Seizure Disorder, PartialPhase 3NCT00141388
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 56 sites in 2 countries.
Trial summary
To evaluate the long-term safety and efficacy of pregabalin in patients with partial seizures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Seizure Disorder, Partial
- What is being tested?
- Pregabalin
- How many people
- 455 participants
- Where
- 56 sitesin 2 countries
- Study dates
- Jul 1998to Oct 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must have met the inclusion criteria for the 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
56 sites in 2 countries.
56 sites in 2 countries
United States48 sites
Pfizer Investigational Site
Ann Arbor, Michigan, 48108
Pfizer Investigational Site
Ann Arbor, Michigan, 48109
Pfizer Investigational Site
Baltimore, Maryland, 21201
Pfizer Investigational Site
Baltimore, Maryland, 21224
Pfizer Investigational Site
Bennington, Vermont, 05201
Pfizer Investigational Site
Birmingham, Alabama, 35249
Pfizer Investigational Site
Birmingham, Alabama, 35255
Pfizer Investigational Site
Birmingham, Alabama, 35294-0021
Pfizer Investigational Site
Boston, Massachusetts, 02130
Pfizer Investigational Site
Boston, Massachusetts, 02215
Pfizer Investigational Site
Chesterfield, Missouri, 63017
Pfizer Investigational Site
Chicago, Illinois, 60612
Pfizer Investigational Site
Cleveland, Ohio, 44195
Pfizer Investigational Site
Columbia, Missouri, 65212
Pfizer Investigational Site
Columbus, Ohio, 43210
Pfizer Investigational Site
Dallas, Texas, 75230
Pfizer Investigational Site
Gainesville, Florida, 32608-1197
Pfizer Investigational Site
Gainesville, Florida, 32610
Pfizer Investigational Site
Greenbelt, Maryland, 20770
Pfizer Investigational Site
Indianapolis, Indiana, 46202
Pfizer Investigational Site
Indianapolis, Indiana, 46254
Pfizer Investigational Site
Iowa City, Iowa, 52242
Pfizer Investigational Site
Kansas City, Kansas, 66160-7314
Pfizer Investigational Site
Kansas City, Kansas, 66160
Pfizer Investigational Site
Lebanon, New Hampshire, 03756
Pfizer Investigational Site
Little Rock, Arkansas, 72205
Pfizer Investigational Site
Los Angeles, California, 90033
Pfizer Investigational Site
Louisville, Kentucky, 40205
Pfizer Investigational Site
Miami, Florida, 33136
Pfizer Investigational Site
Nashville, Tennessee, 37232
Pfizer Investigational Site
New York, New York, 10016
Pfizer Investigational Site
New York, New York, 10032
Pfizer Investigational Site
Pasadena, California, 91105
Pfizer Investigational Site
Phoenix, Arizona, 85006
Pfizer Investigational Site
Plantation, Florida, 33317
Pfizer Investigational Site
Portland, Oregon, 97227
Pfizer Investigational Site
Rochester, New York, 14642
Pfizer Investigational Site
Saint Paul, Minnesota, 55102
Pfizer Investigational Site
San Antonio, Texas, 78229
Pfizer Investigational Site
Spring Hill, Florida, 34609
Pfizer Investigational Site
Springfield, Illinois, 62702
Pfizer Investigational Site
Springfield, Illinois, 62704
Pfizer Investigational Site
St Louis, Missouri, 63110-1092
Pfizer Investigational Site
St Louis, Missouri, 63110
Pfizer Investigational Site
Tallahassee, Florida, 32308
Pfizer Investigational Site
Tucson, Arizona, 85712-2809
Pfizer Investigational Site
Tucson, Arizona, 85712
Pfizer Investigational Site
Winston-Salem, North Carolina, 27157
Canada8 sites
Pfizer Investigational Site
Edmont, Alberta, T5G 0B7
Pfizer Investigational Site
Edmonton, Alberta, T5H 3V9
Pfizer Investigational Site
London, Ontario, N6A 5A5
Pfizer Investigational Site
Montreal, Quebec, H3A 2B4
Pfizer Investigational Site
Ottawa, Ontario, K1H 8L6
Pfizer Investigational Site
Toronto, Ontario, M4Y 1J3
Pfizer Investigational Site
Vancouver, British Columbia, V52 1M9
Pfizer Investigational Site
Vancouver, British Columbia, V67 1Y6
About this study
Official title: Pregabalin 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 efficacy 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 Efficacy
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 startJul 1998
- Study completionOct 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
- 455 participants (actual)
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
- NCT00141388
- Sponsor's protocol ID
- 1008-010
- Status last verified
- Nov 2009
- First submitted
- 30 Aug 2005
- Last updated
- 6 Nov 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregabalin 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
- NCT00141388
- Acronym / sponsor ID
- 1008-010
- Conditions
- Seizure Disorder, Partial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 455 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jul 1998
- Study completion
- Oct 2005 (actual)
- 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 efficacy 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
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Must have met the inclusion criteria for the 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 Efficacy
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 6 Nov 2009.
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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
56 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 56 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 6 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 56 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 Efficacy. 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 6 Nov 2009.