SeizuresPhase 3PREPS EXTNCT00143130
Pregabalin In Partial Seizures Extension Study
A Phase 3 study testing Pregabalin in people with Seizures, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 47 sites in 6 countries.
Trial summary
To evaluate long-term efficacy and safety of pregabalin (150 to 600mg/day) as adjunctive treatment in patients with partial seizures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Seizures
- What is being tested?
- Pregabalin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 227 participants
- Where
- 47 sitesin 6 countries
- Study dates
- Apr 2005to Sep 2007
- 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
- met the inclusion/exclusion criteria for A0081005
- have completed the 21-week study and have shown a significant clinical response and wish to continue treatment
Who cannot join
- Having a treatable cause of seizure.
- Having a progressive neurological or systemic disorder
Trial locations and contacts
47 sites in 6 countries.
47 sites in 6 countries
France18 sites
Pfizer Investigational Site
Bayonne, 64109
Pfizer Investigational Site
Bordeaux, 33076
Pfizer Investigational Site
Grenoble, 38043
Pfizer Investigational Site
Lille, Cedex, 59037
Pfizer Investigational Site
Lyon, Cedex, 69694
Pfizer Investigational Site
Marseille 13, 13009
Pfizer Investigational Site
Marsille, Cedex, 13385
Pfizer Investigational Site
Montpellier, 34295
Pfizer Investigational Site
Nancy, 54000
Pfizer Investigational Site
Nice, Cedex 06002
Pfizer Investigational Site
Paris, Cedex 14, 75674
Pfizer Investigational Site
Paris, 75019
Pfizer Investigational Site
Paris, 75651
Pfizer Investigational Site
Paris, 75674
Pfizer Investigational Site
Rennes, Cedex, 35033
Pfizer Investigational Site
Strasbourg, 67091
Pfizer Investigational Site
Toulouse, 31043
Pfizer Investigational Site
Tours, 37044
Belgium8 sites
Pfizer Investigational Site
Bruges, B-8000
Pfizer Investigational Site
Brussels, 1070
Pfizer Investigational Site
Duffel, B-2570
Pfizer Investigational Site
Ghent, 9000
Pfizer Investigational Site
Leuven, B-3000
Pfizer Investigational Site
Liège, 4000
Pfizer Investigational Site
Tielt, B-8700
Pfizer Investigational Site
Yvoir, 5530
Portugal8 sites
Pfizer Investigational Site
Braga, 4701-965
Pfizer Investigational Site
Coimbra, 3000-075
Pfizer Investigational Site
Funchal, 9000-168
Pfizer Investigational Site
Lisbon
Pfizer Investigational Site
Matosinhos Municipality, 4454-509
Pfizer Investigational Site
Ponta Delgada, 9500-370
Pfizer Investigational Site
Ponta Delgada, 9500
Pfizer Investigational Site
Porto, 4099-001
Poland7 sites
Pfizer Investigational Site
Katowice, 40-635
Pfizer Investigational Site
Krakow, 31-523
Pfizer Investigational Site
Lublin, 27-718
Pfizer Investigational Site
Warsaw, 00-416
Pfizer Investigational Site
Warsaw, 02-097
Pfizer Investigational Site
Warsaw, 02-957
Pfizer Investigational Site
Wroclaw, 50-420
Finland3 sites
Pfizer Investigational Site
Helsinki, 00250
Pfizer Investigational Site
Kuopio, 70210
Pfizer Investigational Site
Tampere, 33520
Switzerland3 sites
Pfizer Investigational Site
Lausanne, CH-1011
Pfizer Investigational Site
Zurich, CH-8008
Pfizer Investigational Site
Zurich, CH-8091
About this study
Official title: Pregabalin in Partial Seizures (PREPS) Extension Study: An 18-month Follow-on Open-label, International, Multicenter Add-on Therapy Trial
To evaluate long-term efficacy and safety of pregabalin (150 to 600mg/day) as adjunctive treatment in patients with partial seizures.
- Conditions
- Seizures
- Being tested
- Pregabalin
- Keywords
- phase 4, open label, seizures, epilepsy, add-on therapy, pregabalin, lyrica
- Medical subject headings
- Seizures, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
Pregabalin
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Not described Receives: Drug: Pregabalin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in seizure frequency.
Measured: 18 months
Secondary outcomes (3)
Seizure-free patients during each 3-month period
Measured: 18 Months
Responder Rate 50% during each 3-month period (proportion of patients with 50% or greater reduction of seizures).
Measured: 18 Months
Responder rate 75% during each 3-month period (proportion of patients with 75% or greater reduction of seizures).
Measured: 18 Months
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 startApr 2005
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SeizuresStudies of the same condition, open and under way.
- 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
- 227 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00143130
- Sponsor's protocol ID
- A0081015
- Acronym
- PREPS EXT
- Status last verified
- Mar 2015
- First submitted
- 31 Aug 2005
- Last updated
- 28 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregabalin in Partial Seizures (PREPS) Extension Study: An 18-month Follow-on Open-label, International, Multicenter Add-on Therapy Trial
- ClinicalTrials.gov ID
- NCT00143130
- Acronym / sponsor ID
- PREPS EXT / A0081015
- Conditions
- Seizures
- Keywords
- phase 4, open label, seizures, epilepsy, add-on therapy, pregabalin, lyrica
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 227 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2005
- Study completion
- Sep 2007 (actual)
- 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.
To evaluate long-term efficacy and safety of pregabalin (150 to 600mg/day) as adjunctive treatment in patients with partial seizures.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: Pregabalin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- met the inclusion/exclusion criteria for A0081005
- have completed the 21-week study and have shown a significant clinical response and wish to continue treatment
Key exclusion criteria (2 listed)
- Having a treatable cause of seizure.
- Having a progressive neurological or systemic disorder
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 |
|---|---|---|
| PregabalinPregabalin | Drug | Single Arm |
Primary outcome
Reduction in seizure frequency.
Time frame: 18 months
3 secondary outcomes
Seizure-free patients during each 3-month period
Time frame: 18 Months
Responder Rate 50% during each 3-month period (proportion of patients with 50% or greater reduction of seizures).
Time frame: 18 Months
Responder rate 75% during each 3-month period (proportion of patients with 75% or greater reduction of seizures).
Time frame: 18 Months
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 28 Jan 2021.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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 6 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 Seizures, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 47 sites in 6 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 28 Jan 2021. 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 France, Belgium, Portugal, Poland, Finland and 1 more country. 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?
Reduction in seizure frequency. (time frame: 18 months). 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 28 Jan 2021; AzTrials last refreshed its copy on 28 Oct 2026.