EpilepsyPhase 3NCT00596466
Extension Study Of Long-Term Safety And Efficacy Of Pregabalin As Monotherapy (Lyrica) In Patients With Partial Seizures
A Phase 3 study testing pregabalin in people with Epilepsy, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 44 sites in 4 countries.
Trial summary
This study will evaluate the long term safety and efficacy of pregabalin (Lyrica) when administered by itself (without any other anti-epileptic medication) to epilepsy patients for the treatment of partial seizures. This is an extension study to a previous clinical trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- pregabalin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 44 sitesin 4 countries
- Study dates
- Apr 2008to Dec 2011
- 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
- Completed the previous protocol and wish to continue to receive pregabalin.
- Diagnosis of epilepsy with partial seizures
Who cannot join
- Early withdrawal from the previous protocol, an episode of status epliepticus, or primary generalized epilepsy.
Trial locations and contacts
44 sites in 4 countries.
44 sites in 4 countries
United States34 sites
Pfizer Investigational Site
Bowling Green, Kentucky, 42101
Pfizer Investigational Site
Charlotte, North Carolina, 28203
Pfizer Investigational Site
Charlotte, North Carolina, 28209
Pfizer Investigational Site
Columbus, Ohio, 43210
Pfizer Investigational Site
Dallas, Texas, 75230
Pfizer Investigational Site
Danville, Indiana, 46122
Pfizer Investigational Site
Denver, Colorado, 80204
Pfizer Investigational Site
Detroit, Michigan, 48202
Pfizer Investigational Site
Fayetteville, Arkansas, 72703
Pfizer Investigational Site
Flowood, Mississippi, 39232
Pfizer Investigational Site
Fort Wayne, Indiana, 46805
Pfizer Investigational Site
Fullerton, California, 92835
Pfizer Investigational Site
Great Falls, Montana, 59405
Pfizer Investigational Site
Houma, Louisiana, 70363
Pfizer Investigational Site
Houston, Texas, 77074
Pfizer Investigational Site
Jacksonville, Florida, 32209
Pfizer Investigational Site
Kansas City, Kansas, 66160
Pfizer Investigational Site
Lexington, Kentucky, 40536
Pfizer Investigational Site
Long Beach, California, 90806
Pfizer Investigational Site
Milwaukee, Wisconsin, 53226
Pfizer Investigational Site
Modesto, California, 95355
Pfizer Investigational Site
Murrieta, California, 92562
Pfizer Investigational Site
Newport Beach, California, 92660
Pfizer Investigational Site
Oklahoma City, Oklahoma, 73112
Pfizer Investigational Site
Oklahoma City, Oklahoma, 73120
Pfizer Investigational Site
Phoenix, Arizona, 85003
Pfizer Investigational Site
Pikesville, Maryland, 21208
Pfizer Investigational Site
Salt Lake City, Utah, 84107
Pfizer Investigational Site
Shreveport, Louisiana, 71105-5634
Pfizer Investigational Site
Suwanee, Georgia, 30024
Pfizer Investigational Site
Temecula, California, 92591
Pfizer Investigational Site
Temple, Texas, 76508
Pfizer Investigational Site
West Jordan, Utah, 84088
Pfizer Investigational Site
Worcester, Massachusetts, 01608
Ukraine6 sites
Pfizer Investigational Site
Dnipropetrovsk, 49005
Pfizer Investigational Site
Dnipropetrovsk, 49115
Pfizer Investigational Site
Kharkiv, 61018
Pfizer Investigational Site
Kharkiv, 61068
Pfizer Investigational Site
Luhansk, 91045
Pfizer Investigational Site
Odesa, 65025
Czechia3 sites
Pfizer Investigational Site
Beroun, 266 01
Pfizer Investigational Site
Brno, 602 00
Pfizer Investigational Site
Litomyšl, 570 14
About this study
Official title: An Open-Label Multicenter Extension Study To Determine Long Term Safety And Efficacy Of Pregabalin (Lyrica) As Monotherapy In Patients With Partial Seizures
This study will evaluate the long term safety and efficacy of pregabalin (Lyrica) when administered by itself (without any other anti-epileptic medication) to epilepsy patients for the treatment of partial seizures. This is an extension study to a previous clinical trial.
- Conditions
- Epilepsy
- Being tested
- pregabalin
- Keywords
- open-label, extension study, pregabalin, partial epilepsy
- Medical subject headings
- Epilepsy, Epilepsies, Partial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pregabalinDrug
pregabalin
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: pregabalin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seizure Frequency
Measured: Baseline up to Week 28
Number of Participants With (All Causality) Adverse Events (AEs) and Serious Adverse Events (SAEs)
Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Participants with multiple occurrences of an AE within a category were counted once within the category.
Measured: Baseline up to Week 28
Number of Participants With Laboratory Test Values of Potential Clinical Importance
Pre-defined criteria were established for each laboratory test (hematology, blood chemistry and urinalysis) to define the values that would be identified as of potential clinical importance.
Measured: Baseline up to Week 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2008 (estimated)
- Study startApr 2008
- Primary completionDec 2011
- Study completionDec 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 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
- NCT00596466
- Sponsor's protocol ID
- A0081160
- Status last verified
- Aug 2012
- First submitted
- 8 Jan 2008
- Last updated
- 26 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Multicenter Extension Study To Determine Long Term Safety And Efficacy Of Pregabalin (Lyrica) As Monotherapy In Patients With Partial Seizures
- ClinicalTrials.gov ID
- NCT00596466
- Acronym / sponsor ID
- A0081160
- Conditions
- Epilepsy
- Keywords
- open-label, extension study, pregabalin, partial epilepsy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 17 Jan 2008 (estimated)
- Results
- Posted 11 Sep 2012
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 evaluate the long term safety and efficacy of pregabalin (Lyrica) when administered by itself (without any other anti-epileptic medication) to epilepsy patients for the treatment of partial seizures. This is an extension study to a previous clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: pregabalin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Completed the previous protocol and wish to continue to receive pregabalin.
- Diagnosis of epilepsy with partial seizures
Key exclusion criteria (1 listed)
- Early withdrawal from the previous protocol, an episode of status epliepticus, or primary generalized epilepsy.
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 |
|---|---|---|
| pregabalinpregabalin | Drug | 1 |
Primary outcome
Seizure Frequency
Time frame: Baseline up to Week 28
Number of Participants With (All Causality) Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Baseline up to Week 28
Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Participants with multiple occurrences of an AE within a category were counted once within the category.
Number of Participants With Laboratory Test Values of Potential Clinical Importance
Time frame: Baseline up to Week 28
Pre-defined criteria were established for each laboratory test (hematology, blood chemistry and urinalysis) to define the values that would be identified as of potential clinical importance.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Epilepsy
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Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
Seizures, Lennox Gastaut Syndrome
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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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Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
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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
44 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing pregabalin in people with Epilepsy, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 44 sites in 4 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 2 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 26 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 44 sites in United States, Ukraine, Czechia, Hong Kong. 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 Sep 2012). 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?
Seizure Frequency (time frame: Baseline up to Week 28). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jan 2021.