Seizure Disorder, PartialPhase 3NCT00141245
To Evaluate 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 46 sites in 13 countries.
Trial summary
To evaluate 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
- 325 participants
- Where
- 46 sitesin 13 countries
- Study dates
- Oct 1998to 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 have absence seizures
Trial locations and contacts
46 sites in 13 countries.
46 sites in 13 countries
Germany8 sites
Pfizer Investigational Site
Erlangen, 91054
Pfizer Investigational Site
Freiburg im Breisgau, 79106
Pfizer Investigational Site
Göttingen, D-37075
Pfizer Investigational Site
Hamburg, 22292
Pfizer Investigational Site
Mainz, 55131
Pfizer Investigational Site
Mönchengladbach, 41179
Pfizer Investigational Site
Munich, D-81377
Pfizer Investigational Site
Münster, 48149
Australia6 sites
Pfizer Investigational Site
Chatswood, New South Wales, 2067
Pfizer Investigational Site
Deakin, Australian Capital Territory, 2600
Pfizer Investigational Site
Heidelberg, VIC 3084
Pfizer Investigational Site
Maroochydore, Queensland, 4558
Pfizer Investigational Site
Westmead, New South Wales, 2145
Pfizer Investigational Site
Woodville, 5011
France6 sites
Pfizer Investigational Site
Dijon, 21000
Pfizer Investigational Site
Lyon, Cedex, 69694
Pfizer Investigational Site
Paris, Cedex, 75674
Pfizer Investigational Site
Paris, 75651
Pfizer Investigational Site
Roubaix, 59100
Pfizer Investigational Site
Tours, Cedex, 37044
United Kingdom6 sites
Pfizer Investigational Site
Bimingham, B15 2QZ
Pfizer Investigational Site
Bucks, SL9 ORJ
Pfizer Investigational Site
Dundee, DD1 9ND
Pfizer Investigational Site
Glasgow, G11 6NT
Pfizer Investigational Site
Liverpool, L9 1AE
Pfizer Investigational Site
York, Y03 7HE
Italy4 sites
Pfizer Investigational Site
Florence, 50135
Pfizer Investigational Site
Pavia, 27100
Pfizer Investigational Site
Perugia, 06123
Pfizer Investigational Site
Pisa, 56126
Spain4 sites
Pfizer Investigational Site
Barcelona, 08036
Pfizer Investigational Site
Donostia / San Sebastian, Guipuzcoa, 20014
Pfizer Investigational Site
Girona, Gerona, 17007
Pfizer Investigational Site
Seville, Sevilla, 41013
Austria2 sites
Pfizer Investigational Site
Graz, A-8035
Pfizer Investigational Site
Innsbruck, A-6020
Finland2 sites
Pfizer Investigational Site
Helsinki, 00029
Pfizer Investigational Site
Turku, FIN-20521
Netherlands2 sites
Pfizer Investigational Site
Heemstede, 2103 SW
Pfizer Investigational Site
Heeze, 5591 VE
South Africa2 sites
Pfizer Investigational Site
Durban, 4052
Pfizer Investigational Site
Parow, Cape Town, 7505
Switzerland2 sites
Pfizer Investigational Site
Lavigny, LE, CN-1775
Pfizer Investigational Site
Tschugg, CH-3233
About this study
Official title: Pregabalin Open-Label, Multicenter Add-On Trial Following a 4-Day Double-Blind Transition Period to Determine Long-Term Safety and Efficacy in Patients With Partial Seizures.
To evaluate 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 startOct 1998
- 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
- 325 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
- NCT00141245
- Sponsor's protocol ID
- 1008-012
- 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 Open-Label, Multicenter Add-On Trial Following a 4-Day Double-Blind Transition Period to Determine Long-Term Safety and Efficacy in Patients With Partial Seizures.
- ClinicalTrials.gov ID
- NCT00141245
- Acronym / sponsor ID
- 1008-012
- Conditions
- Seizure Disorder, Partial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 325 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Oct 1998
- Study completion
- Nov 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 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 (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 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
46 sites in 13 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 46 sites in 13 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 46 sites in Germany, Australia, France, United Kingdom, Italy and 8 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 1 Jan 2007.