Trial Outcomes & Findings for Efficacy Of Pregabalin In Subjects With Post-Stroke Central Neuropathic Pain (NCT NCT00313820)
NCT ID: NCT00313820
Last Updated: 2021-02-09
Results Overview
Mean pain score obtained from last 7 available DPRS scores up to and including day of Week 12 visit or early termination (ET) equivalent. DPRS: subject rated 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain. Self-assessment performed daily on awakening prior to taking study medication.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
220 participants
Primary outcome timeframe
Up to Week 12
Results posted on
2021-02-09
Participant Flow
Two-week screening and washout phase prior to randomization.
Participant milestones
| Measure |
Pregabalin
75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
|
Placebo
75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
|
|---|---|---|
|
Assigned to Treatment
STARTED
|
111
|
109
|
|
Assigned to Treatment
COMPLETED
|
110
|
109
|
|
Assigned to Treatment
NOT COMPLETED
|
1
|
0
|
|
Pregabalin or Placebo Treatment Period
STARTED
|
110
|
109
|
|
Pregabalin or Placebo Treatment Period
COMPLETED
|
93
|
90
|
|
Pregabalin or Placebo Treatment Period
NOT COMPLETED
|
17
|
19
|
Reasons for withdrawal
| Measure |
Pregabalin
75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
|
Placebo
75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
|
|---|---|---|
|
Assigned to Treatment
Other
|
1
|
0
|
|
Pregabalin or Placebo Treatment Period
Adverse Event
|
9
|
4
|
|
Pregabalin or Placebo Treatment Period
Lack of Efficacy
|
0
|
1
|
|
Pregabalin or Placebo Treatment Period
Lost to Follow-up
|
0
|
7
|
|
Pregabalin or Placebo Treatment Period
Withdrawal by Subject
|
6
|
4
|
|
Pregabalin or Placebo Treatment Period
Other
|
2
|
3
|
Baseline Characteristics
Efficacy Of Pregabalin In Subjects With Post-Stroke Central Neuropathic Pain
Baseline characteristics by cohort
| Measure |
Pregabalin
n=110 Participants
75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
|
Placebo
n=109 Participants
75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
|
Total
n=219 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.4 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
57.1 years
STANDARD_DEVIATION 10.2 • n=7 Participants
|
58.2 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
67 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
137 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to Week 12Population: Intent to Treat (ITT): received at least 1 dose study medication and completed at least 1 post-baseline assessment. Endpoint = Week 12 or ET
Mean pain score obtained from last 7 available DPRS scores up to and including day of Week 12 visit or early termination (ET) equivalent. DPRS: subject rated 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain. Self-assessment performed daily on awakening prior to taking study medication.
Outcome measures
| Measure |
Pregabalin
n=108 Participants
75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
|
Placebo
n=108 Participants
75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
|
|---|---|---|
|
Mean Pain Score at Endpoint as Measured by Daily Pain Rating Scale (DPRS)
|
4.8 scores on scale
Standard Error 0.21
|
5.0 scores on scale
Standard Error 0.21
|
SECONDARY outcome
Timeframe: Week 1, Week 2, Week 3, Week 6, Week 9, and Week 12Population: ITT; (n) = number of participants with analyzable data at observation for pregabalin and placebo, respectively; weeks as specified in timeframe through Week 12 \[ET\]
Weekly mean pain score measured by DPRS: subject rated 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain. Self-assessment performed daily on awakening prior to taking study medication.
Outcome measures
| Measure |
Pregabalin
n=110 Participants
75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
|
Placebo
n=109 Participants
75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
|
|---|---|---|
|
Pain Score as Measured by DPRS
Week 6 (n=97, 102)
|
4.9 scores on scale
Standard Error 0.18
|
5.4 scores on scale
Standard Error 0.18
|
|
Pain Score as Measured by DPRS
Week 9 (n=98, 97)
|
4.8 scores on scale
Standard Error 0.18
|
5.2 scores on scale
Standard Error 0.18
|
|
Pain Score as Measured by DPRS
Week 12 [ET] (n=92, 92)
|
4.7 scores on scale
Standard Error 0.18
|
4.9 scores on scale
Standard Error 0.19
|
|
Pain Score as Measured by DPRS
Week 1 (n=108, 108)
|
5.6 scores on scale
Standard Error 0.18
|
6.0 scores on scale
Standard Error 0.18
|
|
Pain Score as Measured by DPRS
Week 2 (n=104, 106)
|
5.3 scores on scale
Standard Error 0.18
|
5.8 scores on scale
Standard Error 0.18
|
|
Pain Score as Measured by DPRS
Week 3 (n=102, 105)
|
5.1 scores on scale
Standard Error 0.18
|
5.6 scores on scale
Standard Error 0.18
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: ITT; endpoint = Week 12 or ET
30% Responder Yes = number of subjects with 30% reduction in mean pain score from baseline to observation; 30% reduction calculated as \[(T minus B) divided by B multiplied by 100\] \< = negative 30. T = endpoint mean pain score (obtained from last 7 available scores from DPRS); B = baseline mean pain score (obtained from average of last 7 daily scores from DPRS). 30% Responder No indicates number of subjects that did not reach 30% reduction in mean pain score.
Outcome measures
| Measure |
Pregabalin
n=108 Participants
75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
|
Placebo
n=108 Participants
75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
|
|---|---|---|
|
Number of Subjects With at Least a 30% Reduction From Baseline in Mean Pain Score at Endpoint
30% Responders Yes
|
48 participants
|
35 participants
|
|
Number of Subjects With at Least a 30% Reduction From Baseline in Mean Pain Score at Endpoint
30% Responders No
|
60 participants
|
73 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: ITT; endpoint = Week 12 or ET
50% Responder Yes = number of subjects with 50% reduction in mean pain score from baseline to observation; 50% reduction calculated as \[(T minus B) divided by B multiplied by 100\] \< = negative 50. T = endpoint mean pain score (obtained from last 7 available scores from DPRS); B = baseline mean pain score (obtained from average of last 7 daily scores from DPRS). 50% Responder No indicates number of subjects that did not reach 50% reduction in mean pain score.
Outcome measures
| Measure |
Pregabalin
n=108 Participants
75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
|
Placebo
n=108 Participants
75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
|
|---|---|---|
|
Number of Subjects With at Least a 50% Reduction From Baseline in Mean Pain Score at Endpoint
50 % Responders Yes
|
26 participants
|
22 participants
|
|
Number of Subjects With at Least a 50% Reduction From Baseline in Mean Pain Score at Endpoint
50 % Responders No
|
82 participants
|
86 participants
|
SECONDARY outcome
Timeframe: Week 1, Week 2, Week 3, Week 6, Week 9, and Week 12Population: ITT; (n) = number of subjects with analyzable data at observation for pregabalin and placebo, respectively; endpoint = Week 12 or ET.
DSIS: subject rated 11-point numeric scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Self-assessment performed daily on awakening prior to taking study medication. Endpoint calculated as mean of last 7 available scores.
Outcome measures
| Measure |
Pregabalin
n=110 Participants
75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
|
Placebo
n=109 Participants
75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
|
|---|---|---|
|
Weekly Mean Sleep Interference Score From Daily Sleep Diary (Daily Sleep Interference Scale [DSIS])
Week 1 (n=108, 108)
|
3.6 scores on scale
Standard Error 0.17
|
4.2 scores on scale
Standard Error 0.17
|
|
Weekly Mean Sleep Interference Score From Daily Sleep Diary (Daily Sleep Interference Scale [DSIS])
Week 2 (n=104, 106)
|
3.5 scores on scale
Standard Error 0.17
|
4.0 scores on scale
Standard Error 0.17
|
|
Weekly Mean Sleep Interference Score From Daily Sleep Diary (Daily Sleep Interference Scale [DSIS])
Week 3 (n=102, 105)
|
3.2 scores on scale
Standard Error 0.17
|
3.9 scores on scale
Standard Error 0.17
|
|
Weekly Mean Sleep Interference Score From Daily Sleep Diary (Daily Sleep Interference Scale [DSIS])
Week 6 (n=98, 102)
|
3.0 scores on scale
Standard Error 0.17
|
3.7 scores on scale
Standard Error 0.17
|
|
Weekly Mean Sleep Interference Score From Daily Sleep Diary (Daily Sleep Interference Scale [DSIS])
Week 9 (n=98, 97)
|
3.0 scores on scale
Standard Error 0.17
|
3.4 scores on scale
Standard Error 0.17
|
|
Weekly Mean Sleep Interference Score From Daily Sleep Diary (Daily Sleep Interference Scale [DSIS])
Week 12 (n=92, 92)
|
3.1 scores on scale
Standard Error 0.18
|
3.2 scores on scale
Standard Error 0.18
|
|
Weekly Mean Sleep Interference Score From Daily Sleep Diary (Daily Sleep Interference Scale [DSIS])
Endpoint [Week 12 or ET] (n=108, 108)
|
3.0 scores on scale
Standard Error 0.19
|
3.1 scores on scale
Standard Error 0.19
|
SECONDARY outcome
Timeframe: Week 12Population: ITT
SF-MPQ Part B VAS consists of a line 0 to 100 millimeters (mm) in length; range is (no pain) to 100 mm (worst possible pain). Subjects placed a mark indicating the intensity of their pain. Distance from left-hand end of line was measured and entered on Case Report Form (CRF) as score in mm. Higher score indicates greater level of pain.
Outcome measures
| Measure |
Pregabalin
n=100 Participants
75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
|
Placebo
n=97 Participants
75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
|
|---|---|---|
|
Short Form-McGill Pain Questionnaire (SF-MPQ Visual Analog Scale [VAS]) - Part B Only
|
48.5 millimeters
Standard Error 2.19
|
49.5 millimeters
Standard Error 2.23
|
SECONDARY outcome
Timeframe: Week 12Population: ITT; (N) = number of subjects with analyzable data at observation for pregabalin and placebo, respectively; Week 12/Last observation carried forward (LOCF).
NPSI: subject rated questionnaire 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 (0 to 100). Higher score indicates a greater intensity of pain.
Outcome measures
| Measure |
Pregabalin
n=110 Participants
75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
|
Placebo
n=109 Participants
75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
|
|---|---|---|
|
Neuropathic Pain Symptom Inventory (NPSI)
Burning Pain (n=108, 108)
|
2.6 scores on scale
Standard Error 0.22
|
2.9 scores on scale
Standard Error 0.23
|
|
Neuropathic Pain Symptom Inventory (NPSI)
Pressing Pain (n=108, 107)
|
2.7 scores on scale
Standard Error 0.18
|
2.6 scores on scale
Standard Error 0.19
|
|
Neuropathic Pain Symptom Inventory (NPSI)
P/D (n=108, 108)
|
2.7 scores on scale
Standard Error 0.20
|
3.1 scores on scale
Standard Error 0.20
|
|
Neuropathic Pain Symptom Inventory (NPSI)
Total Score (n=108, 107)
|
25.7 scores on scale
Standard Error 1.36
|
28.5 scores on scale
Standard Error 1.40
|
|
Neuropathic Pain Symptom Inventory (NPSI)
Paroxysmal Pain (n=108, 108)
|
1.9 scores on scale
Standard Error 0.18
|
2.1 scores on scale
Standard Error 0.18
|
|
Neuropathic Pain Symptom Inventory (NPSI)
Evoked Pain (n=108, 108)
|
2.8 scores on scale
Standard Error 0.19
|
3.2 scores on scale
Standard Error 0.19
|
SECONDARY outcome
Timeframe: Week 12Population: ITT; (n) = number of subjects with analyzable data at observation for pregabalin and placebo, respectively.
MOS: subject 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.
Outcome measures
| Measure |
Pregabalin
n=110 Participants
75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
|
Placebo
n=109 Participants
75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
|
|---|---|---|
|
Medical Outcome Study (MOS) Sleep Scale
Sleep disturbance (n=100, 97)
|
27.1 scores on scale
Standard Error 2.00
|
31.9 scores on scale
Standard Error 2.05
|
|
Medical Outcome Study (MOS) Sleep Scale
Snoring score (n=98, 97)
|
40.6 scores on scale
Standard Error 2.68
|
32.9 scores on scale
Standard Error 2.75
|
|
Medical Outcome Study (MOS) Sleep Scale
Somnolence (n=99, 97)
|
39.9 scores on scale
Standard Error 1.81
|
37.8 scores on scale
Standard Error 1.84
|
|
Medical Outcome Study (MOS) Sleep Scale
Overall sleep problems index (n=100, 97)
|
28.2 scores on scale
Standard Error 1.53
|
32.4 scores on scale
Standard Error 1.57
|
|
Medical Outcome Study (MOS) Sleep Scale
Awaken SOB or headache (n=99, 97)
|
11.3 scores on scale
Standard Error 1.95
|
15.0 scores on scale
Standard Error 1.99
|
|
Medical Outcome Study (MOS) Sleep Scale
Sleep quantity (100, 97)
|
7.0 scores on scale
Standard Error 0.12
|
6.6 scores on scale
Standard Error 0.12
|
|
Medical Outcome Study (MOS) Sleep Scale
Sleep adequacy (n=99, 97)
|
67.5 scores on scale
Standard Error 2.48
|
58.9 scores on scale
Standard Error 2.51
|
SECONDARY outcome
Timeframe: Week 12Population: ITT
MOS: subject rated questionnaire to assess sleep quality and quantity. Optimal sleep component is derived from Sleep Quantity average hours of sleep each night during the past 4 weeks. Number of subjects with response = YES if sleep quantity is 7 or 8 hours per night or response = NO if sleep quantity is \< 7 hours per night.
Outcome measures
| Measure |
Pregabalin
n=100 Participants
75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
|
Placebo
n=97 Participants
75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
|
|---|---|---|
|
Number of Subjects With Yes or No Response for Medical Outcome Study (MOS) Sleep Scale - Optimal Sleep
Optimal sleep = Yes
|
51 participants
|
42 participants
|
|
Number of Subjects With Yes or No Response for Medical Outcome Study (MOS) Sleep Scale - Optimal Sleep
Optimal sleep = No
|
49 participants
|
55 participants
|
SECONDARY outcome
Timeframe: Week 12Population: ITT; Week 12 \[LOCF\]
HADS is subject 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.
Outcome measures
| Measure |
Pregabalin
n=108 Participants
75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
|
Placebo
n=108 Participants
75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
|
|---|---|---|
|
Hospital Anxiety and Depression Scale (HADS) - ITT Population
Week 12 [LOCF] Anxiety score
|
5.5 scores on scale
Standard Error 0.29
|
6.5 scores on scale
Standard Error 0.30
|
|
Hospital Anxiety and Depression Scale (HADS) - ITT Population
Week 12 [LOCF] Depression score
|
6.7 scores on scale
Standard Error 0.30
|
6.5 scores on scale
Standard Error 0.30
|
SECONDARY outcome
Timeframe: Week 12Population: ITT
EQ-5D: subject rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, "confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Outcome measures
| Measure |
Pregabalin
n=98 Participants
75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
|
Placebo
n=97 Participants
75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
|
|---|---|---|
|
Euro Quality of Life (EQ-5D)- Health State Profile Utility Score
|
0.5 scores on scale
Standard Error 0.03
|
0.5 scores on scale
Standard Error 0.03
|
SECONDARY outcome
Timeframe: Week 12Population: ITT
EQ-5D: subject rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.
Outcome measures
| Measure |
Pregabalin
n=99 Participants
75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
|
Placebo
n=97 Participants
75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
|
|---|---|---|
|
EQ-5D - VAS
|
65.7 scores on scale
Standard Error 1.78
|
62.7 scores on scale
Standard Error 1.81
|
SECONDARY outcome
Timeframe: Week 12Population: ITT
PGIC: subject rated instrument to measure subject's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse).
Outcome measures
| Measure |
Pregabalin
n=99 Participants
75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
|
Placebo
n=97 Participants
75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
|
|---|---|---|
|
Patient Global Impression of Change (PGIC)
|
2.9 scores on scale
Standard Error 0.10
|
3.1 scores on scale
Standard Error 0.10
|
SECONDARY outcome
Timeframe: Week 12Population: ITT
CGIC: clinician rated instrument that measures change in a subject's ovall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse).
Outcome measures
| Measure |
Pregabalin
n=101 Participants
75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
|
Placebo
n=97 Participants
75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
|
|---|---|---|
|
Clinical Global Impression of Change (CGIC)
|
2.8 scores on scale
Standard Error 0.10
|
3.1 scores on scale
Standard Error 0.11
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: ITT; Week 12 \[LOCF\].
QANeP: assessment of sensory threshold: subject responds "yes" when monofilament stimulus is felt on area of maximum pain: 1 (lowest/softest 0.07 gram \[g\]) to 6 (highest 300 g) or 7 (not perceived); rated by lowest/softest filament felt when in contact with the skin. Summarized as change from baseline (mean at observation minus mean at baseline).
Outcome measures
| Measure |
Pregabalin
n=106 Participants
75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
|
Placebo
n=107 Participants
75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
|
|---|---|---|
|
Quantitative Assessment of Neuropathic Pain (QANeP) - Sensory Threshold
|
0.0 scores on scale
Standard Deviation 0.89
|
-0.1 scores on scale
Standard Deviation 0.83
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: ITT; (n) = number of subjects with analyzable data at observation for pregabalin and placebo, respectively; Week 12 \[LOCF\].
Subject rated pain scale: static mechanical allodynia (SMA) gentle constant mechanical pressure; dynamic mechanical allodynia (DMA) gentle stroking with foam brush; punctate hyperalgesia (PH) pinprick; cold allodynia (CA) touch with cool metal rod 13-17° celsius (C); cold hyperalgesia (CH) touch with cold metal rod 4° C; temporal summation to tactile stimuli (TSTS) repeated touching/tapping. 11-point numeric scale; range 0 (no pain) to 10 (worst possible pain). Reference area=mirror image of pain site (test area). Summarized as change from baseline (mean at observation minus mean at baseline).
Outcome measures
| Measure |
Pregabalin
n=110 Participants
75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
|
Placebo
n=109 Participants
75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
|
|---|---|---|
|
QANeP - Pain Rating Scales
SMA (n=108, 107)
|
-0.7 scores on scale
Standard Deviation 2.14
|
-0.5 scores on scale
Standard Deviation 1.93
|
|
QANeP - Pain Rating Scales
DMA (n=108, 107)
|
-0.8 scores on scale
Standard Deviation 1.96
|
-0.6 scores on scale
Standard Deviation 1.83
|
|
QANeP - Pain Rating Scales
PH reference area (n=108, 107)
|
-0.2 scores on scale
Standard Deviation 2.60
|
-0.2 scores on scale
Standard Deviation 2.41
|
|
QANeP - Pain Rating Scales
PH test area (n=108, 107)
|
-0.7 scores on scale
Standard Deviation 2.27
|
-0.0 scores on scale
Standard Deviation 2.37
|
|
QANeP - Pain Rating Scales
TSTS (n=108, 106)
|
-1.0 scores on scale
Standard Deviation 2.47
|
-0.5 scores on scale
Standard Deviation 2.25
|
|
QANeP - Pain Rating Scales
CA (n=108, 106)
|
-1.1 scores on scale
Standard Deviation 2.36
|
-0.3 scores on scale
Standard Deviation 1.95
|
|
QANeP - Pain Rating Scales
CH reference area (n=107, 107)
|
0.0 scores on scale
Standard Deviation 2.56
|
-0.2 scores on scale
Standard Deviation 1.74
|
|
QANeP - Pain Rating Scales
CH test area (n=107, 106)
|
-0.9 scores on scale
Standard Deviation 2.47
|
-0.9 scores on scale
Standard Deviation 2.14
|
Adverse Events
Pregabalin
Serious events: 6 serious events
Other events: 59 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pregabalin
n=110 participants at risk
75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
|
Placebo
n=109 participants at risk
75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.91%
1/110
|
0.00%
0/109
|
|
General disorders
Local swelling
|
0.91%
1/110
|
0.00%
0/109
|
|
General disorders
Edema peripheral
|
0.91%
1/110
|
0.00%
0/109
|
|
Infections and infestations
Kidney infection
|
0.91%
1/110
|
0.00%
0/109
|
|
Infections and infestations
Pneumonia
|
0.91%
1/110
|
0.00%
0/109
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/110
|
0.92%
1/109
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/110
|
0.92%
1/109
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.91%
1/110
|
0.00%
0/109
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.91%
1/110
|
0.00%
0/109
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.91%
1/110
|
0.00%
0/109
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
|
0.91%
1/110
|
0.00%
0/109
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.91%
1/110
|
0.00%
0/109
|
|
Nervous system disorders
Convulsion
|
0.00%
0/110
|
0.92%
1/109
|
|
Nervous system disorders
Dizziness
|
0.91%
1/110
|
0.00%
0/109
|
|
Renal and urinary disorders
Hydronephrosis
|
0.91%
1/110
|
0.00%
0/109
|
Other adverse events
| Measure |
Pregabalin
n=110 participants at risk
75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
|
Placebo
n=109 participants at risk
75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
5.5%
6/110
|
1.8%
2/109
|
|
General disorders
Oedema
|
5.5%
6/110
|
0.00%
0/109
|
|
General disorders
Oedema peripheral
|
9.1%
10/110
|
2.8%
3/109
|
|
Infections and infestations
Upper respiratory tract infection
|
2.7%
3/110
|
5.5%
6/109
|
|
Investigations
Weight increased
|
5.5%
6/110
|
1.8%
2/109
|
|
Nervous system disorders
Dizziness
|
28.2%
31/110
|
7.3%
8/109
|
|
Nervous system disorders
Headache
|
6.4%
7/110
|
7.3%
8/109
|
|
Nervous system disorders
Somnolence
|
21.8%
24/110
|
4.6%
5/109
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of \< 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), \< 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER