation 15.11 |
| Placebo | Davidson Trauma Scale (DTS): Frequency | Week 8 (n=118, 120) | 18.47 score on scale | Standard Deviation 15.51 |
Secondary
Davidson Trauma Scale (DTS): Severity
Self-rated instrument to measure symptom severity and treatment outcome in post traumatic stress disorder (PTSD). Scale of 17 PTSD symptoms over previous week; frequency scale: 0 (not at all) to 4 (every day), and severity 0 (not at all distressing) to 4(extremely distressing). The total Davidson Trauma Scale score ranges from 0 to 136.
Time frame: Baseline, Week 8
Population: FAS, LOCF. Number of subjects with evaluable data: (n=pregabalin, placebo), respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Davidson Trauma Scale (DTS): Severity | Baseline (n=116, 118) | 15.55 score on a scale | Standard Deviation 14.16 |
| Pregabalin | Davidson Trauma Scale (DTS): Severity | Week 8 (n=112, 113) | 11.71 score on a scale | Standard Deviation 13.77 |
| Placebo | Davidson Trauma Scale (DTS): Severity | Baseline (n=116, 118) | 17.83 score on a scale | Standard Deviation 16.94 |
| Placebo | Davidson Trauma Scale (DTS): Severity | Week 8 (n=112, 113) | 15.43 score on a scale | Standard Deviation 16.91 |
Secondary
Davidson Trauma Scale (DTS): Total Score
Self-rated instrument to measure symptom severity and treatment outcome in post traumatic stress disorder (PTSD). Scale of 17 PTSD symptoms over previous week; frequency scale: 0 (not at all) to 4 (every day), and severity 0 (not at all distressing) to 4(extremely distressing). The total Davidson Trauma Scale score ranges from 0 to 136.
Time frame: Baseline, Week 8
Population: FAS, LOCF. Number of subjects with evaluable data: (n=pregabalin, placebo), respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Davidson Trauma Scale (DTS): Total Score | Week 8 (n=112, 113) | 26.18 score on scale | Standard Deviation 26.09 |
| Pregabalin | Davidson Trauma Scale (DTS): Total Score | Baseline (n=116, 118) | 34.57 score on scale | Standard Deviation 27.56 |
| Placebo | Davidson Trauma Scale (DTS): Total Score | Week 8 (n=112, 113) | 33.62 score on scale | Standard Deviation 31.65 |
| Placebo | Davidson Trauma Scale (DTS): Total Score | Baseline (n=116, 118) | 38.76 score on scale | Standard Deviation 31.55 |
Secondary
Hospital Anxiety and Depression Scale (HADS) Anxiety Score
Hospital Anxiety and Depression Scale Anxiety Score (HADS-A) consists of 7 items that are assessed by a score of 0 = no anxiety to 3 = severe feeling of anxiety. The anxiety subscale determines a state of generalized anxiety (including anxious mood, restlessness, anxious thoughts, panic attacks). Score range = 0 to 21; higher scores indicate a greater intensity of anxiety
Time frame: Week 8
Population: Full analysis set (FAS), last observation carried forward (LOCF)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin | Hospital Anxiety and Depression Scale (HADS) Anxiety Score | 6.52 score on scale | Standard Error 0.29 |
| Placebo | Hospital Anxiety and Depression Scale (HADS) Anxiety Score | 7.36 score on scale | Standard Error 0.29 |
p-value: 0.03195% CI: [-1.6, -0.08]ANCOVA
Secondary
Hospital Anxiety and Depression Scale (HADS) Anxiety Score - FAS Subset With Moderate/Severe Baseline Scores
Hospital Anxiety and Depression Scale Anxiety Score (HADS-A) consists of 7 items that are assessed by a score of 0 = no anxiety to 3 = severe feeling of anxiety. The anxiety subscale determines a state of generalized anxiety (including anxious mood, restlessness, anxious thoughts, panic attacks). Score range = 0 to 21; higher scores indicate a greater intensity of anxiety.
Time frame: Week 8
Population: Subset of subjects from the FAS who had moderate/severe baseline anxiety scores. LOCF.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin | Hospital Anxiety and Depression Scale (HADS) Anxiety Score - FAS Subset With Moderate/Severe Baseline Scores | 9.94 score on scale | Standard Error 0.77 |
| Placebo | Hospital Anxiety and Depression Scale (HADS) Anxiety Score - FAS Subset With Moderate/Severe Baseline Scores | 11.63 score on scale | Standard Error 0.72 |
p-value: 0.09995% CI: [-3.69, 0.32]ANCOVA
Secondary
Hospital Anxiety and Depression Scale (HADS) Depression Score
Hospital Anxiety and Depression Scale Depression Score (HADS-D) consists of 7 items that are assessed by a score of 0 = no depression to 3 = severe feeling of depression. The depression subscale focuses on the state of lost interest and diminished pleasure response (lowering of hedonic tone). Score range = 0 to 21; higher scores indicate a greater intensity of depression
Time frame: Week 8
Population: FAS LOCF
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin | Hospital Anxiety and Depression Scale (HADS) Depression Score | 5.23 score on scale | Standard Error 0.24 |
| Placebo | Hospital Anxiety and Depression Scale (HADS) Depression Score | 6.20 score on scale | Standard Error 0.24 |
p-value: 0.00395% CI: [-1.61, -0.33]ANCOVA
Secondary
Hospital Anxiety and Depression Scale (HADS) Depression Score - FAS Subset With Moderate/Severe Baseline Scores
Hospital Anxiety and Depression Scale (HADS-D) consists of 7 items that are assessed by a score of 0 = no depression to 3 = severe feeling of depression. The depression subscale focuses on the state of lost interest and diminished pleasure response (lowering of hedonic tone). Score range = 0 to 21; higher scores indicate a greater intensity of depression
Time frame: Week 8
Population: Subset of subjects from the FAS who had moderate/severe baseline depression scores. LOCF.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin | Hospital Anxiety and Depression Scale (HADS) Depression Score - FAS Subset With Moderate/Severe Baseline Scores | 12.04 score on scale | Standard Error 0.79 |
| Placebo | Hospital Anxiety and Depression Scale (HADS) Depression Score - FAS Subset With Moderate/Severe Baseline Scores | 11.80 score on scale | Standard Error 0.79 |
p-value: 0.81995% CI: [-1.87, 2.34]ANCOVA
Secondary
Medical Outcome Study Cognitive Subscale (MOS-Cog); Attention
The number of subjects' responses to each of the 6 questions on the Medical Outcome Study Cognitive (MOS-Cog) subscale were summarized at baseline and Week 8. Category range: all of the time to none of the time. No formal statistical modeling was used.
Time frame: Baseline, Week 8
Population: FAS, LOCF. The number of subjects that answered the question at Week 8 is 120, 121 for pregabalin, placebo respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Medical Outcome Study Cognitive Subscale (MOS-Cog); Attention | Baseline: All of the Time | 5 participants |
| Pregabalin | Medical Outcome Study Cognitive Subscale (MOS-Cog); Attention | Baseline: Most of the Time | 3 participants |
| Pregabalin | Medical Outcome Study Cognitive Subscale (MOS-Cog); Attention | Baseline: A Good Bit of Time | 13 participants |
| Pregabalin | Medical Outcome Study Cognitive Subscale (MOS-Cog); Attention | Baseline: Some of the Time | 24 participants |
| Pregabalin | Medical Outcome Study Cognitive Subscale (MOS-Cog); Attention | Baseline: A Little of the Time | 39 participants |
| Pregabalin | Medical Outcome Study Cognitive Subscale (MOS-Cog); Attention | Baseline: None of the Time | 42 participants |
| Pregabalin | Medical Outcome Study Cognitive Subscale (MOS-Cog); Attention | Week 8: All of the Time | 4 participants |
| Pregabalin | Medical Outcome Study Cognitive Subscale (MOS-Cog); Attention | Week 8: Most of the Time | 10 participants |
| Pregabalin | Medical Outcome Study Cognitive Subscale (MOS-Cog); Attention | Week 8: A Good Bit of Time | 8 participants |
| Pregabalin | Medical Outcome Study Cognitive Subscale (MOS-Cog); Attention | Week 8: Some of the Time | 22 participants |
| Pregabalin | Medical Outcome Study Cognitive Subscale (MOS-Cog); Attention | Week 8: A Little of the Time | 34 participants |
| Pregabalin | Medical Outcome Study Cognitive Subscale (MOS-Cog); Attention | Week 8: None of the Time | 42 participants |
| Placebo | Medical Outcome Study Cognitive Subscale (MOS-Cog); Attention | Week 8: A Little of the Time | 34 participants |
| Placebo | Medical Outcome Study Cognitive Subscale (MOS-Cog); Attention | Baseline: All of the Time | 3 participants |
| Placebo | Medical Outcome Study Cognitive Subscale (MOS-Cog); Attention | Week 8: All of the Time | 5 participants |
| Placebo | Medical Outcome Study Cognitive Subscale (MOS-Cog); Attention | Baseline: Most of the Time | 16 participants |
| Placebo | Medical Outcome Study Cognitive Subscale (MOS-Cog); Attention | Week 8: Some of the Time | 26 participants |
| Placebo | Medical Outcome Study Cognitive Subscale (MOS-Cog); Attention | Baseline: A Good Bit of Time | 14 participants |
| Placebo | Medical Outcome Study Cognitive Subscale (MOS-Cog); Attention | Week 8: Most of the Time | 7 participants |
| Placebo | Medical Outcome Study Cognitive Subscale (MOS-Cog); Attention | Baseline: Some of the Time | 23 participants |
| Placebo | Medical Outcome Study Cognitive Subscale (MOS-Cog); Attention | Week 8: None of the Time | 36 participants |
| Placebo | Medical Outcome Study Cognitive Subscale (MOS-Cog); Attention | Baseline: A Little of the Time | 23 participants |
| Placebo | Medical Outcome Study Cognitive Subscale (MOS-Cog); Attention | Week 8: A Good Bit of Time | 13 participants |
| Placebo | Medical Outcome Study Cognitive Subscale (MOS-Cog); Attention | Baseline: None of the Time | 47 participants |
Secondary
Medical Outcome Study Cognitive Subscale (MOS-Cog); Concentration
The number of subjects' responses to each of the 6 questions on the Medical Outcome Study Cognitive (MOS-Cog) subscale were summarized at baseline and Week 8. Category range: all of the time to none of the time. No formal statistical modeling was used.
Time frame: Baseline, Week 8
Population: FAS, LOCF. The number of subjects that answered the question at Week 8 is 120, 121 for pregabalin, placebo respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Medical Outcome Study Cognitive Subscale (MOS-Cog); Concentration | Baseline: All of the Time | 4 participants |
| Pregabalin | Medical Outcome Study Cognitive Subscale (MOS-Cog); Concentration | Baseline: Most of the Time | 8 participants |
| Pregabalin | Medical Outcome Study Cognitive Subscale (MOS-Cog); Concentration | Baseline: A Good Bit of the Time | 13 participants |
| Pregabalin | Medical Outcome Study Cognitive Subscale (MOS-Cog); Concentration | Baseline: A Little of the Time | 33 participants |
| Pregabalin | Medical Outcome Study Cognitive Subscale (MOS-Cog); Concentration | Baseline: None of the Time | 41 participants |
| Pregabalin | Medical Outcome Study Cognitive Subscale (MOS-Cog); Concentration | Baseline: Some of the Time | 27 participants |
| Pregabalin | Medical Outcome Study Cognitive Subscale (MOS-Cog); Concentration | Week 8: All of the Time | 3 participants |
| Pregabalin | Medical Outcome Study Cognitive Subscale (MOS-Cog); Concentration | Week 8: Most of the Time | 12 participants |
| Pregabalin | Medical Outcome Study Cognitive Subscale (MOS-Cog); Concentration | Week 8: A Good Bit of the Time | 14 participants |
| Pregabalin | Medical Outcome Study Cognitive Subscale (MOS-Cog); Concentration | Week 8: Some of the Time | 26 participants |
| Pregabalin | Medical Outcome Study Cognitive Subscale (MOS-Cog); Concentration | Week 8: A Little of the Time | 27 participants |
| Pregabalin | Medical Outcome Study Cognitive Subscale (MOS-Cog); Concentration | Week 8: None of the Time | 38 participants |
| Placebo | Medical Outcome Study Cognitive Subscale (MOS-Cog); Concentration | Baseline: None of the Time | 39 participants |
| Placebo | Medical Outcome Study Cognitive Subscale (MOS-Cog); Concentration | Baseline: All of the Time | 4 participants |
| Placebo | Medical Outcome Study Cognitive Subscale (MOS-Cog); Concentration | Week 8: A Good Bit of the Time | 16 participants |
| Placebo | Medical Outcome Study Cognitive Subscale (MOS-Cog); Concentration | Baseline: Most of the Time | 14 participants |
| Placebo | Medical Outcome Study Cognitive Subscale (MOS-Cog); Concentration | Week 8: All of the Time | 7 participants |
| Placebo | Medical Outcome Study Cognitive Subscale (MOS-Cog); Concentration | Week 8: A Little of the Time | 33 participants |
| Placebo | Medical Outcome Study Cognitive Subscale (MOS-Cog); Concentration | Baseline: A Little of the Time | 26 participants |
| Placebo | Medical Outcome Study Cognitive Subscale (MOS-Cog); Concentration | Week 8: Most of the Time | 5 participants |
| Placebo | Medical Outcome Study Cognitive Subscale (MOS-Cog); Concentration | Week 8: None of the Time | 33 participants |
| Placebo | Medical Outcome Study Cognitive Subscale (MOS-Cog); Concentration | Baseline: A Good Bit of the Time | 14 participants |
| Placebo | Medical Outcome Study Cognitive Subscale (MOS-Cog); Concentration | Week 8: Some of the Time | 27 participants |
| Placebo | Medical Outcome Study Cognitive Subscale (MOS-Cog); Concentration | Baseline: Some of the Time | 29 participants |
Secondary
Medical Outcome Study Cognitive Subscale (MOS-Cog); Confusion
The number of subjects' responses to each of the 6 questions on the Medical Outcome Study Cognitive (MOS-Cog) subscale were summarized at baseline and Week 8. Category range: all of the time to none of the time. No formal statistical modeling was used.
Time frame: Baseline, Week 8
Population: FAS, LOCF. The number of subjects that answered the question at Week 8 is 119, 121 for pregabalin, placebo respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Medical Outcome Study Cognitive Subscale (MOS-Cog); Confusion | Baseline: All of the Time | 2 particpants |
| Pregabalin | Medical Outcome Study Cognitive Subscale (MOS-Cog); Confusion | Baseline: Most of the Time | 8 particpants |
| Pregabalin | Medical Outcome Study Cognitive Subscale (MOS-Cog); Confusion | Baseline: A Good Bit of the Time | 6 particpants |
| Pregabalin | Medical Outcome Study Cognitive Subscale (MOS-Cog); Confusion | Baseline: Some of the Time | 22 particpants |
| Pregabalin | Medical Outcome Study Cognitive Subscale (MOS-Cog); Confusion | Baseline: A Little of the Time | 23 particpants |
| Pregabalin | Medical Outcome Study Cognitive Subscale (MOS-Cog); Confusion | Baseline: None of the Time | 64 particpants |
| Pregabalin | Medical Outcome Study Cognitive Subscale (MOS-Cog); Confusion | Week 8: All of the Time | 1 particpants |
| Pregabalin | Medical Outcome Study Cognitive Subscale (MOS-Cog); Confusion | Week 8: Most of the Time | 9 particpants |
| Pregabalin | Medical Outcome Study Cognitive Subscale (MOS-Cog); Confusion | Week 8: A Good Bit of the Time | 9 particpants |
| Pregabalin | Medical Outcome Study Cognitive Subscale (MOS-Cog); Confusion | Week 8: Some of the Time | 26 particpants |
| Pregabalin | Medical Outcome Study Cognitive Subscale (MOS-Cog); Confusion | Week 8: A Little of the Time | 22 particpants |
| Pregabalin | Medical Outcome Study Cognitive Subscale (MOS-Cog); Confusion | Week 8: None of the Time | 52 particpants |
| Placebo | Medical Outcome Study Cognitive Subscale (MOS-Cog); Confusion | Baseline: None of the Time | 51 particpants |
| Placebo | Medical Outcome Study Cognitive Subscale (MOS-Cog); Confusion | Baseline: All of the Time | 6 particpants |
| Placebo | Medical Outcome Study Cognitive Subscale (MOS-Cog); Confusion | Week 8: A Good Bit of the Time | 6 particpants |
| Placebo | Medical Outcome Study Cognitive Subscale (MOS-Cog); Confusion | Baseline: Most of the Time | 12 particpants |
| Placebo | Medical Outcome Study Cognitive Subscale (MOS-Cog); Confusion | Week 8: All of the Time | 3 particpants |
| Placebo | Medical Outcome Study Cognitive Subscale (MOS-Cog); Confusion | Baseline: A Good Bit of the Time | 7 particpants |
| Placebo | Medical Outcome Study Cognitive Subscale (MOS-Cog); Confusion | Week 8: A Little of the Time | 27 particpants |
| Placebo | Medical Outcome Study Cognitive Subscale (MOS-Cog); Confusion | Week 8: Most of the Time | 11 particpants |
| Placebo | Medical Outcome Study Cognitive Subscale (MOS-Cog); Confusion | Baseline: A Little of the Time | 35 particpants |
| Placebo | Medical Outcome Study Cognitive Subscale (MOS-Cog); Confusion | Week 8: Some of the Time | 23 particpants |
| Placebo | Medical Outcome Study Cognitive Subscale (MOS-Cog); Confusion | Week 8: None of the Time | 51 particpants |
| Placebo | Medical Outcome Study Cognitive Subscale (MOS-Cog); Confusion | Baseline: Some of the Time | 15 particpants |
Secondary
Medical Outcome Study Cognitive Subscale (MOS-Cog); Memory
The number of subjects' responses to each of the 6 questions on the Medical Outcome Study Cognitive (MOS-Cog) subscale were summarized at baseline and Week 8. Category range: all of the time to none of the time. No formal statistical modeling was used.
Time frame: Baseline, Week 8
Population: FAS, LOCF. The number of subjects that answered the question at Week 8 is 120, 121 for pregabalin, placebo respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Medical Outcome Study Cognitive Subscale (MOS-Cog); Memory | Baseline: All of the Time | 7 participants |
| Pregabalin | Medical Outcome Study Cognitive Subscale (MOS-Cog); Memory | Baseline: Most of the Time | 7 participants |
| Pregabalin | Medical Outcome Study Cognitive Subscale (MOS-Cog); Memory | Baseline: A Good Bit of the Time | 6 participants |
| Pregabalin | Medical Outcome Study Cognitive Subscale (MOS-Cog); Memory | Baseline: Some of the Time | 40 participants |
| Pregabalin | Medical Outcome Study Cognitive Subscale (MOS-Cog); Memory | Baseline: A Little of the Time | 30 participants |
| Pregabalin | Medical Outcome Study Cognitive Subscale (MOS-Cog); Memory | Baseline: None of the Time | 36 participants |
| Pregabalin | Medical Outcome Study Cognitive Subscale (MOS-Cog); Memory | Week 8: All of the Time | 3 participants |
| Pregabalin | Medical Outcome Study Cognitive Subscale (MOS-Cog); Memory | Week 8: Most of the Time | 11 participants |
| Pregabalin | Medical Outcome Study Cognitive Subscale (MOS-Cog); Memory | Week 8: A Good Bit of Time | 13 participants |
| Pregabalin | Medical Outcome Study Cognitive Subscale (MOS-Cog); Memory | Week 8: Some of the Time | 28 participants |
| Pregabalin | Medical Outcome Study Cognitive Subscale (MOS-Cog); Memory | Week 8: A Little of the Time | 36 participants |
| Pregabalin | Medical Outcome Study Cognitive Subscale (MOS-Cog); Memory | Week 8: None of the Time | 29 participants |
| Placebo | Medical Outcome Study Cognitive Subscale (MOS-Cog); Memory | Week 8: A Little of the Time | 35 participants |
| Placebo | Medical Outcome Study Cognitive Subscale (MOS-Cog); Memory | Baseline: All of the Time | 10 participants |
| Placebo | Medical Outcome Study Cognitive Subscale (MOS-Cog); Memory | Week 8: All of the Time | 9 participants |
| Placebo | Medical Outcome Study Cognitive Subscale (MOS-Cog); Memory | Baseline: Most of the Time | 14 participants |
| Placebo | Medical Outcome Study Cognitive Subscale (MOS-Cog); Memory | Week 8: Some of the Time | 31 participants |
| Placebo | Medical Outcome Study Cognitive Subscale (MOS-Cog); Memory | Baseline: A Good Bit of the Time | 8 participants |
| Placebo | Medical Outcome Study Cognitive Subscale (MOS-Cog); Memory | Week 8: Most of the Time | 7 participants |
| Placebo | Medical Outcome Study Cognitive Subscale (MOS-Cog); Memory | Baseline: Some of the Time | 23 participants |
| Placebo | Medical Outcome Study Cognitive Subscale (MOS-Cog); Memory | Week 8: None of the Time | 28 participants |
| Placebo | Medical Outcome Study Cognitive Subscale (MOS-Cog); Memory | Baseline: A Little of the Time | 33 participants |
| Placebo | Medical Outcome Study Cognitive Subscale (MOS-Cog); Memory | Week 8: A Good Bit of Time | 11 participants |
| Placebo | Medical Outcome Study Cognitive Subscale (MOS-Cog); Memory | Baseline: None of the Time | 38 participants |
Secondary
Medical Outcome Study Cognitive Subscale (MOS-Cog); Reasoning
The number of subjects' responses to each of the 6 questions on the Medical Outcome Study Cognitive (MOS-Cog) subscale were summarized at baseline and Week 8. Category range: all of the time to none of the time. No formal statistical modeling was used.
Time frame: Baseline, Week 8
Population: FAS, LOCF. The number of subjects that answered the question at Week 8 is 120, 121 for pregabalin, placebo respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Medical Outcome Study Cognitive Subscale (MOS-Cog); Reasoning | Baseline: Most of the Time | 6 participants |
| Pregabalin | Medical Outcome Study Cognitive Subscale (MOS-Cog); Reasoning | Week 8: All of the Time | 3 participants |
| Pregabalin | Medical Outcome Study Cognitive Subscale (MOS-Cog); Reasoning | Baseline: Some of the Time | 20 participants |
| Pregabalin | Medical Outcome Study Cognitive Subscale (MOS-Cog); Reasoning | Week 8: Most of the Time | 10 participants |
| Pregabalin | Medical Outcome Study Cognitive Subscale (MOS-Cog); Reasoning | Baseline: All of the Time | 5 participants |
| Pregabalin | Medical Outcome Study Cognitive Subscale (MOS-Cog); Reasoning | Week 8: A Good Bit of the Time | 11 participants |
| Pregabalin | Medical Outcome Study Cognitive Subscale (MOS-Cog); Reasoning | Baseline: A Little of the Time | 42 participants |
| Pregabalin | Medical Outcome Study Cognitive Subscale (MOS-Cog); Reasoning | Week 8: Some of the Time | 23 participants |
| Pregabalin | Medical Outcome Study Cognitive Subscale (MOS-Cog); Reasoning | Baseline: A Good Bit of the Time | 5 participants |
| Pregabalin | Medical Outcome Study Cognitive Subscale (MOS-Cog); Reasoning | Week 8: A Little of the Time | 32 participants |
| Pregabalin | Medical Outcome Study Cognitive Subscale (MOS-Cog); Reasoning | Baseline: None of the Time | 48 participants |
| Pregabalin | Medical Outcome Study Cognitive Subscale (MOS-Cog); Reasoning | Week 8: None of the Time | 41 participants |
| Placebo | Medical Outcome Study Cognitive Subscale (MOS-Cog); Reasoning | Baseline: None of the Time | 43 participants |
| Placebo | Medical Outcome Study Cognitive Subscale (MOS-Cog); Reasoning | Baseline: All of the Time | 1 participants |
| Placebo | Medical Outcome Study Cognitive Subscale (MOS-Cog); Reasoning | Baseline: Most of the Time | 15 participants |
| Placebo | Medical Outcome Study Cognitive Subscale (MOS-Cog); Reasoning | Baseline: A Good Bit of the Time | 15 participants |
| Placebo | Medical Outcome Study Cognitive Subscale (MOS-Cog); Reasoning | Baseline: Some of the Time | 25 participants |
| Placebo | Medical Outcome Study Cognitive Subscale (MOS-Cog); Reasoning | Baseline: A Little of the Time | 27 participants |
| Placebo | Medical Outcome Study Cognitive Subscale (MOS-Cog); Reasoning | Week 8: None of the Time | 42 participants |
| Placebo | Medical Outcome Study Cognitive Subscale (MOS-Cog); Reasoning | Week 8: All of the Time | 4 participants |
| Placebo | Medical Outcome Study Cognitive Subscale (MOS-Cog); Reasoning | Week 8: Most of the Time | 5 participants |
| Placebo | Medical Outcome Study Cognitive Subscale (MOS-Cog); Reasoning | Week 8: A Good Bit of the Time | 13 participants |
| Placebo | Medical Outcome Study Cognitive Subscale (MOS-Cog); Reasoning | Week 8: Some of the Time | 27 participants |
| Placebo | Medical Outcome Study Cognitive Subscale (MOS-Cog); Reasoning | Week 8: A Little of the Time | 30 participants |
Secondary
Medical Outcome Study Cognitive Subscale (MOS-Cog); Thinking
The number of subjects' responses to each of the 6 questions on the Medical Outcome Study Cognitive (MOS-Cog) subscale were summarized at baseline and Week 8. Category range: all of the time to none of the time. No formal statistical modeling was used.
Time frame: Baseline, Week 8
Population: FAS, LOCF. The number of subjects that answered the question at Week 8 is 120, 121 for pregabalin, placebo respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Medical Outcome Study Cognitive Subscale (MOS-Cog); Thinking | Baseline: All of the Time | 2 participants |
| Pregabalin | Medical Outcome Study Cognitive Subscale (MOS-Cog); Thinking | Baseline: Most of the Time | 6 participants |
| Pregabalin | Medical Outcome Study Cognitive Subscale (MOS-Cog); Thinking | Baseline: A Good Bit of Time | 3 participants |
| Pregabalin | Medical Outcome Study Cognitive Subscale (MOS-Cog); Thinking | Baseline: Some of the Time | 31 participants |
| Pregabalin | Medical Outcome Study Cognitive Subscale (MOS-Cog); Thinking | Baseline: A Little of the Time | 33 participants |
| Pregabalin | Medical Outcome Study Cognitive Subscale (MOS-Cog); Thinking | Baseline: None of the Time | 51 participants |
| Pregabalin | Medical Outcome Study Cognitive Subscale (MOS-Cog); Thinking | Week 8: All of the Time | 4 participants |
| Pregabalin | Medical Outcome Study Cognitive Subscale (MOS-Cog); Thinking | Week 8: Most of the Time | 6 participants |
| Pregabalin | Medical Outcome Study Cognitive Subscale (MOS-Cog); Thinking | Week 8: A Good Bit of Time | 12 participants |
| Pregabalin | Medical Outcome Study Cognitive Subscale (MOS-Cog); Thinking | Week 8: Some of the Time | 28 participants |
| Pregabalin | Medical Outcome Study Cognitive Subscale (MOS-Cog); Thinking | Week 8: A Little of the Time | 31 participants |
| Pregabalin | Medical Outcome Study Cognitive Subscale (MOS-Cog); Thinking | Week 8: None of the Time | 39 participants |
| Placebo | Medical Outcome Study Cognitive Subscale (MOS-Cog); Thinking | Week 8: A Little of the Time | 31 participants |
| Placebo | Medical Outcome Study Cognitive Subscale (MOS-Cog); Thinking | Baseline: All of the Time | 1 participants |
| Placebo | Medical Outcome Study Cognitive Subscale (MOS-Cog); Thinking | Week 8: All of the Time | 6 participants |
| Placebo | Medical Outcome Study Cognitive Subscale (MOS-Cog); Thinking | Baseline: Most of the Time | 9 participants |
| Placebo | Medical Outcome Study Cognitive Subscale (MOS-Cog); Thinking | Week 8: Some of the Time | 22 participants |
| Placebo | Medical Outcome Study Cognitive Subscale (MOS-Cog); Thinking | Baseline: A Good Bit of Time | 6 participants |
| Placebo | Medical Outcome Study Cognitive Subscale (MOS-Cog); Thinking | Week 8: Most of the Time | 9 participants |
| Placebo | Medical Outcome Study Cognitive Subscale (MOS-Cog); Thinking | Baseline: Some of the Time | 27 participants |
| Placebo | Medical Outcome Study Cognitive Subscale (MOS-Cog); Thinking | Week 8: None of the Time | 47 participants |
| Placebo | Medical Outcome Study Cognitive Subscale (MOS-Cog); Thinking | Baseline: A Little of the Time | 36 participants |
| Placebo | Medical Outcome Study Cognitive Subscale (MOS-Cog); Thinking | Week 8: A Good Bit of Time | 6 participants |
| Placebo | Medical Outcome Study Cognitive Subscale (MOS-Cog); Thinking | Baseline: None of the Time | 45 participants |
Secondary
Medical Outcome Study (MOS) Optimal Sleep
Number of subjects responding to have had optimal sleep. Optimal sleep is 1 item in the Medical Outcome Study (MOS)sleep scale, a patient-reported measure consisting of twelve items that assess the key constructs of sleep. Subjects were asked to recall sleep-related activities over the past week.
Time frame: Week 8
Population: FAS, LOCF.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pregabalin | Medical Outcome Study (MOS) Optimal Sleep | 58 participants |
| Placebo | Medical Outcome Study (MOS) Optimal Sleep | 45 participants |
p-value: 0.26795% CI: [0.76, 2.64]Regression, Logistic
Secondary
Medical Outcome Study (MOS) Sleep Subscales
Medical Outcome Study (MOS) is a patient-rated questionnaire consisting of 12 items that assess key constructs of sleep (7 subscales as well as a 9-item overall sleep problems index. MOS-Sleep Scale is scored from 0 to 100. A higher score indicates more disturbance.
Time frame: Week 8
Population: FAS, LOCF. Number of subjects with evaluable data (n = pregabalin, placebo), respectively.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Medical Outcome Study (MOS) Sleep Subscales | Sleep Disturbance (n=117, 118) | 35.73 score on a scale | Standard Error 1.96 |
| Pregabalin | Medical Outcome Study (MOS) Sleep Subscales | Snoring (n=111, 118) | 38.92 score on a scale | Standard Error 2.04 |
| Pregabalin | Medical Outcome Study (MOS) Sleep Subscales | Awaken Short of Breath/Headache (n= 118, 117) | 14.71 score on a scale | Standard Error 2.14 |
| Pregabalin | Medical Outcome Study (MOS) Sleep Subscales | Sleep Quantity (n=117, 118) | 6.39 score on a scale | Standard Error 0.32 |
| Pregabalin | Medical Outcome Study (MOS) Sleep Subscales | Sleep Adequacy (n=119, 119) | 55.25 score on a scale | Standard Error 2.44 |
| Pregabalin | Medical Outcome Study (MOS) Sleep Subscales | Somnolence (n=116, 114) | 34.64 score on a scale | Standard Error 1.75 |
| Pregabalin | Medical Outcome Study (MOS) Sleep Subscales | Sleep Problems Index-6 (n=112, 111) | 42.20 score on a scale | Standard Error 1.96 |
| Pregabalin | Medical Outcome Study (MOS) Sleep Subscales | Sleep problems Index-9 (n=111, 107) | 35.43 score on a scale | Standard Error 1.49 |
| Placebo | Medical Outcome Study (MOS) Sleep Subscales | Sleep problems Index-9 (n=111, 107) | 42.98 score on a scale | Standard Error 1.52 |
| Placebo | Medical Outcome Study (MOS) Sleep Subscales | Sleep Disturbance (n=117, 118) | 46.45 score on a scale | Standard Error 1.94 |
| Placebo | Medical Outcome Study (MOS) Sleep Subscales | Sleep Adequacy (n=119, 119) | 44.61 score on a scale | Standard Error 2.43 |
| Placebo | Medical Outcome Study (MOS) Sleep Subscales | Snoring (n=111, 118) | 37.87 score on a scale | Standard Error 1.97 |
| Placebo | Medical Outcome Study (MOS) Sleep Subscales | Sleep Problems Index-6 (n=112, 111) | 51.72 score on a scale | Standard Error 1.97 |
| Placebo | Medical Outcome Study (MOS) Sleep Subscales | Awaken Short of Breath/Headache (n= 118, 117) | 20.66 score on a scale | Standard Error 2.13 |
| Placebo | Medical Outcome Study (MOS) Sleep Subscales | Somnolence (n=116, 114) | 32.33 score on a scale | Standard Error 1.77 |
| Placebo | Medical Outcome Study (MOS) Sleep Subscales | Sleep Quantity (n=117, 118) | 6.48 score on a scale | Standard Error 0.32 |
Comparison: Sleep Disturbancep-value: 095% CI: [-15.89, -5.55]ANCOVA
Comparison: Snoringp-value: 0.795% CI: [-4.3, 6.4]ANCOVA
Comparison: Awaken Short of Breath/Headachep-value: 0.0495% CI: [-11.62, -0.28]ANCOVA
Comparison: Sleep Quantityp-value: 0.84695% CI: [-0.92, 0.76]ANCOVA
Comparison: Sleep Adequacyp-value: 0.00195% CI: [4.19, 17.07]ANCOVA
Comparison: Somnolencep-value: 0.32495% CI: [-2.3, 6.92]ANCOVA
Comparison: Sleep Problems Index-6p-value: 095% CI: [-14.71, -4.33]ANCOVA
Comparison: Sleep Problems Index-9p-value: 095% CI: [-11.52, -3.56]ANCOVA
Secondary
Modified Brief Pain Inventory Short Form (m-BPI-sf)
Modified Brief Pain Inventory Short Form (m-BPI-sf): self-administered questionnaire to assess severity of pain (measured by 4 items)and impact of pain on daily functions (measured by 7 items)in past 24 hours. Items are rated on an 11-point scale ranging from 0 to 10, with higher scores indicating greater pain and/or interference due to pain.
Time frame: Baseline, Week 8
Population: Baseline; FAS, LOCF. Number of subjects with evaluable data: (n = pregabalin, placebo), respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Modified Brief Pain Inventory Short Form (m-BPI-sf) | pain interference index Baseline (n=125, 126) | 4.57 score on a scale | Standard Deviation 2.11 |
| Pregabalin | Modified Brief Pain Inventory Short Form (m-BPI-sf) | pain interference index Week 8 (n=120, 121) | 3.31 score on a scale | Standard Deviation 2.41 |
| Pregabalin | Modified Brief Pain Inventory Short Form (m-BPI-sf) | pain severity index Baseline (n= 122, 125) | 5.36 score on a scale | Standard Deviation 1.71 |
| Pregabalin | Modified Brief Pain Inventory Short Form (m-BPI-sf) | pain severity index Week 8 (n=120, 120) | 4.20 score on a scale | Standard Deviation 2.35 |
| Placebo | Modified Brief Pain Inventory Short Form (m-BPI-sf) | pain severity index Week 8 (n=120, 120) | 5.21 score on a scale | Standard Deviation 2.42 |
| Placebo | Modified Brief Pain Inventory Short Form (m-BPI-sf) | pain interference index Baseline (n=125, 126) | 4.69 score on a scale | Standard Deviation 2.36 |
| Placebo | Modified Brief Pain Inventory Short Form (m-BPI-sf) | pain severity index Baseline (n= 122, 125) | 5.72 score on a scale | Standard Deviation 2.04 |
| Placebo | Modified Brief Pain Inventory Short Form (m-BPI-sf) | pain interference index Week 8 (n=120, 121) | 4.17 score on a scale | Standard Deviation 2.49 |
Secondary
Neuropathic Pain Symptom Inventory (NPSI) Total Intensity Score
Neuropathic Pain Symptom Inventory (NPSI) includes 10 descriptors (scale 0-10) of different pain symptoms & 2 temporal items assessing the duration of spontaneous ongoing and paroxysmal pain. A total intensity score is calculated by sub grouping the questions into five pain dimensions, summing the five sub groups, and converting into a percentage.
Time frame: Week 8
Population: FAS. Number of subjects with a non-missing NPSI Total Intensity Score at Baseline and Week 8 (using LOCF) is 100, 106 for pregabalin, placebo respectively.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin | Neuropathic Pain Symptom Inventory (NPSI) Total Intensity Score | 33.29 percentage score on scale | Standard Error 1.68 |
| Placebo | Neuropathic Pain Symptom Inventory (NPSI) Total Intensity Score | 37.12 percentage score on scale | Standard Error 1.66 |
p-value: 0.0995% CI: [-8.28, 0.61]ANCOVA
Secondary
Number of Subjects With 30% and 50% Response in Weekly Mean Daily Pain Rating Score (DPRS) From Baseline Until Endpoint (Week 8)
Based on weekly mean daily pain rating score (DPRS), responders were defined as subjects with a \>= 30% and \>=50% reduction in weekly mean scores from baseline until endpoint (Week 8). Endpoint was calculated as the mean of the last 7 available pain scores from the daily pain diary while in the double-blind treatment phase.
Time frame: Baseline, Week 8
Population: FAS, LOCF.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Number of Subjects With 30% and 50% Response in Weekly Mean Daily Pain Rating Score (DPRS) From Baseline Until Endpoint (Week 8) | 30% Responder | 50 participants |
| Pregabalin | Number of Subjects With 30% and 50% Response in Weekly Mean Daily Pain Rating Score (DPRS) From Baseline Until Endpoint (Week 8) | 50% Responder | 30 participants |
| Placebo | Number of Subjects With 30% and 50% Response in Weekly Mean Daily Pain Rating Score (DPRS) From Baseline Until Endpoint (Week 8) | 30% Responder | 32 participants |
| Placebo | Number of Subjects With 30% and 50% Response in Weekly Mean Daily Pain Rating Score (DPRS) From Baseline Until Endpoint (Week 8) | 50% Responder | 18 participants |
Comparison: 30% responderp-value: 0.03295% CI: [1.05, 3.21]Regression, Logistic
Comparison: 50% responderp-value: 0.08895% CI: [0.92, 3.46]Regression, Logistic
Secondary
Pain Treatment Satisfaction Scale (PTSS): Efficacy
Pain Treatment Satisfaction Scale (PTSS); Efficacy: measure of patient satisfaction with treatment for acute or chronic pain. Response range: 1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment.
Time frame: Screening, Week 8
Population: FAS, LOCF. Number of subjects with evaluable data (n=pregabalin, placebo), respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Pain Treatment Satisfaction Scale (PTSS): Efficacy | Screening (n=112, 110) | 43.23 score on scale | Standard Deviation 24.06 |
| Pregabalin | Pain Treatment Satisfaction Scale (PTSS): Efficacy | End of Treatment (Week 8) (n=122, 121) | 53.21 score on scale | Standard Deviation 30.63 |
| Placebo | Pain Treatment Satisfaction Scale (PTSS): Efficacy | Screening (n=112, 110) | 42.73 score on scale | Standard Deviation 23.98 |
| Placebo | Pain Treatment Satisfaction Scale (PTSS): Efficacy | End of Treatment (Week 8) (n=122, 121) | 37.88 score on scale | Standard Deviation 32.61 |
Secondary
Pain Treatment Satisfaction Scale (PTSS): Impact of Current Pain Medication
Pain Treatment Satisfaction Scale (PTSS); Impact of Current Pain Medication: measure of patient satisfaction with treatment for acute or chronic pain. Response range: 1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment.
Time frame: Screening, Week 8
Population: FAS, LOCF. Number of subjects with evaluable data (n=pregabalin, placebo), respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Pain Treatment Satisfaction Scale (PTSS): Impact of Current Pain Medication | Screening (n=113, 113) | 54.53 score on a scale | Standard Deviation 27.6 |
| Pregabalin | Pain Treatment Satisfaction Scale (PTSS): Impact of Current Pain Medication | End of Treatment (Week 8) (n=122, 121) | 52.64 score on a scale | Standard Deviation 31.87 |
| Placebo | Pain Treatment Satisfaction Scale (PTSS): Impact of Current Pain Medication | Screening (n=113, 113) | 53.60 score on a scale | Standard Deviation 26.07 |
| Placebo | Pain Treatment Satisfaction Scale (PTSS): Impact of Current Pain Medication | End of Treatment (Week 8) (n=122, 121) | 42.56 score on a scale | Standard Deviation 32.52 |
Secondary
Pain Treatment Satisfaction Scale (PTSS): Medication Characteristics
Pain Treatment Satisfaction Scale (PTSS); Medication Characteristics: measure of patient satisfaction with treatment for acute or chronic pain. Response range: 1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment.
Time frame: Screening, Week 8
Population: FAS, LOCF. Number of subjects with evaluable data (n=pregabalin, placebo), respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Pain Treatment Satisfaction Scale (PTSS): Medication Characteristics | Screening (n=112, 110) | 57.44 score on scale | Standard Deviation 21.84 |
| Pregabalin | Pain Treatment Satisfaction Scale (PTSS): Medication Characteristics | End of Treatment (Week 8) (n=122, 121) | 71.52 score on scale | Standard Deviation 19.58 |
| Placebo | Pain Treatment Satisfaction Scale (PTSS): Medication Characteristics | Screening (n=112, 110) | 59.39 score on scale | Standard Deviation 22.21 |
| Placebo | Pain Treatment Satisfaction Scale (PTSS): Medication Characteristics | End of Treatment (Week 8) (n=122, 121) | 70.39 score on scale | Standard Deviation 21 |
Secondary
Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication
Pain Treatment Satisfaction Scale (PTSS); Satisfaction with Current Pain Medication: measure of patient satisfaction with treatment for acute or chronic pain. Response range:1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment.
Time frame: Screening, Week 8
Population: FAS, LOCF. Number of subjects with evaluable data (n=pregabalin, placebo), respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication | Screening (n=112, 110) | 50.33 score on scale | Standard Deviation 20.85 |
| Pregabalin | Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication | Week 8 (n=122, 121) | 62.36 score on scale | Standard Deviation 22.22 |
| Placebo | Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication | Screening (n=112, 110) | 51.05 score on scale | Standard Deviation 20.52 |
| Placebo | Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication | Week 8 (n=122, 121) | 54.15 score on scale | Standard Deviation 22.78 |
Secondary
Patient Global Impression of Change (PGIC)
Patient Global Impression of Change (PGIC): a patient-rated instrument that measures change in patient's overall status on a 7-point scale; range: 1 Very Much Improved to 7 Very Much Worse.
Time frame: Week 8
Population: FAS, LOCF
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Patient Global Impression of Change (PGIC) | very much worse | 3 participants |
| Pregabalin | Patient Global Impression of Change (PGIC) | very much improved | 13 participants |
| Pregabalin | Patient Global Impression of Change (PGIC) | much improved | 27 participants |
| Pregabalin | Patient Global Impression of Change (PGIC) | minimally improved | 41 participants |
| Pregabalin | Patient Global Impression of Change (PGIC) | no change | 30 participants |
| Pregabalin | Patient Global Impression of Change (PGIC) | minimally worse | 3 participants |
| Pregabalin | Patient Global Impression of Change (PGIC) | much worse | 3 participants |
| Placebo | Patient Global Impression of Change (PGIC) | very much worse | 2 participants |
| Placebo | Patient Global Impression of Change (PGIC) | no change | 52 participants |
| Placebo | Patient Global Impression of Change (PGIC) | very much improved | 6 participants |
| Placebo | Patient Global Impression of Change (PGIC) | much worse | 7 participants |
| Placebo | Patient Global Impression of Change (PGIC) | much improved | 22 participants |
| Placebo | Patient Global Impression of Change (PGIC) | minimally worse | 10 participants |
| Placebo | Patient Global Impression of Change (PGIC) | minimally improved | 26 participants |
Secondary
Weekly Mean Pain Score From Daily Pain Diary
Daily Pain Diary scale : mean score from 11-point numerical scale of pain; range:0 (no pain) to 10 (worst possible pain). Mean of scores available for each week.
Time frame: Baseline through Week 8
Population: FAS. Number of subjects with evaluable data: (n = pregabalin, placebo), respectively
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Weekly Mean Pain Score From Daily Pain Diary | Week 1 (n=125, 125) | 5.54 score on scale | Standard Error 0.11 |
| Pregabalin | Weekly Mean Pain Score From Daily Pain Diary | Week 2 (n=121, 119) | 5.37 score on scale | Standard Error 0.13 |
| Pregabalin | Weekly Mean Pain Score From Daily Pain Diary | Week 3 (n=113, 116) | 4.91 score on scale | Standard Error 0.15 |
| Pregabalin | Weekly Mean Pain Score From Daily Pain Diary | Week 4 (n=108, 108) | 4.95 score on scale | Standard Error 0.15 |
| Pregabalin | Weekly Mean Pain Score From Daily Pain Diary | Week 5 (n=106, 104) | 4.80 score on scale | Standard Error 0.16 |
| Pregabalin | Weekly Mean Pain Score From Daily Pain Diary | Week 6 (n=104, 101) | 4.76 score on scale | Standard Error 0.16 |
| Pregabalin | Weekly Mean Pain Score From Daily Pain Diary | Week 7 (n=99, 99) | 4.74 score on scale | Standard Error 0.18 |
| Pregabalin | Weekly Mean Pain Score From Daily Pain Diary | Week 8 (n=97, 97) | 4.64 score on scale | Standard Error 0.18 |
| Placebo | Weekly Mean Pain Score From Daily Pain Diary | Week 8 (n=97, 97) | 5.24 score on scale | Standard Error 0.18 |
| Placebo | Weekly Mean Pain Score From Daily Pain Diary | Week 1 (n=125, 125) | 5.79 score on scale | Standard Error 0.11 |
| Placebo | Weekly Mean Pain Score From Daily Pain Diary | Week 5 (n=106, 104) | 5.26 score on scale | Standard Error 0.16 |
| Placebo | Weekly Mean Pain Score From Daily Pain Diary | Week 2 (n=121, 119) | 5.64 score on scale | Standard Error 0.13 |
| Placebo | Weekly Mean Pain Score From Daily Pain Diary | Week 7 (n=99, 99) | 5.26 score on scale | Standard Error 0.18 |
| Placebo | Weekly Mean Pain Score From Daily Pain Diary | Week 3 (n=113, 116) | 5.44 score on scale | Standard Error 0.15 |
| Placebo | Weekly Mean Pain Score From Daily Pain Diary | Week 6 (n=104, 101) | 5.34 score on scale | Standard Error 0.16 |
| Placebo | Weekly Mean Pain Score From Daily Pain Diary | Week 4 (n=108, 108) | 5.27 score on scale | Standard Error 0.15 |
Comparison: Week 1p-value: 0.09995% CI: [-0.56, 0.05]Mixed Models Analysis
Comparison: Week 2: FASp-value: 0.1595% CI: [-0.62, 0.1]Mixed Models Analysis
Comparison: Week 3: FASp-value: 0.0195% CI: [-0.93, -0.13]Mixed Models Analysis
Comparison: Week 4: FASp-value: 0.13795% CI: [-0.74, 0.1]Mixed Models Analysis
Comparison: Week 5: FASp-value: 0.04195% CI: [-0.9, -0.02]Mixed Models Analysis
Comparison: Week 6: FASp-value: 0.00995% CI: [-1.03, -0.15]Mixed Models Analysis
Comparison: Week 7: FASp-value: 0.03595% CI: [-1.01, -0.04]Mixed Models Analysis
Comparison: Week 8: FASp-value: 0.01995% CI: [-1.1, -0.1]Mixed Models Analysis
Secondary
Weekly Mean Sleep Interference Score
11-point numerical scale with which the patient describes pain interference with sleep over past 24 hours; range: 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep). Endpoint weekly mean score: mean of last 7 available scores from daily sleep interference diary during double-blind treatment.
Time frame: Week 8
Population: FAS, LOCF
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin | Weekly Mean Sleep Interference Score | 2.93 score on scale | Standard Error 0.17 |
| Placebo | Weekly Mean Sleep Interference Score | 3.73 score on scale | Standard Error 0.17 |
p-value: 0.00195% CI: [-1.25, -0.34]ANCOVA