Neuralgia, Pain, Spinal Cord Diseases, Spinal Cord Injuries
Conditions
Keywords
Central Nervous System Diseases, Therapeutic Uses, Wounds and Injuries, Trauma, Nervous System, pregabalin
Brief summary
The purpose of this study is to assess the safety of the long-term use of pregabalin at doses up to 600 mg/day in patients with central neuropathic pain (post spinal cord injury pain, post stroke pain, and multiple sclerosis pain).
Interventions
DRUGpregabalin
Pregabalin capsules taken twice a daily (150-600mg/day)
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion criteria for subjects to be shifted from Study A0081107 * Subjects who completed the 18-week study period in Study A0081107 conducted for chronic neuropathic pain after spinal cord injury; * Subjects who completed assessments of all efficacy endpoints until the end of the treatment phase of the preceding Study A0081107 (V7); Inclusion criteria for subjects to be new participants in this study * Subjects with central neuropathic pain after stroke or multiple sclerosis; * At least 6 months have passed after the onset of central neuropathic pain; * Pain VAS at least 40mm in Visit 1 and Visit 2;
Exclusion criteria
* Creatinine clearance \< 60 mL/min; * Platelet count \< 100 × 103/mm3 ; White blood cell (WBC) count \< 2500 / mm3; Neutrophil count \< 1500/ mm3; * Subjects who are expected to require surgery during the trial;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Peripheral Edema | Baseline, Weeks 4, 20, 36, 52, and 53 | Number of participants who had peripheral edema in lower extremities. Edema was categorized as follows: trace, pitting 1 (lower leg), 2 (lower leg to knee), and 3 (above knee and /or presacral edema). |
| Number of Participants With Facial/Periorbital Edema | Baseline, Weeks 4, 20, 36, 52, and 53 | Number of participants who had facial or periorbital edema. |
| Number of Participants With Generalized or Abdominal Edema | Baseline, Weeks 4, 20, 36, 52, and 53 | Number of participants who had generalized or abdominal edema. |
| Number of Participants With Localized Pain Related to Deep Vein Thrombosis (DVT) | Baseline, Weeks 4, 20, 36, 52, and 53 | DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe. |
| Number of Participants With Localized Tenderness Related to Deep Vein Thrombosis (DVT) | Baseline, Weeks 4, 20, 36, 52, and 53 | DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe. |
| Number of Participants With Swelling Related to Deep Vein Thrombosis (DVT) | Baseline, Weeks 4, 20, 36, 52, and 53 | DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe. |
| Number of Participants With Pitting Edema Related to Deep Vein Thrombosis (DVT) | Baseline, Weeks 4, 20, 36, 52, and 53 | DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe. |
| Number of Participants With Collateral Superficial Veins (Non-varicose) Related to Deep Vein Thrombosis (DVT) | Baseline, Weeks 4, 20, 36, 52, and 53 | DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe. |
| Number of Participants With Skin Redness Related to Deep Vein Thrombosis (DVT) | Baseline, Weeks 4, 20, 36, 52, and 53 | DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe. |
| Number of Participants With Visual Field Deteriorated | 53 weeks | Number of participants who had normal visual field at baseline and showed abnormal result after the study treatment, assessed by confrontational visual field test (neurological examination). |
| Number of Participants With Deterioration in Neurological Examination Findings | 53 weeks | Worsening of the condition relative to baseline was reported as deteriorated. Assessment categories are as follows: normal or abnormal for Cranial Nerve Function, Mental State, and Coordination; normal, mild, moderate, or severe ataxia for Gait; none/absent, normal, or hyper-reflexic for Deep Tendon Reflexes; absent or present for Abnormal Reflexes; normal, mild, moderate, or severe weakness for Muscle Strength; slight, more marked, or considerable increase, or affected parts rigid in flexion or extension for Muscle Tone; absent or present for Sensory Function. |
| Number of Participants With Suicidal Ideation According to Sheehan Suicidality Tracking Scale (Sheehan-STS) | Baseline, Weeks 2, 4, 8, 12, 20, 28, 36, 44, and 52 | The Sheehan-STS is an 8-item prospective rating scale that tracks treatment-emergent suicidal ideation and behaviors. Participants who reported a score of ≥1 (5-point scale ranging from 0: not at all to 4: extremely) for Item 2, 3, 4 or 5 of the Sheehan-STS prognostic scale is considered to have suicidal ideation as the scores are mapped to Category 4 (suicide ideation) of the Columbia Classification Algorithm of Suicide Assessment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Total Scores | Baseline, Weeks 2, 4, 8, 12, 20, 28, 36, 44, and 52 | The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. Range: 0 to 45 for total score. Change = observation mean minus baseline mean. Negative change indicated improvement. |
| Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Sensory Scores | Baseline, Weeks 2, 4, 8, 12, 20, 28, 36, 44, and 52 | The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. Range: 0 to 33 for sensory score. Change = observation mean minus baseline mean. Negative change indicated improvement. |
| Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Affective Scores | Baseline, Weeks 2, 4, 8, 12, 20, 28, 36, 44, and 52 | The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. Range: 0 to 12 for affective score. Change = observation mean minus baseline mean. Negative change indicated improvement. |
| Change From Baseline in the Modified Brief Pain Inventory (10 Item) (mBPI-10)Total Scores at Last Evaluation Score | Baseline, Week 52 | The mBPI-10 is a self administered questionnaire that assesses pain interference with functional activities over the past week. These items are measured on an 11 point scale, ranging from does not interfere (0) to completely interferes (10). A composite score, the Pain Interference Index, will be calculated by averaging the 10 items that comprise the scale. Change = observation mean at Week 52 minus baseline mean. |
Countries
Japan
Participant flow
Recruitment details
Japanese patients with central neuropathic pain after spinal cord injury who had completed the preceding A0081107 study (NCT00407745) were eligible for this study, and Japanese patients with pain after cerebral stroke or with multiple sclerosis pain were newly recruited.
Pre-assignment details
Participants who had joined A0081107 study (NCT00407745) were treated with pregabalin or placebo for 16 weeks and underwent tapering phase prior to this study.
Participants by arm
| Arm | Count |
|---|---|
| Pregabalin Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase. | 103 |
| Total | 103 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 16 |
| Overall Study | Lack of Efficacy | 1 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Pregabalin |
|---|---|
| Age, Customized >=18 and <45 years | 15 Participants |
| Age, Customized >= 45 and <65 years | 60 Participants |
| Age, Customized >=65 years | 28 Participants |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 81 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 91 / 103 |
| serious Total, serious adverse events | 19 / 103 |
Outcome results
Primary
Number of Participants With Collateral Superficial Veins (Non-varicose) Related to Deep Vein Thrombosis (DVT)
DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe.
Time frame: Baseline, Weeks 4, 20, 36, 52, and 53
Population: The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Number of Participants With Collateral Superficial Veins (Non-varicose) Related to Deep Vein Thrombosis (DVT) | Mild at Baseline (n=103) | 0 Participants |
| Pregabalin | Number of Participants With Collateral Superficial Veins (Non-varicose) Related to Deep Vein Thrombosis (DVT) | Moderate at Baseline (n=103) | 0 Participants |
| Pregabalin | Number of Participants With Collateral Superficial Veins (Non-varicose) Related to Deep Vein Thrombosis (DVT) | Severe at Baseline (n=103) | 0 Participants |
| Pregabalin | Number of Participants With Collateral Superficial Veins (Non-varicose) Related to Deep Vein Thrombosis (DVT) | Mild at Week 4 (n=101) | 0 Participants |
| Pregabalin | Number of Participants With Collateral Superficial Veins (Non-varicose) Related to Deep Vein Thrombosis (DVT) | Moderate at Week 4 (n=101) | 0 Participants |
| Pregabalin | Number of Participants With Collateral Superficial Veins (Non-varicose) Related to Deep Vein Thrombosis (DVT) | Severe at Week 4 (n=101) | 0 Participants |
| Pregabalin | Number of Participants With Collateral Superficial Veins (Non-varicose) Related to Deep Vein Thrombosis (DVT) | Mild at Week 20 (n=93) | 0 Participants |
| Pregabalin | Number of Participants With Collateral Superficial Veins (Non-varicose) Related to Deep Vein Thrombosis (DVT) | Moderate at Week 20 (n=93) | 0 Participants |
| Pregabalin | Number of Participants With Collateral Superficial Veins (Non-varicose) Related to Deep Vein Thrombosis (DVT) | Severe at Week 20 (n=93) | 0 Participants |
| Pregabalin | Number of Participants With Collateral Superficial Veins (Non-varicose) Related to Deep Vein Thrombosis (DVT) | Mild at Week 36 (n=90) | 0 Participants |
| Pregabalin | Number of Participants With Collateral Superficial Veins (Non-varicose) Related to Deep Vein Thrombosis (DVT) | Moderate at Week 36 (n=90) | 0 Participants |
| Pregabalin | Number of Participants With Collateral Superficial Veins (Non-varicose) Related to Deep Vein Thrombosis (DVT) | Severe at Week 36 (n=90) | 0 Participants |
| Pregabalin | Number of Participants With Collateral Superficial Veins (Non-varicose) Related to Deep Vein Thrombosis (DVT) | Mild at Week 52/early termination (n=100) | 0 Participants |
| Pregabalin | Number of Participants With Collateral Superficial Veins (Non-varicose) Related to Deep Vein Thrombosis (DVT) | Moderate at Week 52/early termination (n=100) | 0 Participants |
| Pregabalin | Number of Participants With Collateral Superficial Veins (Non-varicose) Related to Deep Vein Thrombosis (DVT) | Severe at Week 52/early termination (n=100) | 0 Participants |
| Pregabalin | Number of Participants With Collateral Superficial Veins (Non-varicose) Related to Deep Vein Thrombosis (DVT) | Mild at Week 53/early termination (n=78) | 0 Participants |
| Pregabalin | Number of Participants With Collateral Superficial Veins (Non-varicose) Related to Deep Vein Thrombosis (DVT) | Moderate at Week 53/early termination (n=78) | 0 Participants |
| Pregabalin | Number of Participants With Collateral Superficial Veins (Non-varicose) Related to Deep Vein Thrombosis (DVT) | Severe at Week 53/early termination (n=78) | 0 Participants |
Primary
Number of Participants With Deterioration in Neurological Examination Findings
Worsening of the condition relative to baseline was reported as deteriorated. Assessment categories are as follows: normal or abnormal for Cranial Nerve Function, Mental State, and Coordination; normal, mild, moderate, or severe ataxia for Gait; none/absent, normal, or hyper-reflexic for Deep Tendon Reflexes; absent or present for Abnormal Reflexes; normal, mild, moderate, or severe weakness for Muscle Strength; slight, more marked, or considerable increase, or affected parts rigid in flexion or extension for Muscle Tone; absent or present for Sensory Function.
Time frame: 53 weeks
Population: The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Number of Participants With Deterioration in Neurological Examination Findings | Cranial Nerve Function | 0 Participants |
| Pregabalin | Number of Participants With Deterioration in Neurological Examination Findings | Mental State | 0 Participants |
| Pregabalin | Number of Participants With Deterioration in Neurological Examination Findings | Coordination: Right (R)- Finger to Nose | 0 Participants |
| Pregabalin | Number of Participants With Deterioration in Neurological Examination Findings | Coordination: Left (L)- Finger to Nose | 2 Participants |
| Pregabalin | Number of Participants With Deterioration in Neurological Examination Findings | Coordination: R- Finger Tapping | 1 Participants |
| Pregabalin | Number of Participants With Deterioration in Neurological Examination Findings | Coordination: L- Finger Tapping | 0 Participants |
| Pregabalin | Number of Participants With Deterioration in Neurological Examination Findings | Coordination: R- Rapid Alternating Hand Movement | 1 Participants |
| Pregabalin | Number of Participants With Deterioration in Neurological Examination Findings | Coordination: L- Rapid Alternating Hand Movement | 2 Participants |
| Pregabalin | Number of Participants With Deterioration in Neurological Examination Findings | Coordination: Romberg Test | 1 Participants |
| Pregabalin | Number of Participants With Deterioration in Neurological Examination Findings | Gait | 1 Participants |
| Pregabalin | Number of Participants With Deterioration in Neurological Examination Findings | Deep Tendon Reflexes: R- Brachioradialis | 1 Participants |
| Pregabalin | Number of Participants With Deterioration in Neurological Examination Findings | Deep Tendon Reflexes: L- Brachioradialis | 1 Participants |
| Pregabalin | Number of Participants With Deterioration in Neurological Examination Findings | Deep Tendon Reflexes: R-Patellar | 3 Participants |
| Pregabalin | Number of Participants With Deterioration in Neurological Examination Findings | Deep Tendon Reflexes: L-Patellar | 3 Participants |
| Pregabalin | Number of Participants With Deterioration in Neurological Examination Findings | Deep Tendon Reflexes: R- Achilles | 2 Participants |
| Pregabalin | Number of Participants With Deterioration in Neurological Examination Findings | Deep Tendon Reflexes: L- Achilles | 3 Participants |
| Pregabalin | Number of Participants With Deterioration in Neurological Examination Findings | Abnormal Reflexes | 1 Participants |
| Pregabalin | Number of Participants With Deterioration in Neurological Examination Findings | Sensory Function: Hypesthesia | 1 Participants |
| Pregabalin | Number of Participants With Deterioration in Neurological Examination Findings | Muscle Strength: R- Upper Limb | 1 Participants |
| Pregabalin | Number of Participants With Deterioration in Neurological Examination Findings | Muscle Strength: L- Upper Limb | 2 Participants |
| Pregabalin | Number of Participants With Deterioration in Neurological Examination Findings | Muscle Strength: R- Lower Limb | 1 Participants |
| Pregabalin | Number of Participants With Deterioration in Neurological Examination Findings | Muscle Strength: L- Lower Limb | 2 Participants |
| Pregabalin | Number of Participants With Deterioration in Neurological Examination Findings | Muscle Tone: R- Upper Limb | 1 Participants |
| Pregabalin | Number of Participants With Deterioration in Neurological Examination Findings | Muscle Tone: L- Upper Limb | 1 Participants |
| Pregabalin | Number of Participants With Deterioration in Neurological Examination Findings | Muscle Tone: R- Lower Limb | 5 Participants |
| Pregabalin | Number of Participants With Deterioration in Neurological Examination Findings | Muscle Tone: L- Lower Limb | 5 Participants |
| Pregabalin | Number of Participants With Deterioration in Neurological Examination Findings | Sensory Function: Anesthesia | 0 Participants |
| Pregabalin | Number of Participants With Deterioration in Neurological Examination Findings | Sensory Function: Allodynia | 1 Participants |
| Pregabalin | Number of Participants With Deterioration in Neurological Examination Findings | Sensory Function: Hyperalgesia | 2 Participants |
Primary
Number of Participants With Facial/Periorbital Edema
Number of participants who had facial or periorbital edema.
Time frame: Baseline, Weeks 4, 20, 36, 52, and 53
Population: The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Number of Participants With Facial/Periorbital Edema | Week 52/early termination (n=100) | 1 Participants |
| Pregabalin | Number of Participants With Facial/Periorbital Edema | Baseline (n=103) | 0 Participants |
| Pregabalin | Number of Participants With Facial/Periorbital Edema | Week 4 (n=101) | 0 Participants |
| Pregabalin | Number of Participants With Facial/Periorbital Edema | Week 20 (n=93) | 0 Participants |
| Pregabalin | Number of Participants With Facial/Periorbital Edema | Week 36 (n=90) | 0 Participants |
| Pregabalin | Number of Participants With Facial/Periorbital Edema | Week 53/early termination (n=78) | 0 Participants |
Primary
Number of Participants With Generalized or Abdominal Edema
Number of participants who had generalized or abdominal edema.
Time frame: Baseline, Weeks 4, 20, 36, 52, and 53
Population: The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Number of Participants With Generalized or Abdominal Edema | Baseline (n=103) | 0 Participants |
| Pregabalin | Number of Participants With Generalized or Abdominal Edema | Week 4 (n=101) | 0 Participants |
| Pregabalin | Number of Participants With Generalized or Abdominal Edema | Week 20 (n=93) | 0 Participants |
| Pregabalin | Number of Participants With Generalized or Abdominal Edema | Week 36 (n=90) | 0 Participants |
| Pregabalin | Number of Participants With Generalized or Abdominal Edema | Week 52/early termination (n=100) | 1 Participants |
| Pregabalin | Number of Participants With Generalized or Abdominal Edema | Week 53/early termination (n=78) | 0 Participants |
Primary
Number of Participants With Localized Pain Related to Deep Vein Thrombosis (DVT)
DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe.
Time frame: Baseline, Weeks 4, 20, 36, 52, and 53
Population: The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Number of Participants With Localized Pain Related to Deep Vein Thrombosis (DVT) | Mild at Baseline (n=103) | 2 Participants |
| Pregabalin | Number of Participants With Localized Pain Related to Deep Vein Thrombosis (DVT) | Moderate at Baseline (n=103) | 3 Participants |
| Pregabalin | Number of Participants With Localized Pain Related to Deep Vein Thrombosis (DVT) | Severe at Baseline (n=103) | 1 Participants |
| Pregabalin | Number of Participants With Localized Pain Related to Deep Vein Thrombosis (DVT) | Mild at Week 4 (n=101) | 5 Participants |
| Pregabalin | Number of Participants With Localized Pain Related to Deep Vein Thrombosis (DVT) | Moderate at Week 4 (n=101) | 1 Participants |
| Pregabalin | Number of Participants With Localized Pain Related to Deep Vein Thrombosis (DVT) | Severe at Week 4 (n=101) | 0 Participants |
| Pregabalin | Number of Participants With Localized Pain Related to Deep Vein Thrombosis (DVT) | Mild at Week 20 (n=93) | 3 Participants |
| Pregabalin | Number of Participants With Localized Pain Related to Deep Vein Thrombosis (DVT) | Moderate at Week 20 (n=93) | 0 Participants |
| Pregabalin | Number of Participants With Localized Pain Related to Deep Vein Thrombosis (DVT) | Severe at Week 20 (n=93) | 0 Participants |
| Pregabalin | Number of Participants With Localized Pain Related to Deep Vein Thrombosis (DVT) | Mild at Week 36 (n=90) | 3 Participants |
| Pregabalin | Number of Participants With Localized Pain Related to Deep Vein Thrombosis (DVT) | Moderate at Week 36 (n=90) | 0 Participants |
| Pregabalin | Number of Participants With Localized Pain Related to Deep Vein Thrombosis (DVT) | Severe at Week 36 (n=90) | 0 Participants |
| Pregabalin | Number of Participants With Localized Pain Related to Deep Vein Thrombosis (DVT) | Mild at Week 52/early termination (n=100) | 3 Participants |
| Pregabalin | Number of Participants With Localized Pain Related to Deep Vein Thrombosis (DVT) | Moderate at Week 52/early termination (n=100) | 0 Participants |
| Pregabalin | Number of Participants With Localized Pain Related to Deep Vein Thrombosis (DVT) | Severe at Week 52/early termination (n=100) | 1 Participants |
| Pregabalin | Number of Participants With Localized Pain Related to Deep Vein Thrombosis (DVT) | Mild at Week 53/early termination (n=78) | 2 Participants |
| Pregabalin | Number of Participants With Localized Pain Related to Deep Vein Thrombosis (DVT) | Moderate at Week 53/early termination (n=78) | 1 Participants |
| Pregabalin | Number of Participants With Localized Pain Related to Deep Vein Thrombosis (DVT) | Severe at Week 53/early termination (n=78) | 0 Participants |
Primary
Number of Participants With Localized Tenderness Related to Deep Vein Thrombosis (DVT)
DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe.
Time frame: Baseline, Weeks 4, 20, 36, 52, and 53
Population: The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Number of Participants With Localized Tenderness Related to Deep Vein Thrombosis (DVT) | Mild at Baseline (n=103) | 0 Participants |
| Pregabalin | Number of Participants With Localized Tenderness Related to Deep Vein Thrombosis (DVT) | Moderate at Baseline (n=103) | 0 Participants |
| Pregabalin | Number of Participants With Localized Tenderness Related to Deep Vein Thrombosis (DVT) | Severe at Baseline (n=103) | 0 Participants |
| Pregabalin | Number of Participants With Localized Tenderness Related to Deep Vein Thrombosis (DVT) | Mild at Week 4 (n=101) | 0 Participants |
| Pregabalin | Number of Participants With Localized Tenderness Related to Deep Vein Thrombosis (DVT) | Moderate at Week 4 (n=101) | 0 Participants |
| Pregabalin | Number of Participants With Localized Tenderness Related to Deep Vein Thrombosis (DVT) | Severe at Week 4 (n=101) | 0 Participants |
| Pregabalin | Number of Participants With Localized Tenderness Related to Deep Vein Thrombosis (DVT) | Mild at Week 20 (n=93) | 0 Participants |
| Pregabalin | Number of Participants With Localized Tenderness Related to Deep Vein Thrombosis (DVT) | Moderate at Week 20 (n=93) | 0 Participants |
| Pregabalin | Number of Participants With Localized Tenderness Related to Deep Vein Thrombosis (DVT) | Severe at Week 20 (n=93) | 0 Participants |
| Pregabalin | Number of Participants With Localized Tenderness Related to Deep Vein Thrombosis (DVT) | Mild at Week 36 (n=90) | 0 Participants |
| Pregabalin | Number of Participants With Localized Tenderness Related to Deep Vein Thrombosis (DVT) | Moderate at Week 36 (n=90) | 0 Participants |
| Pregabalin | Number of Participants With Localized Tenderness Related to Deep Vein Thrombosis (DVT) | Severe at Week 36 (n=90) | 0 Participants |
| Pregabalin | Number of Participants With Localized Tenderness Related to Deep Vein Thrombosis (DVT) | Mild at Week 52/early termination (n=100) | 0 Participants |
| Pregabalin | Number of Participants With Localized Tenderness Related to Deep Vein Thrombosis (DVT) | Moderate at Week 52/early termination (n=100) | 0 Participants |
| Pregabalin | Number of Participants With Localized Tenderness Related to Deep Vein Thrombosis (DVT) | Severe at Week 52/early termination (n=100) | 0 Participants |
| Pregabalin | Number of Participants With Localized Tenderness Related to Deep Vein Thrombosis (DVT) | Mild at Week 53/early termination (n=78) | 0 Participants |
| Pregabalin | Number of Participants With Localized Tenderness Related to Deep Vein Thrombosis (DVT) | Moderate at Week 53/early termination (n=78) | 0 Participants |
| Pregabalin | Number of Participants With Localized Tenderness Related to Deep Vein Thrombosis (DVT) | Severe at Week 53/early termination (n=78) | 0 Participants |
Primary
Number of Participants With Peripheral Edema
Number of participants who had peripheral edema in lower extremities. Edema was categorized as follows: trace, pitting 1 (lower leg), 2 (lower leg to knee), and 3 (above knee and /or presacral edema).
Time frame: Baseline, Weeks 4, 20, 36, 52, and 53
Population: The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Number of Participants With Peripheral Edema | Pitting +3 at Week 36 (n=90) | 0 Participants |
| Pregabalin | Number of Participants With Peripheral Edema | Trace at Baseline (n=103) | 5 Participants |
| Pregabalin | Number of Participants With Peripheral Edema | Pitting +1 at Baseline (n=103) | 9 Participants |
| Pregabalin | Number of Participants With Peripheral Edema | Pitting +2 at Baseline (n=103) | 2 Participants |
| Pregabalin | Number of Participants With Peripheral Edema | Pitting +3 at Baseline (n=103) | 0 Participants |
| Pregabalin | Number of Participants With Peripheral Edema | Trace at Week 4 (n=101) | 8 Participants |
| Pregabalin | Number of Participants With Peripheral Edema | Pitting +1 at Week 4 (n=101) | 8 Participants |
| Pregabalin | Number of Participants With Peripheral Edema | Pitting +2 at Week 4 (n=101) | 4 Participants |
| Pregabalin | Number of Participants With Peripheral Edema | Pitting +3 at Week 4 (n=101) | 1 Participants |
| Pregabalin | Number of Participants With Peripheral Edema | Trace at Week 20 (n=93) | 8 Participants |
| Pregabalin | Number of Participants With Peripheral Edema | Pitting +1 at Week 20 (n=93) | 3 Participants |
| Pregabalin | Number of Participants With Peripheral Edema | Pitting +2 at Week 20 (n=93) | 7 Participants |
| Pregabalin | Number of Participants With Peripheral Edema | Pitting +3 at Week 20 (n=93) | 0 Participants |
| Pregabalin | Number of Participants With Peripheral Edema | Trace at Week 36 (n=90) | 14 Participants |
| Pregabalin | Number of Participants With Peripheral Edema | Pitting +1 at Week 36 (n=90) | 7 Participants |
| Pregabalin | Number of Participants With Peripheral Edema | Pitting +2 at Week 36 (n=90) | 3 Participants |
| Pregabalin | Number of Participants With Peripheral Edema | Trace at Week 52/early termination (n=100) | 10 Participants |
| Pregabalin | Number of Participants With Peripheral Edema | Pitting +1 at Week 52/early termination (n=100) | 7 Participants |
| Pregabalin | Number of Participants With Peripheral Edema | Pitting +2 at Week 52/early termination (n=100) | 2 Participants |
| Pregabalin | Number of Participants With Peripheral Edema | Pitting +3 at Week 52/early termination (n=100) | 0 Participants |
| Pregabalin | Number of Participants With Peripheral Edema | Trace at Week 53/early termination (n=78) | 9 Participants |
| Pregabalin | Number of Participants With Peripheral Edema | Pitting +1 at Week 53/early termination (n=78) | 5 Participants |
| Pregabalin | Number of Participants With Peripheral Edema | Pitting +2 at Week 53/early termination (n=78) | 0 Participants |
| Pregabalin | Number of Participants With Peripheral Edema | Pitting +3 at Week 53/early termination (n=78) | 0 Participants |
Primary
Number of Participants With Pitting Edema Related to Deep Vein Thrombosis (DVT)
DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe.
Time frame: Baseline, Weeks 4, 20, 36, 52, and 53
Population: The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Number of Participants With Pitting Edema Related to Deep Vein Thrombosis (DVT) | Mild at Baseline (n=103) | 6 Participants |
| Pregabalin | Number of Participants With Pitting Edema Related to Deep Vein Thrombosis (DVT) | Moderate at Baseline (n=103) | 1 Participants |
| Pregabalin | Number of Participants With Pitting Edema Related to Deep Vein Thrombosis (DVT) | Severe at Baseline (n=103) | 0 Participants |
| Pregabalin | Number of Participants With Pitting Edema Related to Deep Vein Thrombosis (DVT) | Mild at Week 4 (n=101) | 5 Participants |
| Pregabalin | Number of Participants With Pitting Edema Related to Deep Vein Thrombosis (DVT) | Moderate at Week 4 (n=101) | 2 Participants |
| Pregabalin | Number of Participants With Pitting Edema Related to Deep Vein Thrombosis (DVT) | Severe at Week 4 (n=101) | 0 Participants |
| Pregabalin | Number of Participants With Pitting Edema Related to Deep Vein Thrombosis (DVT) | Mild at Week 20 (n=93) | 4 Participants |
| Pregabalin | Number of Participants With Pitting Edema Related to Deep Vein Thrombosis (DVT) | Moderate at Week 20 (n=93) | 1 Participants |
| Pregabalin | Number of Participants With Pitting Edema Related to Deep Vein Thrombosis (DVT) | Severe at Week 20 (n=93) | 0 Participants |
| Pregabalin | Number of Participants With Pitting Edema Related to Deep Vein Thrombosis (DVT) | Mild at Week 36 (n=90) | 7 Participants |
| Pregabalin | Number of Participants With Pitting Edema Related to Deep Vein Thrombosis (DVT) | Moderate at Week 36 (n=90) | 0 Participants |
| Pregabalin | Number of Participants With Pitting Edema Related to Deep Vein Thrombosis (DVT) | Severe at Week 36 (n=90) | 0 Participants |
| Pregabalin | Number of Participants With Pitting Edema Related to Deep Vein Thrombosis (DVT) | Mild at Week 52/early termination (n=100) | 8 Participants |
| Pregabalin | Number of Participants With Pitting Edema Related to Deep Vein Thrombosis (DVT) | Moderate at Week 52/early termination (n=100) | 0 Participants |
| Pregabalin | Number of Participants With Pitting Edema Related to Deep Vein Thrombosis (DVT) | Severe at Week 52/early termination (n=100) | 0 Participants |
| Pregabalin | Number of Participants With Pitting Edema Related to Deep Vein Thrombosis (DVT) | Mild at Week 53/early termination (n=78) | 4 Participants |
| Pregabalin | Number of Participants With Pitting Edema Related to Deep Vein Thrombosis (DVT) | Moderate at Week 53/early termination (n=78) | 0 Participants |
| Pregabalin | Number of Participants With Pitting Edema Related to Deep Vein Thrombosis (DVT) | Severe at Week 53/early termination (n=78) | 0 Participants |
Primary
Number of Participants With Skin Redness Related to Deep Vein Thrombosis (DVT)
DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe.
Time frame: Baseline, Weeks 4, 20, 36, 52, and 53
Population: The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Number of Participants With Skin Redness Related to Deep Vein Thrombosis (DVT) | Mild at Baseline (n=103) | 0 Participants |
| Pregabalin | Number of Participants With Skin Redness Related to Deep Vein Thrombosis (DVT) | Moderate at Baseline (n=103) | 0 Participants |
| Pregabalin | Number of Participants With Skin Redness Related to Deep Vein Thrombosis (DVT) | Severe at Baseline (n=103) | 0 Participants |
| Pregabalin | Number of Participants With Skin Redness Related to Deep Vein Thrombosis (DVT) | Mild at Week 4 (n=101) | 0 Participants |
| Pregabalin | Number of Participants With Skin Redness Related to Deep Vein Thrombosis (DVT) | Moderate at Week 4 (n=101) | 0 Participants |
| Pregabalin | Number of Participants With Skin Redness Related to Deep Vein Thrombosis (DVT) | Severe at Week 4 (n=101) | 0 Participants |
| Pregabalin | Number of Participants With Skin Redness Related to Deep Vein Thrombosis (DVT) | Mild at Week 20 (n=93) | 1 Participants |
| Pregabalin | Number of Participants With Skin Redness Related to Deep Vein Thrombosis (DVT) | Moderate at Week 20 (n=93) | 0 Participants |
| Pregabalin | Number of Participants With Skin Redness Related to Deep Vein Thrombosis (DVT) | Severe at Week 20 (n=93) | 0 Participants |
| Pregabalin | Number of Participants With Skin Redness Related to Deep Vein Thrombosis (DVT) | Mild at Week 36 (n=90) | 0 Participants |
| Pregabalin | Number of Participants With Skin Redness Related to Deep Vein Thrombosis (DVT) | Moderate at Week 36 (n=90) | 0 Participants |
| Pregabalin | Number of Participants With Skin Redness Related to Deep Vein Thrombosis (DVT) | Severe at Week 36 (n=90) | 0 Participants |
| Pregabalin | Number of Participants With Skin Redness Related to Deep Vein Thrombosis (DVT) | Mild at Week 52/early termination (n=100) | 0 Participants |
| Pregabalin | Number of Participants With Skin Redness Related to Deep Vein Thrombosis (DVT) | Moderate at Week 52/early termination (n=100) | 0 Participants |
| Pregabalin | Number of Participants With Skin Redness Related to Deep Vein Thrombosis (DVT) | Severe at Week 52/early termination (n=100) | 0 Participants |
| Pregabalin | Number of Participants With Skin Redness Related to Deep Vein Thrombosis (DVT) | Mild at Week 53/early termination (n=78) | 0 Participants |
| Pregabalin | Number of Participants With Skin Redness Related to Deep Vein Thrombosis (DVT) | Moderate at Week 53/early termination (n=78) | 0 Participants |
| Pregabalin | Number of Participants With Skin Redness Related to Deep Vein Thrombosis (DVT) | Severe at Week 53/early termination (n=78) | 0 Participants |
Primary
Number of Participants With Suicidal Ideation According to Sheehan Suicidality Tracking Scale (Sheehan-STS)
The Sheehan-STS is an 8-item prospective rating scale that tracks treatment-emergent suicidal ideation and behaviors. Participants who reported a score of ≥1 (5-point scale ranging from 0: not at all to 4: extremely) for Item 2, 3, 4 or 5 of the Sheehan-STS prognostic scale is considered to have suicidal ideation as the scores are mapped to Category 4 (suicide ideation) of the Columbia Classification Algorithm of Suicide Assessment.
Time frame: Baseline, Weeks 2, 4, 8, 12, 20, 28, 36, 44, and 52
Population: The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Number of Participants With Suicidal Ideation According to Sheehan Suicidality Tracking Scale (Sheehan-STS) | Baseline (n=103) | 3 Participants |
| Pregabalin | Number of Participants With Suicidal Ideation According to Sheehan Suicidality Tracking Scale (Sheehan-STS) | Week 2 (n=102) | 2 Participants |
| Pregabalin | Number of Participants With Suicidal Ideation According to Sheehan Suicidality Tracking Scale (Sheehan-STS) | Week 4 (n=101) | 1 Participants |
| Pregabalin | Number of Participants With Suicidal Ideation According to Sheehan Suicidality Tracking Scale (Sheehan-STS) | Week 8 (n=99) | 0 Participants |
| Pregabalin | Number of Participants With Suicidal Ideation According to Sheehan Suicidality Tracking Scale (Sheehan-STS) | Week 12 (n=96) | 0 Participants |
| Pregabalin | Number of Participants With Suicidal Ideation According to Sheehan Suicidality Tracking Scale (Sheehan-STS) | Week 20 (n=93) | 2 Participants |
| Pregabalin | Number of Participants With Suicidal Ideation According to Sheehan Suicidality Tracking Scale (Sheehan-STS) | Week 28 (n=91) | 2 Participants |
| Pregabalin | Number of Participants With Suicidal Ideation According to Sheehan Suicidality Tracking Scale (Sheehan-STS) | Week 36 (n=90) | 2 Participants |
| Pregabalin | Number of Participants With Suicidal Ideation According to Sheehan Suicidality Tracking Scale (Sheehan-STS) | Week 44 (n=85) | 2 Participants |
| Pregabalin | Number of Participants With Suicidal Ideation According to Sheehan Suicidality Tracking Scale (Sheehan-STS) | Week 52 (n=101) | 0 Participants |
Primary
Number of Participants With Swelling Related to Deep Vein Thrombosis (DVT)
DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe.
Time frame: Baseline, Weeks 4, 20, 36, 52, and 53
Population: The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Number of Participants With Swelling Related to Deep Vein Thrombosis (DVT) | Mild at Baseline (n=103) | 4 Participants |
| Pregabalin | Number of Participants With Swelling Related to Deep Vein Thrombosis (DVT) | Moderate at Baseline (n=103) | 2 Participants |
| Pregabalin | Number of Participants With Swelling Related to Deep Vein Thrombosis (DVT) | Severe at Baseline (n=103) | 0 Participants |
| Pregabalin | Number of Participants With Swelling Related to Deep Vein Thrombosis (DVT) | Mild at Week 4 (n=101) | 3 Participants |
| Pregabalin | Number of Participants With Swelling Related to Deep Vein Thrombosis (DVT) | Moderate at Week 4 (n=101) | 2 Participants |
| Pregabalin | Number of Participants With Swelling Related to Deep Vein Thrombosis (DVT) | Severe at Week 4 (n=101) | 0 Participants |
| Pregabalin | Number of Participants With Swelling Related to Deep Vein Thrombosis (DVT) | Mild at Week 20 (n=93) | 3 Participants |
| Pregabalin | Number of Participants With Swelling Related to Deep Vein Thrombosis (DVT) | Moderate at Week 20 (n=93) | 2 Participants |
| Pregabalin | Number of Participants With Swelling Related to Deep Vein Thrombosis (DVT) | Severe at Week 20 (n=93) | 0 Participants |
| Pregabalin | Number of Participants With Swelling Related to Deep Vein Thrombosis (DVT) | Mild at Week 36 (n=90) | 4 Participants |
| Pregabalin | Number of Participants With Swelling Related to Deep Vein Thrombosis (DVT) | Moderate at Week 36 (n=90) | 1 Participants |
| Pregabalin | Number of Participants With Swelling Related to Deep Vein Thrombosis (DVT) | Severe at Week 36 (n=90) | 0 Participants |
| Pregabalin | Number of Participants With Swelling Related to Deep Vein Thrombosis (DVT) | Mild at Week 52/early termination (n=100) | 7 Participants |
| Pregabalin | Number of Participants With Swelling Related to Deep Vein Thrombosis (DVT) | Moderate at Week 52/early termination (n=100) | 0 Participants |
| Pregabalin | Number of Participants With Swelling Related to Deep Vein Thrombosis (DVT) | Severe at Week 52/early termination (n=100) | 0 Participants |
| Pregabalin | Number of Participants With Swelling Related to Deep Vein Thrombosis (DVT) | Mild at Week 53/early termination (n=78) | 5 Participants |
| Pregabalin | Number of Participants With Swelling Related to Deep Vein Thrombosis (DVT) | Moderate at Week 53/early termination (n=78) | 0 Participants |
| Pregabalin | Number of Participants With Swelling Related to Deep Vein Thrombosis (DVT) | Severe at Week 53/early termination (n=78) | 0 Participants |
Primary
Number of Participants With Visual Field Deteriorated
Number of participants who had normal visual field at baseline and showed abnormal result after the study treatment, assessed by confrontational visual field test (neurological examination).
Time frame: 53 weeks
Population: The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Number of Participants With Visual Field Deteriorated | Right eye | 0 Participants |
| Pregabalin | Number of Participants With Visual Field Deteriorated | Left eye | 0 Participants |
Secondary
Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Affective Scores
The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. Range: 0 to 12 for affective score. Change = observation mean minus baseline mean. Negative change indicated improvement.
Time frame: Baseline, Weeks 2, 4, 8, 12, 20, 28, 36, 44, and 52
Population: The full analysis set consists of all participants who received at least one dose of study medication in this long-term study and for whom post-treatment data were available. For study endpoint of efficacy (Week 52), missing values was imputed with the last observation carried forward (LOCF).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Pregabalin | Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Affective Scores | Week 52 (LOCF, n=103) | -1.0 Score on a scale |
| Pregabalin | Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Affective Scores | Week 2 (n=103) | -1.1 Score on a scale |
| Pregabalin | Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Affective Scores | Week 4 (n=102) | -1.3 Score on a scale |
| Pregabalin | Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Affective Scores | Week 8 (n=99) | -1.3 Score on a scale |
| Pregabalin | Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Affective Scores | Week 12 (n=98) | -1.5 Score on a scale |
| Pregabalin | Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Affective Scores | Week 20 (n=95) | -1.6 Score on a scale |
| Pregabalin | Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Affective Scores | Week 28 (n=92) | -1.3 Score on a scale |
| Pregabalin | Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Affective Scores | Week 36 (n=91) | -1.3 Score on a scale |
| Pregabalin | Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Affective Scores | Week 44 (n=87) | -1.3 Score on a scale |
| Pregabalin | Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Affective Scores | Week 52 (n=85) | -1.4 Score on a scale |
Secondary
Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Sensory Scores
The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. Range: 0 to 33 for sensory score. Change = observation mean minus baseline mean. Negative change indicated improvement.
Time frame: Baseline, Weeks 2, 4, 8, 12, 20, 28, 36, 44, and 52
Population: The full analysis set consists of all participants who received at least one dose of study medication in this long-term study and for whom post-treatment data were available. For study endpoint of efficacy (Week 52), missing values was imputed with the last observation carried forward (LOCF).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Pregabalin | Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Sensory Scores | Week 2 (n=103) | -3.1 Score on a scale |
| Pregabalin | Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Sensory Scores | Week 4 (n=102) | -3.9 Score on a scale |
| Pregabalin | Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Sensory Scores | Week 8 (n=99) | -3.9 Score on a scale |
| Pregabalin | Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Sensory Scores | Week 12 (n=98) | -4.2 Score on a scale |
| Pregabalin | Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Sensory Scores | Week 20 (n=95) | -4.5 Score on a scale |
| Pregabalin | Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Sensory Scores | Week 28 (n=92) | -3.8 Score on a scale |
| Pregabalin | Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Sensory Scores | Week 36 (n=91) | -3.7 Score on a scale |
| Pregabalin | Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Sensory Scores | Week 44 (n=87) | -3.1 Score on a scale |
| Pregabalin | Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Sensory Scores | Week 52 (n=85) | -3.6 Score on a scale |
| Pregabalin | Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Sensory Scores | Week 52 (LOCF, n=103) | -3.6 Score on a scale |
Secondary
Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Total Scores
The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. Range: 0 to 45 for total score. Change = observation mean minus baseline mean. Negative change indicated improvement.
Time frame: Baseline, Weeks 2, 4, 8, 12, 20, 28, 36, 44, and 52
Population: The full analysis set consists of all participants who received at least one dose of study medication in this long-term study and for whom post-treatment data were available. For study endpoint of efficacy (Week 52), missing values was imputed with the last observation carried forward (LOCF).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Pregabalin | Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Total Scores | Week 2 (n=103) | -4.2 Score on a scale |
| Pregabalin | Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Total Scores | Week 4 (n=102) | -5.2 Score on a scale |
| Pregabalin | Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Total Scores | Week 8 (n=99) | -5.3 Score on a scale |
| Pregabalin | Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Total Scores | Week 12 (n=98) | -5.7 Score on a scale |
| Pregabalin | Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Total Scores | Week 20 (n=95) | -6.1 Score on a scale |
| Pregabalin | Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Total Scores | Week 28 (n=92) | -5.1 Score on a scale |
| Pregabalin | Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Total Scores | Week 36 (n=91) | -5.0 Score on a scale |
| Pregabalin | Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Total Scores | Week 44 (n=87) | -4.4 Score on a scale |
| Pregabalin | Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Total Scores | Week 52 (n=85) | -5.0 Score on a scale |
| Pregabalin | Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Total Scores | Week 52 (LOCF, n=103) | -4.6 Score on a scale |
Secondary
Change From Baseline in the Modified Brief Pain Inventory (10 Item) (mBPI-10)Total Scores at Last Evaluation Score
The mBPI-10 is a self administered questionnaire that assesses pain interference with functional activities over the past week. These items are measured on an 11 point scale, ranging from does not interfere (0) to completely interferes (10). A composite score, the Pain Interference Index, will be calculated by averaging the 10 items that comprise the scale. Change = observation mean at Week 52 minus baseline mean.
Time frame: Baseline, Week 52
Population: The full analysis set consists of all participants who received at least one dose of study medication in this long-term study and for whom post-treatment data were available.~The number of participants who had mBPI at Week 52/ Early Termination was 101 participants (n=101).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Pregabalin | Change From Baseline in the Modified Brief Pain Inventory (10 Item) (mBPI-10)Total Scores at Last Evaluation Score | -1.4 Score on a scale |