Fibromyalgia
Conditions
Keywords
juvenile primary fibromyalgia syndrome, pediatric fibromyalgia, pregabalin, and Lyrica
Brief summary
This study will compare pregabalin with placebo over a 15 week period in adolescents with fibromyalgia aged 12-17 years to evaluate the safety and efficacy of pregabalin.
Interventions
DRUGplacebo
matching placebo capsules twice daily.
75-450mg/day pregabalin dose optimised at start of study
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of fibromyalgia * 12-17 years of age
Exclusion criteria
* Patients with other pain conditions * Previous treatment with pregabalin * Patients taking excluded medication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Week 15 in Mean Pain Diary Score | Week 15 | The Primary Endpoint is based on the daily pain diary, and is defined as change from baseline to Week 15 in mean pain diary score. The daily pain diary consists of an 11-point numeric rating scale ranging from zero (no pain) to 10 (worst possible pain). The patients rate their pain during the past 24 hours by choosing the appropriate number between 0 (no pain) and 10 (worst possible pain). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS) | Baseline to Week 15 | Mean pain score was calculated for each week during the double-blind treatment phase (Week 1 to Week 15). For each week, only days up to the last day on study medication were considered. A minimum of 4 pain diaries were required to calculate the mean pain score. The pain NRS consists of an 11 point NRS ranging from 0 (no pain) to 10 (worst possible pain). |
| Mean Change From Baseline to Weekly Mean Sleep Quality Score (NRS) | Baseline to Week 15 | Mean sleep quality score was calculated for each week during the double-blind treatment phase (Week 1 to Week 15). A minimum of 4 sleep diaries are required to calculate the mean pain score. The daily quality of sleep diary consists of an 11-point numeric rating scale with which the patient rates the quality of their sleep during the past 24 hours. Zero indicates best possible sleep and 10 indicates worst possible sleep. |
| Change From Baseline to Week 15 in Mean Pain Numeric Rating Scale (1 Week Recall Period) | Week 15 | The weekly pain numeric rating scale (Weekly Pain NRS) consists of an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate greater degree of impairment. Participants choose the number that best describes the pain during the last week. |
| Change From Baseline to Week 15 in Mean Sleep Quality Diary Score | Week 15 | Change from Baseline to endpoint in mean sleep quality score from the daily sleep diary, defined as the mean of the last 7 diary entries prior to Visit 10 in the study while the participant is on study medication. The daily quality of sleep diary consists of an 11-point numeric rating scale with which the patient rates the quality of their sleep during the past 24 hours. Zero indicates best possible sleep and 10 indicates worst possible sleep. |
| Proportion of 50% Responder in Weekly Mean Pain Score (NRS) at Week 15 | Week 15 | At each visit, participants with at least 50% reduction from Baseline in mean pain score were defined as a 50% responder at the visit. The pain NRS consists of an 11 point NRS ranging from 0 (no pain) to 10 (worst possible pain). |
| Proportion of Patient Global Impression Change (PGIC) at Week 15 | Week 15 | Responder rates based on PGIC was derived and tabulated by treatment group. A responder was defined as a participant who reports much improved or very much improved. The PGIC is a patient-rated single item that measures patient's perception of change in their overall status since starting study medication on a scale ranging from 1 (very much improved) to 7 (very much worse). |
| Proportion of 30% Responders in Weekly Mean Pain Score (NRS) at Week 15 | Week 15 | At each visit, participants with at least 30% reduction from Baseline in mean pain score were defined as a 30% responder at the visit. The pain NRS consists of an 11 point NRS ranging from 0 (no pain) to 10 (worst possible pain). |
Countries
Czechia, India, Taiwan, United States
Participant flow
Recruitment details
A total of 147 participants were screened, 107 participants were randomized to treatment. The 107 randomized participants were recruited in 4 countries at 23 study centers.
Pre-assignment details
This study consisted of 4 phases, screening (1 Week), dose optimization (3 Weeks), fixed dose (12 Weeks) and follow-up (1 Week).
Participants by arm
| Arm | Count |
|---|---|
| Pregabalin Pregabalin was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Participants received 75 mg/day to 450 mg/day. Dosing was started on Day 1. The dose was optimized over a 3-week period followed by an additional 12 weeks at the optimized dose. | 54 |
| Placebo Placebo was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Dosing was started on Day 1. | 53 |
| Total | 107 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 4 |
| Overall Study | Insufficient Clinical Response | 0 | 3 |
| Overall Study | Other Reasons | 1 | 1 |
| Overall Study | Protocol Violation | 0 | 2 |
| Overall Study | Withdrawal by Subject | 5 | 7 |
Baseline characteristics
| Characteristic | Pregabalin | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 14.6 years STANDARD_DEVIATION 1.2 | 14.7 years STANDARD_DEVIATION 1.2 | 14.7 years STANDARD_DEVIATION 1.2 |
| Sex: Female, Male Female | 48 Participants | 44 Participants | 92 Participants |
| Sex: Female, Male Male | 6 Participants | 9 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 33 / 54 | 27 / 53 |
| serious Total, serious adverse events | 1 / 54 | 0 / 53 |
Outcome results
Primary
Change From Baseline to Week 15 in Mean Pain Diary Score
The Primary Endpoint is based on the daily pain diary, and is defined as change from baseline to Week 15 in mean pain diary score. The daily pain diary consists of an 11-point numeric rating scale ranging from zero (no pain) to 10 (worst possible pain). The patients rate their pain during the past 24 hours by choosing the appropriate number between 0 (no pain) and 10 (worst possible pain).
Time frame: Week 15
Population: The full analysis set (FAS) population consists of all randomized participants who received at least one dose of study medication.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin | Change From Baseline to Week 15 in Mean Pain Diary Score | -1.60 Units on a scale | Standard Error 0.32 |
| Placebo | Change From Baseline to Week 15 in Mean Pain Diary Score | -0.94 Units on a scale | Standard Error 0.31 |
p-value: 0.12195% CI: [-1.51, 0.18]ANCOVA
Secondary
Change From Baseline to Week 15 in Mean Pain Numeric Rating Scale (1 Week Recall Period)
The weekly pain numeric rating scale (Weekly Pain NRS) consists of an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate greater degree of impairment. Participants choose the number that best describes the pain during the last week.
Time frame: Week 15
Population: The FAS population consists of all randomized participants who received at least one dose of study medication. Baseline observation carried forward (BOCF) for participants with missing Week 15 mean pain score.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin | Change From Baseline to Week 15 in Mean Pain Numeric Rating Scale (1 Week Recall Period) | -1.64 Units on a scale | Standard Error 0.31 |
| Placebo | Change From Baseline to Week 15 in Mean Pain Numeric Rating Scale (1 Week Recall Period) | -0.77 Units on a scale | Standard Error 0.3 |
p-value: 0.03795% CI: [-1.68, -0.05]ANCOVA
Secondary
Change From Baseline to Week 15 in Mean Sleep Quality Diary Score
Change from Baseline to endpoint in mean sleep quality score from the daily sleep diary, defined as the mean of the last 7 diary entries prior to Visit 10 in the study while the participant is on study medication. The daily quality of sleep diary consists of an 11-point numeric rating scale with which the patient rates the quality of their sleep during the past 24 hours. Zero indicates best possible sleep and 10 indicates worst possible sleep.
Time frame: Week 15
Population: The FAS population consists of all randomized participants who received at least one dose of study medication. Last observation carried forward (LOCF) for participants with missing Week 15 mean pain score, i.e., the endpoint mean pain score.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin | Change From Baseline to Week 15 in Mean Sleep Quality Diary Score | -1.13 Units on a scale | Standard Error 0.3 |
| Placebo | Change From Baseline to Week 15 in Mean Sleep Quality Diary Score | -0.94 Units on a scale | Standard Error 0.31 |
p-value: 0.65595% CI: [-1, 0.63]ANCOVA
Secondary
Mean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS)
Mean pain score was calculated for each week during the double-blind treatment phase (Week 1 to Week 15). For each week, only days up to the last day on study medication were considered. A minimum of 4 pain diaries were required to calculate the mean pain score. The pain NRS consists of an 11 point NRS ranging from 0 (no pain) to 10 (worst possible pain).
Time frame: Baseline to Week 15
Population: The FAS population consists of all randomized participants who received at least one dose of study medication.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Mean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS) | Week 4 (N= 50, 46) | -1.45 Units on a scale | Standard Error 0.25 |
| Pregabalin | Mean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS) | Week 8 (N= 46, 44) | -1.65 Units on a scale | Standard Error 0.25 |
| Pregabalin | Mean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS) | Week 1 (N= 52, 49) | -0.48 Units on a scale | Standard Error 0.25 |
| Pregabalin | Mean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS) | Week 9 (N= 46, 42) | -1.61 Units on a scale | Standard Error 0.26 |
| Pregabalin | Mean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS) | Week 5 (N= 49, 44) | -1.27 Units on a scale | Standard Error 0.25 |
| Pregabalin | Mean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS) | Week 11 (N= 44, 38) | -1.93 Units on a scale | Standard Error 0.26 |
| Pregabalin | Mean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS) | Week 3 (N= 52, 44) | -1.27 Units on a scale | Standard Error 0.25 |
| Pregabalin | Mean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS) | Week 12 (N= 43, 34) | -1.75 Units on a scale | Standard Error 0.26 |
| Pregabalin | Mean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS) | Week 6 (N= 49, 44) | -1.47 Units on a scale | Standard Error 0.25 |
| Pregabalin | Mean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS) | Week 13 (N= 42, 33) | -1.75 Units on a scale | Standard Error 0.27 |
| Pregabalin | Mean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS) | Week 2 (N= 54, 47) | -1.11 Units on a scale | Standard Error 0.25 |
| Pregabalin | Mean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS) | Week 14 (N= 41, 34) | -2.01 Units on a scale | Standard Error 0.27 |
| Pregabalin | Mean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS) | Week 7 (N= 48, 42) | -1.67 Units on a scale | Standard Error 0.25 |
| Pregabalin | Mean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS) | Week 15 (N= 35, 33) | -1.90 Units on a scale | Standard Error 0.28 |
| Pregabalin | Mean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS) | Week 10 (N= 45, 40) | -1.82 Units on a scale | Standard Error 0.26 |
| Placebo | Mean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS) | Week 15 (N= 35, 33) | -1.16 Units on a scale | Standard Error 0.3 |
| Placebo | Mean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS) | Week 10 (N= 45, 40) | -0.85 Units on a scale | Standard Error 0.27 |
| Placebo | Mean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS) | Week 1 (N= 52, 49) | -0.41 Units on a scale | Standard Error 0.26 |
| Placebo | Mean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS) | Week 2 (N= 54, 47) | -0.48 Units on a scale | Standard Error 0.26 |
| Placebo | Mean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS) | Week 3 (N= 52, 44) | -0.45 Units on a scale | Standard Error 0.26 |
| Placebo | Mean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS) | Week 4 (N= 50, 46) | -0.55 Units on a scale | Standard Error 0.26 |
| Placebo | Mean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS) | Week 5 (N= 49, 44) | -0.59 Units on a scale | Standard Error 0.26 |
| Placebo | Mean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS) | Week 6 (N= 49, 44) | -0.51 Units on a scale | Standard Error 0.27 |
| Placebo | Mean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS) | Week 7 (N= 48, 42) | -0.77 Units on a scale | Standard Error 0.27 |
| Placebo | Mean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS) | Week 8 (N= 46, 44) | -0.59 Units on a scale | Standard Error 0.27 |
| Placebo | Mean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS) | Week 9 (N= 46, 42) | -0.66 Units on a scale | Standard Error 0.27 |
| Placebo | Mean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS) | Week 11 (N= 44, 38) | -1.07 Units on a scale | Standard Error 0.28 |
| Placebo | Mean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS) | Week 12 (N= 43, 34) | -0.78 Units on a scale | Standard Error 0.28 |
| Placebo | Mean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS) | Week 13 (N= 42, 33) | -1.01 Units on a scale | Standard Error 0.29 |
| Placebo | Mean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS) | Week 14 (N= 41, 34) | -1.11 Units on a scale | Standard Error 0.29 |
Comparison: Statistical analysis of Week 1.p-value: 0.84295% CI: [-0.75, 0.61]Mixed Models Analysis
Comparison: Statistical analysis of Week 2p-value: 0.0795% CI: [-1.32, 0.05]Mixed Models Analysis
Comparison: Statistical analysis of Week 3.p-value: 0.01995% CI: [-1.51, -0.14]Mixed Models Analysis
Comparison: Statistical analysis of Week 4.p-value: 0.01195% CI: [-1.59, -0.21]Mixed Models Analysis
Comparison: Statistical analysis of Week 5.p-value: 0.05695% CI: [-1.38, 0.02]Mixed Models Analysis
Comparison: Statistical analysis of Week 6.p-value: 0.00895% CI: [-1.66, -0.26]Mixed Models Analysis
Comparison: Statistical analysis of Week 7.p-value: 0.01395% CI: [-1.6, -0.19]Mixed Models Analysis
Comparison: Statistical analysis of Week 8.p-value: 0.00495% CI: [-1.77, -0.35]Mixed Models Analysis
Comparison: Statistical analysis of Week 9.p-value: 0.00995% CI: [-1.67, -0.24]Mixed Models Analysis
Comparison: Statistical analysis of Week 10.p-value: 0.00895% CI: [-1.69, -0.25]Mixed Models Analysis
Comparison: Statistical analysis of Week 11.p-value: 0.02195% CI: [-1.59, -0.13]Mixed Models Analysis
Comparison: Statistical analysis of Week 12.p-value: 0.0195% CI: [-1.71, -0.23]Mixed Models Analysis
Comparison: Statistical analysis of Week 13.p-value: 0.05195% CI: [-1.49, 0]Mixed Models Analysis
Comparison: Statistical analysis of Week 14.p-value: 0.0295% CI: [-1.66, -0.14]Mixed Models Analysis
Comparison: Statistical analysis of Week 15.p-value: 0.0695% CI: [-1.51, 0.03]Mixed Models Analysis
Secondary
Mean Change From Baseline to Weekly Mean Sleep Quality Score (NRS)
Mean sleep quality score was calculated for each week during the double-blind treatment phase (Week 1 to Week 15). A minimum of 4 sleep diaries are required to calculate the mean pain score. The daily quality of sleep diary consists of an 11-point numeric rating scale with which the patient rates the quality of their sleep during the past 24 hours. Zero indicates best possible sleep and 10 indicates worst possible sleep.
Time frame: Baseline to Week 15
Population: The FAS population consists of all randomized participants who received at least one dose of study medication.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Mean Change From Baseline to Weekly Mean Sleep Quality Score (NRS) | Week 5 (N= 49, 44) | -0.99 Units on a scale | Standard Error 0.25 |
| Pregabalin | Mean Change From Baseline to Weekly Mean Sleep Quality Score (NRS) | Week 9 (N= 46, 42) | -1.38 Units on a scale | Standard Error 0.26 |
| Pregabalin | Mean Change From Baseline to Weekly Mean Sleep Quality Score (NRS) | Week 2 (N= 54, 47) | -0.84 Units on a scale | Standard Error 0.25 |
| Pregabalin | Mean Change From Baseline to Weekly Mean Sleep Quality Score (NRS) | Week 10 (N= 45, 40) | -1.43 Units on a scale | Standard Error 0.26 |
| Pregabalin | Mean Change From Baseline to Weekly Mean Sleep Quality Score (NRS) | Week 6 (N= 49, 44) | -1.18 Units on a scale | Standard Error 0.25 |
| Pregabalin | Mean Change From Baseline to Weekly Mean Sleep Quality Score (NRS) | Week 11 (N= 44, 38) | -1.39 Units on a scale | Standard Error 0.26 |
| Pregabalin | Mean Change From Baseline to Weekly Mean Sleep Quality Score (NRS) | Week 4 (N= 50, 46) | -1.03 Units on a scale | Standard Error 0.25 |
| Pregabalin | Mean Change From Baseline to Weekly Mean Sleep Quality Score (NRS) | Week 12 (N= 43, 34) | -1.38 Units on a scale | Standard Error 0.26 |
| Pregabalin | Mean Change From Baseline to Weekly Mean Sleep Quality Score (NRS) | Week 7 (N= 48, 42) | -1.30 Units on a scale | Standard Error 0.25 |
| Pregabalin | Mean Change From Baseline to Weekly Mean Sleep Quality Score (NRS) | Week 13 (N= 42, 33) | -1.34 Units on a scale | Standard Error 0.27 |
| Pregabalin | Mean Change From Baseline to Weekly Mean Sleep Quality Score (NRS) | Week 3 (N= 52, 44) | -0.89 Units on a scale | Standard Error 0.25 |
| Pregabalin | Mean Change From Baseline to Weekly Mean Sleep Quality Score (NRS) | Week 14 (N= 41, 34) | -1.36 Units on a scale | Standard Error 0.27 |
| Pregabalin | Mean Change From Baseline to Weekly Mean Sleep Quality Score (NRS) | Week 8 (N= 46, 44) | -1.43 Units on a scale | Standard Error 0.25 |
| Pregabalin | Mean Change From Baseline to Weekly Mean Sleep Quality Score (NRS) | Week 15 (N= 35, 33) | -1.25 Units on a scale | Standard Error 0.28 |
| Pregabalin | Mean Change From Baseline to Weekly Mean Sleep Quality Score (NRS) | Week 1 (N= 52, 49) | -0.52 Units on a scale | Standard Error 0.25 |
| Placebo | Mean Change From Baseline to Weekly Mean Sleep Quality Score (NRS) | Week 15 (N= 35, 33) | -1.08 Units on a scale | Standard Error 0.3 |
| Placebo | Mean Change From Baseline to Weekly Mean Sleep Quality Score (NRS) | Week 1 (N= 52, 49) | -0.30 Units on a scale | Standard Error 0.26 |
| Placebo | Mean Change From Baseline to Weekly Mean Sleep Quality Score (NRS) | Week 2 (N= 54, 47) | -0.65 Units on a scale | Standard Error 0.26 |
| Placebo | Mean Change From Baseline to Weekly Mean Sleep Quality Score (NRS) | Week 3 (N= 52, 44) | -0.44 Units on a scale | Standard Error 0.26 |
| Placebo | Mean Change From Baseline to Weekly Mean Sleep Quality Score (NRS) | Week 4 (N= 50, 46) | -0.54 Units on a scale | Standard Error 0.26 |
| Placebo | Mean Change From Baseline to Weekly Mean Sleep Quality Score (NRS) | Week 5 (N= 49, 44) | -0.61 Units on a scale | Standard Error 0.27 |
| Placebo | Mean Change From Baseline to Weekly Mean Sleep Quality Score (NRS) | Week 6 (N= 49, 44) | -0.54 Units on a scale | Standard Error 0.27 |
| Placebo | Mean Change From Baseline to Weekly Mean Sleep Quality Score (NRS) | Week 7 (N= 48, 42) | -0.81 Units on a scale | Standard Error 0.27 |
| Placebo | Mean Change From Baseline to Weekly Mean Sleep Quality Score (NRS) | Week 8 (N= 46, 44) | -0.42 Units on a scale | Standard Error 0.27 |
| Placebo | Mean Change From Baseline to Weekly Mean Sleep Quality Score (NRS) | Week 9 (N= 46, 42) | -0.81 Units on a scale | Standard Error 0.27 |
| Placebo | Mean Change From Baseline to Weekly Mean Sleep Quality Score (NRS) | Week 10 (N= 45, 40) | -0.66 Units on a scale | Standard Error 0.27 |
| Placebo | Mean Change From Baseline to Weekly Mean Sleep Quality Score (NRS) | Week 11 (N= 44, 38) | -0.95 Units on a scale | Standard Error 0.28 |
| Placebo | Mean Change From Baseline to Weekly Mean Sleep Quality Score (NRS) | Week 12 (N= 43, 34) | -0.77 Units on a scale | Standard Error 0.28 |
| Placebo | Mean Change From Baseline to Weekly Mean Sleep Quality Score (NRS) | Week 13 (N= 42, 33) | -1.00 Units on a scale | Standard Error 0.29 |
| Placebo | Mean Change From Baseline to Weekly Mean Sleep Quality Score (NRS) | Week 14 (N= 41, 34) | -0.94 Units on a scale | Standard Error 0.29 |
Comparison: Statistical analysis of Week 1.p-value: 0.5495% CI: [-0.9, 0.47]Mixed Models Analysis
Comparison: Statistical analysis of Week 2p-value: 0.59395% CI: [-0.87, 0.5]Mixed Models Analysis
Comparison: Statistical analysis of Week 3.p-value: 0.20695% CI: [-1.13, 0.25]Mixed Models Analysis
Comparison: Statistical analysis of Week 4.p-value: 0.16895% CI: [-1.18, 0.21]Mixed Models Analysis
Comparison: Statistical analysis of Week 5.p-value: 0.2895% CI: [-1.08, 0.32]Mixed Models Analysis
Comparison: Statistical analysis of Week 6.p-value: 0.07595% CI: [-1.34, 0.06]Mixed Models Analysis
Comparison: Statistical analysis of Week 7.p-value: 0.16895% CI: [-1.21, 0.21]Mixed Models Analysis
Comparison: Statistical analysis of Week 8.p-value: 0.00695% CI: [-1.73, -0.3]Mixed Models Analysis
Comparison: Statistical analysis of Week 9.p-value: 0.1295% CI: [-1.29, 0.15]Mixed Models Analysis
Comparison: Statistical analysis of Week 10.p-value: 0.03795% CI: [-1.49, -0.05]Mixed Models Analysis
Comparison: Statistical analysis of Week 11.p-value: 0.24695% CI: [-1.16, 0.3]Mixed Models Analysis
Comparison: Statistical analysis of Week 12.p-value: 0.10595% CI: [-1.36, 0.13]Mixed Models Analysis
Comparison: Statistical analysis of Week 13.p-value: 0.37695% CI: [-1.09, 0.41]Mixed Models Analysis
Comparison: Statistical analysis of Week 14.p-value: 0.28595% CI: [-1.18, 0.35]Mixed Models Analysis
Comparison: Statistical analysis of Week 15.p-value: 0.66395% CI: [-0.95, 0.61]Mixed Models Analysis
Secondary
Proportion of 30% Responders in Weekly Mean Pain Score (NRS) at Week 15
At each visit, participants with at least 30% reduction from Baseline in mean pain score were defined as a 30% responder at the visit. The pain NRS consists of an 11 point NRS ranging from 0 (no pain) to 10 (worst possible pain).
Time frame: Week 15
Population: The FAS population consists of all randomized participants who received at least one dose of study medication. Modified baseline observation carried forward (mBOCF) for participants with missing Week 15 mean pain score.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pregabalin | Proportion of 30% Responders in Weekly Mean Pain Score (NRS) at Week 15 | 42.6 percentage of participants |
| Placebo | Proportion of 30% Responders in Weekly Mean Pain Score (NRS) at Week 15 | 38.8 percentage of participants |
Comparison: Statistical analysis at Week 15.p-value: 0.69495% CI: [0.53, 2.58]Regression, Logistic
Secondary
Proportion of 50% Responder in Weekly Mean Pain Score (NRS) at Week 15
At each visit, participants with at least 50% reduction from Baseline in mean pain score were defined as a 50% responder at the visit. The pain NRS consists of an 11 point NRS ranging from 0 (no pain) to 10 (worst possible pain).
Time frame: Week 15
Population: The FAS population consists of all randomized participants who received at least one dose of study medication. mBOCF for participants with missing Week 15 mean pain score.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pregabalin | Proportion of 50% Responder in Weekly Mean Pain Score (NRS) at Week 15 | 20.4 percentage of participants |
| Placebo | Proportion of 50% Responder in Weekly Mean Pain Score (NRS) at Week 15 | 10.2 percentage of participants |
Comparison: Statistical analysis at Week 15.p-value: 0.16295% CI: [0.72, 7.02]Regression, Logistic
Secondary
Proportion of Patient Global Impression Change (PGIC) at Week 15
Responder rates based on PGIC was derived and tabulated by treatment group. A responder was defined as a participant who reports much improved or very much improved. The PGIC is a patient-rated single item that measures patient's perception of change in their overall status since starting study medication on a scale ranging from 1 (very much improved) to 7 (very much worse).
Time frame: Week 15
Population: The FAS population consists of all randomized participants who received at least one dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Proportion of Patient Global Impression Change (PGIC) at Week 15 | Much worse | 0 percentage of participants |
| Pregabalin | Proportion of Patient Global Impression Change (PGIC) at Week 15 | Very much improved | 16.3 percentage of participants |
| Pregabalin | Proportion of Patient Global Impression Change (PGIC) at Week 15 | Much improved | 36.7 percentage of participants |
| Pregabalin | Proportion of Patient Global Impression Change (PGIC) at Week 15 | Minimally improved | 22.4 percentage of participants |
| Pregabalin | Proportion of Patient Global Impression Change (PGIC) at Week 15 | No change | 18.4 percentage of participants |
| Pregabalin | Proportion of Patient Global Impression Change (PGIC) at Week 15 | Minimally worse | 6.1 percentage of participants |
| Pregabalin | Proportion of Patient Global Impression Change (PGIC) at Week 15 | Very much worse | 0 percentage of participants |
| Placebo | Proportion of Patient Global Impression Change (PGIC) at Week 15 | Much worse | 2.3 percentage of participants |
| Placebo | Proportion of Patient Global Impression Change (PGIC) at Week 15 | No change | 38.6 percentage of participants |
| Placebo | Proportion of Patient Global Impression Change (PGIC) at Week 15 | Very much improved | 2.3 percentage of participants |
| Placebo | Proportion of Patient Global Impression Change (PGIC) at Week 15 | Very much worse | 0 percentage of participants |
| Placebo | Proportion of Patient Global Impression Change (PGIC) at Week 15 | Much improved | 27.3 percentage of participants |
| Placebo | Proportion of Patient Global Impression Change (PGIC) at Week 15 | Minimally worse | 2.3 percentage of participants |
| Placebo | Proportion of Patient Global Impression Change (PGIC) at Week 15 | Minimally improved | 27.3 percentage of participants |
Comparison: Statistical analysis at Week 15.p-value: 0.013Cochran-Mantel-Haenszel