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).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
104
Pregabalin capsules taken twice a daily (150-600mg/day)
Chubu Rosai Hospital
Nagoya, Aichi-ken, Japan
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
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
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
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
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
Number of Participants With Swelling Related to Deep Vein Thrombosis (DVT)
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Kimura Clinic
Nagoya, Aichi-ken, Japan
Nagoya Kyoritsu Clinic
Nagoya, Aichi-ken, Japan
Senboku Kumiai General Hospital
Daisen, Akita, Japan
Go neurosurgical clinic
Chikushi-gun, Fukuoka, Japan
Spinal Injuries Center
Iizuka, Fukuoka, Japan
Brain Attack Center Ota Memorial Hospital
Fukuyama, Hiroshima, Japan
Hokkaido Chuo Rosai Hospital Sekison Center
Bibai, Hokkaido, Japan
Hakodate Central General Hospital
Hakodate, Hokkaido, Japan
Kobe Tokushukai Hospital
Kobe, Hyōgo, Japan
...and 16 more locations
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
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
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
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
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
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
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
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
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
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
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