Partial SeizuresPhase 3NCT00537238

Pregabalin Versus Levetiracetam In Partial Seizures

A Phase 3 study testing pregabalin and levetiracetam in people with Partial Seizures, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 72 sites in 21 countries.

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 will compare pregabalin and levetiracetam in patients with partial seizures. It will also evaluate the safety and tolerability of pregabalin and levetiracetam in these patients. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Partial Seizures
What is being tested?: pregabalin and levetiracetam
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 509 participants
Where: 72 sitesin 21 countries
Study dates: Oct 2007to May 2012
Phase: Phase 3
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

Who may be able to join

Subjects (male or female) must be > 18 years of age, with a diagnosis of epilepsy with partial seizures, as defined in the International League Against Epilepsy (ILAE) classification of seizures.
Partial seizures may be simple or complex, with or without secondary tonic-clonic generalization.
Subjects must be have been diagnosed with epilepsy for at least 2 years, and must have been unresponsive to treatment with at least two but no more than five prior antiepileptic drugs (AEDs), and at the time of study enrollment are on stable dosages of 1 or 2 standard AEDs.

Who cannot join

Females who are pregnant, breastfeeding, or intend to become pregnant during the course of the trial will be excluded
Subjects with other neurologic illness that could impair endpoint assessment, or subjects with Lennox-Gastaut syndrome, absence seizures, status epileptics within the 12 months prior to trial entry, or with seizures due to an underlying medical illness or metabolic syndrome, will be excluded.

Trial locations and contacts

72 sites in 21 countries.

Country

City, postcode or hospital

72 sites in 21 countries

Czechia7 sites

Pfizer Investigational Site
Brno, 602 00
Pfizer Investigational Site
Hradec Králové, 500 03
Pfizer Investigational Site
Olomouc, 775 20
Pfizer Investigational Site
Ostrava-Trebovice, 772 00
Pfizer Investigational Site
Prague, 140 59
Pfizer Investigational Site
Příbram, 26195
Pfizer Investigational Site
Rychnov nad Kněžnou, 516 01

Other trials in Czechia

South Korea7 sites

Pfizer Investigational Site
Busan, 602-715
Pfizer Investigational Site
Daejeon, 301-721
Pfizer Investigational Site
Seoul, 110-744
Pfizer Investigational Site
Seoul, 120-752
Pfizer Investigational Site
Seoul, 135-710
Pfizer Investigational Site
Seoul, 137-701
Pfizer Investigational Site
Seoul, 138-736

Other trials in South Korea

Bulgaria6 sites

Pfizer Investigational Site
Kyustendil
Pfizer Investigational Site
Pernik, 2300
Pfizer Investigational Site
Plovdiv, 4000
Pfizer Investigational Site
Rousse
Pfizer Investigational Site
Sofia, 1113
Pfizer Investigational Site
Sofia, 1407

Other trials in Bulgaria

Philippines6 sites

Pfizer Investigational Site
Cebu City, 6000
Pfizer Investigational Site
Davao City, 8000
Pfizer Investigational Site
Makati City, 1200
Pfizer Investigational Site
Manila, 1000
Pfizer Investigational Site
Quezon City, 1100
Pfizer Investigational Site
Tondo, Manila, 1000

Other trials in Philippines

Russia6 sites

Pfizer Investigational Site
Moscow, 107150
Pfizer Investigational Site
Moscow, 125367
Pfizer Investigational Site
Moscow, 129128
Pfizer Investigational Site
Saint Petersburg, 194044
Pfizer Investigational Site
Saint Petersburg, 194354
Pfizer Investigational Site
Saint Petersburg, 197022

Other trials in Russia

Spain6 sites

Pfizer Investigational Site
Alicante, 03010
Pfizer Investigational Site
Barcelona, 08035
Pfizer Investigational Site
Córdoba, 14008
Pfizer Investigational Site
Donostia / San Sebastian, Guipuzcoa, 20014
Pfizer Investigational Site
Girona, 17007
Pfizer Investigational Site
Seville, 41071

Other trials in Spain

Italy4 sites

Pfizer Investigational Site
Florence, 50125
Pfizer Investigational Site
Foggia, 71100
Pfizer Investigational Site
Pisa, 56126
Pfizer Investigational Site
Siena, 53100

Other trials in Italy

India3 sites

Pfizer Investigational Site
Chandigarh, Punjab, 160 012
Pfizer Investigational Site
Ludhiana, Punjab, 141 008
Pfizer Investigational Site
Pune, Maharashtra, 411 004

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Taiwan3 sites

Pfizer Investigational Site
Kaohsiung City, 807
Pfizer Investigational Site
Taichung, 407
Pfizer Investigational Site
Tainan, 704

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Turkey (Türkiye)3 sites

Pfizer Investigational Site
Ankara, 06100
Pfizer Investigational Site
Çapa, Istanbul, 34390
Pfizer Investigational Site
Cerrahpasa / Istanbul, 34098

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Belgium2 sites

Pfizer Investigational Site
Duffel, B-2570
Pfizer Investigational Site
Yvoir, B-5530

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Colombia2 sites

Pfizer Investigational Site
Barranquilla, Atlántico, 0
Pfizer Investigational Site
Bogota, Cundinamarca, 0

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Costa Rica2 sites

Pfizer Investigational Site
Montes de Oca, Provincia de San José
Pfizer Investigational Site
San José

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France2 sites

Pfizer Investigational Site
Strasbourg, 67091
Pfizer Investigational Site
Toulouse, 31043

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Germany2 sites

Pfizer Investigational Site
Bonn, 53105
Pfizer Investigational Site
Hamburg, 22083

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Greece2 sites

Pfizer Investigational Site
Athens, 11521
Pfizer Investigational Site
Thessaloniki, 57010

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Lithuania2 sites

Pfizer Investigational Site
Kaunas, 50009
Pfizer Investigational Site
Vilnius, 08661

Other trials in Lithuania

Mexico2 sites

Pfizer Investigational Site
Distrito Federal, 14269
Pfizer Investigational Site
San Luis Potosí City, 78223

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Peru2 sites

Pfizer Investigational Site
Lima, L 11
Pfizer Investigational Site
Lima, Lima 1

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Venezuela2 sites

Pfizer Investigational Site
Caracas, Libertador, 1010
Pfizer Investigational Site
Caracas, Miranda, 1080-A

Other trials in Venezuela

Panama1 site

Pfizer Investigational Site
Panama City

Other trials in Panama

About this study

Official title: A Randomized, Double-Blind, Parallel-Group Multi-Center Comparative Flexible-Dose Study Of Pregabalin Versus Levetiracetam As Adjunctive Therapy To Reduce Seizure Frequency In Subjects With Partial Seizures

This study will compare pregabalin and levetiracetam in patients with partial seizures. It will also evaluate the safety and tolerability of pregabalin and levetiracetam in these patients.

Conditions: Partial Seizures
Being tested: pregabalin, levetiracetam
Keywords: Epilepsies partial, Partial Seizure Disorder, Complex Partial Seizure Disorder, Epilepsy
Medical subject headings: Seizures, Epilepsies, Partial, Epilepsy, Complex Partial, Epilepsy

What participants receive

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

pregabalinDrug
300, 450, 600 mg/day administered orally, BID until seizure control/improvement or intolerable side effects
levetiracetamDrug
1000, 2000, 3000 mg/day administered orally, BID until seizure control/improvement or intolerable side effects

Study groups in NCT00537238
Study group	Role	What they receive
B	Active comparator	Not described Receives: Drug: pregabalin
A	Active comparator	Not described Receives: Drug: levetiracetam

What is being measured

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

Proportion of Participants With Response to Treatment
Participants who had at least 50% reduction in 28-day seizure rate from baseline to the end of the maintenance phase were considered as responders. The 28-day seizure rate was calculated as number of partial seizures in the period divided by difference of number of days in the period and number of missing diary day entries in the period, multiplied by 28.
Measured: Baseline up to Week 16

Secondary outcomes (7)

Percent Change From Baseline in 28 Day Seizure Frequency at Week 16
The seizures were recorded by the participants, by a family member, by a caregiver, or by a legal guardian and documented in a daily seizure diary. Participant's 28-day seizure frequency of all partial seizure was assessed during double blind (TP + MP) phase compared with baseline.
Measured: Baseline, Week 16
Change From Baseline in the Proportion of 28-day Secondarily Generalized Tonic-clonic (SGTC) Seizure Rate to 28-day All Partial Seizure Rate at Week 16
Change was calculated as (proportion of SGTC seizure rate divided by all partial seizure rates during double blind phase) minus (proportion of SGTC seizure rate divided by all partial seizure rates at baseline). Negative values indicated reductions in seizures.
Measured: Baseline, Week 16
Percentage of Participants Without Seizures
Seizure free for 28 days was defined as participants who have not experienced any seizure (simple partial, complex partial and SGTC) for at least 28 consecutive days from their last seizure until the end of the maintenance phase. Same participant could be seizure free for a specific type of seizure but not necessarily for the other types of seizure.
Measured: Baseline up to Week 16
Change From Baseline in Brief Psychiatric Rating Scale - Anchored (BPRS-A) Total and Core Score at Week 7, 10, 13, 16 and Follow-up
BPRS-A:18-item clinician rated scale assesses somatic concern,anxiety, emotional withdrawal,conceptual disorganization,hallucinatory behavior(HB), guilt feelings,suspiciousness,disorientation,tension,mannerisms and posturing,grandiosity,depressive mood,hostility,motor retardation,uncooperativeness,unusual thought content,blunted affect,excitement. Items rated on 7-point scale 1 (not reported) to 7 (very severe). Total score=sum of items(range 18-126), core score=sum of conceptual disorganization, suspiciousness, HB, unusual thought content(range 4-28). Higher total/core score=more impairment.
Measured: Baseline, Week 7, 10, 13, 16 and Follow-up (Day 7 of taper phase)
Hospital Anxiety and Depression Scale (HADS) Score
HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.
Measured: Baseline, Week 16
Medical Outcomes Study Sleep Scale (MOS-SS) Score
Participant-rated 12-item questionnaire to assess constructs of sleep over past week; 7 subscales:sleep disturbance,snoring,awakened short of breath,sleep adequacy,somnolence (range:0-100);sleep quantity (range:0-24),optimal sleep(yes/no), and 9 item index measures of sleep disturbance provide composite scores:sleep problem summary,overall sleep problem. Except adequacy,optimal sleep and quantity, higher scores=more impairment. Scores transformed (actual raw score[RS] minus lowest possible score divided by possible RS range*100);total score range:0-100;higher score=more intensity of attribute.
Measured: Baseline, Week 16
Percentage of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) Score
MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Percentage of participants with optimal sleep are reported.
Measured: Baseline, Week 16

Timeline

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

Oct 2007May 2012

First posted1 Oct 2007 (estimated)
Study startOct 2007
Primary completionMay 2012
Study completionMay 2012

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Partial SeizuresStudies 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: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 509 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00537238
Sponsor's protocol ID: A0081157
Status last verified: May 2013
First submitted: 27 Sep 2007
Last updated: 28 Jan 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Zaccara G, Almas M, Pitman V, Knapp L, Posner H. Efficacy and safety of pregabalin versus levetiracetam as adjunctive therapy in patients with partial seizures: a randomized, double-blind, noninferiority trial. Epilepsia. 2014 Jul;55(7):1048-57. doi: 10.1111/epi.12679. Epub 2014 Jun 5.
PubMed 24902473

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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All Partial Seizures trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Parallel-Group Multi-Center Comparative Flexible-Dose Study Of Pregabalin Versus Levetiracetam As Adjunctive Therapy To Reduce Seizure Frequency In Subjects With Partial Seizures
ClinicalTrials.gov ID: NCT00537238
Acronym / sponsor ID: A0081157
Conditions: Partial Seizures
Keywords: Epilepsies partial, Partial Seizure Disorder, Complex Partial Seizure Disorder, Epilepsy
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 509 participants (actual)
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
Study start: Oct 2007
Primary completion: May 2012 (actual)
Study completion: May 2012 (actual)
First posted: 1 Oct 2007 (estimated)
Results: Posted 11 Jul 2013

Clinical summary

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

This study will compare pregabalin and levetiracetam in patients with partial seizures. It will also evaluate the safety and tolerability of pregabalin and levetiracetam in these patients.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
B	Active comparator	Drug: pregabalin
A	Active comparator	Drug: levetiracetam

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Subjects (male or female) must be > 18 years of age, with a diagnosis of epilepsy with partial seizures, as defined in the International League Against Epilepsy (ILAE) classification of seizures.
Partial seizures may be simple or complex, with or without secondary tonic-clonic generalization.
Subjects must be have been diagnosed with epilepsy for at least 2 years, and must have been unresponsive to treatment with at least two but no more than five prior antiepileptic drugs (AEDs), and at the time of study enrollment are on stable dosages of 1 or 2 standard AEDs.

Key exclusion criteria (2 listed)

Females who are pregnant, breastfeeding, or intend to become pregnant during the course of the trial will be excluded
Subjects with other neurologic illness that could impair endpoint assessment, or subjects with Lennox-Gastaut syndrome, absence seizures, status epileptics within the 12 months prior to trial entry, or with seizures due to an underlying medical illness or metabolic syndrome, will be excluded.

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
pregabalin300, 450, 600 mg/day administered orally, BID until seizure control/improvement or intolerable side effects	Drug	B
levetiracetam1000, 2000, 3000 mg/day administered orally, BID until seizure control/improvement or intolerable side effects	Drug	A

Primary outcome

Proportion of Participants With Response to Treatment
Time frame: Baseline up to Week 16
Participants who had at least 50% reduction in 28-day seizure rate from baseline to the end of the maintenance phase were considered as responders. The 28-day seizure rate was calculated as number of partial seizures in the period divided by difference of number of days in the period and number of missing diary day entries in the period, multiplied by 28.

7 secondary outcomes

Percent Change From Baseline in 28 Day Seizure Frequency at Week 16
Time frame: Baseline, Week 16
Change From Baseline in the Proportion of 28-day Secondarily Generalized Tonic-clonic (SGTC) Seizure Rate to 28-day All Partial Seizure Rate at Week 16
Time frame: Baseline, Week 16
Percentage of Participants Without Seizures
Time frame: Baseline up to Week 16
Change From Baseline in Brief Psychiatric Rating Scale - Anchored (BPRS-A) Total and Core Score at Week 7, 10, 13, 16 and Follow-up
Time frame: Baseline, Week 7, 10, 13, 16 and Follow-up (Day 7 of taper phase)
Hospital Anxiety and Depression Scale (HADS) Score
Time frame: Baseline, Week 16
Medical Outcomes Study Sleep Scale (MOS-SS) Score
Time frame: Baseline, Week 16
Percentage of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) Score
Time frame: Baseline, Week 16

Results and safety

Results posted to the registry on 11 Jul 2013, 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	254	80
Levetiracetam	255	82

Primary outcome: Proportion of Participants With Response to Treatment

Time frame: Baseline up to Week 16. Number. Unit: proportion of participants

Measure	Pregabalin n = 164	Levetiracetam n = 177
Value	0.59	0.59

Pregabalin vs Levetiracetam: Difference in Proportion: 0.00 (90% CI -0.08 to 0.09)

Population analysed: Per protocol population included all randomized participants who had at least 28 days of study drug during the maintenance phase and a minimum of 28 days of utilizable seizure diary data during baseline and maintenance phases of the study and had no major protocol violation.

7 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pregabalin	24 of 254 (9.4%)	148 of 254 (58.3%)	Not reported
Levetiracetam	24 of 255 (9.4%)	127 of 255 (49.8%)	Not reported

Limitations and caveats (from the sponsor): Results for BPRS were provided as change in scores at Week 16 compared to baseline instead of absolute scores as per planned analysis.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24902473Zaccara G, Almas M, Pitman V, Knapp L, Posner H. Efficacy and safety of pregabalin versus levetiracetam as adjunctive therapy in patients with partial seizures: a randomized, double-blind, noninferiority trial. Epilepsia. 2014 Jul;55(7):1048-57. doi: 10.1111/epi.12679. Epub 2014 Jun 5.

Related trials for Partial Seizures

Not yet recruiting
Electrophysiological Dose-Response to Anterior Thalamic Deep Brain Stimulation in Drug-Resistant Focal Epilepsy
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A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures (X-TOLE3)
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An Open-label Study of XEN1101 in Epilepsy
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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

72 sites in 21 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing pregabalin and levetiracetam in people with Partial Seizures, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 72 sites in 21 countries.

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 3 inclusion and 2 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 28 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 72 sites in Czechia, South Korea, Bulgaria, Philippines, Russia and 16 more countries. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jul 2013). 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?

Proportion of Participants With Response to Treatment (time frame: Baseline up to Week 16). 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 NCT00537238, which also lists 1 linked publication.

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 28 Jan 2021.