Neuralgia, Spinal Cord Injuries
Conditions
Keywords
Pain, central neuropathic pain
Brief summary
The purpose of this study is to evaluate if pregabalin relieves nerve pain associated with spinal cord injury compared to placebo (pill that contains no active medicine). This study will also evaluate the safety of pregabalin in this patient population.
Interventions
DRUGplacebo
Placebo
DRUGpregabalin
Pregabalin capsules taken twice daily up to 17 weeks (150-600 mg/day)
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects with nerve pain after Spinal cord injury (traumatic, diving, ischemic and after removal of benign tumors (except meningioma and fibromas) * Pain has to be chronic(continuous for at least 3 months or intermittent for at least 6 months * Pain score at least 4 in 4 of 7 days prior to receive treatment.
Exclusion criteria
* Pregabalin use in the last 60 days, prior intolerance to pregabalin * Creatinine clearance \<60 mL/min. * White blood cell count \<2500/mm3; neutrophil count \<1500/mm3; platelet count \<100 x 103/ mm3. * Abuse of drugs or alcohol * Unstable medial conditions * Clinically significant abnormal electrocardiogram (ECG). * Presence of severe pain associated with conditions other than spinal cord injury that could confound the assessment or self-evaluation of pain due to spinal cord injury.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration Adjusted Average Change (DAAC) of Mean Pain Score | Baseline, Week 16 | DAAC was derived from participant's daily pain diary, where pain was measured on an 11-point Numerical Rating Scale (NRS-Pain)ranging from 0 (did not interfere with sleep) to 10 (completely interfered \[unable to sleep due to pain\]). The DAAC was calculated as the mean of all daily pain diary rating post baseline minus the baseline score then multiplied by the proportion of the planned study duration completed by the participant. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Weekly Mean Pain Score | Baseline, Week 16 | Mean weekly score was calculated as the average of the available daily diary pain score values for the week. Pain score was measured on an 11-point numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain). |
| Number of Participants With >=30% Reduction in Weekly Mean Pain Score From Baseline | Baseline, Week 16 | Mean weekly score was calculated as the average of the available daily diary pain score values for the week. Pain score was measured on an 11-point numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain). |
| Number of Participants With Categorical Scores on the Patient Global Impression of Change (PGIC) (Full Scale) | Baseline, Week 16 | The PGIC is a participant-rated instrument measuring change in the participant's overall status on a 7-point scale: 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse. |
| Change From Baseline in Weekly Mean Sleep Interference Score | Baseline, Week 16 | Pain-related sleep interference was assessed on an 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered \[unable to sleep due to pain\]). |
| Change From Baseline in Weekly Mean Pain Score by Week | Baseline, Week 1 through16 | Mean weekly score was calculated as the average of the available daily diary pain score values for the week. Pain score was measured on an 11-point numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain). |
| Number of Participants With >=50% Reduction in Weekly Mean Pain Score From Baseline | Baseline, Week 16 | Mean weekly score was calculated as the average of the available daily diary pain score values for the week. Pain score was measured on an 11-point numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain). |
| Change From Baseline in Modified Brief Pain Inventory Interference Scale (10-Item) (mBPI-10) Total Score | Baseline, Week 16 | The Modified Brief Pain Inventory (mBPI-10) Interference Scale is a self administered questionnaire that assessed pain interference with functional activities over the past week. The items were measured on an 11 point scale, ranging from does not interfere (0) to completely interferes (10). A composite score, the pain interference index, was calculated by averaging the 10 items that comprised the scale. |
| Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP) - Static Mechanical Allodynia | Baseline, Week 16 | Participant rated pain scale. The pain produced by the applied stimulus (static mechanical allodynia - gentle constant mechanical pressure) was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain). |
| Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP) - Dynamic Mechanical Allodynia | Baseline, Week 16 | Participant rated pain scale. The pain produced by the applied stimulus (dynamic mechanical allodynia - gentle stroking with foam brush) was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain). |
| Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Punctata Hyperalgesia | Baseline, Week 16 | Participant rated pain scale. The pain produced by the applied stimulus (Punctata hyperalgesia - pinprick) was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain). |
| Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Temporal Summation to Tactile Stimuli | Baseline, Week 16 | Participant rated pain scale. The pain produced by the applied stimulus (Temporal summation to tactile stimuli - repeated touching/tapping) was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain). |
| Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Cold Allodynia | Baseline, Week 16 | Participant rated pain scale. The pain produced by the applied stimulus (Cold allodynia - touch with cool metal rod 13-17 degrees celsius was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain). |
| Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Cold Hyperalgesia Subscales | Baseline, Week 16 | Participant rated pain scale. The pain produced by the applied stimulus (Cold hyperalgesia - touch with cold metal rod 4 degrees celsius) was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain). |
| Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - 12 Items Total Intensity Score | Baseline, Week 16 | Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: burning \[superficial\] spontaneous pain, pressing \[deep\] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia \[P/D\]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain. |
| Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Burning Spontaneous Pain | Baseline, Week 16 | Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: burning \[superficial\] spontaneous pain, pressing \[deep\] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia \[P/D\]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain. |
| Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Pressing Spontaneous Pain | Baseline, Week 16 | Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: burning \[superficial\] spontaneous pain, pressing \[deep\] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia \[P/D\]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain. |
| Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Evoked Pain | Baseline, Week 16 | Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: burning \[superficial\] spontaneous pain, pressing \[deep\] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia \[P/D\]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain. |
| Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Paresthesia/Dysesthesia | Baseline, Week 16 | Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: burning \[superficial\] spontaneous pain, pressing \[deep\] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia \[P/D\]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain. |
| Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Individual Item (1, 2, 3, 5, 6, 8, 9, 10, 11, 12) Score | Baseline, Week 16 | Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: burning \[superficial\] spontaneous pain, pressing \[deep\] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia \[P/D\]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain. |
| Number of Participants With Improved Duration of Brief Pain Attacks Based on NPSI - Duration (Item 4) | Baseline, Week 16 | NPSI - Temporal item which assesses the duration (number of hours during the last 24 hours) of spontaneous ongoing pain. Improved duration would be a decrease in the number of hours of spontaneous ongoing pain during the last 24 hours compared to baseline. |
| Number of Participants With Improvement in the Number of Attacks Based on NPSI - Number of Attacks (Item 7) | Baseline, Week 16 | NPSI - Temporal item which assesses the paroxysmal pain (number of pain attacks during the last 24 hours). Improvement in the number of attacks would be a decrease in the number of paroxysms during the last 24 hours compared to baseline. |
| Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS)- 9-Item Overall Sleep Problems Index | Baseline, Week 16 | Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute. |
| Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Disturbance | Baseline, Week 16 | Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute. |
| Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Adequacy | Baseline, Week 16 | Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute. |
| Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Snoring | Baseline, Week 16 | Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute. |
| Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Awaken Short of Breath or With a Headache | Baseline, Week 16 | Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute. |
| Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Quantity | Baseline, Week 16 | Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute. |
| Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Somnolence | Baseline, Week 16 | Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute. |
| Number of Participants Having Optimal Sleep Based on Medical Outcomes Study Sleep Scale (MOS-SS) | Baseline, Week 16 | Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute. |
| Change From Baseline in Hospital and Anxiety Depression Scale (HADS) - Anxiety | Baseline, Week 16 | HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms. |
| Change From Baseline in Hospital and Anxiety Depression Scale (HADS) - Depression | Baseline, Week 16 | HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms. |
| Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Paroxysmal Pain | Baseline, Week 16 | Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: burning \[superficial\] spontaneous pain, pressing \[deep\] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia \[P/D\]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Weekly Mean Sleep Interference Score by Week | Baseline, Week 1 through 16 | Pain related sleep interference was assessed on an 11 point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered \[unable to sleep due to pain\]). |
Countries
Chile, China, Colombia, Czechia, Hong Kong, India, Japan, Philippines, Russia, United States
Participant flow
Pre-assignment details
1 participant was randomized after the first dose of study drug was taken; the participant was randomized to placebo, but the actual drug taken was pregabalin. This partcipant was included in the placebo group for all baseline characteristics and efficacy outcome measures; and in the pregabalin group for overall study and adverse events reporting.
Participants by arm
| Arm | Count |
|---|---|
| Pregabalin Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study. | 111 |
| Placebo Placebo matching study treatment. | 108 |
| Total | 219 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 8 | 8 |
| Overall Study | Lack of Efficacy | 1 | 2 |
| Overall Study | Other | 2 | 0 |
| Overall Study | Protocol Violation | 5 | 3 |
| Overall Study | Randomized, unknown if treated | 0 | 1 |
| Overall Study | Withdrawal by Subject | 3 | 3 |
Baseline characteristics
| Characteristic | Pregabalin | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 46.1 years STANDARD_DEVIATION 12.7 | 45.6 years STANDARD_DEVIATION 13.8 | 45.9 years STANDARD_DEVIATION 13.3 |
| Age, Customized >= 65 years | 9 participants | 10 participants | 19 participants |
| Age, Customized Between 18 and 44 years | 52 participants | 53 participants | 105 participants |
| Age, Customized Between 45 and 64 years | 50 participants | 45 participants | 95 participants |
| Sex: Female, Male Female | 27 Participants | 16 Participants | 43 Participants |
| Sex: Female, Male Male | 84 Participants | 92 Participants | 176 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 78 / 112 | 56 / 107 |
| serious Total, serious adverse events | 9 / 112 | 10 / 107 |
Outcome results
Primary
Duration Adjusted Average Change (DAAC) of Mean Pain Score
DAAC was derived from participant's daily pain diary, where pain was measured on an 11-point Numerical Rating Scale (NRS-Pain)ranging from 0 (did not interfere with sleep) to 10 (completely interfered \[unable to sleep due to pain\]). The DAAC was calculated as the mean of all daily pain diary rating post baseline minus the baseline score then multiplied by the proportion of the planned study duration completed by the participant.
Time frame: Baseline, Week 16
Population: mITT: all randomized participants who received at least one dose of study medication except the 8 participants who were randomized before protocol amendment 2.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin | Duration Adjusted Average Change (DAAC) of Mean Pain Score | -1.66 score on scale | Standard Error 0.157 |
| Placebo | Duration Adjusted Average Change (DAAC) of Mean Pain Score | -1.07 score on scale | Standard Error 0.149 |
Comparison: Null hypothesis - the mean DAAC for the pregabalin group is equal to the mean DAAC for the placebo group; Alternative hypothesis - the mean DAAC for the placebo group differs from the mean DAAC for the pregabalin group.~ANCOVA model included baseline severity of pain and Baseline Pain Catastrophizing Scale (PCS) Total Score as covariates and pooled center and treatment as fixed (class) cofactors.p-value: 0.003295% CI: [-0.98, -0.2]ANCOVA
Secondary
Change From Baseline in Hospital and Anxiety Depression Scale (HADS) - Anxiety
HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.
Time frame: Baseline, Week 16
Population: mITT; LOCF; (n) = number of participants with data available for analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Change From Baseline in Hospital and Anxiety Depression Scale (HADS) - Anxiety | Baseline | 6.7 score on scale | Standard Deviation 4.41 |
| Pregabalin | Change From Baseline in Hospital and Anxiety Depression Scale (HADS) - Anxiety | Change from baseline at endpoint (n = 100, 99) | -1.4 score on scale | Standard Deviation 3.21 |
| Placebo | Change From Baseline in Hospital and Anxiety Depression Scale (HADS) - Anxiety | Baseline | 6.9 score on scale | Standard Deviation 4.12 |
| Placebo | Change From Baseline in Hospital and Anxiety Depression Scale (HADS) - Anxiety | Change from baseline at endpoint (n = 100, 99) | -0.8 score on scale | Standard Deviation 3.55 |
Comparison: Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.p-value: 0.116495% CI: [-1.54, 0.17]ANCOVA
Secondary
Change From Baseline in Hospital and Anxiety Depression Scale (HADS) - Depression
HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.
Time frame: Baseline, Week 16
Population: mITT; LOCF; (n) = number of participants with data available for analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Change From Baseline in Hospital and Anxiety Depression Scale (HADS) - Depression | Baseline | 5.2 score on scale | Standard Deviation 3.96 |
| Pregabalin | Change From Baseline in Hospital and Anxiety Depression Scale (HADS) - Depression | Change from baseline at endpoint (n = 100, 99) | -1.0 score on scale | Standard Deviation 3.44 |
| Placebo | Change From Baseline in Hospital and Anxiety Depression Scale (HADS) - Depression | Baseline | 6.3 score on scale | Standard Deviation 3.99 |
| Placebo | Change From Baseline in Hospital and Anxiety Depression Scale (HADS) - Depression | Change from baseline at endpoint (n = 100, 99) | -0.5 score on scale | Standard Deviation 3.56 |
Comparison: Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.p-value: 0.027995% CI: [-1.87, -0.11]ANCOVA
Secondary
Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS)- 9-Item Overall Sleep Problems Index
Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.
Time frame: Baseline, Week 16
Population: mITT; LOCF; (n) = number of participants with data available for analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS)- 9-Item Overall Sleep Problems Index | Baseline (n = 105, 103) | 45.7 score on scale | Standard Deviation 18.02 |
| Pregabalin | Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS)- 9-Item Overall Sleep Problems Index | Change from baseline at endpoint (n = 100, 95) | -10.8 score on scale | Standard Deviation 16.7 |
| Placebo | Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS)- 9-Item Overall Sleep Problems Index | Baseline (n = 105, 103) | 45.9 score on scale | Standard Deviation 19 |
| Placebo | Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS)- 9-Item Overall Sleep Problems Index | Change from baseline at endpoint (n = 100, 95) | -5.8 score on scale | Standard Deviation 16.21 |
Comparison: Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.p-value: 0.026295% CI: [-9.19, -0.59]ANCOVA
Secondary
Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Awaken Short of Breath or With a Headache
Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.
Time frame: Baseline, Week 16
Population: mITT; LOCF; (n) = number of participants with data available for analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Awaken Short of Breath or With a Headache | Baseline (n = 105, 105) | 15.0 score on scale | Standard Deviation 23 |
| Pregabalin | Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Awaken Short of Breath or With a Headache | Change from baseline at endpoint (n = 100, 98) | -6.2 score on scale | Standard Deviation 22.33 |
| Placebo | Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Awaken Short of Breath or With a Headache | Baseline (n = 105, 105) | 12.8 score on scale | Standard Deviation 23.23 |
| Placebo | Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Awaken Short of Breath or With a Headache | Change from baseline at endpoint (n = 100, 98) | -0.2 score on scale | Standard Deviation 22.52 |
Comparison: Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.p-value: 0.034795% CI: [-9.91, -0.37]ANCOVA
Secondary
Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Adequacy
Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.
Time frame: Baseline, Week 16
Population: mITT; LOCF; (n) = number of participants with data available for analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Adequacy | Baseline (n = 105, 104) | 42.3 score on scale | Standard Deviation 25.92 |
| Pregabalin | Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Adequacy | Change from baseline at endpoint (n = 100, 97) | 11.6 score on scale | Standard Deviation 27.26 |
| Placebo | Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Adequacy | Baseline (n = 105, 104) | 43.8 score on scale | Standard Deviation 26.92 |
| Placebo | Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Adequacy | Change from baseline at endpoint (n = 100, 97) | 5.7 score on scale | Standard Deviation 28.83 |
Comparison: Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.p-value: 0.099895% CI: [-1.11, 12.66]ANCOVA
Secondary
Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Disturbance
Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.
Time frame: Baseline, Week 16
Population: mITT; LOCF; (n) = number of participants with data available for analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Disturbance | Baseline (n = 105, 104) | 51.9 score on scale | Standard Deviation 25.88 |
| Pregabalin | Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Disturbance | Change from baseline at endpoint (n = 100, 97) | -17.3 score on scale | Standard Deviation 25.25 |
| Placebo | Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Disturbance | Baseline (n = 105, 104) | 51.2 score on scale | Standard Deviation 26.68 |
| Placebo | Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Disturbance | Change from baseline at endpoint (n = 100, 97) | -8.0 score on scale | Standard Deviation 21.7 |
Comparison: Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.p-value: 0.004195% CI: [-14.55, -2.78]ANCOVA
Secondary
Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Quantity
Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.
Time frame: Baseline, Week 16
Population: mITT; LOCF; (n) = number of participants with data available for analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Quantity | Baseline (n = 104,105) | 5.9 score on scale | Standard Deviation 1.45 |
| Pregabalin | Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Quantity | Change from baseline at endpoint (n = 100, 98) | 0.6 score on scale | Standard Deviation 1.42 |
| Placebo | Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Quantity | Baseline (n = 104,105) | 6.2 score on scale | Standard Deviation 1.64 |
| Placebo | Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Quantity | Change from baseline at endpoint (n = 100, 98) | 0.2 score on scale | Standard Deviation 1.29 |
Comparison: Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.p-value: 0.043695% CI: [0.01, 0.76]ANCOVA
Secondary
Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Snoring
Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.
Time frame: Baseline, Week 16
Population: mITT; LOCF; (n) = number of participants with data available for analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Snoring | Baseline (n = 105, 104) | 31.2 score on scale | Standard Deviation 34.07 |
| Pregabalin | Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Snoring | Change from baseline at endpoint (n = 100, 97) | 2.2 score on scale | Standard Deviation 25.88 |
| Placebo | Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Snoring | Baseline (n = 105, 104) | 35.6 score on scale | Standard Deviation 35.47 |
| Placebo | Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Snoring | Change from baseline at endpoint (n = 100, 97) | -4.7 score on scale | Standard Deviation 27.5 |
Comparison: Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.p-value: 0.104895% CI: [-1.2, 12.61]ANCOVA
Secondary
Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Somnolence
Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.
Time frame: Baseline, Week 16
Population: mITT; LOCF; (n) = number of participants with data available for analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Somnolence | Baseline (n = 105, 105) | 36.3 score on scale | Standard Deviation 19.81 |
| Pregabalin | Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Somnolence | Change from baseline at endpoint (n = 100, 97) | -0.8 score on scale | Standard Deviation 20.64 |
| Placebo | Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Somnolence | Baseline (n = 105, 105) | 39.7 score on scale | Standard Deviation 23.43 |
| Placebo | Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Somnolence | Change from baseline at endpoint (n = 100, 97) | -4.9 score on scale | Standard Deviation 22.31 |
Comparison: Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.p-value: 0.276195% CI: [-2.44, 8.49]ANCOVA
Secondary
Change From Baseline in Modified Brief Pain Inventory Interference Scale (10-Item) (mBPI-10) Total Score
The Modified Brief Pain Inventory (mBPI-10) Interference Scale is a self administered questionnaire that assessed pain interference with functional activities over the past week. The items were measured on an 11 point scale, ranging from does not interfere (0) to completely interferes (10). A composite score, the pain interference index, was calculated by averaging the 10 items that comprised the scale.
Time frame: Baseline, Week 16
Population: mITT; LOCF; (n) = number of participants with data available for analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Change From Baseline in Modified Brief Pain Inventory Interference Scale (10-Item) (mBPI-10) Total Score | Baseline | 4.7 score on scale | Standard Deviation 2.18 |
| Pregabalin | Change From Baseline in Modified Brief Pain Inventory Interference Scale (10-Item) (mBPI-10) Total Score | Change from baseline at endpoint (n = 100, 99) | -1.6 score on scale | Standard Deviation 2.19 |
| Placebo | Change From Baseline in Modified Brief Pain Inventory Interference Scale (10-Item) (mBPI-10) Total Score | Baseline | 4.9 score on scale | Standard Deviation 2.21 |
| Placebo | Change From Baseline in Modified Brief Pain Inventory Interference Scale (10-Item) (mBPI-10) Total Score | Change from baseline at endpoint (n = 100, 99) | -1.1 score on scale | Standard Deviation 2.02 |
Comparison: Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.p-value: 0.043895% CI: [-1.08, -0.02]ANCOVA
Secondary
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - 12 Items Total Intensity Score
Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: burning \[superficial\] spontaneous pain, pressing \[deep\] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia \[P/D\]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain.
Time frame: Baseline, Week 16
Population: mITT; LOCF; (n) = number of participants with data available for analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - 12 Items Total Intensity Score | Baseline (n = 104, 106) | 0.4 score on scale | Standard Deviation 0.2 |
| Pregabalin | Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - 12 Items Total Intensity Score | Change from baseline at endpoint (n = 99, 99) | -0.1 score on scale | Standard Deviation 0.21 |
| Placebo | Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - 12 Items Total Intensity Score | Baseline (n = 104, 106) | 0.4 score on scale | Standard Deviation 0.22 |
| Placebo | Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - 12 Items Total Intensity Score | Change from baseline at endpoint (n = 99, 99) | -0.1 score on scale | Standard Deviation 0.17 |
Comparison: Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.p-value: 0.137795% CI: [-0.09, 0.01]ANCOVA
Secondary
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Burning Spontaneous Pain
Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: burning \[superficial\] spontaneous pain, pressing \[deep\] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia \[P/D\]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain.
Time frame: Baseline, Week 16
Population: mITT; LOCF;(n) = number of participants with data available for analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Burning Spontaneous Pain | Baseline | 0.5 score on scale | Standard Deviation 0.32 |
| Pregabalin | Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Burning Spontaneous Pain | Change from baseline at endpoint (n = 100, 99) | -0.1 score on scale | Standard Deviation 0.34 |
| Placebo | Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Burning Spontaneous Pain | Baseline | 0.5 score on scale | Standard Deviation 0.3 |
| Placebo | Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Burning Spontaneous Pain | Change from baseline at endpoint (n = 100, 99) | -0.1 score on scale | Standard Deviation 0.28 |
Comparison: Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.p-value: 0.331295% CI: [-0.11, 0.04]ANCOVA
Secondary
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Evoked Pain
Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: burning \[superficial\] spontaneous pain, pressing \[deep\] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia \[P/D\]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain.
Time frame: Baseline, Week 16
Population: mITT; LOCF; (n) = number of participants with data available for analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Evoked Pain | Baseline | 0.4 score on scale | Standard Deviation 0.29 |
| Pregabalin | Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Evoked Pain | Change from baseline at endpoint (n = 100, 99) | -0.1 score on scale | Standard Deviation 0.24 |
| Placebo | Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Evoked Pain | Baseline | 0.4 score on scale | Standard Deviation 0.29 |
| Placebo | Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Evoked Pain | Change from baseline at endpoint (n = 100, 99) | -0.1 score on scale | Standard Deviation 0.22 |
Comparison: Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.p-value: 0.891195% CI: [-0.06, 0.05]ANCOVA
Secondary
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Individual Item (1, 2, 3, 5, 6, 8, 9, 10, 11, 12) Score
Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: burning \[superficial\] spontaneous pain, pressing \[deep\] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia \[P/D\]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain.
Time frame: Baseline, Week 16
Population: mITT; LOCF; (n) = number of participants with data available for analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Individual Item (1, 2, 3, 5, 6, 8, 9, 10, 11, 12) Score | 1- Burning pain (n = 100, 99) | -1.39 score on scale | Standard Deviation 3.42 |
| Pregabalin | Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Individual Item (1, 2, 3, 5, 6, 8, 9, 10, 11, 12) Score | 2- Squeezing pain (n = 100, 99) | -1.04 score on scale | Standard Deviation 3.181 |
| Pregabalin | Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Individual Item (1, 2, 3, 5, 6, 8, 9, 10, 11, 12) Score | 3- Pain like pressure (n = 100, 99) | -0.73 score on scale | Standard Deviation 3.429 |
| Pregabalin | Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Individual Item (1, 2, 3, 5, 6, 8, 9, 10, 11, 12) Score | 5- Electric shocks (n = 100, 99) | -1.77 score on scale | Standard Deviation 3.426 |
| Pregabalin | Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Individual Item (1, 2, 3, 5, 6, 8, 9, 10, 11, 12) Score | 6- Stabbing pain (n = 100, 99) | -1.13 score on scale | Standard Deviation 3.541 |
| Pregabalin | Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Individual Item (1, 2, 3, 5, 6, 8, 9, 10, 11, 12) Score | 8- By light touching (n = 100, 99) | -0.78 score on scale | Standard Deviation 3.08 |
| Pregabalin | Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Individual Item (1, 2, 3, 5, 6, 8, 9, 10, 11, 12) Score | 9- By pressure (n = 100, 99) | -1.22 score on scale | Standard Deviation 2.784 |
| Pregabalin | Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Individual Item (1, 2, 3, 5, 6, 8, 9, 10, 11, 12) Score | 10- By something cold (n = 100, 99) | -0.89 score on scale | Standard Deviation 3.372 |
| Pregabalin | Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Individual Item (1, 2, 3, 5, 6, 8, 9, 10, 11, 12) Score | 11- Pins and needles (n = 99, 99) | -1.01 score on scale | Standard Deviation 3.125 |
| Pregabalin | Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Individual Item (1, 2, 3, 5, 6, 8, 9, 10, 11, 12) Score | 12- Tingling (n = 99, 99) | -0.99 score on scale | Standard Deviation 3.559 |
| Placebo | Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Individual Item (1, 2, 3, 5, 6, 8, 9, 10, 11, 12) Score | 10- By something cold (n = 100, 99) | -0.52 score on scale | Standard Deviation 2.459 |
| Placebo | Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Individual Item (1, 2, 3, 5, 6, 8, 9, 10, 11, 12) Score | 1- Burning pain (n = 100, 99) | -1.00 score on scale | Standard Deviation 2.825 |
| Placebo | Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Individual Item (1, 2, 3, 5, 6, 8, 9, 10, 11, 12) Score | 8- By light touching (n = 100, 99) | -0.94 score on scale | Standard Deviation 2.683 |
| Placebo | Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Individual Item (1, 2, 3, 5, 6, 8, 9, 10, 11, 12) Score | 2- Squeezing pain (n = 100, 99) | -0.41 score on scale | Standard Deviation 3.11 |
| Placebo | Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Individual Item (1, 2, 3, 5, 6, 8, 9, 10, 11, 12) Score | 12- Tingling (n = 99, 99) | -0.83 score on scale | Standard Deviation 3.034 |
| Placebo | Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Individual Item (1, 2, 3, 5, 6, 8, 9, 10, 11, 12) Score | 3- Pain like pressure (n = 100, 99) | -0.20 score on scale | Standard Deviation 3.326 |
| Placebo | Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Individual Item (1, 2, 3, 5, 6, 8, 9, 10, 11, 12) Score | 9- By pressure (n = 100, 99) | -1.10 score on scale | Standard Deviation 2.675 |
| Placebo | Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Individual Item (1, 2, 3, 5, 6, 8, 9, 10, 11, 12) Score | 5- Electric shocks (n = 100, 99) | -0.68 score on scale | Standard Deviation 3.664 |
| Placebo | Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Individual Item (1, 2, 3, 5, 6, 8, 9, 10, 11, 12) Score | 11- Pins and needles (n = 99, 99) | -0.62 score on scale | Standard Deviation 3.269 |
| Placebo | Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Individual Item (1, 2, 3, 5, 6, 8, 9, 10, 11, 12) Score | 6- Stabbing pain (n = 100, 99) | -0.52 score on scale | Standard Deviation 2.804 |
Comparison: Item 1 - Burning pain~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.p-value: 0.331295% CI: [-1.13, 0.38]ANCOVA
Comparison: Item 2 - Squeezing pain~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.p-value: 0.097695% CI: [-1.37, 0.12]ANCOVA
Comparison: Item 3 - Pain like pressure~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.p-value: 0.053895% CI: [-1.54, 0.01]ANCOVA
Comparison: Item 5 - Electric shocks~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.p-value: 0.323995% CI: [-1.15, 0.38]ANCOVA
Comparison: Item 6 - Stabbing pain~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.p-value: 0.191295% CI: [-1.23, 0.25]ANCOVA
Comparison: Item 8 - By light touching~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.p-value: 0.67295% CI: [-0.55, 0.85]ANCOVA
Comparison: Item 9 - By pressure~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.p-value: 0.782195% CI: [-0.74, 0.56]ANCOVA
Comparison: Item 10 - By something cold~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.p-value: 0.685195% CI: [-0.84, 0.55]ANCOVA
Comparison: Item 11 - Pins and needles~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.p-value: 0.36195% CI: [-1.12, 0.41]ANCOVA
Comparison: Item 12 - Tingling~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.p-value: 0.491595% CI: [-1.07, 0.52]ANCOVA
Secondary
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Paresthesia/Dysesthesia
Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: burning \[superficial\] spontaneous pain, pressing \[deep\] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia \[P/D\]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain.
Time frame: Baseline, Week 16
Population: mITT; LOCF; (n) = number of participants with data available for analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Paresthesia/Dysesthesia | Baseline (n = 104, 106) | 0.5 score on scale | Standard Deviation 0.28 |
| Pregabalin | Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Paresthesia/Dysesthesia | Change from baseline at endpoint (n = 99, 99) | -0.1 score on scale | Standard Deviation 0.29 |
| Placebo | Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Paresthesia/Dysesthesia | Baseline (n = 104, 106) | 0.5 score on scale | Standard Deviation 0.28 |
| Placebo | Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Paresthesia/Dysesthesia | Change from baseline at endpoint (n = 99, 99) | -0.1 score on scale | Standard Deviation 0.27 |
Comparison: Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.p-value: 0.373195% CI: [-0.1, 0.04]ANCOVA
Secondary
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Paroxysmal Pain
Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: burning \[superficial\] spontaneous pain, pressing \[deep\] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia \[P/D\]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain.
Time frame: Baseline, Week 16
Population: mITT; LOCF; (n) = number of participants with data available for analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Paroxysmal Pain | Baseline | 0.4 score on scale | Standard Deviation 0.29 |
| Pregabalin | Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Paroxysmal Pain | Change from baseline at endpoint (n = 100, 99) | -0.1 score on scale | Standard Deviation 0.31 |
| Placebo | Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Paroxysmal Pain | Baseline | 0.3 score on scale | Standard Deviation 0.3 |
| Placebo | Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Paroxysmal Pain | Change from baseline at endpoint (n = 100, 99) | -0.1 score on scale | Standard Deviation 0.26 |
Comparison: Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.p-value: 0.13795% CI: [-0.12, 0.02]ANCOVA
Secondary
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Pressing Spontaneous Pain
Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: burning \[superficial\] spontaneous pain, pressing \[deep\] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia \[P/D\]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain.
Time frame: Baseline, Week 16
Population: mITT; LOCF; (n) = number of participants with data available for analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Pressing Spontaneous Pain | Baseline | 0.4 score on scale | Standard Deviation 0.31 |
| Pregabalin | Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Pressing Spontaneous Pain | Change from baseline at endpoint (n = 100, 99) | -0.1 score on scale | Standard Deviation 0.28 |
| Placebo | Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Pressing Spontaneous Pain | Baseline | 0.4 score on scale | Standard Deviation 0.31 |
| Placebo | Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Pressing Spontaneous Pain | Change from baseline at endpoint (n = 100, 99) | -0.0 score on scale | Standard Deviation 0.26 |
Comparison: Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.p-value: 0.04495% CI: [-0.13, 0]ANCOVA
Secondary
Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Cold Allodynia
Participant rated pain scale. The pain produced by the applied stimulus (Cold allodynia - touch with cool metal rod 13-17 degrees celsius was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain).
Time frame: Baseline, Week 16
Population: mITT; LOCF; (n) = number of participants with data available for analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Cold Allodynia | Baseline (n = 83, 82) | 2.5 score on scale | Standard Deviation 2.97 |
| Pregabalin | Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Cold Allodynia | Change from baseline at endpoint (n = 79, 72) | -0.1 score on scale | Standard Deviation 2.12 |
| Placebo | Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Cold Allodynia | Baseline (n = 83, 82) | 2.7 score on scale | Standard Deviation 3.13 |
| Placebo | Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Cold Allodynia | Change from baseline at endpoint (n = 79, 72) | 0.4 score on scale | Standard Deviation 2.66 |
Comparison: At/Above level~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.p-value: 0.312395% CI: [-1.42, 0.46]ANCOVA
Comparison: Below level~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.p-value: 0.13695% CI: [-1.28, 0.18]ANCOVA
Secondary
Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Cold Hyperalgesia Subscales
Participant rated pain scale. The pain produced by the applied stimulus (Cold hyperalgesia - touch with cold metal rod 4 degrees celsius) was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain).
Time frame: Baseline, Week 16
Population: mITT; LOCF; (n) = number of participants with data available for analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Cold Hyperalgesia Subscales | Baseline (n = 83, 82) | 2.8 score on scale | Standard Deviation 3.18 |
| Pregabalin | Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Cold Hyperalgesia Subscales | Change from baseline at endpoint (n = 79, 72) | -0.1 score on scale | Standard Deviation 2.6 |
| Placebo | Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Cold Hyperalgesia Subscales | Baseline (n = 83, 82) | 2.8 score on scale | Standard Deviation 3.25 |
| Placebo | Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Cold Hyperalgesia Subscales | Change from baseline at endpoint (n = 79, 72) | 0.4 score on scale | Standard Deviation 2.82 |
Comparison: At/Above level~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.p-value: 0.425795% CI: [-1.53, 0.65]ANCOVA
Comparison: Below level~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.p-value: 0.200595% CI: [-1.34, 0.28]ANCOVA
Secondary
Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP) - Dynamic Mechanical Allodynia
Participant rated pain scale. The pain produced by the applied stimulus (dynamic mechanical allodynia - gentle stroking with foam brush) was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain).
Time frame: Baseline, Week 16
Population: mITT; LOCF; (n) = number of participants with data available for analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP) - Dynamic Mechanical Allodynia | Baseline (n = 83, 82) | 2.7 score on scale | Standard Deviation 2.81 |
| Pregabalin | Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP) - Dynamic Mechanical Allodynia | Change from baseline at endpoint (n = 79, 75) | -0.6 score on scale | Standard Deviation 2.35 |
| Placebo | Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP) - Dynamic Mechanical Allodynia | Baseline (n = 83, 82) | 2.3 score on scale | Standard Deviation 2.84 |
| Placebo | Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP) - Dynamic Mechanical Allodynia | Change from baseline at endpoint (n = 79, 75) | -0.3 score on scale | Standard Deviation 2.32 |
Comparison: At/Above level~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.p-value: 0.568995% CI: [-0.97, 0.54]ANCOVA
Comparison: Below level~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.p-value: 0.476495% CI: [-0.87, 0.41]ANCOVA
Secondary
Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Punctata Hyperalgesia
Participant rated pain scale. The pain produced by the applied stimulus (Punctata hyperalgesia - pinprick) was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain).
Time frame: Baseline, Week 16
Population: mITT; LOCF; (n) = number of participants with data available for analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Punctata Hyperalgesia | Baseline (n=83,82) | 3.9 score on scale | Standard Deviation 3.41 |
| Pregabalin | Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Punctata Hyperalgesia | Change from baseline at endpoint (n=79,75) | -1.0 score on scale | Standard Deviation 2.36 |
| Placebo | Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Punctata Hyperalgesia | Baseline (n=83,82) | 3.4 score on scale | Standard Deviation 3.19 |
| Placebo | Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Punctata Hyperalgesia | Change from baseline at endpoint (n=79,75) | -0.4 score on scale | Standard Deviation 2.15 |
Comparison: At/Above level~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.p-value: 0.336295% CI: [-1.4, 0.48]ANCOVA
Comparison: Below level~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.p-value: 0.311395% CI: [-0.96, 0.31]ANCOVA
Secondary
Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP) - Static Mechanical Allodynia
Participant rated pain scale. The pain produced by the applied stimulus (static mechanical allodynia - gentle constant mechanical pressure) was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain).
Time frame: Baseline, Week 16
Population: mITT; LOCF; (n) = number of participants with data available for analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP) - Static Mechanical Allodynia | Baseline (n = 83, 82) | 2.9 score on scale | Standard Deviation 3.16 |
| Pregabalin | Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP) - Static Mechanical Allodynia | Change from baseline at endpoint (n = 79, 75) | -1.0 score on scale | Standard Deviation 2.69 |
| Placebo | Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP) - Static Mechanical Allodynia | Baseline (n = 83, 82) | 2.6 score on scale | Standard Deviation 2.95 |
| Placebo | Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP) - Static Mechanical Allodynia | Change from baseline at endpoint (n = 79, 75) | -0.3 score on scale | Standard Deviation 2.48 |
Comparison: At/above level: within 2 dermatomes above or below the neurological level of injury (NLI).~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.p-value: 0.710395% CI: [-1.06, 0.72]ANCOVA
Comparison: Below level: more than 2 dermatomes below the NLI.~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.p-value: 0.074795% CI: [-1.28, 0.06]ANCOVA
Secondary
Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Temporal Summation to Tactile Stimuli
Participant rated pain scale. The pain produced by the applied stimulus (Temporal summation to tactile stimuli - repeated touching/tapping) was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain).
Time frame: Baseline, Week 16
Population: mITT; LOCF; (n) = number of participants with data available for analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Temporal Summation to Tactile Stimuli | Baseline (n = 83, 82) | 4.1 score on scale | Standard Deviation 3.54 |
| Pregabalin | Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Temporal Summation to Tactile Stimuli | Change from baseline at endpoint (n = 79, 75) | -0.5 score on scale | Standard Deviation 2.21 |
| Placebo | Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Temporal Summation to Tactile Stimuli | Baseline (n = 83, 82) | 3.9 score on scale | Standard Deviation 3.48 |
| Placebo | Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Temporal Summation to Tactile Stimuli | Change from baseline at endpoint (n = 79, 75) | -0.8 score on scale | Standard Deviation 2.37 |
Comparison: At/Above level~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.p-value: 0.272195% CI: [-1.67, 0.48]ANCOVA
Comparison: Below level~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.p-value: 0.490695% CI: [-0.43, 0.9]ANCOVA
Secondary
Change From Baseline in Weekly Mean Pain Score
Mean weekly score was calculated as the average of the available daily diary pain score values for the week. Pain score was measured on an 11-point numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain).
Time frame: Baseline, Week 16
Population: mITT; modified baseline observation carried forward (mBOCF) imputation: mBOCF mean pain score was defined as the baseline mean pain score for participants who discontinued double-blind treatment due to adverse event or who had no postbaseline observations and as the last observation carried forward (LOCF) mean pain score for all other participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Change From Baseline in Weekly Mean Pain Score | Change from baseline at endpoint | -1.9 score on scale | Standard Deviation 1.91 |
| Pregabalin | Change From Baseline in Weekly Mean Pain Score | Baseline | 6.5 score on scale | Standard Deviation 1.45 |
| Placebo | Change From Baseline in Weekly Mean Pain Score | Baseline | 6.5 score on scale | Standard Deviation 1.41 |
| Placebo | Change From Baseline in Weekly Mean Pain Score | Change from baseline at endpoint | -1.2 score on scale | Standard Deviation 1.78 |
Comparison: Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.p-value: 0.006695% CI: [-1.2, -0.2]ANCOVA
Secondary
Change From Baseline in Weekly Mean Pain Score by Week
Mean weekly score was calculated as the average of the available daily diary pain score values for the week. Pain score was measured on an 11-point numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain).
Time frame: Baseline, Week 1 through16
Population: ITT population: defined as all randomized participants who took at least one dose of study medication. (This population included the 8 participants who were randomized before the protocol amendment 2). (n) = number of participants with data for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Change From Baseline in Weekly Mean Pain Score by Week | Change at Week 1 (n = 111, 107) | -0.85 score on scale | Standard Deviation 1.04 |
| Pregabalin | Change From Baseline in Weekly Mean Pain Score by Week | Change at Week 9 (n = 98, 97) | -1.99 score on scale | Standard Deviation 1.81 |
| Pregabalin | Change From Baseline in Weekly Mean Pain Score by Week | Change at Week 5 (n = 105, 101) | -1.87 score on scale | Standard Deviation 1.73 |
| Pregabalin | Change From Baseline in Weekly Mean Pain Score by Week | Change at Week 10 (n = 97, 91) | -2.03 score on scale | Standard Deviation 1.75 |
| Pregabalin | Change From Baseline in Weekly Mean Pain Score by Week | Change at Week 3 (n = 107, 105) | -1.35 score on scale | Standard Deviation 1.35 |
| Pregabalin | Change From Baseline in Weekly Mean Pain Score by Week | Change at Week 11 (n = 96, 90) | -2.04 score on scale | Standard Deviation 1.82 |
| Pregabalin | Change From Baseline in Weekly Mean Pain Score by Week | Change at Week 6 (n = 105, 99) | -1.89 score on scale | Standard Deviation 1.9 |
| Pregabalin | Change From Baseline in Weekly Mean Pain Score by Week | Change at Week 12 (n = 96, 91) | -1.90 score on scale | Standard Deviation 1.83 |
| Pregabalin | Change From Baseline in Weekly Mean Pain Score by Week | Change at Week 2 (n = 110, 105) | -1.26 score on scale | Standard Deviation 1.21 |
| Pregabalin | Change From Baseline in Weekly Mean Pain Score by Week | Change at Week 13 (n = 93, 91) | -2.02 score on scale | Standard Deviation 1.76 |
| Pregabalin | Change From Baseline in Weekly Mean Pain Score by Week | Change at Week 7 (n = 103, 98) | -2.02 score on scale | Standard Deviation 1.86 |
| Pregabalin | Change From Baseline in Weekly Mean Pain Score by Week | Change at Week 14 (n = 93, 92) | -2.00 score on scale | Standard Deviation 1.76 |
| Pregabalin | Change From Baseline in Weekly Mean Pain Score by Week | Change at Week 4 (n = 107, 103) | -1.64 score on scale | Standard Deviation 1.61 |
| Pregabalin | Change From Baseline in Weekly Mean Pain Score by Week | Change at Week 15 (n = 93, 92) | -2.09 score on scale | Standard Deviation 1.8 |
| Pregabalin | Change From Baseline in Weekly Mean Pain Score by Week | Change at Week 8 (n = 101, 97) | -1.96 score on scale | Standard Deviation 1.82 |
| Pregabalin | Change From Baseline in Weekly Mean Pain Score by Week | Change at Week 16 (n = 89, 90) | -2.17 score on scale | Standard Deviation 1.78 |
| Pregabalin | Change From Baseline in Weekly Mean Pain Score by Week | Baseline (n = 111, 108) | 6.44 score on scale | Standard Deviation 1.44 |
| Placebo | Change From Baseline in Weekly Mean Pain Score by Week | Change at Week 16 (n = 89, 90) | -1.36 score on scale | Standard Deviation 1.87 |
| Placebo | Change From Baseline in Weekly Mean Pain Score by Week | Baseline (n = 111, 108) | 6.51 score on scale | Standard Deviation 1.4 |
| Placebo | Change From Baseline in Weekly Mean Pain Score by Week | Change at Week 1 (n = 111, 107) | -0.38 score on scale | Standard Deviation 0.89 |
| Placebo | Change From Baseline in Weekly Mean Pain Score by Week | Change at Week 2 (n = 110, 105) | -0.62 score on scale | Standard Deviation 1.3 |
| Placebo | Change From Baseline in Weekly Mean Pain Score by Week | Change at Week 3 (n = 107, 105) | -0.86 score on scale | Standard Deviation 1.35 |
| Placebo | Change From Baseline in Weekly Mean Pain Score by Week | Change at Week 4 (n = 107, 103) | -1.03 score on scale | Standard Deviation 1.53 |
| Placebo | Change From Baseline in Weekly Mean Pain Score by Week | Change at Week 5 (n = 105, 101) | -1.07 score on scale | Standard Deviation 1.5 |
| Placebo | Change From Baseline in Weekly Mean Pain Score by Week | Change at Week 6 (n = 105, 99) | -1.22 score on scale | Standard Deviation 1.72 |
| Placebo | Change From Baseline in Weekly Mean Pain Score by Week | Change at Week 7 (n = 103, 98) | -1.34 score on scale | Standard Deviation 1.75 |
| Placebo | Change From Baseline in Weekly Mean Pain Score by Week | Change at Week 8 (n = 101, 97) | -1.32 score on scale | Standard Deviation 1.82 |
| Placebo | Change From Baseline in Weekly Mean Pain Score by Week | Change at Week 9 (n = 98, 97) | -1.37 score on scale | Standard Deviation 1.75 |
| Placebo | Change From Baseline in Weekly Mean Pain Score by Week | Change at Week 10 (n = 97, 91) | -1.32 score on scale | Standard Deviation 1.81 |
| Placebo | Change From Baseline in Weekly Mean Pain Score by Week | Change at Week 11 (n = 96, 90) | -1.43 score on scale | Standard Deviation 1.84 |
| Placebo | Change From Baseline in Weekly Mean Pain Score by Week | Change at Week 12 (n = 96, 91) | -1.44 score on scale | Standard Deviation 1.93 |
| Placebo | Change From Baseline in Weekly Mean Pain Score by Week | Change at Week 13 (n = 93, 91) | -1.39 score on scale | Standard Deviation 1.92 |
| Placebo | Change From Baseline in Weekly Mean Pain Score by Week | Change at Week 14 (n = 93, 92) | -1.34 score on scale | Standard Deviation 1.89 |
| Placebo | Change From Baseline in Weekly Mean Pain Score by Week | Change at Week 15 (n = 93, 92) | -1.41 score on scale | Standard Deviation 1.85 |
Comparison: Week 1~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.p-value: 0.029595% CI: [-0.94, -0.05]Mixed Models Analysis
Comparison: Week 2~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.p-value: 0.003395% CI: [-1.11, -0.22]Mixed Models Analysis
Comparison: Week 3~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.p-value: 0.018595% CI: [-0.98, -0.09]Mixed Models Analysis
Comparison: Week 4~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.p-value: 0.00495% CI: [-1.1, -0.21]Mixed Models Analysis
Comparison: Week 5~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.p-value: 0.000495% CI: [-1.26, -0.36]Mixed Models Analysis
Comparison: Week 6~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.p-value: 0.001895% CI: [-1.17, -0.27]Mixed Models Analysis
Comparison: Week 7~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.p-value: 0.002795% CI: [-1.14, -0.24]Mixed Models Analysis
Comparison: Week 8~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.p-value: 0.004195% CI: [-1.11, -0.21]Mixed Models Analysis
Comparison: Week 9~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.p-value: 0.005895% CI: [-1.09, -0.18]Mixed Models Analysis
Comparison: Week 10~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.p-value: 0.003195% CI: [-1.14, -0.23]Mixed Models Analysis
Comparison: Week 11~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.p-value: 0.007695% CI: [-1.08, -0.17]Mixed Models Analysis
Comparison: Week 12~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.p-value: 0.032895% CI: [-0.95, -0.04]Mixed Models Analysis
Comparison: Week 13~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.p-value: 0.01595% CI: [-1.02, -0.11]Mixed Models Analysis
Comparison: Week 14~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.p-value: 0.004895% CI: [-1.11, -0.2]Mixed Models Analysis
Comparison: Week 15~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.p-value: 0.00395% CI: [-1.15, -0.24]Mixed Models Analysis
Comparison: Week 16~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.p-value: 0.001195% CI: [-1.22, -0.3]Mixed Models Analysis
Secondary
Change From Baseline in Weekly Mean Sleep Interference Score
Pain-related sleep interference was assessed on an 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered \[unable to sleep due to pain\]).
Time frame: Baseline, Week 16
Population: mITT; LOCF; (n) = number of participants with data available for analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Change From Baseline in Weekly Mean Sleep Interference Score | Baseline (n = 105, 105) | 4.9 score on scale | Standard Deviation 2.48 |
| Pregabalin | Change From Baseline in Weekly Mean Sleep Interference Score | Change from baseline at endpoint (n = 105, 104) | -2.0 score on scale | Standard Deviation 2.35 |
| Placebo | Change From Baseline in Weekly Mean Sleep Interference Score | Baseline (n = 105, 105) | 5.2 score on scale | Standard Deviation 2.24 |
| Placebo | Change From Baseline in Weekly Mean Sleep Interference Score | Change from baseline at endpoint (n = 105, 104) | -1.0 score on scale | Standard Deviation 1.77 |
Comparison: Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.p-value: <0.000195% CI: [-1.6, -0.56]ANCOVA
Secondary
Number of Participants Having Optimal Sleep Based on Medical Outcomes Study Sleep Scale (MOS-SS)
Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.
Time frame: Baseline, Week 16
Population: mITT; LOCF; (N) = number of participants with data available for analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pregabalin | Number of Participants Having Optimal Sleep Based on Medical Outcomes Study Sleep Scale (MOS-SS) | 49 participants |
| Placebo | Number of Participants Having Optimal Sleep Based on Medical Outcomes Study Sleep Scale (MOS-SS) | 30 participants |
Comparison: Null hypothesis - The rate of subjects with optimal sleep for the pregabain group was equal to the rate of subjects with optimal sleep for the placebo group; Alternative hypothesis - The rate of subjects with optimal sleep for the pregabain group was not equal to the rate of subjects with optimal sleep for the placebo group.p-value: 0.002495% CI: [1.443, 5.491]Regression, Logistic
Secondary
Number of Participants With >=30% Reduction in Weekly Mean Pain Score From Baseline
Mean weekly score was calculated as the average of the available daily diary pain score values for the week. Pain score was measured on an 11-point numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain).
Time frame: Baseline, Week 16
Population: mITT; LOCF: LOCF Endpoint corresponded to the last 7 days of diary data up to and including Week 16 and applied if the Week 16 assessment was missing; (N) = number of participants that can be analyzed for the endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pregabalin | Number of Participants With >=30% Reduction in Weekly Mean Pain Score From Baseline | 48 participants |
| Placebo | Number of Participants With >=30% Reduction in Weekly Mean Pain Score From Baseline | 33 participants |
Comparison: Null hypothesis - The rate of responder for the pregabain group was equal to the rate of responder for the placebo group; Alternative hypothesis - The rate of responder for the pregabain group was not equal to the rate of responder for the placebo groupp-value: 0.03995% CI: [1.032, 3.328]Regression, Logistic
Secondary
Number of Participants With >=50% Reduction in Weekly Mean Pain Score From Baseline
Mean weekly score was calculated as the average of the available daily diary pain score values for the week. Pain score was measured on an 11-point numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain).
Time frame: Baseline, Week 16
Population: mITT; LOCF; (N) = number of participants with data available for analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pregabalin | Number of Participants With >=50% Reduction in Weekly Mean Pain Score From Baseline | 31 participants |
| Placebo | Number of Participants With >=50% Reduction in Weekly Mean Pain Score From Baseline | 16 participants |
Comparison: Null hypothesis - The rate of responder for the pregabain group was equal to the rate of responder for the placebo group; Alternative hypothesis - The rate of responder for the pregabain group was not equal to the rate of responder for the placebo group.p-value: 0.025695% CI: [1.103, 4.546]Regression, Logistic
Secondary
Number of Participants With Categorical Scores on the Patient Global Impression of Change (PGIC) (Full Scale)
The PGIC is a participant-rated instrument measuring change in the participant's overall status on a 7-point scale: 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse.
Time frame: Baseline, Week 16
Population: mITT; LOCF; (N) = number of participants with data available for analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Number of Participants With Categorical Scores on the Patient Global Impression of Change (PGIC) (Full Scale) | 3-Minimally improved | 38 participants |
| Pregabalin | Number of Participants With Categorical Scores on the Patient Global Impression of Change (PGIC) (Full Scale) | 5-Minimally worse | 2 participants |
| Pregabalin | Number of Participants With Categorical Scores on the Patient Global Impression of Change (PGIC) (Full Scale) | 2-Much improved | 33 participants |
| Pregabalin | Number of Participants With Categorical Scores on the Patient Global Impression of Change (PGIC) (Full Scale) | 6-Much worse | 0 participants |
| Pregabalin | Number of Participants With Categorical Scores on the Patient Global Impression of Change (PGIC) (Full Scale) | 4-No change | 19 participants |
| Pregabalin | Number of Participants With Categorical Scores on the Patient Global Impression of Change (PGIC) (Full Scale) | 7-Very much worse | 1 participants |
| Pregabalin | Number of Participants With Categorical Scores on the Patient Global Impression of Change (PGIC) (Full Scale) | 1-Very much improved | 7 participants |
| Placebo | Number of Participants With Categorical Scores on the Patient Global Impression of Change (PGIC) (Full Scale) | 7-Very much worse | 0 participants |
| Placebo | Number of Participants With Categorical Scores on the Patient Global Impression of Change (PGIC) (Full Scale) | 1-Very much improved | 2 participants |
| Placebo | Number of Participants With Categorical Scores on the Patient Global Impression of Change (PGIC) (Full Scale) | 2-Much improved | 25 participants |
| Placebo | Number of Participants With Categorical Scores on the Patient Global Impression of Change (PGIC) (Full Scale) | 3-Minimally improved | 24 participants |
| Placebo | Number of Participants With Categorical Scores on the Patient Global Impression of Change (PGIC) (Full Scale) | 4-No change | 40 participants |
| Placebo | Number of Participants With Categorical Scores on the Patient Global Impression of Change (PGIC) (Full Scale) | 5-Minimally worse | 5 participants |
| Placebo | Number of Participants With Categorical Scores on the Patient Global Impression of Change (PGIC) (Full Scale) | 6-Much worse | 3 participants |
Comparison: Null hypothesis - The raw mean score for the pregabain group was equal to the raw mean score for the placebo group; Alternative hypothesis - The raw mean score for the pregabain group was not equal to the raw mean score for the placebo group.p-value: 0.0006Cochran-Mantel-Haenszel
Secondary
Number of Participants With Improved Duration of Brief Pain Attacks Based on NPSI - Duration (Item 4)
NPSI - Temporal item which assesses the duration (number of hours during the last 24 hours) of spontaneous ongoing pain. Improved duration would be a decrease in the number of hours of spontaneous ongoing pain during the last 24 hours compared to baseline.
Time frame: Baseline, Week 16
Population: MITT; LOCF; (N) = number of participants with data available for analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pregabalin | Number of Participants With Improved Duration of Brief Pain Attacks Based on NPSI - Duration (Item 4) | 39 participants |
| Placebo | Number of Participants With Improved Duration of Brief Pain Attacks Based on NPSI - Duration (Item 4) | 28 participants |
Comparison: Null hypothesis - The rate of subjects with improvement for the pregabain group was equal to the rate of subjects with improvement for the placebo group; Alternative hypothesis - The rate of subjects with improvement for the pregabain group was not equal to the rate of subjects with improvement for the placebo group.p-value: 0.0536Cochran-Mantel-Haenszel
Secondary
Number of Participants With Improvement in the Number of Attacks Based on NPSI - Number of Attacks (Item 7)
NPSI - Temporal item which assesses the paroxysmal pain (number of pain attacks during the last 24 hours). Improvement in the number of attacks would be a decrease in the number of paroxysms during the last 24 hours compared to baseline.
Time frame: Baseline, Week 16
Population: MITT; LOCF; (N) = number of participants with data available for analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pregabalin | Number of Participants With Improvement in the Number of Attacks Based on NPSI - Number of Attacks (Item 7) | 48 participants |
| Placebo | Number of Participants With Improvement in the Number of Attacks Based on NPSI - Number of Attacks (Item 7) | 38 participants |
Comparison: Null hypothesis - The rate of subjects with improvement for the pregabain group was equal to the rate of subjects with improvement for the placebo group; Alternative hypothesis - The rate of subjects with improvement for the pregabain group was not equal to the rate of subjects with improvement for the placebo group.p-value: 0.3107Cochran-Mantel-Haenszel
Other Pre-specified
Change From Baseline in Weekly Mean Sleep Interference Score by Week
Pain related sleep interference was assessed on an 11 point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered \[unable to sleep due to pain\]).
Time frame: Baseline, Week 1 through 16
Population: ITT; (n) = number of participants with data available for analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Change From Baseline in Weekly Mean Sleep Interference Score by Week | Change at Week 8 (n = 101, 96) | -1.97 score on scale | Standard Deviation 2.18 |
| Pregabalin | Change From Baseline in Weekly Mean Sleep Interference Score by Week | Change at Week 4 (n = 107, 102) | -1.59 score on scale | Standard Deviation 1.85 |
| Pregabalin | Change From Baseline in Weekly Mean Sleep Interference Score by Week | Change at Week 9 (n = 98, 96) | -2.03 score on scale | Standard Deviation 2.13 |
| Pregabalin | Change From Baseline in Weekly Mean Sleep Interference Score by Week | Change at Week 2 (n = 110, 104) | -1.29 score on scale | Standard Deviation 1.63 |
| Pregabalin | Change From Baseline in Weekly Mean Sleep Interference Score by Week | Change at Week 10 (n = 97, 90) | -2.18 score on scale | Standard Deviation 2.06 |
| Pregabalin | Change From Baseline in Weekly Mean Sleep Interference Score by Week | Change at Week 11 (n = 96, 89) | -2.08 score on scale | Standard Deviation 2.15 |
| Pregabalin | Change From Baseline in Weekly Mean Sleep Interference Score by Week | Change at Week 5 (n = 105, 100) | -1.81 score on scale | Standard Deviation 2.05 |
| Pregabalin | Change From Baseline in Weekly Mean Sleep Interference Score by Week | Change at Week 12 (n = 96, 90) | -2.07 score on scale | Standard Deviation 2.21 |
| Pregabalin | Change From Baseline in Weekly Mean Sleep Interference Score by Week | Change at Week 1 (n = 111, 106) | -0.96 score on scale | Standard Deviation 1.45 |
| Pregabalin | Change From Baseline in Weekly Mean Sleep Interference Score by Week | Change at Week 13 (n = 93, 90) | -2.08 score on scale | Standard Deviation 2.21 |
| Pregabalin | Change From Baseline in Weekly Mean Sleep Interference Score by Week | Change at Week 6 (n = 105, 98) | -1.86 score on scale | Standard Deviation 2.14 |
| Pregabalin | Change From Baseline in Weekly Mean Sleep Interference Score by Week | Change at Week 14 (n = 93, 91) | -2.09 score on scale | Standard Deviation 2.13 |
| Pregabalin | Change From Baseline in Weekly Mean Sleep Interference Score by Week | Change at Week 3 (n = 107, 104) | -1.36 score on scale | Standard Deviation 1.68 |
| Pregabalin | Change From Baseline in Weekly Mean Sleep Interference Score by Week | Change at Week 15 (n = 93, 91) | -2.15 score on scale | Standard Deviation 2.1 |
| Pregabalin | Change From Baseline in Weekly Mean Sleep Interference Score by Week | Change at Week 7 (n = 103, 97) | -1.98 score on scale | Standard Deviation 2.19 |
| Pregabalin | Change From Baseline in Weekly Mean Sleep Interference Score by Week | Change at Week 16 (n = 89, 89) | -2.25 score on scale | Standard Deviation 2.24 |
| Pregabalin | Change From Baseline in Weekly Mean Sleep Interference Score by Week | Baseline (n = 111, 107) | 4.86 score on scale | Standard Deviation 2.46 |
| Placebo | Change From Baseline in Weekly Mean Sleep Interference Score by Week | Change at Week 16 (n = 89, 89) | -1.17 score on scale | Standard Deviation 1.82 |
| Placebo | Change From Baseline in Weekly Mean Sleep Interference Score by Week | Baseline (n = 111, 107) | 5.18 score on scale | Standard Deviation 2.23 |
| Placebo | Change From Baseline in Weekly Mean Sleep Interference Score by Week | Change at Week 1 (n = 111, 106) | -0.26 score on scale | Standard Deviation 0.85 |
| Placebo | Change From Baseline in Weekly Mean Sleep Interference Score by Week | Change at Week 2 (n = 110, 104) | -0.49 score on scale | Standard Deviation 1.17 |
| Placebo | Change From Baseline in Weekly Mean Sleep Interference Score by Week | Change at Week 3 (n = 107, 104) | -0.61 score on scale | Standard Deviation 1.27 |
| Placebo | Change From Baseline in Weekly Mean Sleep Interference Score by Week | Change at Week 4 (n = 107, 102) | -0.90 score on scale | Standard Deviation 1.45 |
| Placebo | Change From Baseline in Weekly Mean Sleep Interference Score by Week | Change at Week 5 (n = 105, 100) | -0.91 score on scale | Standard Deviation 1.38 |
| Placebo | Change From Baseline in Weekly Mean Sleep Interference Score by Week | Change at Week 6 (n = 105, 98) | -0.99 score on scale | Standard Deviation 1.48 |
| Placebo | Change From Baseline in Weekly Mean Sleep Interference Score by Week | Change at Week 7 (n = 103, 97) | -1.10 score on scale | Standard Deviation 1.5 |
| Placebo | Change From Baseline in Weekly Mean Sleep Interference Score by Week | Change at Week 8 (n = 101, 96) | -1.11 score on scale | Standard Deviation 1.59 |
| Placebo | Change From Baseline in Weekly Mean Sleep Interference Score by Week | Change at Week 9 (n = 98, 96) | -1.11 score on scale | Standard Deviation 1.72 |
| Placebo | Change From Baseline in Weekly Mean Sleep Interference Score by Week | Change at Week 11 (n = 96, 89) | -1.20 score on scale | Standard Deviation 1.85 |
| Placebo | Change From Baseline in Weekly Mean Sleep Interference Score by Week | Change at Week 12 (n = 96, 90) | -1.20 score on scale | Standard Deviation 1.75 |
| Placebo | Change From Baseline in Weekly Mean Sleep Interference Score by Week | Change at Week 13 (n = 93, 90) | -1.19 score on scale | Standard Deviation 1.82 |
| Placebo | Change From Baseline in Weekly Mean Sleep Interference Score by Week | Change at Week 14 (n = 93, 91) | -1.18 score on scale | Standard Deviation 1.83 |
| Placebo | Change From Baseline in Weekly Mean Sleep Interference Score by Week | Change at Week 15 (n = 93, 91) | -1.11 score on scale | Standard Deviation 1.83 |
| Placebo | Change From Baseline in Weekly Mean Sleep Interference Score by Week | Change at Week 10 (n = 97, 90) | -1.12 score on scale | Standard Deviation 1.74 |
Comparison: Week 1.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.p-value: 0.000495% CI: [-1.23, -0.35]Mixed Models Analysis
Comparison: Week2~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.p-value: <0.000195% CI: [-1.31, -0.43]Mixed Models Analysis
Comparison: Week 3.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.p-value: 0.000495% CI: [-1.24, -0.36]Mixed Models Analysis
Comparison: Week 4.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.p-value: 0.000895% CI: [-1.2, -0.32]Mixed Models Analysis
Comparison: Week 5.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.p-value: <0.000195% CI: [-1.38, -0.49]Mixed Models Analysis
Comparison: Week 6.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.p-value: <0.000195% CI: [-1.37, -0.48]Mixed Models Analysis
Comparison: Week 7.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.p-value: <0.000195% CI: [-1.35, -0.47]Mixed Models Analysis
Comparison: Week 8.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.p-value: <0.000195% CI: [-1.35, -0.46]Mixed Models Analysis
Comparison: Week 9.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.p-value: <0.000195% CI: [-1.39, -0.5]Mixed Models Analysis
Comparison: Week 10.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.p-value: <0.000195% CI: [-1.53, -0.63]Mixed Models Analysis
Comparison: Week 11.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.p-value: <0.000195% CI: [-1.39, -0.49]Mixed Models Analysis
Comparison: Week 12.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.p-value: <0.000195% CI: [-1.37, -0.47]Mixed Models Analysis
Comparison: Week 13.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.p-value: <0.000195% CI: [-1.38, -0.47]Mixed Models Analysis
Comparison: Week 14.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.p-value: <0.000195% CI: [-1.41, -0.51]Mixed Models Analysis
Comparison: Week 15.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.p-value: <0.000195% CI: [-1.53, -0.63]Mixed Models Analysis
Comparison: Week 16.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.p-value: <0.000195% CI: [-1.51, -0.61]Mixed Models Analysis