SeizuresPhase 4NCT00141427
Pregabalin In Partial Seizures: An Open-Label, International, Multicenter Add-On Therapy Trial.
A Phase 4 study testing Pregabalin in people with Seizures, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 57 sites in 9 countries.
Trial summary
To assess the clinical improvement (change in seizure frequency), safety and tolerability of patients with partial seizures following adjunctive therapy of pregabalin BID in addition to existing standard AEDs. 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
- How many people
- 540 participants
- Where
- 57 sitesin 9 countries
- Study dates
- Nov 2004to May 2006
- Phase
- Phase 4
- 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
- Male and female subjects with a diagnosis of partial epilepsy.
- 18 years and older.
Who cannot join
- Having a treatable cause of seizure.
- Having a progressive neurological or systemic disorder
Trial locations and contacts
57 sites in 9 countries.
57 sites in 9 countries
France17 sites
Pfizer Investigational Site
Bayonne, 64109
Pfizer Investigational Site
Bordeaux, 33076
Pfizer Investigational Site
Grenoble, 38043
Pfizer Investigational Site
Lille, 59037
Pfizer Investigational Site
Lyon, Cedex, 69694
Pfizer Investigational Site
Marseille, Cedex 05, 13005
Pfizer Investigational Site
Marseille, 13009
Pfizer Investigational Site
Montpellier, Cedex 5, 34295
Pfizer Investigational Site
Nancy, 54000
Pfizer Investigational Site
Nice, 06031
Pfizer Investigational Site
Paris, 75013
Pfizer Investigational Site
Paris, 75014
Pfizer Investigational Site
Paris, 75019
Pfizer Investigational Site
Rennes, 35033
Pfizer Investigational Site
Strasbourg, 67091
Pfizer Investigational Site
Toulouse, 31403
Pfizer Investigational Site
Tours, 37044
Belgium8 sites
Pfizer Investigational Site
Bruges, 8000
Pfizer Investigational Site
Brussels, B-1070
Pfizer Investigational Site
Duffel, 2570
Pfizer Investigational Site
Ghent, 9000
Pfizer Investigational Site
Leuven, 3000
Pfizer Investigational Site
Liège, B-4000
Pfizer Investigational Site
Tielt, 8700
Pfizer Investigational Site
Yvoir, 5530
Netherlands7 sites
Pfizer Investigational Site
Alkmaar, NL-1815 JD
Pfizer Investigational Site
Breda
Pfizer Investigational Site
Heeze, 5591 VE
Pfizer Investigational Site
Hilversum, NL-1213 XZ
Pfizer Investigational Site
Oss, 5342 BT
Pfizer Investigational Site
Southwest Heemstede, 2103
Pfizer Investigational Site
The Hague, South Holland, 2512 VA
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
Portugal6 sites
Pfizer Investigational Site
Braga, 4701-965
Pfizer Investigational Site
Funchal, 9000-168
Pfizer Investigational Site
Lisbon, 1169-050
Pfizer Investigational Site
Matosinhos Municipality, 4454-509
Pfizer Investigational Site
Ponta Delgada, 9500-370
Pfizer Investigational Site
Porto, 4099-001
United Kingdom5 sites
Pfizer Investigational Site
Cambridge, Cambs, CB2 2QQ
Pfizer Investigational Site
Glasgow, G11 6NT
Pfizer Investigational Site
Oxford, OX2 6HE
Pfizer Investigational Site
Plymouth, Devon, PL6 8DH
Pfizer Investigational Site
Truro, Cornwall, TR1 3LJ
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, 8008
Pfizer Investigational Site
Zurich, 8091
Location not given1 site
Pfizer Investigational Site
About this study
Official title: Pregabalin In Partial Seizures (Preps) : An Open-Label, International, Multicenter Add-On Therapy Trial
To assess the clinical improvement (change in seizure frequency), safety and tolerability of patients with partial seizures following adjunctive therapy of pregabalin BID in addition to existing standard AEDs.
- Conditions
- Seizures
- Being tested
- Pregabalin
- Medical subject headings
- Seizures
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.
Reduction in seizure frequency.
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 2004
- Study completionMay 2006
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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 540 participants
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
- NCT00141427
- Sponsor's protocol ID
- A0081005
- Status last verified
- Jun 2006
- First submitted
- 31 Aug 2005
- Last updated
- 25 Jan 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregabalin In Partial Seizures (Preps) : An Open-Label, International, Multicenter Add-On Therapy Trial
- ClinicalTrials.gov ID
- NCT00141427
- Acronym / sponsor ID
- A0081005
- Conditions
- Seizures
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 540 participants
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2004
- Study completion
- May 2006 (actual)
- 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 assess the clinical improvement (change in seizure frequency), safety and tolerability of patients with partial seizures following adjunctive therapy of pregabalin BID in addition to existing standard AEDs.
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)
- Male and female subjects with a diagnosis of partial epilepsy.
- 18 years and older.
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 |
|---|---|---|
| Pregabalin | Drug | – |
Primary outcome
Reduction in seizure frequency.
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 25 Jan 2021.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Seizures
RecruitingPhase 3
Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
Seizures, Lennox Gastaut Syndrome
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Focal Seizure, Epilepsy
RecruitingPhase 3
A Study to Test the Efficacy and Safety of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures
Stereotypical Prolonged Seizures
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy
Not yet recruitingPhase 4
Study of Electrocardiogram (ECG) Safety of Sezaby in Neonatal Seizures
Neonatal Seizure
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
57 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pregabalin in people with Seizures, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 57 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 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 25 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 57 sites in France, Belgium, Netherlands, Poland, Portugal 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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.. 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 25 Jan 2021.