Epilepsies, PartialPhase 3NCT00143143
Pregabalin Open-Label Extension Trial in Patients With Partial Seizures
A Phase 3 study testing Pregabalin in people with Epilepsies, Partial and Epilepsy, Complex Partial, run by Pfizer at 47 sites in 9 countries.
Trial summary
The primary purpose of the protocol is to evaluate the long-term safety 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
- Epilepsies, Partial, Epilepsy, Complex Partial
- What is being tested?
- Pregabalin
- How many people
- 300 participants
- Where
- 47 sitesin 9 countries
- Study dates
- Sep 2001to Feb 2006
- 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
- Patients must have met the inclusion criteria for Study 1008-157, have received double-blind study medication, and wish to receive open-label pregabalin
- Have the diagnosis of epilepsy with partial seizures and have a minimum of 4 partial seizures during the 6 weeks prior to screening
- Be currently taking 1 to 3 AEDs.
Who cannot join
- Have a treatable cause of seizures
- Experienced a serious adverse event during Study 1008-157 which was determined to be possibly related to study medication
Trial locations and contacts
47 sites in 9 countries.
47 sites in 9 countries
Germany11 sites
Pfizer Investigational Site
Berlin, 10365
Pfizer Investigational Site
Berlin, 13353
Pfizer Investigational Site
Bielefeld, 33617
Pfizer Investigational Site
Bonn, 53127
Pfizer Investigational Site
Essen, 45147
Pfizer Investigational Site
Frankfurt, 60528
Pfizer Investigational Site
Freiburg im Breisgau, 79106
Pfizer Investigational Site
Göttingen, D-37075
Pfizer Investigational Site
Kehl, 77694
Pfizer Investigational Site
Marburg, 35039
Pfizer Investigational Site
Ulm, 89075
France9 sites
Pfizer Investigational Site
Colomiers, 31770
Pfizer Investigational Site
Dommartin-lès-Toul, 54201
Pfizer Investigational Site
Lille, Cedex, 59037
Pfizer Investigational Site
Marseille, Cedex 05, 13005
Pfizer Investigational Site
Marseille, 13274
Pfizer Investigational Site
Montpellier, Cedex 5, 34295
Pfizer Investigational Site
Paris, Cedex 13, 75651
Pfizer Investigational Site
Rennes, Cedex, 35033
Pfizer Investigational Site
Strasbourg, 67091
Canada8 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
Halifax, Nova Scotia, B3H 3A7
Pfizer Investigational Site
London, Ontario, N6A 5A5
Pfizer Investigational Site
Ottawa, Ontario, K1H 8L6
Pfizer Investigational Site
Trois-Rivières, Quebec, G8Z 4K4
Pfizer Investigational Site
Vancouver, British Columbia, V5Z 1M9
Spain5 sites
Pfizer Investigational Site
Barcelona, Barcelona, 08036
Pfizer Investigational Site
Donostia / San Sebastian, 20014
Pfizer Investigational Site
Girona, Gerona, 17007
Pfizer Investigational Site
Madrid, Madrid, 28034
Pfizer Investigational Site
Madrid, Madrid, 28040
Austria4 sites
Pfizer Investigational Site
Innsbruck, A6020
Pfizer Investigational Site
Mauer bei Amstetten, 3362
Pfizer Investigational Site
Sankt Pölten, A3100
Pfizer Investigational Site
Vienna, 1090
Italy4 sites
Pfizer Investigational Site
Florence, 50122
Pfizer Investigational Site
Perugia, 06123
Pfizer Investigational Site
Pisa, 56126
Pfizer Investigational Site
Siena, 53100
United Kingdom3 sites
Pfizer Investigational Site
Fazakerley, Liverpool, L9 7LJ
Pfizer Investigational Site
Glascow, Scotland, G11 6NT
Pfizer Investigational Site
York, Y031 8HE
Lithuania2 sites
Pfizer Investigational Site
Vilnius, 2600
Pfizer Investigational Site
Vilnius, LT-2600
Location not given1 site
Pfizer Investigational Site
About this study
Official title: Pregabalin BID Open-Label Add-On Trial: A Follow-Up Study To Determine Long-Term Safety and Efficacy in Patients With Partial Seizures
The primary purpose of the protocol is to evaluate the long-term safety of pregabalin in patients with partial seizures.
- Conditions
- Epilepsies, Partial, Epilepsy, Complex Partial
- Being tested
- Pregabalin
- Medical subject headings
- Epilepsies, Partial, Epilepsy, Complex 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 assessments are performed at quarterly visits up until the study is closed.
Secondary outcomes (1)
Seizure frequency is assessed throughout the study until the study is closed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2005 (estimated)
- Study startSep 2001
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epilepsies, 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
- 300 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
- NCT00143143
- Sponsor's protocol ID
- 1008-000-164
- Status last verified
- Mar 2006
- First submitted
- 30 Aug 2005
- Last updated
- 24 Jul 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregabalin BID Open-Label Add-On Trial: A Follow-Up Study To Determine Long-Term Safety and Efficacy in Patients With Partial Seizures
- ClinicalTrials.gov ID
- NCT00143143
- Acronym / sponsor ID
- 1008-000-164
- Conditions
- Epilepsies, Partial, Epilepsy, Complex Partial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Sep 2001
- Study completion
- Feb 2006
- First posted
- 2 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.
The primary purpose of the protocol is to evaluate the long-term safety 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 (3 listed)
- Patients must have met the inclusion criteria for Study 1008-157, have received double-blind study medication, and wish to receive open-label pregabalin
- Have the diagnosis of epilepsy with partial seizures and have a minimum of 4 partial seizures during the 6 weeks prior to screening
- Be currently taking 1 to 3 AEDs.
Key exclusion criteria (2 listed)
- Have a treatable cause of seizures
- Experienced a serious adverse event during Study 1008-157 which was determined to be possibly related to study medication
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 assessments are performed at quarterly visits up until the study is closed.
1 secondary outcome
Seizure frequency is assessed throughout the study until the study is closed.
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 24 Jul 2006.
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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
47 sites in 9 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 Epilepsies, Partial and Epilepsy, Complex Partial, run by Pfizer at 47 sites in 9 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 3 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 24 Jul 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in Germany, France, Canada, Spain, Austria and 3 more countries. 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 assessments are performed at quarterly visits up until the study is closed.. 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 24 Jul 2006; AzTrials last refreshed its copy on 6 Nov 2026.