This study collects post-marketing safety and efficacy surveillance data in real world clinical use of pregabalin for its approved indications in Korea.
continuous patients with target disorders in collaborating institutions
Study Type
OBSERVATIONAL
Enrollment
4,175
Pregabalin treatment can be started with a dose of 150 mg per day. Based on individual subject response and tolerability, the dosage may be increased to 300 mg per day after 1 week. The maximum dosage of 600 mg per day may be achieved after an additional week.
Peripheral neuropathic pain: Pregabalin treatment can be started at a dose of 150 mg per day. Based on individual subject response and tolerability, the dosage may be increased to 300 mg per day after an interval of 3 to 7 days, and if needed, to a maximum dose of 600 mg per day after an additional 7-day interval. Central neuropathic pain: Pregabalin treatment can be started at a dose of 150 mg per day. Based on individual subject response and tolerability, the dosage may be increased to 300 mg per day after an interval of 1 week, and if needed, to a maximum dose of 600 mg per day after an additional 1 week interval. In case that tolerability could not be shown in the targeted daily dose, dose reduction may be considered.
Percentage of Participants Achieving 28 Days Seizure Free Period in Intent-to Treat (ITT) Population
Participants were regarded as seizure-free if no seizures (partial or other) were reported for the participant during the period of 28 days in the study.
Time frame: Baseline through Week 12
Percentage of Participants Achieving 28 Days Seizure Free Period in Per Protocol (PP) Population
Participants were regarded as seizure-free if no seizures (partial or other) were reported for the participant during the period of 28 days in the study.
Time frame: Baseline through Week 12
Percentage of Participants With Improvement in Seizure Frequency in ITT Population
Percentage of participants with improvement in seizure frequency of greater than or equal to 75%; greater than or equal to 50% to 74%; 0% to 49% were considered.
Time frame: Baseline through Week 12
Percentage of Participants With Improvement in Seizure Frequency in PP Population
Percentage of participants with improvement in seizure frequency of greater than or equal to 75%; greater than or equal to 50% to 74%; 0% to 49% were considered.
Time frame: Baseline through Week 12
Change From Baseline in Daily Pain Score for NeP in ITT Population at Week 6
Daily Pain Rating Score (DPRS): participant rated 11-point Likert scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain.
Time frame: Baseline and Week 6
Change From Baseline in Daily Pain Score for NeP in PP Population at Week 6
DPRS: participant rated 11-point Likert scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The recommended dose of pregabalin for fibromyalgia is 300 to 450 mg/day. Dosing should begin at 75 mg two times a day (150 mg/day) and may be increased to 150 mg two times a day (300 mg/day) within 1 week based on efficacy and tolerability. Subjects who do not experience sufficient benefit with 300 mg/day may be further increased to 225 mg two times a day (450 mg/day). Treatment with doses above 450 mg/day is not recommended.
Time frame: Baseline and Week 6
Change From Baseline in Daily Pain Score for Fibromyalgia in ITT Population at Week 6
DPRS: participant rated 11-point Likert scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain.
Time frame: Baseline and Week 6
Change From Baseline in Daily Pain Score for Fibromyalgia in PP Population at Week 6
DPRS: participant rated 11-point Likert scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain.
Time frame: Baseline and Week 6
Change From Baseline in Sleep Interference Score for NeP in ITT Population at Week 6
Daily Sleep Interference Score (DSIS): participant rated 11-point Likert scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Self-assessment performed daily on awakening prior to taking study medication.
Time frame: Baseline and Week 6
Change From Baseline in Sleep Interference Score for NeP in PP Population at Week 6
DSIS: participant rated 11-point Likert scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Self-assessment performed daily on awakening prior to taking study medication.
Time frame: Baseline and Week 6
Change From Baseline in Sleep Interference Score for Fibromyalgia in ITT Population at Week 6
DSIS: participant rated 11-point Likert scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Self-assessment performed daily on awakening prior to taking study medication.
Time frame: Baseline and Week 6
Change From Baseline in Sleep Interference Score for Fibromyalgia in PP Population at Week 6
DSIS: participant rated 11-point Likert scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Self-assessment performed daily on awakening prior to taking study medication.
Time frame: Baseline and Week 6
Number of Participants With Clinician's Global Impression of Change (CGIC) Scale for NeP in ITT Population
CGIC: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Change is defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse), 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected.
Time frame: Week 6
Number of Participants With CGIC Scale for NeP in PP Population
CGIC: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Change is defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse), 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected.
Time frame: Week 6
Number of Participants With Patient's Global Impression of Change (PGIC) Scale for NeP in ITT Population
PGIC was defined as participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Change was defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse) , 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected.
Time frame: Week 6
Number of Participants With PGIC Scale for NeP in PP Population
PGIC was defined as participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Change was defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse) , 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected.
Time frame: Week 6
Number of Participants With CGIC Scale for Fibromyalgia in ITT Population
CGIC: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Change was defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse), 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected.
Time frame: Week 6
Number of Participants With CGIC Scale for Fibromyalgia in PP Population
CGIC: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Change was defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse), 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected.
Time frame: Week 6
Number of Participants With PGIC Scale for Fibromyalgia in ITT Population
PGIC was defined as participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Change is defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse) , 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected.
Time frame: Week 6
Number of Participants With PGIC Scale for Fibromyalgia in PP Population
PGIC was defined as participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Change is defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse) , 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected.
Time frame: Week 6