Seizure Disorder, PartialPhase 3NCT00141336
To Evaluate the Long-Term Safety and Efficacy of Pregabalin in Patients With Partial Seizures.
A Phase 3 study testing Pregabalin in people with Seizure Disorder, Partial, run by Pfizer at 103 sites in 2 countries.
Trial summary
To evaluate the long-term safety and tolerability of pregabalin in patients with partial seizures. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Seizure Disorder, Partial
- What is being tested?
- Pregabalin
- How many people
- 750 participants
- Where
- 103 sitesin 2 countries
- Study dates
- Nov 1999to Jul 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Must have met the inclusion criteria for preceding double-blind study
- Have received double-blind study medication and wish to receive open-label pregabalin.
Who cannot join
- Cannot have absence seizures
Trial locations and contacts
103 sites in 2 countries.
103 sites in 2 countries
United States97 sites
Pfizer Investigational Site
Albuquerque, New Mexico, 87131-5021
Pfizer Investigational Site
Albuquerque, New Mexico, 87131-5281
Pfizer Investigational Site
Albuquerque, New Mexico, 87131
Pfizer Investigational Site
Alexandria, Virginia, 22304
Pfizer Investigational Site
Alexandria, Virginia, 22311
Pfizer Investigational Site
Asheville, North Carolina, 28803
Pfizer Investigational Site
Asheville, North Carolina, 28806
Pfizer Investigational Site
Atlanta, Georgia, 30322
Pfizer Investigational Site
Bakersfield, California, 93301
Pfizer Investigational Site
Baltimore, Maryland, 21287
Pfizer Investigational Site
Bellevue, Washington, 98004
Pfizer Investigational Site
Berkeley, California, 94705
Pfizer Investigational Site
Brooklyn, New York, 11203
Pfizer Investigational Site
Charlottesville, Virginia, 22908
Pfizer Investigational Site
Chicago, Illinois, 60611
Pfizer Investigational Site
Chicago, Illinois, 60612
Pfizer Investigational Site
Chicago, Illinois, 60640
Pfizer Investigational Site
Cincinnati, Ohio, 45219
Pfizer Investigational Site
Cincinnati, Ohio, 45242
Pfizer Investigational Site
Columbus, Ohio, 43210
Pfizer Investigational Site
Concord, California, 94520
Pfizer Investigational Site
Concord, New Hampshire, 03301
Pfizer Investigational Site
Covina, California, 91723
Pfizer Investigational Site
Cranston, Rhode Island, 02920
Pfizer Investigational Site
Crestview Hills, Kentucky, 41017
Pfizer Investigational Site
Dallas, Texas, 75216
Pfizer Investigational Site
Dallas, Texas, 75230
Pfizer Investigational Site
Dallas, Texas, 75243
Pfizer Investigational Site
Danbury, Connecticut, 06810
Pfizer Investigational Site
Denver, Colorado, 80218
Pfizer Investigational Site
Detroit, Michigan, 48202-2689
Pfizer Investigational Site
Dover, New Hampshire, 03820
Pfizer Investigational Site
El Cajon, California, 92021
Pfizer Investigational Site
Encino, California, 91436
Pfizer Investigational Site
Englewood, Colorado, 80110
Pfizer Investigational Site
Fort Worth, Texas, 76107-2699
Pfizer Investigational Site
Fort Worth, Texas, 76107
Pfizer Investigational Site
Friday Harbor, Washington, 98004
Pfizer Investigational Site
Golden Valley, Minnesota, 55422
Pfizer Investigational Site
Houston, Texas, 77002
Pfizer Investigational Site
Houston, Texas, 77025
Pfizer Investigational Site
Houston, Texas, 77030
Pfizer Investigational Site
Jackson, Mississippi, 39216
Pfizer Investigational Site
Knoxville, Tennessee, 37916
Pfizer Investigational Site
La Mesa, California, 91942
Pfizer Investigational Site
Las Vegas, Nevada, 89102
Pfizer Investigational Site
Las Vegas, Nevada, 89106
Pfizer Investigational Site
Louisville, Kentucky, 40202
Pfizer Investigational Site
Lubbock, Texas, 79410
Pfizer Investigational Site
Marina Del Ray, California, 90292
Pfizer Investigational Site
Marshfield, Wisconsin, 54449
Pfizer Investigational Site
Martinez, California, 94553
Pfizer Investigational Site
Medford, Oregon, 97504
Pfizer Investigational Site
Memphis, Tennessee, 38103
Pfizer Investigational Site
Miami, Florida, 33173
Pfizer Investigational Site
Miami, Florida, 33176
Pfizer Investigational Site
Milwaukee, Wisconsin, 53226
Pfizer Investigational Site
Minneapolis, Minnesota, 55422
Pfizer Investigational Site
Morgantown, West Virginia, 26507
Pfizer Investigational Site
New Brunswick, New Jersey, 08901
Pfizer Investigational Site
New Brunswick, New Jersey, 08903
Pfizer Investigational Site
New York, New York, 10021
Pfizer Investigational Site
Northridge, California, 91325
Pfizer Investigational Site
Oklahoma City, Oklahoma, 73104-5068
Pfizer Investigational Site
Orlando, Florida, 32806
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19104
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19107
Pfizer Investigational Site
Phoenix, Arizona, 85013
Pfizer Investigational Site
Pinole, California, 94564
Pfizer Investigational Site
Pittsburgh, Pennsylvania, 15212
Pfizer Investigational Site
Portland, Oregon, 97201
Pfizer Investigational Site
Portland, Oregon, 97209
Pfizer Investigational Site
Portland, Oregon, 97210
Pfizer Investigational Site
Raleigh, North Carolina, 27607
Pfizer Investigational Site
Redondo Beach, California, 90277
Pfizer Investigational Site
Ridgewood, New Jersey, 07450
Pfizer Investigational Site
Ridley Park, Pennsylvania, 19078
Pfizer Investigational Site
Roanoke, Virginia, 24014
Pfizer Investigational Site
Roanoke, Virginia, 24016
Pfizer Investigational Site
Ruston, Louisiana, 71270
Pfizer Investigational Site
Sacramento, California, 95816
Pfizer Investigational Site
Sacramento, California, 95823
Pfizer Investigational Site
San Antonio, Texas, 78207
Pfizer Investigational Site
San Antonio, Texas, 78229
Pfizer Investigational Site
San Diego, California, 92120
Pfizer Investigational Site
Santa Monica, California, 90404
Pfizer Investigational Site
Spokane, Washington, 99202
Pfizer Investigational Site
Spokane, Washington, 99204
Pfizer Investigational Site
St Louis, Missouri, 63110
Pfizer Investigational Site
Sterling, Virginia, 20165
Pfizer Investigational Site
Tampa, Florida, 33609
Pfizer Investigational Site
The Bronx, New York, 10467
Pfizer Investigational Site
Tucson, Arizona, 85724
Pfizer Investigational Site
Upland, Pennsylvania, 19013
Pfizer Investigational Site
Walnut Creek, California, 94598
Pfizer Investigational Site
Winston-Salem, North Carolina, 27103
Pfizer Investigational Site
Winston-Salem, North Carolina, 37103
Canada6 sites
Pfizer Investigational Site
Barrie, Ontario, L4M 4S5
Pfizer Investigational Site
Calgary, Alberta, T2N 2T9
Pfizer Investigational Site
Edmonton, Alberta, T5G 0B7
Pfizer Investigational Site
Edmonton, Alberta, T5H 3V9
Pfizer Investigational Site
London, Ontario, N6A 5A5
Pfizer Investigational Site
Toronto, Ontario, M5C 1R6
About this study
Official title: Pregabalin BID Open-Label Add-On Trial: An Open-Label, Multicenter Follow-On Study to Determine Long-Term Safety and Efficacy in Patients With Partial Seizures.
To evaluate the long-term safety and tolerability of pregabalin in patients with partial seizures.
- Conditions
- Seizure Disorder, Partial
- Being tested
- Pregabalin
- Medical subject headings
- Epilepsies, Partial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Tolerability
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2005 (estimated)
- Study startNov 1999
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seizure Disorder, PartialStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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
- 750 participants
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00141336
- Sponsor's protocol ID
- 1008-035
- Status last verified
- Dec 2006
- First submitted
- 30 Aug 2005
- Last updated
- 1 Jan 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregabalin BID Open-Label Add-On Trial: An Open-Label, Multicenter Follow-On Study to Determine Long-Term Safety and Efficacy in Patients With Partial Seizures.
- ClinicalTrials.gov ID
- NCT00141336
- Acronym / sponsor ID
- 1008-035
- Conditions
- Seizure Disorder, Partial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 750 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 1999
- Study completion
- Jul 2005
- First posted
- 1 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the long-term safety and tolerability of pregabalin in patients with partial seizures.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Must have met the inclusion criteria for preceding double-blind study
- Have received double-blind study medication and wish to receive open-label pregabalin.
Key exclusion criteria (1 listed)
- Cannot have absence 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 |
|---|---|---|
| Pregabalin | Drug | – |
Primary outcome
Safety Tolerability
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2007.
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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
103 sites in 2 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 Seizure Disorder, Partial, run by Pfizer at 103 sites in 2 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 1 Jan 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 103 sites in United States, Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety Tolerability. 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 1 Jan 2007.