Lyrica (Pregabalin) Korean Post Marketing Surveillance Study

Study Overview
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Brief Summary
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This study collects post-marketing safety and efficacy surveillance data in real world clinical use of pregabalin for its approved indications in Korea.

Detailed Description
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continuous patients with target disorders in collaborating institutions

Official Title
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Post Marketing Surveillance Study For Observing Safety And Efficacy Of Lyrica

Conditions
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Epilepsy, Neuropathic Pain, Fibromyalgia, Post-market Surveillance

Intervention / Treatment
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* Drug: pregabalin (Lyrica)
* Drug: pregabalin (Lyrica)
* Drug: pregabalin (Lyrica)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any patient treated with pregabalin for an approved indication by Korean Food and Drug Administration Exclusion Criteria: Non-consenting Hypersensitivity to the active substance or to any of the excipients galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Epilepsy<br> | Drug: pregabalin (Lyrica)<br>* 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.<br>|
| Neuropathic Pain<br> | Drug: pregabalin (Lyrica)<br>* 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.<br>|
| Fibromyalgia<br> | Drug: pregabalin (Lyrica)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline and Week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Week 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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epilepsy, neuropathic pain, fibromyalgia, post-market surveillance, prospective observational