Epilepsies, PartialPhase 3NCT00524030

Efficacy And Safety Study Of Pregabalin (Lyrica) As Monotherapy In Patients With Partial Seizures

A Phase 3 study testing pregabalin 600 mg/day and pregabalin 150 mg/day in people with Epilepsies, Partial, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 73 sites in 4 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

This study will determine the safety and efficacy of pregabalin (Lyrica) when administered by itself (without any other anti-epileptic medication) to epilepsy subjects for the treatment of partial seizures. The duration of the trial is about 6 months. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Epilepsies, Partial
What is being tested?: pregabalin 600 mg/day and pregabalin 150 mg/day
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 161 participants
Where: 73 sitesin 4 countries
Study dates: Sep 2007to Jun 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

Diagnosis of epilepsy with partial seizures.
Males or females, age 18 years or older.
Documented history of at least 4 partial seizures in the 8 weeks prior to the screening visit.
Stable treatment with 1 to 2 anti-epileptic drugs in the 8 weeks prior to the screening visit.

Who cannot join

Current diagnosis of febrile seizures or seizures related to an ongoing acute medical event.
Seizures occurring only in cluster patterns, or seizures of a metabolic, toxic or infectious origin.
Primary generalized epilepsy or status epilepticus within the previous year.

Trial locations and contacts

73 sites in 4 countries.

Country

City, postcode or hospital

73 sites in 4 countries

United States63 sites

Pfizer Investigational Site
Altoona, Pennsylvania, 16602
Pfizer Investigational Site
Anderson, Indiana, 46016
Pfizer Investigational Site
Atlanta, Georgia, 30309
Pfizer Investigational Site
Atlanta, Georgia, 30342
Pfizer Investigational Site
Bowling Green, Kentucky, 42101
Pfizer Investigational Site
Cedarhurst, New York, 11516
Pfizer Investigational Site
Charlotte, North Carolina, 28207
Pfizer Investigational Site
Charlotte, North Carolina, 28209
Pfizer Investigational Site
Cleveland, Ohio, 44195
Pfizer Investigational Site
Columbus, Ohio, 43210-1250
Pfizer Investigational Site
Columbus, Ohio, 43210
Pfizer Investigational Site
Dallas, Texas, 75230
Pfizer Investigational Site
Danville, Indiana, 46122
Pfizer Investigational Site
Decatur, Georgia, 30033
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
Hattiesburg, Mississippi, 39401-7246
Pfizer Investigational Site
Houma, Louisiana, 70363
Pfizer Investigational Site
Houston, Texas, 77074-2906
Pfizer Investigational Site
Indiana, Pennsylvania, 15701
Pfizer Investigational Site
Jacksonville, Florida, 32209
Pfizer Investigational Site
Kansas City, Kansas, 66160
Pfizer Investigational Site
Lawrenceville, Georgia, 30045
Pfizer Investigational Site
Lexington, Kentucky, 40536-0284
Pfizer Investigational Site
Lexington, Kentucky, 40536
Pfizer Investigational Site
Long Beach, California, 90806
Pfizer Investigational Site
Melbourne, Florida, 32901
Pfizer Investigational Site
Memphis, Tennessee, 38120
Pfizer Investigational Site
Memphis, Tennessee, 38163
Pfizer Investigational Site
Miami, Florida, 33126
Pfizer Investigational Site
Miami, Florida, 33136
Pfizer Investigational Site
Milwaukee, Wisconsin, 53226
Pfizer Investigational Site
Minneapolis, Minnesota, 55422
Pfizer Investigational Site
Modesto, California, 95355
Pfizer Investigational Site
Murray, Utah, 84107
Pfizer Investigational Site
Murrieta, California, 92562
Pfizer Investigational Site
Nashville, Tennessee, 37232
Pfizer Investigational Site
Newport Beach, California, 92660
Pfizer Investigational Site
Northport, Alabama, 35476
Pfizer Investigational Site
Oklahoma City, Oklahoma, 73112
Pfizer Investigational Site
Oklahoma City, Oklahoma, 73120
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19140
Pfizer Investigational Site
Phoenix, Arizona, 85003
Pfizer Investigational Site
Phoenix, Arizona, 85013
Pfizer Investigational Site
Pikesville, Maryland, 21208
Pfizer Investigational Site
Rocky Mount, North Carolina, 27804
Pfizer Investigational Site
Salt Lake City, Utah, 84107
Pfizer Investigational Site
San Antonio, Texas, 78258
Pfizer Investigational Site
Sarasota, Florida, 34232
Pfizer Investigational Site
Sarasota, Florida, 34233
Pfizer Investigational Site
Shreveport, Louisiana, 71105-5634
Pfizer Investigational Site
Sun City, Arizona, 85351
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, 01605
Pfizer Investigational Site
Worcester, Massachusetts, 01608

Other trials in United States

Ukraine6 sites

Pfizer Investigational Site
Dnipropetrovsk, 49027
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

Other trials in Ukraine

Czechia3 sites

Pfizer Investigational Site
Beroun, 266 01
Pfizer Investigational Site
Brno, 602 00
Pfizer Investigational Site
Litomyšl, 570 14

Other trials in Czechia

Hong Kong1 site

Pfizer Investigational Site
New Territories

Other trials in Hong Kong

About this study

Official title: A Double-Blind, Randomized, Multicenter Efficacy And Safety Study Of Pregabalin (Lyrica) As Monotherapy In Patients With Partial Seizures

Read the detailed description

After review of the interim analysis results, the independent Data Monitoring Committee (DMC) recommended to stop the study based on positive efficacy findings for the primary efficacy endpoint according to pre-specified stopping rules. Pfizer accepted the DMC recommendation and made the decision to stop the study on September 7, 2011.

Conditions: Epilepsies, Partial
Being tested: pregabalin 600 mg/day, pregabalin 150 mg/day
Keywords: Epilepsy, partial seizures, pregabalin monotherapy, 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.

pregabalin 600 mg/dayDrug
pregabalin 600 mg/day (300mg BID), duration is 20 weeks.
pregabalin 150 mg/dayDrug
pregabalin 150 mg/day (75mg BID), duration is 20 weeks.

Study groups in NCT00524030
Study group	Role	What they receive
1	Experimental	Not described Receives: Drug: pregabalin 600 mg/day
2	Experimental	Not described Receives: Drug: pregabalin 150 mg/day

What is being measured

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

Percentage of Participants in the Pregabalin 600 mg/Day Treatment Group Discontinuing the Study Due to at Least 1 Pre-Defined Seizure Exit Criteria
Participants who discontinued due to: episode of status epilepticus (SE); secondarily generalized tonic-clonic (SGTC) seizure if none within 2 years of study entry; 28-day study seizure rate during double-blind phase (DBP) greater than (>)2 times maximum (Max) 28-day study seizure rate during baseline phase (BLP); 2-day study seizure rate during DBP >2 times Max 2-day study seizure rate during BLP; or unacceptable clinically significant increase in frequency/intensity of seizure activity. Determined as exit rate:(1-Kaplan-Meier [KM] product limit estimate for survival function) * 100%
Measured: Week 2 up to Week 18

Secondary outcomes (7)

Percentage of Participants in the Pregabalin 150 mg/Day Treatment Group Discontinuing the Study Due to at Least 1 Pre-Defined Seizure Exit Criteria
Participants who discontinued due to: episode of SE; SGTC seizure if none within 2 years of study entry; 28-day study seizure rate during DBP >2 times Max 28-day study seizure rate during BLP; 2-day study seizure rate during DBP >2 times Max 2-day study seizure rate during BLP; or unacceptable clinically significant increase in frequency/intensity of seizure activity. Determined as exit rate, defined as (1-KM product limit estimate for survival function) * 100%
Measured: Week 2 up to Week 18
Percentage of Participants Completing 20 Weeks of Double-Blind Treatment
Measured: Randomization up to Week 20
Percentage of Participants Who Met Protocol-Specified Exit Events
Percentage of participants experiencing any of the following (could have had more than 1): 1) episode of SE; 2) SGTC seizure if none had been experienced within 2 years of study entry; 3) 28-day study seizure rate during DBP >2 times the Max 28-day study seizure rate during BLP; 4) 2-day study seizure rate during the DBP >2 times the Max 2-day study seizure rate during BLP; or 5) unacceptable clinically significant increase in frequency/intensity of seizure activity
Measured: Week 2 up to Week 18
Mean Time on Pregabalin Monotherapy
Measured: Week 2 to Week 20
Percentage of Seizure-Free Participants by Study Phase
Percentage of participants who were seizure-free during the last 28 days on double-blind study medication (monotherapy phase, Days 112-140), during the monotherapy portion of the double-blind treatment phase (Days 56-140), and during all of the double-blind treatment phase (Days 1-140)
Measured: Day 1 up to Day 140
Pregabalin Population Pharmacokinetics (PK)
Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.
Measured: Baseline up to 20 weeks
Pregabalin Exposure-Response Analysis
Percentage of participants predicted to exit the study due to any seizure exit criteria at Day 126. The exit rate at Day 126 was predicted using the final model (log normal distribution with respect to treatment group) and the parameter estimates.
Measured: Day 126

Timeline

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

Sep 2007Jun 2011

First posted3 Sep 2007 (estimated)
Study startSep 2007
Primary completionApr 2011
Study completionJun 2011

Why it stopped: See termination reason in detailed description.

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 Epilepsies, 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: 161 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00524030
Sponsor's protocol ID: A0081047
Status last verified: Dec 2018
First submitted: 30 Aug 2007
Last updated: 20 Jan 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

French J, Kwan P, Fakhoury T, Pitman V, DuBrava S, Knapp L, Yurkewicz L. Pregabalin monotherapy in patients with partial-onset seizures: a historical-controlled trial. Neurology. 2014 Feb 18;82(7):590-7. doi: 10.1212/WNL.0000000000000119. Epub 2014 Jan 10.
PubMed 24415567

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

RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
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RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
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Active, not recruitingPhase 2
A Study to Evaluate XEN1101 as Adjunctive Therapy in Focal Epilepsy
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Enrolling by invitationPhase 3
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All Epilepsies, Partial trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-Blind, Randomized, Multicenter Efficacy And Safety Study Of Pregabalin (Lyrica) As Monotherapy In Patients With Partial Seizures
ClinicalTrials.gov ID: NCT00524030
Acronym / sponsor ID: A0081047
Conditions: Epilepsies, Partial
Keywords: Epilepsy, partial seizures, pregabalin monotherapy, double-blind and randomized trial
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: See termination reason in detailed description.
Enrolment: 161 participants (actual)
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
Study start: Sep 2007
Primary completion: Apr 2011 (actual)
Study completion: Jun 2011 (actual)
First posted: 3 Sep 2007 (estimated)
Results: Posted 10 May 2012

Clinical summary

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

Detailed description

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 600 mg/day
2	Experimental	Drug: pregabalin 150 mg/day

Who may qualify

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

Key inclusion criteria (4 listed)

Diagnosis of epilepsy with partial seizures.
Males or females, age 18 years or older.
Documented history of at least 4 partial seizures in the 8 weeks prior to the screening visit.
Stable treatment with 1 to 2 anti-epileptic drugs in the 8 weeks prior to the screening visit.

Key exclusion criteria (3 listed)

Current diagnosis of febrile seizures or seizures related to an ongoing acute medical event.
Seizures occurring only in cluster patterns, or seizures of a metabolic, toxic or infectious origin.
Primary generalized epilepsy or status epilepticus within the previous year.

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 600 mg/daypregabalin 600 mg/day (300mg BID), duration is 20 weeks.	Drug	1
pregabalin 150 mg/daypregabalin 150 mg/day (75mg BID), duration is 20 weeks.	Drug	2

Primary outcome

Percentage of Participants in the Pregabalin 600 mg/Day Treatment Group Discontinuing the Study Due to at Least 1 Pre-Defined Seizure Exit Criteria
Time frame: Week 2 up to Week 18
Participants who discontinued due to: episode of status epilepticus (SE); secondarily generalized tonic-clonic (SGTC) seizure if none within 2 years of study entry; 28-day study seizure rate during double-blind phase (DBP) greater than (>)2 times maximum (Max) 28-day study seizure rate during baseline phase (BLP); 2-day study seizure rate during DBP >2 times Max 2-day study seizure rate during BLP; or unacceptable clinically significant increase in frequency/intensity of seizure activity. Determined as exit rate:(1-Kaplan-Meier [KM] product limit estimate for survival function) * 100%

7 secondary outcomes

Percentage of Participants in the Pregabalin 150 mg/Day Treatment Group Discontinuing the Study Due to at Least 1 Pre-Defined Seizure Exit Criteria
Time frame: Week 2 up to Week 18
Percentage of Participants Completing 20 Weeks of Double-Blind Treatment
Time frame: Randomization up to Week 20
Percentage of Participants Who Met Protocol-Specified Exit Events
Time frame: Week 2 up to Week 18
Mean Time on Pregabalin Monotherapy
Time frame: Week 2 to Week 20
Percentage of Seizure-Free Participants by Study Phase
Time frame: Day 1 up to Day 140
Pregabalin Population Pharmacokinetics (PK)
Time frame: Baseline up to 20 weeks
Pregabalin Exposure-Response Analysis
Time frame: Day 126

Results and safety

Results posted to the registry on 10 May 2012, 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 150 mg/Day	32	15
Pregabalin 600 mg/Day	129	70

Primary outcome: Percentage of Participants in the Pregabalin 600 mg/Day Treatment Group Discontinuing the Study Due to at Least 1 Pre-Defined Seizure Exit Criteria

Time frame: Week 2 up to Week 18. Number (95% Confidence Interval). Unit: Percentage of Participants

Measure	Pregabalin 600 mg/Day n = 102
Value	31.9 (20.7 to 43.1)

Pregabalin 600 mg/Day: p <0.001, Wald Test
Pregabalin 600 mg/Day: p <0.001, Wald Test

Population analysed: Modified Intent to Treat (MITT) Efficacy Set: The first 125 participants randomized who received at least 1 dose of pregabalin in DB treatment phase, had BL seizure assessment, and participated in DB efficacy assessment after Week 2. Number of participants analyzed (N)= number of MITT participants with discontinuation/completion data.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline to Week 21. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pregabalin 150 mg/Day	1 of 32 (3.1%)	15 of 32 (46.9%)	Not reported
Pregabalin 600 mg/Day	17 of 129 (13.2%)	75 of 129 (58.1%)	Not reported

Limitations and caveats (from the sponsor): External Data Monitoring Committee (DMC) determined study met criteria to stop early for positive efficacy. Exit rate was the basis for primary analysis and is what is reported here.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24415567French J, Kwan P, Fakhoury T, Pitman V, DuBrava S, Knapp L, Yurkewicz L. Pregabalin monotherapy in patients with partial-onset seizures: a historical-controlled trial. Neurology. 2014 Feb 18;82(7):590-7. doi: 10.1212/WNL.0000000000000119. Epub 2014 Jan 10.

Related trials for Epilepsies, Partial

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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

73 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 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: stopped early, as of the sponsor's last update on 20 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 73 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 10 May 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?

Percentage of Participants in the Pregabalin 600 mg/Day Treatment Group Discontinuing the Study Due to at Least 1 Pre-Defined Seizure Exit Criteria (time frame: Week 2 up to Week 18). 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 NCT00524030, 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 20 Jan 2021.