NeuralgiaNCT00922987

Clinical Study With Lyrica In Patients Suffering From Epilepsy

An observational study of Neuralgia and Epilepsy, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 61 sites in Slovakia.

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

Clinical study with Lyrica (pregabalin) in patients suffering from epilepsy. This drug is used as adjunctive therapy with one or more antiepileptics. Lyrica has potential to reduce seizure frequency. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Neuralgia, Epilepsy
What is being tested?: Lyrica (pregabalin)
How many people: 286 participants
Where: 61 sitesSlovakia
Study dates: Sep 2009to Jun 2010
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: * Adult patiens with partial seizures. * Other inclusion criteria according to Summary of Product Characteristics (SmPC).

Who may be able to join

Adult patients with partial seizures.

Who cannot join

Contraindications according to Summary of Product Characteristics (SmPC).

Trial locations and contacts

61 sites in 1 country.

City, postcode or hospital

61 sites in 1 country

Slovakia61 sites

Pfizer Investigational Site
Banská Bystrica, 97401
Pfizer Investigational Site
Banská Bystrica, 975 17
Pfizer Investigational Site
Bardejov, 08501
Pfizer Investigational Site
Bojnice, 97201
Pfizer Investigational Site
Bratislava, 80101
Pfizer Investigational Site
Bratislava, 81369
Pfizer Investigational Site
Bratislava, 82606
Pfizer Investigational Site
Bratislava, 83103
Pfizer Investigational Site
Bratislava, 83305
Pfizer Investigational Site
Bratislava, 84104
Pfizer Investigational Site
Čadca, 02201
Pfizer Investigational Site
Dolný Kubín, 02601
Pfizer Investigational Site
Dubnica nad Váhom, 1841
Pfizer Investigational Site
Dunajská Streda, 92901
Pfizer Investigational Site
Handlová, 97251
Pfizer Investigational Site
Hlohovec, 92001
Pfizer Investigational Site
Humenné, 06601
Pfizer Investigational Site
Kemarok, 06001
Pfizer Investigational Site
Komárno, 94501
Pfizer Investigational Site
Košice, 04001
Pfizer Investigational Site
Košice, 04011
Pfizer Investigational Site
Košice, 04012
Pfizer Investigational Site
Košice, 04015
Pfizer Investigational Site
Košice, 04086
Pfizer Investigational Site
Košice, 04190
Pfizer Investigational Site
Krompachy, 05342
Pfizer Investigational Site
Levice, 93401
Pfizer Investigational Site
Levoča, 05401
Pfizer Investigational Site
Liptovský Mikuláš, 03101
Pfizer Investigational Site
Malacky, 90122
Pfizer Investigational Site
Martin, 03601
Pfizer Investigational Site
Martin, 03659
Pfizer Investigational Site
Modra, 90001
Pfizer Investigational Site
Myjava, 90713
Pfizer Investigational Site
Nitra, 94901
Pfizer Investigational Site
Nové Mesto nad Váhom, 91501
Pfizer Investigational Site
Nové Zámky, 94034
Pfizer Investigational Site
Nové Zámky, 94073
Pfizer Investigational Site
Piešťany, 92101
Pfizer Investigational Site
Poltár, 98701
Pfizer Investigational Site
Prešov, 08001
Pfizer Investigational Site
Púchov, 2001
Pfizer Investigational Site
Ružomberok, 03401
Pfizer Investigational Site
Ružomberok, 03426
Pfizer Investigational Site
Šahy, 93601
Pfizer Investigational Site
Sereď, 92601
Pfizer Investigational Site
Skalica, 90982
Pfizer Investigational Site
Snina, 06901
Pfizer Investigational Site
Spišská Nová Ves, 05201
Pfizer Investigational Site
Šurany, 94218
Pfizer Investigational Site
Trebišov, 07501
Pfizer Investigational Site
Trenčín, 91101
Pfizer Investigational Site
Trnava, 91701
Pfizer Investigational Site
Trnava, 91775
Pfizer Investigational Site
Trstená, 02801
Pfizer Investigational Site
Vranov Nad Toplov, 09327
Pfizer Investigational Site
Žilina, 01001
Pfizer Investigational Site
Žilina, 012 07
Pfizer Investigational Site
Zlaté Moravce, 95301
Pfizer Investigational Site
Zvolen, 86001
Pfizer Investigational Site
Zvolen, 96001

Other trials in Slovakia

About this study

Official title: Non-Interventional Study (NIS) With Lyrica In Patients With Epilepsy As Adjunctive Therapy Of Partial Seizures To Reduce Seizure Frequency

Clinical study with Lyrica (pregabalin) in patients suffering from epilepsy. This drug is used as adjunctive therapy with one or more antiepileptics. Lyrica has potential to reduce seizure frequency.

Read the detailed description

Included all adult patients with partial seizures and without contraindications according to Summary of Product Characteristics (SmPC).

Conditions: Neuralgia, Epilepsy
Being tested: Lyrica (pregabalin)
Keywords: lyrica pregabalin epilepsy partial seizures
Medical subject headings: Neuralgia, Epilepsy

What participants receive

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

Lyrica (pregabalin)Drug
The daily dose may range from 150mg to 600mg, administered as two single doses. The treatment should be started with 150mg daily dose (2x75mg). Depending on response and tolerability after 7 days may the dose be increased to 300mg/day (2x150mg) and after further 7 days to maximum dose 600mg/day (2x300mg)

Study groups in NCT00922987
Study group	Role	What they receive
Lyrica		Adult patients with partial seizures (type of epilepsy). Inclusion criteria according to Summary of Product Characteristics Receives: Drug: Lyrica (pregabalin)

What is being measured

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

Percentage of Participants With a 50 Percent or Greater Reduction From Baseline in 28 Day Partial Seizure Frequency
Responder rate was defined as the percentage of participants with at least a 50% reduction in 28-day partial seizure frequency from baseline during the maintenance phase (Week 4 - Week 16). The percent change in partial seizure frequency in the maintenance phase was the change from baseline in partial seizure frequency * 100, divided by the partial seizure frequency at the baseline visit.
Measured: Baseline through week 16 or early termination (ET)

Secondary outcomes (6)

Percentage Change From Baseline in 28 Day Partial Seizure Frequency at Final Visit
The partial seizure frequency for the baseline period was the total number of partial seizures recorded for that period at Visit 0 (week 0). For each participant's final visit, the 28 day partial seizure frequency equals total number of partial seizures since the last visit * 28 divided by total number of days since the last visit. For percent change from baseline: change from baseline in partial seizure frequency*100 divided by partial seizure frequency at baseline visit.
Measured: Baseline and week 16 or ET
Number of Participants With no Seizures (Partial or Other) During the Last 4 Weeks in the Study
Participants were regarded as seizure-free if no seizures (partial or other) were reported for the participant during the last 4 weeks in the study.
Measured: Week 4 through week 16 or ET
Change From Baseline in Visual Analog Scale of Anxiety (VAS-A) Scores at Week 4 and Final Visit
VAS-A consists of a visual analog scale ranging from, 0 mm (no anxiety) to 100 mm (extreme anxiety).
Measured: Baseline, week 4 and week 16 or ET
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)
CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected.
Measured: Baseline
Number of Participants With Change in Clinical Global Impression of Severity (CGI-C) From Baseline at Final Visit
The CGI-C scale measures a physician's global impression of a participant's clinical condition at final visit in terms of change relative to the start of treatment (CGI-C).
At final visit, the participants CGI-C will be categorized into a three point scale as: improvement: CGI response of very much improved, much improved or minimally improved; no change: CGI response of no change; worsening: CGI response of very much worse, much worse or minimally worse.
Measured: Week 16 or ET
Change From Baseline in Medical Outcome Study (MOS) Sleep Scale Sub-scores at Week 16 or ET
MOS: participant rated questionnaire, assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Transformed scores (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); sub-scales total score range= 0-100; higher score indicates greater intensity of attribute.
Measured: Baseline and week 16 or ET

Timeline

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

Sep 2009Jun 2010

First posted18 Jun 2009 (estimated)
Study startSep 2009
Primary completionJun 2010
Study completionJun 2010

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 NeuralgiaStudies 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: Cohort
Time perspective: Prospective
Enrolment: 286 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00922987
Sponsor's protocol ID: A0081236
Status last verified: Jul 2011
First submitted: 17 Jun 2009
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?

See locations

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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: Non-Interventional Study (NIS) With Lyrica In Patients With Epilepsy As Adjunctive Therapy Of Partial Seizures To Reduce Seizure Frequency
ClinicalTrials.gov ID: NCT00922987
Acronym / sponsor ID: A0081236
Conditions: Neuralgia, Epilepsy
Keywords: lyrica pregabalin epilepsy partial seizures
Study type: Observational
Recruitment status: Completed
Enrolment: 286 participants (actual)
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
Study start: Sep 2009
Primary completion: Jun 2010 (actual)
Study completion: Jun 2010 (actual)
First posted: 18 Jun 2009 (estimated)
Results: Posted 21 Jun 2011

Clinical summary

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

Clinical study with Lyrica (pregabalin) in patients suffering from epilepsy. This drug is used as adjunctive therapy with one or more antiepileptics. Lyrica has potential to reduce seizure frequency.

Detailed description

Included all adult patients with partial seizures and without contraindications according to Summary of Product Characteristics (SmPC).

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Lyrica	–	Drug: Lyrica (pregabalin)Adult patients with partial seizures (type of epilepsy). Inclusion criteria according to Summary of Product Characteristics

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: * Adult patiens with partial seizures. * Other inclusion criteria according to Summary of Product Characteristics (SmPC).

Key inclusion criteria (1 listed)

Adult patients with partial seizures.

Key exclusion criteria (1 listed)

Contraindications according to Summary of Product Characteristics (SmPC).

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
Lyrica (pregabalin)The daily dose may range from 150mg to 600mg, administered as two single doses. The treatment should be started with 150mg daily dose (2x75mg). Depending on response and tolerability after 7 days may the dose be increased to 300mg/day (2x150mg) and after further 7 days to maximum dose 600mg/day (2x300mg)	Drug	Lyrica

Primary outcome

Percentage of Participants With a 50 Percent or Greater Reduction From Baseline in 28 Day Partial Seizure Frequency
Time frame: Baseline through week 16 or early termination (ET)
Responder rate was defined as the percentage of participants with at least a 50% reduction in 28-day partial seizure frequency from baseline during the maintenance phase (Week 4 - Week 16). The percent change in partial seizure frequency in the maintenance phase was the change from baseline in partial seizure frequency * 100, divided by the partial seizure frequency at the baseline visit.

6 secondary outcomes

Percentage Change From Baseline in 28 Day Partial Seizure Frequency at Final Visit
Time frame: Baseline and week 16 or ET
Number of Participants With no Seizures (Partial or Other) During the Last 4 Weeks in the Study
Time frame: Week 4 through week 16 or ET
Change From Baseline in Visual Analog Scale of Anxiety (VAS-A) Scores at Week 4 and Final Visit
Time frame: Baseline, week 4 and week 16 or ET
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)
Time frame: Baseline
Number of Participants With Change in Clinical Global Impression of Severity (CGI-C) From Baseline at Final Visit
Time frame: Week 16 or ET
Change From Baseline in Medical Outcome Study (MOS) Sleep Scale Sub-scores at Week 16 or ET
Time frame: Baseline and week 16 or ET

Results and safety

Results posted to the registry on 21 Jun 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	281	277

Primary outcome: Percentage of Participants With a 50 Percent or Greater Reduction From Baseline in 28 Day Partial Seizure Frequency

Time frame: Baseline through week 16 or early termination (ET). Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Pregabalin n = 260
Value	85.00 (80.66 to 89.34)

Population analysed: The modified full analysis set (MFAS) included all participants who received at least 1 dose of the study drug and who had at least one baseline seizure. Participants who discontinued during first 4 weeks titration phase were regarded as missing and were excluded from the analysis.

6 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	1 of 281 (0.4%)	4 of 281 (1.4%)	Not reported

Limitations and caveats (from the sponsor): On review of blinded data it was decided that an additional analysis set, MFAS was required. MFAS was created for analysis of seizure data. The outcomes related to seizure data were therefore analyzed for MFAS population and not FAS population.

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.

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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

61 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Neuralgia and Epilepsy, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 61 sites in Slovakia.

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 1 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.

Where is the study taking place?

The record lists 61 sites in Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.

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 21 Jun 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 With a 50 Percent or Greater Reduction From Baseline in 28 Day Partial Seizure Frequency (time frame: Baseline through week 16 or early termination (ET)). 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 NCT00922987.

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; AzTrials last refreshed its copy on 6 Nov 2026.