Seizure Disorder, PartialPhase 3NCT00150293
Evaluation of 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 83 sites in 11 countries.
Trial summary
To determine 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
- 337 participants
- Where
- 83 sitesin 11 countries
- Study dates
- Mar 2002to Nov 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 preceding double-blind study
- Have received double-blind study medication and wish to receive open-label pregabalin.
Who cannot join
- Cannot be pregnant or considering becoming pregnant during the course of the study.
- Cannot be receiving any concomitant medication that could alter the effectiveness of the pregabalin response or affect seizure frequency.
Trial locations and contacts
83 sites in 11 countries.
83 sites in 11 countries
Poland18 sites
Pfizer Investigational Site
Bialystok, 15-276
Pfizer Investigational Site
Bydgoszcz, 85-826
Pfizer Investigational Site
Choroszcz, 16-070
Pfizer Investigational Site
Gdansk, 80-211
Pfizer Investigational Site
Gdansk, 82-803
Pfizer Investigational Site
Grudziądz, 86-300
Pfizer Investigational Site
Katowice, 46-645
Pfizer Investigational Site
Krakow, 31-112
Pfizer Investigational Site
Lublin, 20-718
Pfizer Investigational Site
Mosina, 62-050
Pfizer Investigational Site
Olsztyn, 10-561
Pfizer Investigational Site
Płock, 09-402
Pfizer Investigational Site
Poznan, 60-780
Pfizer Investigational Site
Poznan, 61-285
Pfizer Investigational Site
Torun, 87-100
Pfizer Investigational Site
Warsaw, 00-909
Pfizer Investigational Site
Warsaw, 02-957
Pfizer Investigational Site
Warsaw
Canada16 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
Montreal, Quebec, H1T 2M4
Pfizer Investigational Site
Montreal, Quebec, H2L 4M1
Pfizer Investigational Site
Montreal, Quebec, H3A 2B4
Pfizer Investigational Site
Ottawa, Ontario, K1L 8L6
Pfizer Investigational Site
Penticton, British Columbia, V2A 4V8
Pfizer Investigational Site
Québec, Quebec, G1J 1Z4
Pfizer Investigational Site
Regina, Saskatchewan, S4T 1A5
Pfizer Investigational Site
Saskatoon, Saskatchewan, S7N 0W8
Pfizer Investigational Site
Toronto, Ontario, M5T 2S8
Pfizer Investigational Site
Vancouver, British Columbia, V5Z 1M9
Pfizer Investigational Site
Windsor, Ontario, N8X5A6
Germany13 sites
Pfizer Investigational Site
Berlin, BE10362
Pfizer Investigational Site
Bernau, 16321
Pfizer Investigational Site
Bonn, 53127
Pfizer Investigational Site
Dresden, 01307
Pfizer Investigational Site
Erlangen, 91054
Pfizer Investigational Site
Essen, 45147
Pfizer Investigational Site
Frankfurt, HE 60528
Pfizer Investigational Site
Freiburg im Breisgau, 79106
Pfizer Investigational Site
Göttingen, D-37075
Pfizer Investigational Site
Hamburg, D-22337
Pfizer Investigational Site
Mainz, 55101
Pfizer Investigational Site
München, 81377
Pfizer Investigational Site
Ulm, Baden-Wurttemberg, 89081
United Kingdom9 sites
Pfizer Investigational Site
Blackpool, FY3 8BP
Pfizer Investigational Site
Dundee, DD1 9SY
Pfizer Investigational Site
Glasgow, G11 6NT
Pfizer Investigational Site
Leeds, LS9 7TF
Pfizer Investigational Site
London, E1 1BB
Pfizer Investigational Site
Middlesbrough, N. York, TS5 5AZ
Pfizer Investigational Site
Northampton, NN1 5BD
Pfizer Investigational Site
Washington, Tyne & Wear, NE38 9JZ
Pfizer Investigational Site
Wolverhampton, WV10 0QP
Australia8 sites
Pfizer Investigational Site
Cairns, Queensland, 4870
Pfizer Investigational Site
Camperdown, New South Wales, 2050
Pfizer Investigational Site
Chastwood, New South Wales, 2067
Pfizer Investigational Site
Deakin, Australian Capital Territory, 2600
Pfizer Investigational Site
Footscray, Victoria, 3011
Pfizer Investigational Site
Maroochydore, Queensland, 4558
Pfizer Investigational Site
Parkville, Victoria, 3050
Pfizer Investigational Site
Perth, Western Australia, 6001
Spain7 sites
Pfizer Investigational Site
Barcelona, Barcelona, 08036
Pfizer Investigational Site
Girona, 17007
Pfizer Investigational Site
Granada, Granada, 18013
Pfizer Investigational Site
Madrid, 28034
Pfizer Investigational Site
Madrid, 28040
Pfizer Investigational Site
Málaga, Malaga, 29010
Pfizer Investigational Site
Zaragoza, Zaragoza, 50009
Austria5 sites
Pfizer Investigational Site
Auenbruggerplatz 22, A-8035 GRAZ
Pfizer Investigational Site
Graz, 8020
Pfizer Investigational Site
Innsbruck, A6020
Pfizer Investigational Site
Linz, 4020
Pfizer Investigational Site
Vienna, 1220
Netherlands3 sites
Pfizer Investigational Site
AE Breda, 4836
Pfizer Investigational Site
Blaricum, 1261 AN
Pfizer Investigational Site
Ve Heeze, 5591
Portugal2 sites
Pfizer Investigational Site
Coimbra, 3000-075
Pfizer Investigational Site
Porto, 4099
Location not given1 site
Pfizer Investigational Site
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 determine 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 posted8 Sep 2005 (estimated)
- Study startMar 2002
- Study completionNov 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
- 337 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
- NCT00150293
- Sponsor's protocol ID
- 1008-114
- Status last verified
- Mar 2015
- First submitted
- 6 Sep 2005
- Last updated
- 5 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2015. 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
- NCT00150293
- Acronym / sponsor ID
- 1008-114
- Conditions
- Seizure Disorder, Partial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 337 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Mar 2002
- Study completion
- Nov 2005
- First posted
- 8 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 determine 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 preceding double-blind study
- Have received double-blind study medication and wish to receive open-label pregabalin.
Key exclusion criteria (2 listed)
- Cannot be pregnant or considering becoming pregnant during the course of the study.
- Cannot be receiving any concomitant medication that could alter the effectiveness of the pregabalin response or affect 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 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 5 Mar 2015.
Related trials for Seizure Disorder, Partial
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Focal Seizure, Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy
Active, not recruitingPhase 2
A Study to Evaluate XEN1101 as Adjunctive Therapy in Focal Epilepsy
Focal Epilepsy
Not yet recruiting
Electrophysiological Dose-Response to Anterior Thalamic Deep Brain Stimulation in Drug-Resistant Focal Epilepsy
Drug Resistant Epilepsy, Focal Epilepsy
Enrolling by invitationPhase 3
An Open-label Study of XEN1101 in Epilepsy
Focal Epilepsy, Tonic-Clonic Seizures
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
83 sites in 11 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 83 sites in 11 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 5 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 83 sites in Poland, Canada, Germany, United Kingdom, Australia and 5 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 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 5 Mar 2015.