EpilepsyNCT01220180

Lyrica (Pregabalin) Korean Post Marketing Surveillance Study

An observational study of Epilepsy and Neuropathic Pain, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study collects post-marketing safety and efficacy surveillance data in real world clinical use of pregabalin for its approved indications in Korea. Read more about this study

Who is it for?: Any age
Conditions the study is for: Epilepsy, Neuropathic Pain, Fibromyalgia
What is being tested?: pregabalin (Lyrica)
How many people: 4,175 participants
Where: No sites listed yet
Study dates: Jul 2006to Apr 2011
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Korean adult patients with epilepsy, neuropathic pain or fibromyalgia, prescribed pregabalin for within label use

Who may be able to join

Any patient treated with pregabalin for an approved indication by Korean Food and Drug Administration

Who cannot join

Non-consenting
Hypersensitivity to the active substance or to any of the excipients
galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.

About this study

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

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

Read the detailed description

continuous patients with target disorders in collaborating institutions

Conditions: Epilepsy, Neuropathic Pain, Fibromyalgia, Post-market Surveillance
Being tested: pregabalin (Lyrica)
Keywords: epilepsy, neuropathic pain, fibromyalgia, post-market surveillance, prospective observational
Medical subject headings: Epilepsy, Neuralgia, Fibromyalgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

pregabalin (Lyrica)Drug
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.
pregabalin (Lyrica)Drug
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.
pregabalin (Lyrica)Drug
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.

Study groups in NCT01220180
Study group	Role	What they receive
Epilepsy		Not described Receives: Drug: pregabalin (Lyrica)
Neuropathic Pain		Not described Receives: Drug: pregabalin (Lyrica)
Fibromyalgia		Not described Receives: Drug: pregabalin (Lyrica)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and Week 6

Secondary outcomes (12)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2006Apr 2011

First posted13 Oct 2010 (estimated)
Study startJul 2006
Primary completionApr 2011
Study completionApr 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for EpilepsyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Ecologic or community
Time perspective: Prospective
Enrolment: 4,175 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01220180
Sponsor's protocol ID: A0081138
Status last verified: Nov 2011
First submitted: 7 Oct 2010
Last updated: 25 Jan 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Epilepsy trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Post Marketing Surveillance Study For Observing Safety And Efficacy Of Lyrica
ClinicalTrials.gov ID: NCT01220180
Acronym / sponsor ID: A0081138
Conditions: Epilepsy, Neuropathic Pain, Fibromyalgia, Post-market Surveillance
Keywords: epilepsy, neuropathic pain, fibromyalgia, post-market surveillance, prospective observational
Study type: Observational
Recruitment status: Completed
Enrolment: 4,175 participants (actual)
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
Study start: Jul 2006
Primary completion: Apr 2011 (actual)
Study completion: Apr 2011 (actual)
First posted: 13 Oct 2010 (estimated)
Results: Posted 8 Dec 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

continuous patients with target disorders in collaborating institutions

Study design

Observational model: Ecologic or community
Time perspective: Prospective
Number of arms: 3

Arm	Type	Receives
Epilepsy	–	Drug: pregabalin (Lyrica)
Neuropathic Pain	–	Drug: pregabalin (Lyrica)
Fibromyalgia	–	Drug: pregabalin (Lyrica)

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Korean adult patients with epilepsy, neuropathic pain or fibromyalgia, prescribed pregabalin for within label use

Key inclusion criteria (1 listed)

Any patient treated with pregabalin for an approved indication by Korean Food and Drug Administration

Key exclusion criteria (3 listed)

Non-consenting
Hypersensitivity to the active substance or to any of the excipients
galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
pregabalin (Lyrica)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.	Drug	Epilepsy
pregabalin (Lyrica)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.	Drug	Neuropathic Pain
pregabalin (Lyrica)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.	Drug	Fibromyalgia

Primary outcome

Percentage of Participants Achieving 28 Days Seizure Free Period in Intent-to Treat (ITT) Population
Time frame: Baseline through Week 12
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.
Percentage of Participants Achieving 28 Days Seizure Free Period in Per Protocol (PP) Population
Time frame: Baseline through Week 12
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.
Percentage of Participants With Improvement in Seizure Frequency in ITT Population
Time frame: Baseline through Week 12
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.
Percentage of Participants With Improvement in Seizure Frequency in PP Population
Time frame: Baseline through Week 12
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.
Change From Baseline in Daily Pain Score for NeP in ITT Population at Week 6
Time frame: Baseline and 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.
Change From Baseline in Daily Pain Score for NeP in PP Population at Week 6
Time frame: Baseline and 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.
Change From Baseline in Daily Pain Score for Fibromyalgia in ITT Population at Week 6
Time frame: Baseline and 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.
Change From Baseline in Daily Pain Score for Fibromyalgia in PP Population at Week 6
Time frame: Baseline and 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.

12 secondary outcomes

Change From Baseline in Sleep Interference Score for NeP in ITT Population at Week 6
Time frame: Baseline and Week 6
Change From Baseline in Sleep Interference Score for NeP in PP Population at Week 6
Time frame: Baseline and Week 6
Change From Baseline in Sleep Interference Score for Fibromyalgia in ITT Population at Week 6
Time frame: Baseline and Week 6
Change From Baseline in Sleep Interference Score for Fibromyalgia in PP Population at Week 6
Time frame: Baseline and Week 6
Number of Participants With Clinician's Global Impression of Change (CGIC) Scale for NeP in ITT Population
Time frame: Week 6
Number of Participants With CGIC Scale for NeP in PP Population
Time frame: Week 6
Number of Participants With Patient's Global Impression of Change (PGIC) Scale for NeP in ITT Population
Time frame: Week 6
Number of Participants With PGIC Scale for NeP in PP Population
Time frame: Week 6
Number of Participants With CGIC Scale for Fibromyalgia in ITT Population
Time frame: Week 6
Number of Participants With CGIC Scale for Fibromyalgia in PP Population
Time frame: Week 6
Number of Participants With PGIC Scale for Fibromyalgia in ITT Population
Time frame: Week 6
Number of Participants With PGIC Scale for Fibromyalgia in PP Population
Time frame: Week 6

Results and safety

Results posted to the registry on 8 Dec 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pregabalin	4,175	3,968

Primary outcome: Percentage of Participants Achieving 28 Days Seizure Free Period in Intent-to Treat (ITT) Population

Time frame: Baseline through Week 12. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Pregabalin n = 644
Value	66.30 (62.65 to 69.96)

Population analysed: ITT population included participants who received at least 1 dose of the study medication and indication of use was epilepsy.

Primary outcome: Percentage of Participants Achieving 28 Days Seizure Free Period in Per Protocol (PP) Population

Time frame: Baseline through Week 12. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Pregabalin n = 575
Value	67.13 (63.29 to 70.97)

Population analysed: PP population included participants who received the study medication for at least 12 weeks and indication of use was epilepsy.

Primary outcome: Percentage of Participants With Improvement in Seizure Frequency in ITT Population

Time frame: Baseline through Week 12. Number. Unit: Percentage of participants

Measure	Pregabalin n = 644
Greater than or equal to 75%	55.75
Greater than or equal to 50% to 74%	28.57
0% to 49%	14.13
Worsening	1.55

Population analysed: ITT population included participants who received at least 1 dose of the study medication and indication of use was epilepsy.

Primary outcome: Percentage of Participants With Improvement in Seizure Frequency in PP Population

Time frame: Baseline through Week 12. Number. Unit: Percentage of participants

Measure	Pregabalin n = 575
Greater than or equal to 75%	57.22
Greater than or equal to 50% to 74%	29.39
0% to 49%	12.52
Worsening	0.87

Population analysed: PP population included participants who received the study medication for at least 12 weeks and indication of use was epilepsy.

12 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pregabalin	2 of 4,174 (0%)	190 of 4,174 (4.6%)	Not reported

Limitations and caveats (from the sponsor): It is highly likely that Adverse Events were under reported for this study as it was a Non Interventional study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Epilepsy

Not yet recruiting
Clinical Trial of SEEG for Drug-resistant Epilepsy
Drug-Resistant Epilepsy
RecruitingPhase 3
Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
Seizures, Lennox Gastaut Syndrome
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
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Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

Questions about this trial

What is this clinical trial studying?

An observational study of Epilepsy and Neuropathic Pain, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Dec 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving 28 Days Seizure Free Period in Intent-to Treat (ITT) Population (time frame: Baseline through Week 12). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01220180.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2021.