Partial SeizuresPhase 3NCT00141258
Pregabalin Epilepsy Add-On Trial
A Phase 3 study testing pregabalin in people with Partial Seizures, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 5 sites in South Korea.
Trial summary
To evaluate the efficacy of pregabalin as adjunctive therapy, using a flexible, optimized dose schedule with dose adjustment based on clinical response and tolerability, compared to placebo in subjects with partial seizures Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Partial Seizures
- What is being tested?
- pregabalin
- How many people
- 178 participants
- Where
- 5 sitesSouth Korea
- Study dates
- Oct 2005to Aug 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
- Have a diagnosis of epilepsy with partial seizures (as defined in the ILAE Classification of Seizures) and be currently taking 1-3 AEDs
- Have a minimum of 4 partial seizures occurring over at least 2 days during the 6-week baseline with no 28-day period free of partial seizures
Who cannot join
- Have a treatable cause of seizures
- Are currently receiving treatment with CNS-active compounds (exception: single antidepressant, hypnotics, and standard AEDs), vigabatrin, Felbatol (felbamate), Neurontin (gabapentin)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
South Korea5 sites
Pfizer Investigational Site
Daegu
Pfizer Investigational Site
Daejeon
Pfizer Investigational Site
Gwangju
Pfizer Investigational Site
Incheon
Pfizer Investigational Site
Seoul
About this study
Official title: Pregabalin Add-On Titration Trial: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy and Safety of Pregabalin (150 mg - 600 mg/Day) Using a Flexible, Optimized Dose Schedule in Subjects With Partial Seizures
To evaluate the efficacy of pregabalin as adjunctive therapy, using a flexible, optimized dose schedule with dose adjustment based on clinical response and tolerability, compared to placebo in subjects with partial seizures
- Conditions
- Partial 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.
Response ratio (RRatio or symmetrized percent change) for all partial seizures
Secondary outcomes (1)
Responder rate, Percent change, Percent of SGTC responders, Seizure freedom measures, Change in number of seizure-free days (SFD) per a 28-day period, Analysis by seizure type, HADS, Weekly and endpoint mean sleep interference scores from DSIS, QOLIE-31
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 2005
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Partial 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 178 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
- NCT00141258
- Sponsor's protocol ID
- A0081079
- Status last verified
- Apr 2009
- First submitted
- 30 Aug 2005
- Last updated
- 22 Jan 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregabalin Add-On Titration Trial: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy and Safety of Pregabalin (150 mg - 600 mg/Day) Using a Flexible, Optimized Dose Schedule in Subjects With Partial Seizures
- ClinicalTrials.gov ID
- NCT00141258
- Acronym / sponsor ID
- A0081079
- Conditions
- Partial Seizures
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2005
- Study completion
- Aug 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 evaluate the efficacy of pregabalin as adjunctive therapy, using a flexible, optimized dose schedule with dose adjustment based on clinical response and tolerability, compared to placebo in subjects with partial seizures
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Have a diagnosis of epilepsy with partial seizures (as defined in the ILAE Classification of Seizures) and be currently taking 1-3 AEDs
- Have a minimum of 4 partial seizures occurring over at least 2 days during the 6-week baseline with no 28-day period free of partial seizures
Key exclusion criteria (2 listed)
- Have a treatable cause of seizures
- Are currently receiving treatment with CNS-active compounds (exception: single antidepressant, hypnotics, and standard AEDs), vigabatrin, Felbatol (felbamate), Neurontin (gabapentin)
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
Response ratio (RRatio or symmetrized percent change) for all partial seizures
1 secondary outcome
Responder rate, Percent change, Percent of SGTC responders, Seizure freedom measures, Change in number of seizure-free days (SFD) per a 28-day period, Analysis by seizure type, HADS, Weekly and endpoint mean sleep interference scores from DSIS, QOLIE-31
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 22 Jan 2021.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Partial Seizures
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A Study to Evaluate the Efficacy and Safety of Cannabidiol Oral Solution (CBD-OS [GWP42003-P, JZP926]) for the Treatment of Focal-Onset Seizures
Focal Seizures
Enrolling by invitationPhase 2
SPN-817 Open-Label Extension Study in Adults With Focal Onset Seizures
Focal Onset Seizures
Active, not recruitingPhase 4
Open-label Study of Cenobamate Monotherapy in Adult Subjects With Newly Diagnosed or Recurrent Partial-Onset Epilepsy
Focal Onset Seizure
RecruitingObservational study
Investigating Epilepsy: Screening and Evaluation
Seizures, Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy
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
5 sites in 1 country: 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 Partial Seizures, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 5 sites in South Korea.
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 22 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 5 sites in South Korea. 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?
Response ratio (RRatio or symmetrized percent change) for all partial seizures. 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 22 Jan 2021.