Epilepsies, Partial, Partial Seizures
Conditions
Keywords
Partial epilepsy, partial seizures, epilepsy, seizures, adjunctive therapy, intervention, controlled-release, placebo-controlled, seizure
Brief summary
Approximately 30% percent of subjects with partial seizures are refractory to treatment with single or combination antiepileptic drugs. The present study will compare the efficacy of two different dosages of pregabalin CR dosed once daily as compared to placebo, when used as adjunctive therapy in subjects requiring adjunctive therapy for partial onset epilepsy, using a randomized, parallel group design.
Interventions
DRUGpregabalin
Controlled Release Tablets, 82.5 mg, once per day (QD) for 3 days
DRUGplacebo
matched to the active drug
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of epilepsy with partial onset seizures (seizures may be simple or complex, with or without evolution into a bilateral, convulsive seizure) * Currently taking 1 to 3 anti-epilepsy medicines (AEDs) at stable dosages, and who have taken at least 2 prior (or ongoing) AEDs
Exclusion criteria
* Primary generalized seizures (for example, absence, myoclonic seizures or Lennox-Gastaut Syndrome) * Status epilepticus within one year prior to screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Log Transformed (Loge) 28-day Seizure Rate for All Partial Onset Seizures During the Double-blind Treatment Phase | Week 0 to Week 14 | Seizures were recorded and documented in a daily Seizure Diary by the participants, family member, caregiver, or legal guardian. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) were not counted toward eligibility, or in the primary or secondary efficacy analyses. Natural logarithm of the 28-day seizure rate was reported in this outcome measure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change From Baseline in 28-day Partial Seizure Rate During the Double-blind Treatment Phase | Week 0 to Week 14 | Seizures were recorded and documented in a daily Seizure Diary by the participants, family member, caregiver, or legal guardian. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) were not counted toward eligibility, or in the primary or secondary efficacy analyses. Natural logarithm of the 28-day seizure rate was reported in this outcome measure. |
| Frequency of Secondary Generalized Tonic-clonic Seizures (SGTC) During the Double-blind Treatment Phase | Week 0 to Week 14 | Seizures were recorded and documented in a daily Seizure Diary by the participants, family member, caregiver, or legal guardian. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) were not counted toward eligibility, or in the primary or secondary efficacy analyses. |
| Log Transformed 28-day SGTC Rate for All SGTCs During the Double-blind Maintenance Phase | Week 2 to Week 14 | Seizures were recorded and documented in a daily Seizure Diary by the participants, family member, caregiver, or legal guardian. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) were not counted toward eligibility, or in the primary or secondary efficacy analyses. Natural logarithm of the 28-day seizure rate was reported in this outcome measure. |
| Percentage of Participants With ≥50% Reduction in 28-day SGTC Seizure Rate From Baseline During the Double-blind Treatment Phase | Week 0 to Week 14 | Seizures were recorded and documented in a daily Seizure Diary by the participants, family member, caregiver, or legal guardian. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) were not counted toward eligibility, or in the primary or secondary efficacy analyses. |
| Loge 28-day Seizure Rate for All Partial Onset Seizures During the Double-blind Maintenance Phase | Week 2 to Week 14 | Seizures were recorded and documented in a daily Seizure Diary by the participants, family member, caregiver, or legal guardian. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) were not counted toward eligibility, or in the primary or secondary efficacy analyses. Natural logarithm of the 28-day seizure rate was reported in this outcome measure. |
| Change From Baseline in Hospital Anxiety and Depression Scale - Anxiety (HADS-A) Total Score at Week 14 | Baseline, Week 14 | 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 Anxiety and Depression Scale - Depression (HADS-D) Total Score at Week 14 | Baseline, Week 14 | 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 Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Disturbance Score at Week 14 | Baseline, Week 14 | Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range \* 100); total score range: 0 to 100; higher score = greater intensity of attribute. |
| Change From Baseline in MOS-SS - Snoring Score at Week 14 | Baseline, Week 14 | Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range \* 100); total score range: 0 to 100; higher score = greater intensity of attribute. |
| Change From Baseline in MOS-SS - Awaken Short of Breath or With Headache Score at Week 14 | Baseline, Week 14 | Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range \* 100); total score range: 0 to 100; higher score = greater intensity of attribute. |
| Change From Baseline in MOS-SS - Quantity of Sleep (Hours) at Week 14 | Baseline, Week 14 | Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range \* 100); total score range: 0 to 100; higher score = greater intensity of attribute. |
| Change From Baseline in MOS-SS - Sleep Adequacy Score at Week 14 | Baseline, Week 14 | Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range \* 100); total score range: 0 to 100; higher score = greater intensity of attribute. |
| Change From Baseline in MOS-SS - Sleep Somnolence Score at Week 14 | Baseline, Week 14 | Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range \* 100); total score range: 0 to 100; higher score = greater intensity of attribute. |
| Percentage of Participants With a ≥50% Reduction in the 28-day Partial Seizure Rate From Baseline During the Double-blind Treatment Phase | Week 0 to Week 14 | Seizures were recorded and documented in a daily Seizure Diary by the participants, family member, caregiver, or legal guardian. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) were not counted toward eligibility, or in the primary or secondary efficacy analyses. Participants who had a ≥50% reduction in the 28-day partial seizure rate from baseline were defined as a responder, otherwise they were default as a non-responder. |
| Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Problems Index II Score at Week 14 | Baseline, Week 14 | Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range \* 100); total score range: 0 to 100; higher score = greater intensity of attribute. |
| Percent of Participants Reporting Optimal Sleep on the MOS-SS - Optimal Sleep Subscale | Week 14 | Optimal sleep was considered between 7 to 8 hours of average sleep per night inclusive, while average sleep less than or greater than the 7 to 8 hour of average sleep per night was non-optimal. |
| Benefit, Satisfaction, and Willingness to Continue Measure (BSW): Benefit From Treatment Question | Week 14 | The BSW consisted of 3 single-item measures designed to capture the participant's perception of the effect of treatment in terms of the relative benefit, their satisfaction, and their intention or willingness to continue on therapy. The BSW was read aloud to the participant by the investigator or designated center personnel and then was given to the participant to complete independently. |
| BSW: Satisfaction From Treatment Question | Week 14 | The BSW consisted of 3 single-item measures designed to capture the participant's perception of the effect of treatment in terms of the relative benefit, their satisfaction, and their intention or willingness to continue on therapy. The BSW was read aloud to the participant by the investigator or designated center personnel and then was given to the participant to complete independently. |
| BSW: Willingness to Continue Question | Week 14 | The BSW consisted of 3 single-item measures designed to capture the participant's perception of the effect of treatment in terms of the relative benefit, their satisfaction, and their intention or willingness to continue on therapy. The BSW was read aloud to the participant by the investigator or designated center personnel and then was given to the participant to complete independently. |
| Percentage of Participants With New or Intensified Physical Examination Findings During the Double-blind Treatment Phase | Day 1 to Week 15 | Physical examinations included general appearance (including hight at baseline), vital sign (sitting heart rate and sitting blood pressure), weight, skin (examination for the presence of rash), HEENT (examinatin of head, eyes, ears, nose and throat), chest ausculation of lung fields), cardiovascular (ausculatin of heart sounds (S1 and S2) and for the presence of murmurs, gallops, or rubs), gastrointestinal (abdominal rigidity and tenderness), an extremities (e.g. edema). Clinically significant physical examination abnormalities were considered as adverse events based on investigator's discretion. |
| Percentage of Participants With New or Intensified Neurological Examination Findings During the Double-blind Treatment Phase | Day 1 to Week 15 | Neurological examinations included level of consciousness, mental status, cranial nerve assessment, muscle strength, reflexes, pin prick and vibratory sensation (the latter using a 128-Hz tuning fork), coordination and gait. |
| Percentage of Participants With Self-injurious or Suicidal Ideation or Behavior on Columbia Classification Algorithm of Suicide Assessment (C-CASA) | Week -8 (Screening), Week 0 (Baseline), and Week 14 (double-blind treatment phase) | C-CASA is described as a standardized suicidal rating system. The C-CASA has eight categories (4 suicidal events: completed suicide, suicide attempt, preparatory act toward imminent suicidal behavior (PAISB), and suicidal ideation; 2 nonsuicidal events: self-injurious behavior, no suicidal intent (SIB-NSI) and other no deliberate self-harm, and 2 indeterminate or potentially suicidal events: self-injurious behavior, suicidal intent unknown and not enough information) that distinguish suicidal events from nonsuicidal events and indeterminate or potentially suicidal events. |
| Percentage of Participants With a Relevant Increase in Sitting Blood Pressure (BP) From Baseline During the Double-blind Treatment Phase | Day 1 to Week 15 | Physical examinations included general appearance (including hight at baseline), vital sign (sitting heart rate and sitting blood pressure), weight, skin (examination for the presence of rash), HEENT (examinatin of head, eyes, ears, nose and throat), chest (ausculation of lung fields), cardiovascular (ausculatin of heart sounds (S1 and S2) and for the presence of murmurs, gallops, or rubs), gastrointestinal(abdominal rigidity and tenderness), an extremities (e.g. edema). |
| Percentage of Participants With Corrected QT (QTc) Interval Greater Than or Equal to 450 ms | Week 15 | The original ECG was reviewed by the investigator and kept on site as part of source documentation. A central ECG reader was also used for this study. QT interval corrected using the Fridericia formula (QTcF) and QT interval corrected using the Bazett's formula (QTcB) were calculated. |
| Percentage of Participants With Relevant ECG Interval-increases From Baseline During the Double-blind Treatment Phase | Week 15 | The original ECG was reviewed by the investigator and kept on site as part of source documentation. A central ECG reader was also used for this study. 25/50% represents ≥25% or ≥50% increase over baseline respectively, based on cut points. Cut points are 100 ms for QRS and 200 ms for PR. |
| Percentage of Participants With Laboratory Test Abnormalities During the Study | Day 1 to Week 15 | Laboratory samples in hematology, chemistry, and urinalysis were analyzed by a cental laboratory. Any laboratory value that was identified as clinically significant was reported as an AE. LLN: Lower limit of normal, ULN: Uper limit of normal, RBC: Red Blood Cell, WBC: White Blood Cell, AST: Aspartate Aminotransferase, ALT: Alanine Aminotransferase, BUN: Blood Urea Nitrogen |
| Change From Baseline in MOS-SS - Sleep Problems Index I Score at Week 14 | Baseline, Week 14 | Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range \* 100); total score range: 0 to 100; higher score = greater intensity of attribute. |
Countries
Argentina, Bosnia and Herzegovina, Bulgaria, Czechia, Germany, Hong Kong, Hungary, India, Malaysia, Mexico, Poland, Puerto Rico, Romania, Russia, Serbia, Singapore, Thailand, United States
Participant flow
Recruitment details
This was a multicenter, multinational study and included four standard phases: an 8-week baseline observation phase, a 2-week dose escalation phase, a 12-week fixed-dose maintenance phase, and a 1-week taper phase.
Pre-assignment details
An 8-week baseline observation phase began immediately after the screening visit. Througout the observation phase the participants continued their current anti-epileptic drugs (AEDs) at the prescribed dosage, eligibility was re-evaluated at Week -4 and Week 0, and the participants recorded all seizures in daily seizure diaries.
Participants by arm
| Arm | Count |
|---|---|
| Pregabalin 165 mg After the 2-week dose escalation phase, the participants received 165 mg of pregabalin once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing. | 100 |
| Pregabalin 330 mg After the 2-week dose escalation phase, the participants received 330 mg of pregabalin once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing. | 113 |
| Placebo After the 2-week dose escalation phase, the participants received placebo once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing. | 110 |
| Total | 323 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event (AE) related to study drug | 3 | 8 | 3 |
| Overall Study | Does not meet entrance criteria | 0 | 2 | 0 |
| Overall Study | Insufficient clinical response | 0 | 0 | 1 |
| Overall Study | Lost to Follow-up | 1 | 0 | 2 |
| Overall Study | No longer willing to participate | 3 | 3 | 2 |
| Overall Study | Protocol Violation | 0 | 1 | 1 |
| Overall Study | Reason not provided | 2 | 1 | 3 |
Baseline characteristics
| Characteristic | Pregabalin 165 mg | Pregabalin 330 mg | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 37.88 years STANDARD_DEVIATION 13.1 | 39.58 years STANDARD_DEVIATION 13.15 | 38.72 years STANDARD_DEVIATION 13.25 | 38.76 years STANDARD_DEVIATION 13.14 |
| Sex: Female, Male Female | 53 Participants | 55 Participants | 61 Participants | 169 Participants |
| Sex: Female, Male Male | 47 Participants | 58 Participants | 49 Participants | 154 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 14 / 100 | 21 / 113 | 3 / 110 |
| serious Total, serious adverse events | 5 / 100 | 5 / 113 | 2 / 110 |
Outcome results
Primary
Log Transformed (Loge) 28-day Seizure Rate for All Partial Onset Seizures During the Double-blind Treatment Phase
Seizures were recorded and documented in a daily Seizure Diary by the participants, family member, caregiver, or legal guardian. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) were not counted toward eligibility, or in the primary or secondary efficacy analyses. Natural logarithm of the 28-day seizure rate was reported in this outcome measure.
Time frame: Week 0 to Week 14
Population: The intent-to treat (ITT) population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin 165 mg | Log Transformed (Loge) 28-day Seizure Rate for All Partial Onset Seizures During the Double-blind Treatment Phase | Baseline | 2.24 ln (seizures per 28 days) | Standard Deviation 0.757 |
| Pregabalin 165 mg | Log Transformed (Loge) 28-day Seizure Rate for All Partial Onset Seizures During the Double-blind Treatment Phase | Week 14 | 1.84 ln (seizures per 28 days) | Standard Deviation 1.003 |
| Pregabalin 330 mg | Log Transformed (Loge) 28-day Seizure Rate for All Partial Onset Seizures During the Double-blind Treatment Phase | Baseline | 2.33 ln (seizures per 28 days) | Standard Deviation 0.873 |
| Pregabalin 330 mg | Log Transformed (Loge) 28-day Seizure Rate for All Partial Onset Seizures During the Double-blind Treatment Phase | Week 14 | 1.80 ln (seizures per 28 days) | Standard Deviation 1.03 |
| Placebo | Log Transformed (Loge) 28-day Seizure Rate for All Partial Onset Seizures During the Double-blind Treatment Phase | Baseline | 2.32 ln (seizures per 28 days) | Standard Deviation 0.91 |
| Placebo | Log Transformed (Loge) 28-day Seizure Rate for All Partial Onset Seizures During the Double-blind Treatment Phase | Week 14 | 1.93 ln (seizures per 28 days) | Standard Deviation 1.132 |
Comparison: ANCOVA model with the following fixed terms was used to calculate the p-value: loge (baseline 28-day seizure rate + 1) as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg controlled-release (CR), pregabalin 330 mg CR). 88 participants in each group (264 total) should have provided approximately 90% power.p-value: 0.907695% CI: [-16.28, 17.11]ANCOVA
Comparison: ANCOVA model with the following fixed terms was used to calculate the p-value: loge (baseline 28-day seizure rate + 1) as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg controlled-release (CR), pregabalin 330 mg CR). 88 participants in each group (264 total) should have provided approximately 90% power.p-value: 0.090795% CI: [-26.07, 2.25]ANCOVA
Secondary
Benefit, Satisfaction, and Willingness to Continue Measure (BSW): Benefit From Treatment Question
The BSW consisted of 3 single-item measures designed to capture the participant's perception of the effect of treatment in terms of the relative benefit, their satisfaction, and their intention or willingness to continue on therapy. The BSW was read aloud to the participant by the investigator or designated center personnel and then was given to the participant to complete independently.
Time frame: Week 14
Population: The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin 165 mg | Benefit, Satisfaction, and Willingness to Continue Measure (BSW): Benefit From Treatment Question | Not done | 2.0 percentage of participants |
| Pregabalin 165 mg | Benefit, Satisfaction, and Willingness to Continue Measure (BSW): Benefit From Treatment Question | Much benefit | 54.0 percentage of participants |
| Pregabalin 165 mg | Benefit, Satisfaction, and Willingness to Continue Measure (BSW): Benefit From Treatment Question | No | 12.0 percentage of participants |
| Pregabalin 165 mg | Benefit, Satisfaction, and Willingness to Continue Measure (BSW): Benefit From Treatment Question | Little benefit | 31.0 percentage of participants |
| Pregabalin 165 mg | Benefit, Satisfaction, and Willingness to Continue Measure (BSW): Benefit From Treatment Question | Missing | 1.0 percentage of participants |
| Pregabalin 330 mg | Benefit, Satisfaction, and Willingness to Continue Measure (BSW): Benefit From Treatment Question | Much benefit | 56.3 percentage of participants |
| Pregabalin 330 mg | Benefit, Satisfaction, and Willingness to Continue Measure (BSW): Benefit From Treatment Question | No | 17.9 percentage of participants |
| Pregabalin 330 mg | Benefit, Satisfaction, and Willingness to Continue Measure (BSW): Benefit From Treatment Question | Little benefit | 23.2 percentage of participants |
| Pregabalin 330 mg | Benefit, Satisfaction, and Willingness to Continue Measure (BSW): Benefit From Treatment Question | Not done | 1.8 percentage of participants |
| Pregabalin 330 mg | Benefit, Satisfaction, and Willingness to Continue Measure (BSW): Benefit From Treatment Question | Missing | 0.9 percentage of participants |
| Placebo | Benefit, Satisfaction, and Willingness to Continue Measure (BSW): Benefit From Treatment Question | Missing | 0.9 percentage of participants |
| Placebo | Benefit, Satisfaction, and Willingness to Continue Measure (BSW): Benefit From Treatment Question | Not done | 1.8 percentage of participants |
| Placebo | Benefit, Satisfaction, and Willingness to Continue Measure (BSW): Benefit From Treatment Question | No | 22.0 percentage of participants |
| Placebo | Benefit, Satisfaction, and Willingness to Continue Measure (BSW): Benefit From Treatment Question | Much benefit | 42.2 percentage of participants |
| Placebo | Benefit, Satisfaction, and Willingness to Continue Measure (BSW): Benefit From Treatment Question | Little benefit | 33.0 percentage of participants |
Secondary
BSW: Satisfaction From Treatment Question
The BSW consisted of 3 single-item measures designed to capture the participant's perception of the effect of treatment in terms of the relative benefit, their satisfaction, and their intention or willingness to continue on therapy. The BSW was read aloud to the participant by the investigator or designated center personnel and then was given to the participant to complete independently.
Time frame: Week 14
Population: The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin 165 mg | BSW: Satisfaction From Treatment Question | Yes | 84.0 percentage of participants |
| Pregabalin 165 mg | BSW: Satisfaction From Treatment Question | No | 13.0 percentage of participants |
| Pregabalin 165 mg | BSW: Satisfaction From Treatment Question | Missing | 3.0 percentage of participants |
| Pregabalin 330 mg | BSW: Satisfaction From Treatment Question | Yes | 80.4 percentage of participants |
| Pregabalin 330 mg | BSW: Satisfaction From Treatment Question | No | 17.9 percentage of participants |
| Pregabalin 330 mg | BSW: Satisfaction From Treatment Question | Missing | 1.8 percentage of participants |
| Placebo | BSW: Satisfaction From Treatment Question | No | 23.9 percentage of participants |
| Placebo | BSW: Satisfaction From Treatment Question | Missing | 2.8 percentage of participants |
| Placebo | BSW: Satisfaction From Treatment Question | Yes | 73.4 percentage of participants |
Secondary
BSW: Willingness to Continue Question
The BSW consisted of 3 single-item measures designed to capture the participant's perception of the effect of treatment in terms of the relative benefit, their satisfaction, and their intention or willingness to continue on therapy. The BSW was read aloud to the participant by the investigator or designated center personnel and then was given to the participant to complete independently.
Time frame: Week 14
Population: The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin 165 mg | BSW: Willingness to Continue Question | No | 18.0 percentage of participants |
| Pregabalin 165 mg | BSW: Willingness to Continue Question | Missing | 3.0 percentage of participants |
| Pregabalin 165 mg | BSW: Willingness to Continue Question | Yes | 79.0 percentage of participants |
| Pregabalin 330 mg | BSW: Willingness to Continue Question | No | 22.3 percentage of participants |
| Pregabalin 330 mg | BSW: Willingness to Continue Question | Yes | 75.9 percentage of participants |
| Pregabalin 330 mg | BSW: Willingness to Continue Question | Missing | 1.8 percentage of participants |
| Placebo | BSW: Willingness to Continue Question | Yes | 70.6 percentage of participants |
| Placebo | BSW: Willingness to Continue Question | Missing | 2.8 percentage of participants |
| Placebo | BSW: Willingness to Continue Question | No | 26.6 percentage of participants |
Secondary
Change From Baseline in Hospital Anxiety and Depression Scale - Anxiety (HADS-A) Total Score at Week 14
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 14
Population: The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin 165 mg | Change From Baseline in Hospital Anxiety and Depression Scale - Anxiety (HADS-A) Total Score at Week 14 | -0.8 units on a scale | Standard Deviation 3.34 |
| Pregabalin 330 mg | Change From Baseline in Hospital Anxiety and Depression Scale - Anxiety (HADS-A) Total Score at Week 14 | -0.4 units on a scale | Standard Deviation 3.19 |
| Placebo | Change From Baseline in Hospital Anxiety and Depression Scale - Anxiety (HADS-A) Total Score at Week 14 | -0.5 units on a scale | Standard Deviation 3.13 |
Comparison: ANCOVA model with the following fixed terms was used to calculate the p-value: HADS-A baseline score as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg controlled-release (CR), pregabalin 330 mg CR). No adjustments for multiplicity were taken.p-value: 0.46595% CI: [-1.1, 0.5]ANCOVA
Comparison: ANCOVA model with the following fixed terms was used to calculate the p-value: HADS-A baseline score as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg controlled-release (CR), pregabalin 330 mg CR). No adjustments for multiplicity were taken.p-value: 0.969295% CI: [-0.8, 0.8]ANCOVA
Secondary
Change From Baseline in Hospital Anxiety and Depression Scale - Depression (HADS-D) Total Score at Week 14
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 14
Population: The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin 165 mg | Change From Baseline in Hospital Anxiety and Depression Scale - Depression (HADS-D) Total Score at Week 14 | -0.5 units on a scale | Standard Deviation 3.16 |
| Pregabalin 330 mg | Change From Baseline in Hospital Anxiety and Depression Scale - Depression (HADS-D) Total Score at Week 14 | -0.8 units on a scale | Standard Deviation 3.49 |
| Placebo | Change From Baseline in Hospital Anxiety and Depression Scale - Depression (HADS-D) Total Score at Week 14 | -0.1 units on a scale | Standard Deviation 3.17 |
Comparison: ANCOVA model with the following fixed terms was used to calculate the p-value: HADS-D baseline score as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg controlled-release (CR), pregabalin 330 mg CR). No adjustments for multiplicity were taken.p-value: 0.269395% CI: [-1.3, 0.4]ANCOVA
Comparison: ANCOVA model with the following fixed terms was used to calculate the p-value: HADS-D baseline score as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg controlled-release (CR), pregabalin 330 mg CR). No adjustments for multiplicity were taken.p-value: 0.189395% CI: [-1.4, 0.3]ANCOVA
Secondary
Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Disturbance Score at Week 14
Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range \* 100); total score range: 0 to 100; higher score = greater intensity of attribute.
Time frame: Baseline, Week 14
Population: The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin 165 mg | Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Disturbance Score at Week 14 | -3.9 units on a scale | Standard Deviation 19.89 |
| Pregabalin 330 mg | Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Disturbance Score at Week 14 | -1.5 units on a scale | Standard Deviation 17.93 |
| Placebo | Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Disturbance Score at Week 14 | -1.9 units on a scale | Standard Deviation 14.1 |
Comparison: ANCOVA model with the following fixed terms was used to calculate the p-value: sleep disturbance score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).p-value: 0.734795% CI: [-5.2, 3.6]ANOVA
Comparison: ANCOVA model with the following fixed terms was used to calculate the p-value: sleep disturbance score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).p-value: 0.897195% CI: [-4, 4.6]ANCOVA
Secondary
Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Problems Index II Score at Week 14
Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range \* 100); total score range: 0 to 100; higher score = greater intensity of attribute.
Time frame: Baseline, Week 14
Population: The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin 165 mg | Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Problems Index II Score at Week 14 | -2.4 units on a scale | Standard Deviation 15.62 |
| Pregabalin 330 mg | Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Problems Index II Score at Week 14 | 0.7 units on a scale | Standard Deviation 14.53 |
| Placebo | Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Problems Index II Score at Week 14 | 0.7 units on a scale | Standard Deviation 11.3 |
Comparison: ANCOVA model with the following fixed terms was used to calculate the p-value: sleep problems index II score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).p-value: 0.243195% CI: [-5.8, 1.5]ANOVA
Comparison: ANCOVA model with the following fixed terms was used to calculate the p-value: sleep problems index II score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).p-value: 0.865495% CI: [-3.2, 3.8]ANCOVA
Secondary
Change From Baseline in MOS-SS - Awaken Short of Breath or With Headache Score at Week 14
Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range \* 100); total score range: 0 to 100; higher score = greater intensity of attribute.
Time frame: Baseline, Week 14
Population: The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin 165 mg | Change From Baseline in MOS-SS - Awaken Short of Breath or With Headache Score at Week 14 | 0.2 units on a scale | Standard Deviation 20.75 |
| Pregabalin 330 mg | Change From Baseline in MOS-SS - Awaken Short of Breath or With Headache Score at Week 14 | 1.0 units on a scale | Standard Deviation 24.48 |
| Placebo | Change From Baseline in MOS-SS - Awaken Short of Breath or With Headache Score at Week 14 | -0.8 units on a scale | Standard Deviation 18.96 |
Comparison: ANCOVA model with the following fixed terms was used to calculate the p-value: awaken short of breath or with headache score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).p-value: 0.770895% CI: [-4.4, 5.9]ANOVA
Comparison: ANCOVA model with the following fixed terms was used to calculate the p-value: awaken short of breath or with headache score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).p-value: 0.35695% CI: [-2.7, 7.4]ANCOVA
Secondary
Change From Baseline in MOS-SS - Quantity of Sleep (Hours) at Week 14
Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range \* 100); total score range: 0 to 100; higher score = greater intensity of attribute.
Time frame: Baseline, Week 14
Population: The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin 165 mg | Change From Baseline in MOS-SS - Quantity of Sleep (Hours) at Week 14 | 0.2 hours | Standard Deviation 1.31 |
| Pregabalin 330 mg | Change From Baseline in MOS-SS - Quantity of Sleep (Hours) at Week 14 | -0.1 hours | Standard Deviation 1.18 |
| Placebo | Change From Baseline in MOS-SS - Quantity of Sleep (Hours) at Week 14 | -0.1 hours | Standard Deviation 1.25 |
Comparison: ANCOVA model with the following fixed terms was used to calculate the p-value: quantity of sleep at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).p-value: 0.112995% CI: [-0.1, 0.5]ANOVA
Comparison: ANCOVA model with the following fixed terms was used to calculate the p-value: quantity of sleep at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).p-value: 0.938895% CI: [-0.3, 0.3]ANCOVA
Secondary
Change From Baseline in MOS-SS - Sleep Adequacy Score at Week 14
Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range \* 100); total score range: 0 to 100; higher score = greater intensity of attribute.
Time frame: Baseline, Week 14
Population: The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin 165 mg | Change From Baseline in MOS-SS - Sleep Adequacy Score at Week 14 | 2.3 units on a scale | Standard Deviation 31.14 |
| Pregabalin 330 mg | Change From Baseline in MOS-SS - Sleep Adequacy Score at Week 14 | -1.7 units on a scale | Standard Deviation 31.44 |
| Placebo | Change From Baseline in MOS-SS - Sleep Adequacy Score at Week 14 | -1.5 units on a scale | Standard Deviation 24.55 |
Comparison: ANCOVA model with the following fixed terms was used to calculate the p-value: sleep adequacy score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).p-value: 0.905395% CI: [-7.5, 6.6]ANOVA
Comparison: ANCOVA model with the following fixed terms was used to calculate the p-value: sleep adequacy score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).p-value: 0.637195% CI: [-8.5, 5.2]ANCOVA
Secondary
Change From Baseline in MOS-SS - Sleep Problems Index I Score at Week 14
Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range \* 100); total score range: 0 to 100; higher score = greater intensity of attribute.
Time frame: Baseline, Week 14
Population: The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin 165 mg | Change From Baseline in MOS-SS - Sleep Problems Index I Score at Week 14 | -2.2 units on a scale | Standard Deviation 16.91 |
| Pregabalin 330 mg | Change From Baseline in MOS-SS - Sleep Problems Index I Score at Week 14 | 0.4 units on a scale | Standard Deviation 16.43 |
| Placebo | Change From Baseline in MOS-SS - Sleep Problems Index I Score at Week 14 | 0.3 units on a scale | Standard Deviation 12.62 |
Comparison: ANCOVA model with the following fixed terms was used to calculate the p-value: sleep problems index I score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).p-value: 0.590395% CI: [-5, 2.8]ANOVA
Comparison: ANCOVA model with the following fixed terms was used to calculate the p-value: sleep problems index I score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).p-value: 0.712695% CI: [-3.1, 4.5]ANCOVA
Secondary
Change From Baseline in MOS-SS - Sleep Somnolence Score at Week 14
Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range \* 100); total score range: 0 to 100; higher score = greater intensity of attribute.
Time frame: Baseline, Week 14
Population: The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin 165 mg | Change From Baseline in MOS-SS - Sleep Somnolence Score at Week 14 | -0.5 units on a scale | Standard Deviation 17.29 |
| Pregabalin 330 mg | Change From Baseline in MOS-SS - Sleep Somnolence Score at Week 14 | 5.2 units on a scale | Standard Deviation 19.42 |
| Placebo | Change From Baseline in MOS-SS - Sleep Somnolence Score at Week 14 | 5.0 units on a scale | Standard Deviation 18.72 |
Comparison: ANCOVA model with the following fixed terms was used to calculate the p-value: sleep somnolence score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).p-value: 0.011995% CI: [-11.4, -1.4]ANOVA
Comparison: ANCOVA model with the following fixed terms was used to calculate the p-value: sleep somnolence score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).p-value: 0.990995% CI: [-4.9, 4.8]ANCOVA
Secondary
Change From Baseline in MOS-SS - Snoring Score at Week 14
Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range \* 100); total score range: 0 to 100; higher score = greater intensity of attribute.
Time frame: Baseline, Week 14
Population: The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin 165 mg | Change From Baseline in MOS-SS - Snoring Score at Week 14 | -3.5 units on a scale | Standard Deviation 25.44 |
| Pregabalin 330 mg | Change From Baseline in MOS-SS - Snoring Score at Week 14 | 5.4 units on a scale | Standard Deviation 26 |
| Placebo | Change From Baseline in MOS-SS - Snoring Score at Week 14 | -0.6 units on a scale | Standard Deviation 22.71 |
Comparison: ANCOVA model with the following fixed terms was used to calculate the p-value: snoring score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).p-value: 0.397295% CI: [-9.1, 3.6]ANOVA
Comparison: ANCOVA model with the following fixed terms was used to calculate the p-value: snoring score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).p-value: 0.031995% CI: [0.6, 12.9]ANCOVA
Secondary
Frequency of Secondary Generalized Tonic-clonic Seizures (SGTC) During the Double-blind Treatment Phase
Seizures were recorded and documented in a daily Seizure Diary by the participants, family member, caregiver, or legal guardian. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) were not counted toward eligibility, or in the primary or secondary efficacy analyses.
Time frame: Week 0 to Week 14
Population: The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin 165 mg | Frequency of Secondary Generalized Tonic-clonic Seizures (SGTC) During the Double-blind Treatment Phase | 3.99 seizures per 28 days | Standard Deviation 8.667 |
| Pregabalin 330 mg | Frequency of Secondary Generalized Tonic-clonic Seizures (SGTC) During the Double-blind Treatment Phase | 4.43 seizures per 28 days | Standard Deviation 14.736 |
| Placebo | Frequency of Secondary Generalized Tonic-clonic Seizures (SGTC) During the Double-blind Treatment Phase | 7.51 seizures per 28 days | Standard Deviation 24.979 |
Comparison: A generalized linear model accounting for treatment and geographical region as fixed effects and baseline seizure frequency as a covariate was used to calculate the p-value. This generalized linear model assumed that the SGTC seizure frequency was from a Poisson distribution with a canonical log link function.p-value: 0.607395% CI: [-0.53, 0.31]Generalized linear model (GLM)
Comparison: A generalized linear model accounting for treatment and geographical region as fixed effects and baseline seizure frequency as a covariate was used to calculate the p-value. This generalized linear model assumed that the SGTC seizure frequency was from a Poisson distribution with a canonical log link function.p-value: 0.410995% CI: [-0.53, 0.22]GLM
Secondary
Loge 28-day Seizure Rate for All Partial Onset Seizures During the Double-blind Maintenance Phase
Seizures were recorded and documented in a daily Seizure Diary by the participants, family member, caregiver, or legal guardian. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) were not counted toward eligibility, or in the primary or secondary efficacy analyses. Natural logarithm of the 28-day seizure rate was reported in this outcome measure.
Time frame: Week 2 to Week 14
Population: The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin 165 mg | Loge 28-day Seizure Rate for All Partial Onset Seizures During the Double-blind Maintenance Phase | 1.91 ln(28-day seizure rate) | Standard Error 0.07 |
| Pregabalin 330 mg | Loge 28-day Seizure Rate for All Partial Onset Seizures During the Double-blind Maintenance Phase | 1.77 ln(28-day seizure rate) | Standard Error 0.064 |
| Placebo | Loge 28-day Seizure Rate for All Partial Onset Seizures During the Double-blind Maintenance Phase | 1.88 ln(28-day seizure rate) | Standard Error 0.065 |
Comparison: ANCOVA model with the following fixed terms was used to calculate the p-value: loge (baseline 28-day seizure rate + 1) as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).p-value: 0.803495% CI: [-14.37, 22.15]ANCOVA
Comparison: ANCOVA model with the following fixed terms was used to calculate the p-value: loge (baseline 28-day seizure rate + 1) as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).p-value: 0.190595% CI: [-24.81, 5.87]ANCOVA
Secondary
Log Transformed 28-day SGTC Rate for All SGTCs During the Double-blind Maintenance Phase
Seizures were recorded and documented in a daily Seizure Diary by the participants, family member, caregiver, or legal guardian. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) were not counted toward eligibility, or in the primary or secondary efficacy analyses. Natural logarithm of the 28-day seizure rate was reported in this outcome measure.
Time frame: Week 2 to Week 14
Population: The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin 165 mg | Log Transformed 28-day SGTC Rate for All SGTCs During the Double-blind Maintenance Phase | 0.46 ln (seizures per 28 days) | Standard Error 0.049 |
| Pregabalin 330 mg | Log Transformed 28-day SGTC Rate for All SGTCs During the Double-blind Maintenance Phase | 0.48 ln (seizures per 28 days) | Standard Error 0.045 |
| Placebo | Log Transformed 28-day SGTC Rate for All SGTCs During the Double-blind Maintenance Phase | 0.48 ln (seizures per 28 days) | Standard Error 0.046 |
Comparison: ANCOVA model with the following fixed terms was used to calculate the p-value: loge (baseline 28-day seizure rate + 1) as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).p-value: 0.826895% CI: [-12.97, 11.75]ANCOVA
Comparison: ANCOVA model with the following fixed terms was used to calculate the p-value: loge (baseline 28-day seizure rate + 1) as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).p-value: 0.902495% CI: [-10.69, 13.66]ANCOVA
Secondary
Percentage Change From Baseline in 28-day Partial Seizure Rate During the Double-blind Treatment Phase
Seizures were recorded and documented in a daily Seizure Diary by the participants, family member, caregiver, or legal guardian. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) were not counted toward eligibility, or in the primary or secondary efficacy analyses. Natural logarithm of the 28-day seizure rate was reported in this outcome measure.
Time frame: Week 0 to Week 14
Population: The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin 165 mg | Percentage Change From Baseline in 28-day Partial Seizure Rate During the Double-blind Treatment Phase | -15.00 ln (seizures per 28 days) | Standard Error 11.668 |
| Pregabalin 330 mg | Percentage Change From Baseline in 28-day Partial Seizure Rate During the Double-blind Treatment Phase | -31.54 ln (seizures per 28 days) | Standard Error 10.772 |
| Placebo | Percentage Change From Baseline in 28-day Partial Seizure Rate During the Double-blind Treatment Phase | -5.70 ln (seizures per 28 days) | Standard Error 10.918 |
Comparison: ANCOVA model was used to calculate the p-value.p-value: 0.540495% CI: [-39.16, 20.56]ANCOVA
Comparison: ANCOVA model was used to calculate the p-value.p-value: 0.078695% CI: [-54.64, 2.97]ANCOVA
Secondary
Percentage of Participants With ≥50% Reduction in 28-day SGTC Seizure Rate From Baseline During the Double-blind Treatment Phase
Seizures were recorded and documented in a daily Seizure Diary by the participants, family member, caregiver, or legal guardian. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) were not counted toward eligibility, or in the primary or secondary efficacy analyses.
Time frame: Week 0 to Week 14
Population: The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pregabalin 165 mg | Percentage of Participants With ≥50% Reduction in 28-day SGTC Seizure Rate From Baseline During the Double-blind Treatment Phase | 1.0 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With ≥50% Reduction in 28-day SGTC Seizure Rate From Baseline During the Double-blind Treatment Phase | 1.9 percentage of participants |
| Placebo | Percentage of Participants With ≥50% Reduction in 28-day SGTC Seizure Rate From Baseline During the Double-blind Treatment Phase | 1.9 percentage of participants |
Comparison: A 2-sided Cochran-Mantel-Haenszel test stratified by geographical region (U.S., Europe, Asia, or Rest of the World) wtih percentage of responders summarized by treatment group was used to calculate the p-value.p-value: 0.67Cochran-Mantel-Haenszel
Comparison: A 2-sided Cochran-Mantel-Haenszel test stratified by geographical region (U.S., Europe, Asia, or Rest of the World) wtih percentage of responders summarized by treatment group was used to calculate the p-value.p-value: 0.927Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With a ≥50% Reduction in the 28-day Partial Seizure Rate From Baseline During the Double-blind Treatment Phase
Seizures were recorded and documented in a daily Seizure Diary by the participants, family member, caregiver, or legal guardian. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) were not counted toward eligibility, or in the primary or secondary efficacy analyses. Participants who had a ≥50% reduction in the 28-day partial seizure rate from baseline were defined as a responder, otherwise they were default as a non-responder.
Time frame: Week 0 to Week 14
Population: The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin 165 mg | Percentage of Participants With a ≥50% Reduction in the 28-day Partial Seizure Rate From Baseline During the Double-blind Treatment Phase | Responder | 37.8 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With a ≥50% Reduction in the 28-day Partial Seizure Rate From Baseline During the Double-blind Treatment Phase | Non-responder | 62.2 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With a ≥50% Reduction in the 28-day Partial Seizure Rate From Baseline During the Double-blind Treatment Phase | Responder | 45.9 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With a ≥50% Reduction in the 28-day Partial Seizure Rate From Baseline During the Double-blind Treatment Phase | Non-responder | 54.1 percentage of participants |
| Placebo | Percentage of Participants With a ≥50% Reduction in the 28-day Partial Seizure Rate From Baseline During the Double-blind Treatment Phase | Responder | 35.8 percentage of participants |
| Placebo | Percentage of Participants With a ≥50% Reduction in the 28-day Partial Seizure Rate From Baseline During the Double-blind Treatment Phase | Non-responder | 64.2 percentage of participants |
Comparison: A 2-sided Cochran-Mantel-Haenszel test stratified by geographical region (U.S., Europe, Asia, or Rest of the World) was used to calculate the p-value. No adjustments for multiplicity were taken.p-value: 0.752Cochran-Mantel-Haenszel
Comparison: A 2-sided Cochran-Mantel-Haenszel test stratified by geographical region (U.S., Europe, Asia, or Rest of the World) was used to calculate the p-value. No adjustments for multiplicity were taken.p-value: 0.125Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With a Relevant Increase in Sitting Blood Pressure (BP) From Baseline During the Double-blind Treatment Phase
Physical examinations included general appearance (including hight at baseline), vital sign (sitting heart rate and sitting blood pressure), weight, skin (examination for the presence of rash), HEENT (examinatin of head, eyes, ears, nose and throat), chest (ausculation of lung fields), cardiovascular (ausculatin of heart sounds (S1 and S2) and for the presence of murmurs, gallops, or rubs), gastrointestinal(abdominal rigidity and tenderness), an extremities (e.g. edema).
Time frame: Day 1 to Week 15
Population: The safety population included all randomized participants who took at least one dose of the study medication. The safety population consisted of: Pregabalin 165 mg: 100, Pregabalin 330 mg: 113, Placebo: 110.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin 165 mg | Percentage of Participants With a Relevant Increase in Sitting Blood Pressure (BP) From Baseline During the Double-blind Treatment Phase | Maximum increase in systolic BP ≥30 mmHg | 1.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With a Relevant Increase in Sitting Blood Pressure (BP) From Baseline During the Double-blind Treatment Phase | Maximum increase in diastolic BP ≥20 mmHg | 5.1 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With a Relevant Increase in Sitting Blood Pressure (BP) From Baseline During the Double-blind Treatment Phase | Maximum increase in systolic BP ≥30 mmHg | 1.8 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With a Relevant Increase in Sitting Blood Pressure (BP) From Baseline During the Double-blind Treatment Phase | Maximum increase in diastolic BP ≥20 mmHg | 5.5 percentage of participants |
| Placebo | Percentage of Participants With a Relevant Increase in Sitting Blood Pressure (BP) From Baseline During the Double-blind Treatment Phase | Maximum increase in systolic BP ≥30 mmHg | 0.9 percentage of participants |
| Placebo | Percentage of Participants With a Relevant Increase in Sitting Blood Pressure (BP) From Baseline During the Double-blind Treatment Phase | Maximum increase in diastolic BP ≥20 mmHg | 2.8 percentage of participants |
Secondary
Percentage of Participants With Corrected QT (QTc) Interval Greater Than or Equal to 450 ms
The original ECG was reviewed by the investigator and kept on site as part of source documentation. A central ECG reader was also used for this study. QT interval corrected using the Fridericia formula (QTcF) and QT interval corrected using the Bazett's formula (QTcB) were calculated.
Time frame: Week 15
Population: The safety population included all randomized participants who took at least one dose of the study medication. The safety population consisted of: Pregabalin 165 mg: 100, Pregabalin 330 mg: 113, Placebo: 110.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin 165 mg | Percentage of Participants With Corrected QT (QTc) Interval Greater Than or Equal to 450 ms | Maximum QTcB 450 - <480 | 8.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With Corrected QT (QTc) Interval Greater Than or Equal to 450 ms | Maximum QTcB 480 - <500 | 1.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With Corrected QT (QTc) Interval Greater Than or Equal to 450 ms | Maximum QTcB ≥500 | 0.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With Corrected QT (QTc) Interval Greater Than or Equal to 450 ms | Maximum QTcF 450 - <480 | 3.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With Corrected QT (QTc) Interval Greater Than or Equal to 450 ms | Maximum QTcF 480 - <500 | 1.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With Corrected QT (QTc) Interval Greater Than or Equal to 450 ms | Maximum QTcF ≥500 | 0.0 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With Corrected QT (QTc) Interval Greater Than or Equal to 450 ms | Maximum QTcF ≥500 | 0.0 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With Corrected QT (QTc) Interval Greater Than or Equal to 450 ms | Maximum QTcB 450 - <480 | 5.3 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With Corrected QT (QTc) Interval Greater Than or Equal to 450 ms | Maximum QTcF 450 - <480 | 2.7 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With Corrected QT (QTc) Interval Greater Than or Equal to 450 ms | Maximum QTcF 480 - <500 | 0.0 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With Corrected QT (QTc) Interval Greater Than or Equal to 450 ms | Maximum QTcB 480 - <500 | 0.0 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With Corrected QT (QTc) Interval Greater Than or Equal to 450 ms | Maximum QTcB ≥500 | 1.8 percentage of participants |
| Placebo | Percentage of Participants With Corrected QT (QTc) Interval Greater Than or Equal to 450 ms | Maximum QTcB 480 - <500 | 0.9 percentage of participants |
| Placebo | Percentage of Participants With Corrected QT (QTc) Interval Greater Than or Equal to 450 ms | Maximum QTcB ≥500 | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Corrected QT (QTc) Interval Greater Than or Equal to 450 ms | Maximum QTcF ≥500 | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Corrected QT (QTc) Interval Greater Than or Equal to 450 ms | Maximum QTcF 450 - <480 | 3.6 percentage of participants |
| Placebo | Percentage of Participants With Corrected QT (QTc) Interval Greater Than or Equal to 450 ms | Maximum QTcB 450 - <480 | 10.0 percentage of participants |
| Placebo | Percentage of Participants With Corrected QT (QTc) Interval Greater Than or Equal to 450 ms | Maximum QTcF 480 - <500 | 0.0 percentage of participants |
Secondary
Percentage of Participants With Laboratory Test Abnormalities During the Study
Laboratory samples in hematology, chemistry, and urinalysis were analyzed by a cental laboratory. Any laboratory value that was identified as clinically significant was reported as an AE. LLN: Lower limit of normal, ULN: Uper limit of normal, RBC: Red Blood Cell, WBC: White Blood Cell, AST: Aspartate Aminotransferase, ALT: Alanine Aminotransferase, BUN: Blood Urea Nitrogen
Time frame: Day 1 to Week 15
Population: The safety population included all randomized participants who took at least one dose of the study medication. The safety population consisted of: Pregabalin 165 mg: 100, Pregabalin 330 mg: 113, Placebo: 110.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin 165 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Chloride <0.9xLLN | 0.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Eosinophils (%) >1.2xULN | 6.3 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Hematocrit (HCT) <0.8xLLN | 0.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Potassium >1.1xULN | 1.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Monocytes (absolute) >1.2xULN | 0.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Hemoglobin (HGB) <0.8xLLN , | 1.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Potassium <0.9xLLN | 2.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Monocytes (%) >1.2xULN | 1.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Lymphocytes (absolute) <0.8xLLN | 4.2 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Sodium >1.05xULN | 0.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Total Bilirubin >1.5xULN | 0.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Urine Nitrite ≥1 | 11.7 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Sodium <0.95xLLN | 1.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | AST >3.0xULN | 0.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Urine Glucose (qualitative) ≥1 | 0.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Uric Acid >1.2xULN | 1.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | ALT >3.0xULN | 0.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Lymphocytes (absolute) >1.2xULN | 2.1 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Creatinine >1.3xULN | 0.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Alkaline Phosphatase >3.0xULN | 0.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Platelets <0.5xLLN | 0.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | BUN >1.3xULN | 0.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Total Protein <0.8xLLN | 0.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Urine pH >8 | 1.1 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Albumin >1.2xULN | 0.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Total Protein >1.2xULN | 0.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Lymphocytes (%) <0.8xLLN | 0.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Albumin <0.8xLLN | 0.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Urine WBC ≥20 | 4.8 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Urine pH <4.5 | 0.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Lymphocytes (%) >1.2xULN | 1.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Urine Blood/Hgb (qualitative) ≥1 | 8.5 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Urine Specific Gravity >1.030 | 1.1 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Neutrophils (absolute) <0.8xLLN | 3.1 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Platelets >1.75xULN | 0.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Urine Specific Gravity <1.003 | 0.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Neutrophils (absolute) >1.2xULN | 0.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Urine RBC ≥20 | 13.3 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Glucose >1.5xULN | 0.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Neutrophils (%) <0.8xLLN | 1.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Urine Protein (qualitative) ≥1 | 3.2 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Glucose <0.6xLLN | 0.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Neutrophils (%) >1.2xULN | 0.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | WBC Count <0.6xLLN | 0.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Calcium >1.1xULN | 0.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Basophils (absolute) >1.2xULN | 0.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | RBC Count <0.8xLLN | 0.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Calcium <0.9xLLN | 0.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Basophils (%) >1.2xULN | 0.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Urine Ketones (qualitative) ≥1 | 2.1 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Chloride >1.1xULN | 0.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Eosinophils (absolute) >1.2xULN | 3.1 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | White Blood Cell Count >1.5xULN | 0.0 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Urine Glucose (qualitative) ≥1 | 0.9 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Hemoglobin (HGB) <0.8xLLN , | 0.9 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Hematocrit (HCT) <0.8xLLN | 0.9 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | RBC Count <0.8xLLN | 0.0 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Platelets <0.5xLLN | 0.0 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Platelets >1.75xULN | 0.0 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | WBC Count <0.6xLLN | 0.9 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | White Blood Cell Count >1.5xULN | 0.0 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Lymphocytes (absolute) <0.8xLLN | 0.9 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Lymphocytes (absolute) >1.2xULN | 1.8 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Lymphocytes (%) <0.8xLLN | 0.0 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Lymphocytes (%) >1.2xULN | 0.0 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Neutrophils (absolute) <0.8xLLN | 1.8 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Neutrophils (absolute) >1.2xULN | 0.0 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Neutrophils (%) <0.8xLLN | 0.0 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Neutrophils (%) >1.2xULN | 0.0 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Basophils (absolute) >1.2xULN | 0.0 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Basophils (%) >1.2xULN | 0.0 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Eosinophils (absolute) >1.2xULN | 3.7 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Eosinophils (%) >1.2xULN | 4.6 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Monocytes (absolute) >1.2xULN | 1.8 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Monocytes (%) >1.2xULN | 0.0 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Total Bilirubin >1.5xULN | 0.0 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | AST >3.0xULN | 0.0 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | ALT >3.0xULN | 0.0 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Alkaline Phosphatase >3.0xULN | 0.0 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Total Protein <0.8xLLN | 0.0 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Total Protein >1.2xULN | 0.0 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Albumin <0.8xLLN | 0.0 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Albumin >1.2xULN | 0.0 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | BUN >1.3xULN | 0.0 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Creatinine >1.3xULN | 0.0 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Uric Acid >1.2xULN | 0.9 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Sodium <0.95xLLN | 0.0 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Sodium >1.05xULN | 0.0 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Potassium <0.9xLLN | 0.0 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Potassium >1.1xULN | 0.0 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Chloride <0.9xLLN | 0.0 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Chloride >1.1xULN | 0.0 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Calcium <0.9xLLN | 0.0 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Calcium >1.1xULN | 0.0 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Glucose <0.6xLLN | 0.0 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Glucose >1.5xULN | 0.9 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Urine Specific Gravity <1.003 | 1.9 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Urine Specific Gravity >1.030 | 1.9 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Urine pH <4.5 | 0.0 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Urine pH >8 | 1.9 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Urine Ketones (qualitative) ≥1 | 1.9 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Urine Protein (qualitative) ≥1 | 2.8 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Urine Blood/Hgb (qualitative) ≥1 | 9.4 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Urine Nitrite ≥1 | 5.7 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Urine RBC ≥20 | 0.0 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With Laboratory Test Abnormalities During the Study | Urine WBC ≥20 | 3.7 percentage of participants |
| Placebo | Percentage of Participants With Laboratory Test Abnormalities During the Study | Hematocrit (HCT) <0.8xLLN | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Laboratory Test Abnormalities During the Study | Potassium >1.1xULN | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Laboratory Test Abnormalities During the Study | Eosinophils (absolute) >1.2xULN | 1.9 percentage of participants |
| Placebo | Percentage of Participants With Laboratory Test Abnormalities During the Study | Urine Ketones (qualitative) ≥1 | 1.9 percentage of participants |
| Placebo | Percentage of Participants With Laboratory Test Abnormalities During the Study | Chloride <0.9xLLN | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Laboratory Test Abnormalities During the Study | Basophils (%) >1.2xULN | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Laboratory Test Abnormalities During the Study | Platelets >1.75xULN | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Laboratory Test Abnormalities During the Study | Chloride >1.1xULN | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Laboratory Test Abnormalities During the Study | Basophils (absolute) >1.2xULN | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Laboratory Test Abnormalities During the Study | Urine WBC ≥20 | 29.6 percentage of participants |
| Placebo | Percentage of Participants With Laboratory Test Abnormalities During the Study | Calcium <0.9xLLN | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Laboratory Test Abnormalities During the Study | Neutrophils (%) >1.2xULN | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Laboratory Test Abnormalities During the Study | Urine Protein (qualitative) ≥1 | 1.0 percentage of participants |
| Placebo | Percentage of Participants With Laboratory Test Abnormalities During the Study | Calcium >1.1xULN | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Laboratory Test Abnormalities During the Study | Neutrophils (%) <0.8xLLN | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Laboratory Test Abnormalities During the Study | Platelets <0.5xLLN | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Laboratory Test Abnormalities During the Study | Glucose <0.6xLLN | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Laboratory Test Abnormalities During the Study | Neutrophils (absolute) >1.2xULN | 1.9 percentage of participants |
| Placebo | Percentage of Participants With Laboratory Test Abnormalities During the Study | Urine RBC ≥20 | 9.5 percentage of participants |
| Placebo | Percentage of Participants With Laboratory Test Abnormalities During the Study | Glucose >1.5xULN | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Laboratory Test Abnormalities During the Study | Neutrophils (absolute) <0.8xLLN | 1.9 percentage of participants |
| Placebo | Percentage of Participants With Laboratory Test Abnormalities During the Study | Urine Blood/Hgb (qualitative) ≥1 | 9.5 percentage of participants |
| Placebo | Percentage of Participants With Laboratory Test Abnormalities During the Study | Urine Specific Gravity <1.003 | 1.0 percentage of participants |
| Placebo | Percentage of Participants With Laboratory Test Abnormalities During the Study | Lymphocytes (%) >1.2xULN | 0.9 percentage of participants |
| Placebo | Percentage of Participants With Laboratory Test Abnormalities During the Study | RBC Count <0.8xLLN | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Laboratory Test Abnormalities During the Study | Urine Specific Gravity >1.030 | 4.8 percentage of participants |
| Placebo | Percentage of Participants With Laboratory Test Abnormalities During the Study | Lymphocytes (%) <0.8xLLN | 1.9 percentage of participants |
| Placebo | Percentage of Participants With Laboratory Test Abnormalities During the Study | Hemoglobin (HGB) <0.8xLLN , | 0.9 percentage of participants |
| Placebo | Percentage of Participants With Laboratory Test Abnormalities During the Study | Total Protein >1.2xULN | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Laboratory Test Abnormalities During the Study | Urine pH <4.5 | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Laboratory Test Abnormalities During the Study | Albumin <0.8xLLN | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Laboratory Test Abnormalities During the Study | Total Protein <0.8xLLN | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Laboratory Test Abnormalities During the Study | Lymphocytes (absolute) >1.2xULN | 3.8 percentage of participants |
| Placebo | Percentage of Participants With Laboratory Test Abnormalities During the Study | Albumin >1.2xULN | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Laboratory Test Abnormalities During the Study | Alkaline Phosphatase >3.0xULN | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Laboratory Test Abnormalities During the Study | Urine Nitrite ≥1 | 13.3 percentage of participants |
| Placebo | Percentage of Participants With Laboratory Test Abnormalities During the Study | BUN >1.3xULN | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Laboratory Test Abnormalities During the Study | ALT >3.0xULN | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Laboratory Test Abnormalities During the Study | Urine pH >8 | 1.9 percentage of participants |
| Placebo | Percentage of Participants With Laboratory Test Abnormalities During the Study | Creatinine >1.3xULN | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Laboratory Test Abnormalities During the Study | AST >3.0xULN | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Laboratory Test Abnormalities During the Study | Lymphocytes (absolute) <0.8xLLN | 1.9 percentage of participants |
| Placebo | Percentage of Participants With Laboratory Test Abnormalities During the Study | Uric Acid >1.2xULN | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Laboratory Test Abnormalities During the Study | Total Bilirubin >1.5xULN | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Laboratory Test Abnormalities During the Study | White Blood Cell Count >1.5xULN | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Laboratory Test Abnormalities During the Study | Sodium <0.95xLLN | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Laboratory Test Abnormalities During the Study | Monocytes (%) >1.2xULN | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Laboratory Test Abnormalities During the Study | Urine Glucose (qualitative) ≥1 | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Laboratory Test Abnormalities During the Study | Sodium >1.05xULN | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Laboratory Test Abnormalities During the Study | Monocytes (absolute) >1.2xULN | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Laboratory Test Abnormalities During the Study | WBC Count <0.6xLLN | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Laboratory Test Abnormalities During the Study | Potassium <0.9xLLN | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Laboratory Test Abnormalities During the Study | Eosinophils (%) >1.2xULN | 3.8 percentage of participants |
Secondary
Percentage of Participants With New or Intensified Neurological Examination Findings During the Double-blind Treatment Phase
Neurological examinations included level of consciousness, mental status, cranial nerve assessment, muscle strength, reflexes, pin prick and vibratory sensation (the latter using a 128-Hz tuning fork), coordination and gait.
Time frame: Day 1 to Week 15
Population: The safety population included all randomized participants who took at least one dose of the study medication. The safety population consisted of: Pregabalin 165 mg: 100, Pregabalin 330 mg: 113, Placebo: 110.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin 165 mg | Percentage of Participants With New or Intensified Neurological Examination Findings During the Double-blind Treatment Phase | Any | 21.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With New or Intensified Neurological Examination Findings During the Double-blind Treatment Phase | Mental state | 1.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With New or Intensified Neurological Examination Findings During the Double-blind Treatment Phase | Cranial nerve VII | 1.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With New or Intensified Neurological Examination Findings During the Double-blind Treatment Phase | None | 79.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With New or Intensified Neurological Examination Findings During the Double-blind Treatment Phase | Level of consciousness | 0.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With New or Intensified Neurological Examination Findings During the Double-blind Treatment Phase | Cranial nerve VIII | 0.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With New or Intensified Neurological Examination Findings During the Double-blind Treatment Phase | Cranial nerve function | 0.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With New or Intensified Neurological Examination Findings During the Double-blind Treatment Phase | Gait and station | 0.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With New or Intensified Neurological Examination Findings During the Double-blind Treatment Phase | Cranial nerve XI | 0.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With New or Intensified Neurological Examination Findings During the Double-blind Treatment Phase | Vibration | 11.1 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With New or Intensified Neurological Examination Findings During the Double-blind Treatment Phase | Deep tendon reflexes | 3.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With New or Intensified Neurological Examination Findings During the Double-blind Treatment Phase | Pain sensation | 0.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With New or Intensified Neurological Examination Findings During the Double-blind Treatment Phase | Cranial nerve II | 0.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With New or Intensified Neurological Examination Findings During the Double-blind Treatment Phase | Reflexes | 1.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With New or Intensified Neurological Examination Findings During the Double-blind Treatment Phase | Muscle strength | 2.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With New or Intensified Neurological Examination Findings During the Double-blind Treatment Phase | Cranial nerve III | 0.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With New or Intensified Neurological Examination Findings During the Double-blind Treatment Phase | Coordination | 1.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With New or Intensified Neurological Examination Findings During the Double-blind Treatment Phase | Motor function | 1.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With New or Intensified Neurological Examination Findings During the Double-blind Treatment Phase | Cranial nerve V | 0.0 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With New or Intensified Neurological Examination Findings During the Double-blind Treatment Phase | Pain sensation | 0.0 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With New or Intensified Neurological Examination Findings During the Double-blind Treatment Phase | None | 78.8 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With New or Intensified Neurological Examination Findings During the Double-blind Treatment Phase | Any | 21.2 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With New or Intensified Neurological Examination Findings During the Double-blind Treatment Phase | Coordination | 1.8 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With New or Intensified Neurological Examination Findings During the Double-blind Treatment Phase | Cranial nerve function | 0.9 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With New or Intensified Neurological Examination Findings During the Double-blind Treatment Phase | Cranial nerve II | 0.0 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With New or Intensified Neurological Examination Findings During the Double-blind Treatment Phase | Cranial nerve III | 0.0 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With New or Intensified Neurological Examination Findings During the Double-blind Treatment Phase | Cranial nerve V | 0.0 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With New or Intensified Neurological Examination Findings During the Double-blind Treatment Phase | Cranial nerve VII | 0.0 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With New or Intensified Neurological Examination Findings During the Double-blind Treatment Phase | Cranial nerve VIII | 0.9 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With New or Intensified Neurological Examination Findings During the Double-blind Treatment Phase | Cranial nerve XI | 0.0 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With New or Intensified Neurological Examination Findings During the Double-blind Treatment Phase | Deep tendon reflexes | 1.8 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With New or Intensified Neurological Examination Findings During the Double-blind Treatment Phase | Gait and station | 0.0 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With New or Intensified Neurological Examination Findings During the Double-blind Treatment Phase | Level of consciousness | 0.0 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With New or Intensified Neurological Examination Findings During the Double-blind Treatment Phase | Mental state | 1.8 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With New or Intensified Neurological Examination Findings During the Double-blind Treatment Phase | Motor function | 2.7 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With New or Intensified Neurological Examination Findings During the Double-blind Treatment Phase | Muscle strength | 0.0 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With New or Intensified Neurological Examination Findings During the Double-blind Treatment Phase | Reflexes | 0.9 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With New or Intensified Neurological Examination Findings During the Double-blind Treatment Phase | Vibration | 10.8 percentage of participants |
| Placebo | Percentage of Participants With New or Intensified Neurological Examination Findings During the Double-blind Treatment Phase | Level of consciousness | 0.9 percentage of participants |
| Placebo | Percentage of Participants With New or Intensified Neurological Examination Findings During the Double-blind Treatment Phase | Cranial nerve V | 0.0 percentage of participants |
| Placebo | Percentage of Participants With New or Intensified Neurological Examination Findings During the Double-blind Treatment Phase | Vibration | 12.0 percentage of participants |
| Placebo | Percentage of Participants With New or Intensified Neurological Examination Findings During the Double-blind Treatment Phase | Mental state | 1.8 percentage of participants |
| Placebo | Percentage of Participants With New or Intensified Neurological Examination Findings During the Double-blind Treatment Phase | Cranial nerve III | 1.8 percentage of participants |
| Placebo | Percentage of Participants With New or Intensified Neurological Examination Findings During the Double-blind Treatment Phase | Reflexes | 1.9 percentage of participants |
| Placebo | Percentage of Participants With New or Intensified Neurological Examination Findings During the Double-blind Treatment Phase | Motor function | 3.6 percentage of participants |
| Placebo | Percentage of Participants With New or Intensified Neurological Examination Findings During the Double-blind Treatment Phase | Cranial nerve II | 0.0 percentage of participants |
| Placebo | Percentage of Participants With New or Intensified Neurological Examination Findings During the Double-blind Treatment Phase | None | 68.2 percentage of participants |
| Placebo | Percentage of Participants With New or Intensified Neurological Examination Findings During the Double-blind Treatment Phase | Muscle strength | 1.9 percentage of participants |
| Placebo | Percentage of Participants With New or Intensified Neurological Examination Findings During the Double-blind Treatment Phase | Cranial nerve function | 0.0 percentage of participants |
| Placebo | Percentage of Participants With New or Intensified Neurological Examination Findings During the Double-blind Treatment Phase | Cranial nerve XI | 0.0 percentage of participants |
| Placebo | Percentage of Participants With New or Intensified Neurological Examination Findings During the Double-blind Treatment Phase | Coordination | 1.8 percentage of participants |
| Placebo | Percentage of Participants With New or Intensified Neurological Examination Findings During the Double-blind Treatment Phase | Deep tendon reflexes | 2.7 percentage of participants |
| Placebo | Percentage of Participants With New or Intensified Neurological Examination Findings During the Double-blind Treatment Phase | Cranial nerve VIII | 0.0 percentage of participants |
| Placebo | Percentage of Participants With New or Intensified Neurological Examination Findings During the Double-blind Treatment Phase | Pain sensation | 1.9 percentage of participants |
| Placebo | Percentage of Participants With New or Intensified Neurological Examination Findings During the Double-blind Treatment Phase | Gait and station | 0.9 percentage of participants |
| Placebo | Percentage of Participants With New or Intensified Neurological Examination Findings During the Double-blind Treatment Phase | Cranial nerve VII | 0.9 percentage of participants |
| Placebo | Percentage of Participants With New or Intensified Neurological Examination Findings During the Double-blind Treatment Phase | Any | 31.8 percentage of participants |
Secondary
Percentage of Participants With New or Intensified Physical Examination Findings During the Double-blind Treatment Phase
Physical examinations included general appearance (including hight at baseline), vital sign (sitting heart rate and sitting blood pressure), weight, skin (examination for the presence of rash), HEENT (examinatin of head, eyes, ears, nose and throat), chest ausculation of lung fields), cardiovascular (ausculatin of heart sounds (S1 and S2) and for the presence of murmurs, gallops, or rubs), gastrointestinal (abdominal rigidity and tenderness), an extremities (e.g. edema). Clinically significant physical examination abnormalities were considered as adverse events based on investigator's discretion.
Time frame: Day 1 to Week 15
Population: The safety population included all randomized participants who took at least one dose of the study medication. The safety population consisted of: Pregabalin 165 mg: 100, Pregabalin 330 mg: 113, Placebo: 110.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin 165 mg | Percentage of Participants With New or Intensified Physical Examination Findings During the Double-blind Treatment Phase | General | 1.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With New or Intensified Physical Examination Findings During the Double-blind Treatment Phase | Skin | 2.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With New or Intensified Physical Examination Findings During the Double-blind Treatment Phase | Head | 1.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With New or Intensified Physical Examination Findings During the Double-blind Treatment Phase | Ears | 3.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With New or Intensified Physical Examination Findings During the Double-blind Treatment Phase | Eyes | 1.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With New or Intensified Physical Examination Findings During the Double-blind Treatment Phase | Nose | 0.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With New or Intensified Physical Examination Findings During the Double-blind Treatment Phase | Throat | 0.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With New or Intensified Physical Examination Findings During the Double-blind Treatment Phase | Lungs | 0.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With New or Intensified Physical Examination Findings During the Double-blind Treatment Phase | Heart | 1.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With New or Intensified Physical Examination Findings During the Double-blind Treatment Phase | Abdomen | 0.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With New or Intensified Physical Examination Findings During the Double-blind Treatment Phase | Extremities | 2.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With New or Intensified Physical Examination Findings During the Double-blind Treatment Phase | Other | 14.0 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With New or Intensified Physical Examination Findings During the Double-blind Treatment Phase | Other | 7.1 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With New or Intensified Physical Examination Findings During the Double-blind Treatment Phase | General | 2.7 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With New or Intensified Physical Examination Findings During the Double-blind Treatment Phase | Throat | 0.0 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With New or Intensified Physical Examination Findings During the Double-blind Treatment Phase | Heart | 0.0 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With New or Intensified Physical Examination Findings During the Double-blind Treatment Phase | Skin | 6.2 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With New or Intensified Physical Examination Findings During the Double-blind Treatment Phase | Nose | 0.0 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With New or Intensified Physical Examination Findings During the Double-blind Treatment Phase | Extremities | 2.7 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With New or Intensified Physical Examination Findings During the Double-blind Treatment Phase | Head | 1.8 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With New or Intensified Physical Examination Findings During the Double-blind Treatment Phase | Lungs | 0.0 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With New or Intensified Physical Examination Findings During the Double-blind Treatment Phase | Eyes | 2.7 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With New or Intensified Physical Examination Findings During the Double-blind Treatment Phase | Ears | 1.8 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With New or Intensified Physical Examination Findings During the Double-blind Treatment Phase | Abdomen | 0.0 percentage of participants |
| Placebo | Percentage of Participants With New or Intensified Physical Examination Findings During the Double-blind Treatment Phase | Ears | 0.9 percentage of participants |
| Placebo | Percentage of Participants With New or Intensified Physical Examination Findings During the Double-blind Treatment Phase | Eyes | 3.6 percentage of participants |
| Placebo | Percentage of Participants With New or Intensified Physical Examination Findings During the Double-blind Treatment Phase | Abdomen | 0.0 percentage of participants |
| Placebo | Percentage of Participants With New or Intensified Physical Examination Findings During the Double-blind Treatment Phase | Nose | 1.8 percentage of participants |
| Placebo | Percentage of Participants With New or Intensified Physical Examination Findings During the Double-blind Treatment Phase | Throat | 1.8 percentage of participants |
| Placebo | Percentage of Participants With New or Intensified Physical Examination Findings During the Double-blind Treatment Phase | Lungs | 0.0 percentage of participants |
| Placebo | Percentage of Participants With New or Intensified Physical Examination Findings During the Double-blind Treatment Phase | Extremities | 1.8 percentage of participants |
| Placebo | Percentage of Participants With New or Intensified Physical Examination Findings During the Double-blind Treatment Phase | General | 0.0 percentage of participants |
| Placebo | Percentage of Participants With New or Intensified Physical Examination Findings During the Double-blind Treatment Phase | Skin | 4.5 percentage of participants |
| Placebo | Percentage of Participants With New or Intensified Physical Examination Findings During the Double-blind Treatment Phase | Heart | 0.0 percentage of participants |
| Placebo | Percentage of Participants With New or Intensified Physical Examination Findings During the Double-blind Treatment Phase | Head | 0.0 percentage of participants |
| Placebo | Percentage of Participants With New or Intensified Physical Examination Findings During the Double-blind Treatment Phase | Other | 10.9 percentage of participants |
Secondary
Percentage of Participants With Relevant ECG Interval-increases From Baseline During the Double-blind Treatment Phase
The original ECG was reviewed by the investigator and kept on site as part of source documentation. A central ECG reader was also used for this study. 25/50% represents ≥25% or ≥50% increase over baseline respectively, based on cut points. Cut points are 100 ms for QRS and 200 ms for PR.
Time frame: Week 15
Population: The safety population included all randomized participants who took at least one dose of the study medication. The safety population consisted of: Pregabalin 165 mg: 100, Pregabalin 330 mg: 113, Placebo: 110.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin 165 mg | Percentage of Participants With Relevant ECG Interval-increases From Baseline During the Double-blind Treatment Phase | Max. QTcF interval rise: ≥60 | 0.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With Relevant ECG Interval-increases From Baseline During the Double-blind Treatment Phase | Max. QTcB interval rise: 30≤x<60 | 5.4 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With Relevant ECG Interval-increases From Baseline During the Double-blind Treatment Phase | Max. QTcF interval rise: 30≤x<60 | 3.2 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With Relevant ECG Interval-increases From Baseline During the Double-blind Treatment Phase | Max PR interval rise:%change≥25/50% | 1.1 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With Relevant ECG Interval-increases From Baseline During the Double-blind Treatment Phase | Max. QTcB interval rise: ≥60 | 0.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With Relevant ECG Interval-increases From Baseline During the Double-blind Treatment Phase | Max QRS complex rise:%change≥25/50% | 1.1 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With Relevant ECG Interval-increases From Baseline During the Double-blind Treatment Phase | Max. QTcB interval rise: ≥60 | 1.9 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With Relevant ECG Interval-increases From Baseline During the Double-blind Treatment Phase | Max. QTcF interval rise: 30≤x<60 | 1.9 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With Relevant ECG Interval-increases From Baseline During the Double-blind Treatment Phase | Max QRS complex rise:%change≥25/50% | 1.9 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With Relevant ECG Interval-increases From Baseline During the Double-blind Treatment Phase | Max. QTcF interval rise: ≥60 | 0.0 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With Relevant ECG Interval-increases From Baseline During the Double-blind Treatment Phase | Max PR interval rise:%change≥25/50% | 1.0 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With Relevant ECG Interval-increases From Baseline During the Double-blind Treatment Phase | Max. QTcB interval rise: 30≤x<60 | 1.9 percentage of participants |
| Placebo | Percentage of Participants With Relevant ECG Interval-increases From Baseline During the Double-blind Treatment Phase | Max. QTcB interval rise: 30≤x<60 | 3.1 percentage of participants |
| Placebo | Percentage of Participants With Relevant ECG Interval-increases From Baseline During the Double-blind Treatment Phase | Max PR interval rise:%change≥25/50% | 2.1 percentage of participants |
| Placebo | Percentage of Participants With Relevant ECG Interval-increases From Baseline During the Double-blind Treatment Phase | Max QRS complex rise:%change≥25/50% | 1.0 percentage of participants |
| Placebo | Percentage of Participants With Relevant ECG Interval-increases From Baseline During the Double-blind Treatment Phase | Max. QTcF interval rise: ≥60 | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Relevant ECG Interval-increases From Baseline During the Double-blind Treatment Phase | Max. QTcB interval rise: ≥60 | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Relevant ECG Interval-increases From Baseline During the Double-blind Treatment Phase | Max. QTcF interval rise: 30≤x<60 | 2.1 percentage of participants |
Secondary
Percentage of Participants With Self-injurious or Suicidal Ideation or Behavior on Columbia Classification Algorithm of Suicide Assessment (C-CASA)
C-CASA is described as a standardized suicidal rating system. The C-CASA has eight categories (4 suicidal events: completed suicide, suicide attempt, preparatory act toward imminent suicidal behavior (PAISB), and suicidal ideation; 2 nonsuicidal events: self-injurious behavior, no suicidal intent (SIB-NSI) and other no deliberate self-harm, and 2 indeterminate or potentially suicidal events: self-injurious behavior, suicidal intent unknown and not enough information) that distinguish suicidal events from nonsuicidal events and indeterminate or potentially suicidal events.
Time frame: Week -8 (Screening), Week 0 (Baseline), and Week 14 (double-blind treatment phase)
Population: The safety population included all randomized participants who took at least one dose of the study medication. The safety population consisted of: Pregabalin 165 mg: 100, Pregabalin 330 mg: 113, Placebo: 110.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin 165 mg | Percentage of Participants With Self-injurious or Suicidal Ideation or Behavior on Columbia Classification Algorithm of Suicide Assessment (C-CASA) | SIB-NSI (Lifetime prior to Screening) | 1.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With Self-injurious or Suicidal Ideation or Behavior on Columbia Classification Algorithm of Suicide Assessment (C-CASA) | Suicidal ideation at Week 14 | 4.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With Self-injurious or Suicidal Ideation or Behavior on Columbia Classification Algorithm of Suicide Assessment (C-CASA) | PAISB at Week 0 | 0.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With Self-injurious or Suicidal Ideation or Behavior on Columbia Classification Algorithm of Suicide Assessment (C-CASA) | Suicide attempts at Week 0 | 1.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With Self-injurious or Suicidal Ideation or Behavior on Columbia Classification Algorithm of Suicide Assessment (C-CASA) | Suicide attempt (Lifetime prior to Screening) | 2.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With Self-injurious or Suicidal Ideation or Behavior on Columbia Classification Algorithm of Suicide Assessment (C-CASA) | SIB-NSI at Week 0 | 1.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With Self-injurious or Suicidal Ideation or Behavior on Columbia Classification Algorithm of Suicide Assessment (C-CASA) | Suicidal ideation (Lifetime prior to Screening) | 11.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With Self-injurious or Suicidal Ideation or Behavior on Columbia Classification Algorithm of Suicide Assessment (C-CASA) | PAISB (Lifetime prior to Screening) | 1.0 percentage of participants |
| Pregabalin 165 mg | Percentage of Participants With Self-injurious or Suicidal Ideation or Behavior on Columbia Classification Algorithm of Suicide Assessment (C-CASA) | Suicidal ideation at Week 0 | 8.0 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With Self-injurious or Suicidal Ideation or Behavior on Columbia Classification Algorithm of Suicide Assessment (C-CASA) | Suicide attempts at Week 0 | 0.9 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With Self-injurious or Suicidal Ideation or Behavior on Columbia Classification Algorithm of Suicide Assessment (C-CASA) | Suicide attempt (Lifetime prior to Screening) | 1.8 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With Self-injurious or Suicidal Ideation or Behavior on Columbia Classification Algorithm of Suicide Assessment (C-CASA) | PAISB (Lifetime prior to Screening) | 1.8 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With Self-injurious or Suicidal Ideation or Behavior on Columbia Classification Algorithm of Suicide Assessment (C-CASA) | Suicidal ideation (Lifetime prior to Screening) | 10.6 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With Self-injurious or Suicidal Ideation or Behavior on Columbia Classification Algorithm of Suicide Assessment (C-CASA) | SIB-NSI (Lifetime prior to Screening) | 0.9 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With Self-injurious or Suicidal Ideation or Behavior on Columbia Classification Algorithm of Suicide Assessment (C-CASA) | PAISB at Week 0 | 0.9 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With Self-injurious or Suicidal Ideation or Behavior on Columbia Classification Algorithm of Suicide Assessment (C-CASA) | Suicidal ideation at Week 0 | 7.1 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With Self-injurious or Suicidal Ideation or Behavior on Columbia Classification Algorithm of Suicide Assessment (C-CASA) | SIB-NSI at Week 0 | 0.0 percentage of participants |
| Pregabalin 330 mg | Percentage of Participants With Self-injurious or Suicidal Ideation or Behavior on Columbia Classification Algorithm of Suicide Assessment (C-CASA) | Suicidal ideation at Week 14 | 2.7 percentage of participants |
| Placebo | Percentage of Participants With Self-injurious or Suicidal Ideation or Behavior on Columbia Classification Algorithm of Suicide Assessment (C-CASA) | Suicidal ideation (Lifetime prior to Screening) | 14.5 percentage of participants |
| Placebo | Percentage of Participants With Self-injurious or Suicidal Ideation or Behavior on Columbia Classification Algorithm of Suicide Assessment (C-CASA) | Suicide attempt (Lifetime prior to Screening) | 5.5 percentage of participants |
| Placebo | Percentage of Participants With Self-injurious or Suicidal Ideation or Behavior on Columbia Classification Algorithm of Suicide Assessment (C-CASA) | Suicidal ideation at Week 0 | 2.7 percentage of participants |
| Placebo | Percentage of Participants With Self-injurious or Suicidal Ideation or Behavior on Columbia Classification Algorithm of Suicide Assessment (C-CASA) | PAISB (Lifetime prior to Screening) | 4.5 percentage of participants |
| Placebo | Percentage of Participants With Self-injurious or Suicidal Ideation or Behavior on Columbia Classification Algorithm of Suicide Assessment (C-CASA) | Suicidal ideation at Week 14 | 1.8 percentage of participants |
| Placebo | Percentage of Participants With Self-injurious or Suicidal Ideation or Behavior on Columbia Classification Algorithm of Suicide Assessment (C-CASA) | Suicide attempts at Week 0 | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Self-injurious or Suicidal Ideation or Behavior on Columbia Classification Algorithm of Suicide Assessment (C-CASA) | SIB-NSI (Lifetime prior to Screening) | 0.9 percentage of participants |
| Placebo | Percentage of Participants With Self-injurious or Suicidal Ideation or Behavior on Columbia Classification Algorithm of Suicide Assessment (C-CASA) | SIB-NSI at Week 0 | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Self-injurious or Suicidal Ideation or Behavior on Columbia Classification Algorithm of Suicide Assessment (C-CASA) | PAISB at Week 0 | 0.0 percentage of participants |
Secondary
Percent of Participants Reporting Optimal Sleep on the MOS-SS - Optimal Sleep Subscale
Optimal sleep was considered between 7 to 8 hours of average sleep per night inclusive, while average sleep less than or greater than the 7 to 8 hour of average sleep per night was non-optimal.
Time frame: Week 14
Population: The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pregabalin 165 mg | Percent of Participants Reporting Optimal Sleep on the MOS-SS - Optimal Sleep Subscale | 67.7 percentage of participants |
| Pregabalin 330 mg | Percent of Participants Reporting Optimal Sleep on the MOS-SS - Optimal Sleep Subscale | 60.2 percentage of participants |
| Placebo | Percent of Participants Reporting Optimal Sleep on the MOS-SS - Optimal Sleep Subscale | 60.2 percentage of participants |
Comparison: Logistic regression model was used to calculate the p-value, with the fixed effects for sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg controlled-release (CR), pregabalin 330 mg CR), average hours per night of sleep at baseline as a coninuous covariate, and optimal sleep at Week 14 as dependent variable. No adjustments for multiplicity were taken.p-value: 0.324195% CI: [0.74, 2.5]Regression, Logistic
Comparison: Logistic regression model was used to calculate the p-value, with the fixed effects for sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg controlled-release (CR), pregabalin 330 mg CR), average hours per night of sleep at baseline as a coninuous covariate, and optimal sleep at Week 14 as dependent variable. No adjustments for multiplicity were taken.p-value: 0.893295% CI: [0.54, 1.71]Regression, Logistic