Epilepsy, PartialPhase 2NCT00141414
To Evaluate the Long-Term Safety of Pregabalin in Refractory Partial Epilepsy.
A Phase 2 study testing Pregabalin in people with Epilepsy, Partial, run by Pfizer at 25 sites in 2 countries.
Trial summary
To evaluate the long-term safety of pregabalin in refractory partial epilepsy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy, Partial
- What is being tested?
- Pregabalin
- How many people
- 82 participants
- Where
- 25 sitesin 2 countries
- Study dates
- Nov 1997to Oct 2005
- Phase
- Phase 2
- 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 preceding double-blind study.
- Have received double-blind study medication and wish to receive open-label pregabalin.
Who cannot join
- Pregnant or considering becoming pregnant.
- Receiving any concomitant medication that could alter the effectiveness of their medication response or seizure frequency.
Trial locations and contacts
25 sites in 2 countries.
25 sites in 2 countries
United States24 sites
Pfizer Investigational Site
Ann Arbor, Michigan, 48108-0768
Pfizer Investigational Site
Baltimore, Maryland, 21201
Pfizer Investigational Site
Baltimore, Maryland, 21287
Pfizer Investigational Site
Boston, Massachusetts, 02215
Pfizer Investigational Site
Chesterfield, Missouri, 63017
Pfizer Investigational Site
Cleveland, Ohio, 44195
Pfizer Investigational Site
Columbus, Ohio, 43210
Pfizer Investigational Site
Indianapolis, Indiana, 46202
Pfizer Investigational Site
Indianapolis, Indiana, 46254
Pfizer Investigational Site
Little Rock, Arkansas, 72205
Pfizer Investigational Site
Los Angeles, California, 90033
Pfizer Investigational Site
Madison, Wisconsin, 53715
Pfizer Investigational Site
Madison, Wisconsin, 53792
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
Philadelphia, Pennsylvania, 19104
Pfizer Investigational Site
Plantation, Florida, 33317
Pfizer Investigational Site
Rochester, New York, 14642
Pfizer Investigational Site
Saint Paul, Minnesota, 55102
Pfizer Investigational Site
Stanford, California, 94305
Pfizer Investigational Site
The Bronx, New York, 10467
Pfizer Investigational Site
Winston-Salem, North Carolina, 27157
About this study
Official title: Pregabablin Open-Label, Follow-On Safety Trial In Patients With Refractory Partial Epilepsy.
To evaluate the long-term safety of pregabalin in refractory partial epilepsy.
- Conditions
- Epilepsy, 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
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 1997
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epilepsy, 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 82 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
- NCT00141414
- Sponsor's protocol ID
- 1008-008
- 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
- Pregabablin Open-Label, Follow-On Safety Trial In Patients With Refractory Partial Epilepsy.
- ClinicalTrials.gov ID
- NCT00141414
- Acronym / sponsor ID
- 1008-008
- Conditions
- Epilepsy, Partial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 1997
- Study completion
- Oct 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 of pregabalin in refractory partial epilepsy.
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 preceding double-blind study.
- Have received double-blind study medication and wish to receive open-label pregabalin.
Key exclusion criteria (2 listed)
- Pregnant or considering becoming pregnant.
- Receiving any concomitant medication that could alter the effectiveness of their medication response or seizure frequency.
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
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
25 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pregabalin in people with Epilepsy, Partial, run by Pfizer at 25 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 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 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 25 sites in United States, Germany. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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. 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.