Epilepsy, PartialPhase 3NCT00280059
Study Of The Safety And Efficacy Of Lyrica In The Treatment Of Newly Diagnosed Partial Epilepsy
A Phase 3 study testing Pregabalin and Lamotrigine in people with Epilepsy, Partial, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 102 sites in 29 countries.
Trial summary
The purpose of this study is to assess whether Lyrica is a safe and effective treatment for partial epilepsy in comparison with an established treatment, Lamictal. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Epilepsy, Partial
- What is being tested?
- Pregabalin and Lamotrigine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 660 participants
- Where
- 102 sitesin 29 countries
- Study dates
- Aug 2006to Apr 2010
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must be diagnosed with partial epilepsy and have experienced at least 2 partial seizures (simple partial, complex partial or partial seizure with secondary generalization) in the past year with one in the past 6 months.
Who cannot join
- Treatable causes of seizures, for example identified etiologies including metabolic, neoplastic or active infectious origin.
- Primary generalized seizures.
Trial locations and contacts
102 sites in 29 countries.
102 sites in 29 countries
South Korea9 sites
Pfizer Investigational Site
Daejeon, 301-721
Pfizer Investigational Site
Gwangju, 501-757
Pfizer Investigational Site
Incheon, 405-760
Pfizer Investigational Site
Seoul, 110-744
Pfizer Investigational Site
Seoul, 120-752
Pfizer Investigational Site
Seoul, 134-701
Pfizer Investigational Site
Seoul, 135-710
Pfizer Investigational Site
Seoul, 137-701
Pfizer Investigational Site
Seoul, 138-736
Czechia7 sites
Pfizer Investigational Site
Brno, 602 00
Pfizer Investigational Site
Hradec Králové, 500 05
Pfizer Investigational Site
Ostrava, 708 58
Pfizer Investigational Site
Pelhřimov, 393 01
Pfizer Investigational Site
Prague, 140 59
Pfizer Investigational Site
Rychnov nad Kněžnou, 516 01
Pfizer Investigational Site
Zlín, 760 01
Germany6 sites
Pfizer Investigational Site
Berlin, 10365
Pfizer Investigational Site
Bonn, 53105
Pfizer Investigational Site
Essen, 45147
Pfizer Investigational Site
Frankfurt, 60528
Pfizer Investigational Site
Ulm, 89075
Pfizer Investigational Site
Ulm, 89081
India6 sites
Pfizer Investigational Site
Bangalore, Karnataka, 560 054
Pfizer Investigational Site
Bangalore, 560 034
Pfizer Investigational Site
Chennai, Tamil Nadu, 600 006
Pfizer Investigational Site
Indore, Madhya Pradesh, 452001
Pfizer Investigational Site
Lucknow, 226 014
Pfizer Investigational Site
New Delhi, 110 002
Bulgaria5 sites
Pfizer Investigational Site
Plovdiv, 4000
Pfizer Investigational Site
Sofia, 1113
Pfizer Investigational Site
Sofia, 1309
Pfizer Investigational Site
Sofia, 1524
Pfizer Investigational Site
Varna, 9010
Portugal5 sites
Pfizer Investigational Site
Amadora, 2700-276
Pfizer Investigational Site
Coimbra, 3000-548
Pfizer Investigational Site
Coimbra, 3040-853 Coimbra
Pfizer Investigational Site
Porto, 4099-001
Pfizer Investigational Site
Porto, 4200-319
Slovakia5 sites
Pfizer Investigational Site
Bratislava, 813 69
Pfizer Investigational Site
Bratislava, 82606
Pfizer Investigational Site
Bratislava, 833 05
Pfizer Investigational Site
Košice, 04015
Pfizer Investigational Site
Žilina, 012 07
Spain5 sites
Pfizer Investigational Site
Badalona, Barcelona, 08916
Pfizer Investigational Site
Girona, 17007
Pfizer Investigational Site
Madrid, 28040
Pfizer Investigational Site
Valencia, 46009
Pfizer Investigational Site
Valencia, 46014
China4 sites
Pfizer Investigational Site
Cheng Du Si Chaun, 610041
Pfizer Investigational Site
Chongqing, 400016
Pfizer Investigational Site
Tianjin, 300052
Pfizer Investigational Site
Xi’an, Shanxi, 710032
Italy4 sites
Pfizer Investigational Site
Bologna, 40139
Pfizer Investigational Site
Florence, 50125
Pfizer Investigational Site
Foggia, 71100
Pfizer Investigational Site
Pisa, 56126
United Kingdom4 sites
Pfizer Investigational Site
Glasgow, G11 6NT
Pfizer Investigational Site
Liverpool, L9 7LJ
Pfizer Investigational Site
Stoke-on-Trent, Staffordshire, ST4 7LN
Pfizer Investigational Site
Treliske, Truro, Cornwall, TR1 3LJ
Belgium3 sites
Pfizer Investigational Site
Bruges, 8000
Pfizer Investigational Site
Brussels, 1070
Pfizer Investigational Site
Leuven, 3000
France3 sites
Pfizer Investigational Site
Bordeaux, 33076
Pfizer Investigational Site
Nancy, 54035
Pfizer Investigational Site
Strasbourg, 67091
Hong Kong3 sites
Pfizer Investigational Site
Hong Kong
Pfizer Investigational Site
Kowloon
Pfizer Investigational Site
Shatin
Hungary3 sites
Pfizer Investigational Site
Budapest, 1145
Pfizer Investigational Site
Győr, 9023
Pfizer Investigational Site
Nyíregyháza, 4400
Lithuania3 sites
Pfizer Investigational Site
Kaunas, 50009
Pfizer Investigational Site
Vilnius, 03215
Pfizer Investigational Site
Vilnius, 08661
Romania3 sites
Pfizer Investigational Site
Bucharest, 050098
Pfizer Investigational Site
Bucharest, 11461
Pfizer Investigational Site
Cluj-Napoca, Jud. Cluj, 400012
Sweden3 sites
Pfizer Investigational Site
Gothenburg, 413 45
Pfizer Investigational Site
Linköping, 581 85
Pfizer Investigational Site
Uppsala, 75185
Taiwan3 sites
Pfizer Investigational Site
Tainan
Pfizer Investigational Site
Taipei, 112
Pfizer Investigational Site
Taipei
Thailand3 sites
Pfizer Investigational Site
Bangkok, 10400
Pfizer Investigational Site
Muang, Changwat Khon Kaen, 40002
Pfizer Investigational Site
Rajthevee, Bangkok, 10400
Colombia2 sites
Pfizer Investigational Site
Bogota, Cundinamarca, 0
Pfizer Investigational Site
Cali, Valle del Cauca Department
Estonia2 sites
Pfizer Investigational Site
Tallinn, 10138
Pfizer Investigational Site
Tartu, 51014
Finland2 sites
Pfizer Investigational Site
Kuopio, 70210
Pfizer Investigational Site
Tampere, 33520
Latvia2 sites
Pfizer Investigational Site
Riga, LV 1002
Pfizer Investigational Site
Riga, LV 1038
Mexico2 sites
Pfizer Investigational Site
Mexico City, Mexico City, 14000
Pfizer Investigational Site
San Luis Potosí City, 78223
Norway2 sites
Pfizer Investigational Site
Lillehammer, 2629
Pfizer Investigational Site
Trondheim, 7006
Netherlands1 site
Pfizer Investigational Site
The Hague, South Holland, 2512 VA
About this study
Official title: A Randomized, Comparative, Double-Blind, Parallel-Group, Multicenter, Monotherapy, Study Of Pregabalin (Lyrica) And Lamotrigine (Lamictal) In Patients With Newly Diagnosed Partial Seizures
The purpose of this study is to assess whether Lyrica is a safe and effective treatment for partial epilepsy in comparison with an established treatment, Lamictal.
- Conditions
- Epilepsy, Partial
- Being tested
- Pregabalin, Lamotrigine
- Keywords
- Epilepsy, partial seizures, pregabalin monotherapy, lamotrigine comparator, double-blind and randomized trial
- Medical subject headings
- Epilepsies, Partial, Epilepsy, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
dose 150-600 mg/day given BID
LamotrigineDrug
dose 100-500 mg/day given BID
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Pregabalin |
| 2 | Active comparator | Not described Receives: Drug: Lamotrigine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Seizure-free Participants (Responders) During Efficacy Assessment Phase
Responders = participants who achieved any 6 consecutive months (>182 days) of seizure-freedom (absence of partial seizures, generalized seizures and unclassified epileptic seizures) during the 52 week efficacy assessment phase.
Measured: Week 5 up to Week 56
Secondary outcomes (17)
Time to 6 Consecutive Months of Seizure-freedom After 4-week Dose Escalation Phase: All Seizures
Time in days, from first day of study medication to the first 6 months of seizure freedom after Day 28. Participants who did not achieve 6 months seizure freedom after Day 28 were censored from analysis.
Measured: Week 4 up to Week 56
Exit Due to Adverse Events During the Double-blind Treatment Phase (Including Dose Escalation Phase)
Number of participants who exited the study due to adverse events during the double-blind treatment period. Time in days, from first day of study treatment to day of exit from the study due to an adverse event (ie, last day on study medication) during the double blind treatment period (including dose escalation phase) was inestimable. Observations with other reasons for exiting or participants who did not exit the study were right censored as of the last day on study medication.
Measured: Week 0 to Week 56
Exit for Any Reason During the Double-blind Treatment Phase (Including Dose Escalation Phase)
Number of participants who exited the study for any reason during the double blind treatment phase. Time in days, from first day of study treatment to day of exit from the study due to any reason (ie, last day on study medication) was inestimable. Participants who did not exit the study were right censored as of the last day on study medication.
Measured: Week 0 to Week 56
Exit Due to Lack of Efficacy After 4-week Dose Escalation Phase
Number of participants who exited the study due to lack of efficacy after the 4-week dose escalation phase. Time in days, from first day of study treatment to day of exit due to lack of efficacy after Day 28 of the escalation phase (ie, last day on study medication) was inestimable. Participants who did not exit or exited for a different reason were right censored as of the last day on study medication.
Measured: Week 4 up to Week 56
Exit Due to Any Reason After 4-week Dose Escalation Phase
Number of participants who exited the study due to any reason after the 4-week dose escalation phase. Time in days, from first day of study treatment to day of exit after Day 28 of the study due to any reason (ie, last day on study medication) was inestimable. Participants who did not exit or did not reach this phase were right censored as of the last day on study medication.
Measured: Week 4 up to Week 56
Time to First Seizure After the 4-Week Dose Escalation Phase
Time in days, from first day of study treatment to the day of first seizure after Day 28 of the escalation phase (ie, last day on study medication). Participants who did not reach this phase or who did not have a seizure after Day 28 were right censored from the analysis as of the last day on study medication.
Measured: Week 4 up to Week 56
Median Monthy Seizure Frequency: All Partial Seizures
All partial seizures include complex partial seizures, simple partial seizures, and partial seizures evolving to secondarily generalized seizures. Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period * 28. Month of time = number of months after Week 4 (Dose Escalation).
Measured: Baseline up to Week 60
Mean Monthy Seizure Frequency: All Partial Seizures
All partial seizures include complex partial seizures, simple partial seizures, and partial seizures evolving to secondarily generalized seizures. Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period * 28. Month of time = number of months after Week 4 (Dose Escalation).
Measured: Baseline up to Week 60
Median Monthy Seizure Frequency: All Seizures
Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period * 28. Month of time = number of months after Week 4 (Dose Escalation).
Measured: Baseline up to Week 60
Mean Monthy Seizure Frequency: All Seizures
Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period * 28. Month of time = number of months after Week 4 (Dose Escalation).
Measured: Baseline up to Week 60
Median Monthy Seizure Frequency of Responders for the Months After Achieving 6 Consecutive Months of Seizure Freedom: All Partial Seizures
All partial seizures include complex partial seizures, simple partial seizures, and partial seizures evolving to secondarily generalized seizures. Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period * 28. Responder = participant who achieved at least 6 months of seizure freedom after Week 4 and up to Week 56. Monthly seizure frequency measured from day of achievement of 6 months of seizure freedom.
Measured: Month 1 through Month 9 (after 6 months seizure freedom achieved)
Mean Monthy Seizure Frequency of Responders for the Months After Achieving 6 Consecutive Months of Seizure Freedom: All Partial Seizures
All partial seizures include complex partial seizures, simple partial seizures, and partial seizures evolving to secondarily generalized seizures. Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period * 28. Responder = participant who achieved at least 6 months of seizure freedom after Week 4 and up to Week 56. Monthly seizure frequency measured from day of achievement of 6 months of seizure freedom.
Measured: Month 1 through Month 9 (after 6 months seizure freedom achieved)
Median Monthy Seizure Frequency of Responders for the Months After Achieving 6 Consecutive Months of Seizure Freedom: All Seizures
Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period * 28. Responder = participant who achieved at least 6 months of seizure freedom after Week 4 and up to Week 56. Monthly seizure frequency measured from day of achievement of 6 months of seizure freedom.
Measured: Month 1 through Month 9 (after 6 months seizure freedom achieved)
Mean Monthy Seizure Frequency of Responders for the Months After Achieving 6 Consecutive Months of Seizure Freedom: All Seizures
Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period * 28. Responder = participant who achieved at least 6 months of seizure freedom after Week 4 and up to Week 56. Monthly seizure frequency measured from day of achievement of 6 months of seizure freedom.
Measured: Month 1 through Month 9 (after 6 months seizure freedom achieved)
Percentage of Participants Who Achieved at Least 6 Consecutive Months of Seizure Freedom (Responders) by Final Dosage Levels and Treatment Group
Responder = participant who achieved at least 6-months of seizure freedom (all seizures) after Week 4, and up to Week 56. Dose Level defined as last total-daily-dose received after Week 4, and up to Week 56.
Measured: Week 5 up to Week 56
Change From Baseline to Week 56 in Hospital Anxiety and Depression Scale (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; 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 symptoms. Scores relative to start of randomized treatment.
Measured: Baseline to Week 56
Medical Outcomes Study Sleep Scale (MOS-SS): Optimal Sleep Subscale
MOS-SS: subject-rated instrument used to assess the key constructs of sleep over the past week; assesses sleep quantity and quality and is comprised 12 items yielding 7 subscale scores and 2 composite index scores. Optimal Sleep subscale is derived from sleep quantity average hours of sleep each night during the past week. Number of subjects with response Optimal if sleep quantity was 7 or 8 hours of sleep per night, and Non-optimal if average sleep was less than or greater than 7 to 8 hours per night. Analysis assesses the MOS-Sleep scale relative to the start of randomized treatment.
Measured: Week 8, Week 32, and Week 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2006 (estimated)
- Study startAug 2006
- Primary completionDec 2009
- Study completionApr 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Epilepsy, PartialStudies 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
- 660 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00280059
- Sponsor's protocol ID
- A0081046
- Status last verified
- Mar 2015
- First submitted
- 18 Jan 2006
- Last updated
- 28 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Kwan P, Brodie MJ, Kalviainen R, Yurkewicz L, Weaver J, Knapp LE. Efficacy and safety of pregabalin versus lamotrigine in patients with newly diagnosed partial seizures: a phase 3, double-blind, randomised, parallel-group trial. Lancet Neurol. 2011 Oct;10(10):881-90. doi: 10.1016/S1474-4422(11)70154-5. Epub 2011 Aug 31.
PubMed 21889410
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, Comparative, Double-Blind, Parallel-Group, Multicenter, Monotherapy, Study Of Pregabalin (Lyrica) And Lamotrigine (Lamictal) In Patients With Newly Diagnosed Partial Seizures
- ClinicalTrials.gov ID
- NCT00280059
- Acronym / sponsor ID
- A0081046
- Conditions
- Epilepsy, Partial
- Keywords
- Epilepsy, partial seizures, pregabalin monotherapy, lamotrigine comparator, double-blind and randomized trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 660 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- Dec 2009 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 20 Jan 2006 (estimated)
- Results
- Posted 24 Oct 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess whether Lyrica is a safe and effective treatment for partial epilepsy in comparison with an established treatment, Lamictal.
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 |
|---|---|---|
| 1 | Experimental | Drug: Pregabalin |
| 2 | Active comparator | Drug: Lamotrigine |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients must be diagnosed with partial epilepsy and have experienced at least 2 partial seizures (simple partial, complex partial or partial seizure with secondary generalization) in the past year with one in the past 6 months.
Key exclusion criteria (2 listed)
- Treatable causes of seizures, for example identified etiologies including metabolic, neoplastic or active infectious origin.
- Primary generalized seizures.
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 |
|---|---|---|
| Pregabalindose 150-600 mg/day given BID | Drug | 1 |
| Lamotriginedose 100-500 mg/day given BID | Drug | 2 |
Primary outcome
Percentage of Seizure-free Participants (Responders) During Efficacy Assessment Phase
Time frame: Week 5 up to Week 56
Responders = participants who achieved any 6 consecutive months (>182 days) of seizure-freedom (absence of partial seizures, generalized seizures and unclassified epileptic seizures) during the 52 week efficacy assessment phase.
17 secondary outcomes
Time to 6 Consecutive Months of Seizure-freedom After 4-week Dose Escalation Phase: All Seizures
Time frame: Week 4 up to Week 56
Exit Due to Adverse Events During the Double-blind Treatment Phase (Including Dose Escalation Phase)
Time frame: Week 0 to Week 56
Exit for Any Reason During the Double-blind Treatment Phase (Including Dose Escalation Phase)
Time frame: Week 0 to Week 56
Exit Due to Lack of Efficacy After 4-week Dose Escalation Phase
Time frame: Week 4 up to Week 56
Exit Due to Any Reason After 4-week Dose Escalation Phase
Time frame: Week 4 up to Week 56
Time to First Seizure After the 4-Week Dose Escalation Phase
Time frame: Week 4 up to Week 56
Median Monthy Seizure Frequency: All Partial Seizures
Time frame: Baseline up to Week 60
Mean Monthy Seizure Frequency: All Partial Seizures
Time frame: Baseline up to Week 60
Median Monthy Seizure Frequency: All Seizures
Time frame: Baseline up to Week 60
Mean Monthy Seizure Frequency: All Seizures
Time frame: Baseline up to Week 60
Median Monthy Seizure Frequency of Responders for the Months After Achieving 6 Consecutive Months of Seizure Freedom: All Partial Seizures
Time frame: Month 1 through Month 9 (after 6 months seizure freedom achieved)
Mean Monthy Seizure Frequency of Responders for the Months After Achieving 6 Consecutive Months of Seizure Freedom: All Partial Seizures
Time frame: Month 1 through Month 9 (after 6 months seizure freedom achieved)
Median Monthy Seizure Frequency of Responders for the Months After Achieving 6 Consecutive Months of Seizure Freedom: All Seizures
Time frame: Month 1 through Month 9 (after 6 months seizure freedom achieved)
Mean Monthy Seizure Frequency of Responders for the Months After Achieving 6 Consecutive Months of Seizure Freedom: All Seizures
Time frame: Month 1 through Month 9 (after 6 months seizure freedom achieved)
Percentage of Participants Who Achieved at Least 6 Consecutive Months of Seizure Freedom (Responders) by Final Dosage Levels and Treatment Group
Time frame: Week 5 up to Week 56
Change From Baseline to Week 56 in Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline to Week 56
Medical Outcomes Study Sleep Scale (MOS-SS): Optimal Sleep Subscale
Time frame: Week 8, Week 32, and Week 56
Results and safety
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 21889410Kwan P, Brodie MJ, Kalviainen R, Yurkewicz L, Weaver J, Knapp LE. Efficacy and safety of pregabalin versus lamotrigine in patients with newly diagnosed partial seizures: a phase 3, double-blind, randomised, parallel-group trial. Lancet Neurol. 2011 Oct;10(10):881-90. doi: 10.1016/S1474-4422(11)70154-5. Epub 2011 Aug 31.
- 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
102 sites in 29 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pregabalin and Lamotrigine in people with Epilepsy, Partial, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 102 sites in 29 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 1 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 102 sites in South Korea, Czechia, Germany, India, Bulgaria and 24 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 24 Oct 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 Seizure-free Participants (Responders) During Efficacy Assessment Phase (time frame: Week 5 up to Week 56). 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 NCT00280059, 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.