EpilepsyNCT00684424
Non-Interventional Study With LYRICA (Pregabalin) In Patients With Epilepsy As Adjunctive Therapy Of Partial Seizures To Reduce Seizure Frequency
An observational study of Epilepsy, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc..
Trial summary
The primary efficacy parameter will be the responder rate, defined as the proportion of subjects who had at least a 50% reduction in 28 day seizure rate during the maintenance phase Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- Non-Interventional Study
- How many people
- 199 participants
- Where
- No sites listed yet
- Study dates
- Jul 2008to Mar 2009
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study population: outpatients
Who may be able to join
- age over 18 years old, patients with epilepsia with partial seizures
- Enrollment to study is fully on physician decision in compliance with current SPC.
Who cannot join
- Patient who did not meet indication according to SPC Lyrica
About this study
Official title: Non-Interventional Study (NIS) With Lyrica In Patients With Epilepsy As Adjunctive Therapy Of Partial Seizures To Reduce Seizure Frequency
The primary efficacy parameter will be the responder rate, defined as the proportion of subjects who had at least a 50% reduction in 28 day seizure rate during the maintenance phase
- Conditions
- Epilepsy
- Being tested
- Non-Interventional Study
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Interventional StudyOther
Observational Only
| Study group | Role | What they receive |
|---|---|---|
| Outpatients with epilepsy | Not described Receives: Other: Non-Interventional Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responders: Number of Subjects With a 50% or Greater Reduction in Seizure Frequency
Responders: number of subjects with a 50 percent (%) or greater reduction in partial seizure frequency from Baseline to Final visit. Seizure frequency in treatment period = total number of partial seizures in maintenance treatment phase * 28 divided by total number of days in the maintenance treatment phase. Missing category includes subjects with missing attack date, insufficient length of treatment period or no seizures in both baseline and treatment periods. Subjects with zero seizures in the baseline period and some seizures in the treatment period were treated as non-responders.
Measured: Baseline through Week 16
Secondary outcomes (11)
Antiepileptic Drugs Used in the Past
Antiepileptic drug history: number of subjects who took each class of antiepileptic drug prior to entering the study. Subjects who took more than one antiepileptic drug were counted for each of the drug classes.
Measured: Baseline
Change in 28 Day Partial Seizure Frequency
Change in 28-day partial seizure frequency between the baseline period and treatment period. Baseline period = the 4 weeks (28 days) prior to Baseline visit. Treatment period = last 12 weeks (84 days) of the study (maintenance treatment phase excluding 4-week titration phase). Seizure frequency in baseline period = total number of partial seizures in baseline phase * 28 divided by total number of days in the baseline phase. Seizure frequency in treatment period = total number of partial seizures in maintenance treatment phase * 28 divided by total number of days in maintenance treatment phase.
Measured: Baseline through Week 16 (Final Visit )
Seizure Freedom: Number of Seizure-free Subjects During the Last 4 Weeks of the Study
Seizure Freedom (responders): subjects with no seizures (partial or other) during the last 4 weeks of the study. Non-responders: subjects with seizures (partial or other)during the last 4 weeks of the study. Subjects, who discontinued less than 4 weeks into the observation period were excluded from analysis. The 4 week period excludes the titration phase of the study. Missing category includes subjects with missing attack date or insufficient length of treatment period.
Measured: Week 8 up to Week 16 (Last 4 weeks of the treatment period)
Concomitant Drug Treatments
Concomitant drugs treatments (drugs other than, and in addition to study medication): number of subjects who took each concomitant drug during the study (baseline through end of study). World Health Organization (WHO) Drug (v02Q2) coding dictionary applied.
Measured: Baseline through Week 16 (Final Visit)
Average Dosage of Pregabalin Taken at Baseline and Final Visit
Average doses of pregabalin in milligrams per day (mg/day) taken at baseline and final visit shown by number of participants at each dose.
Measured: Baseline, Week 16 (Final Visit )
Visual Analog Scale of Anxiety (VAS-A)
Visual Analog Scale of anxiety self assessment: metric measurement (in 2 mm interval) from the visual analog scale; 0 mm = no anxiety, 100 mm = extreme anxiety at each visit.
Measured: Baseline, Week 4, Week 16 (Final Visit), Last Observation Carried Forward
Change From Baseline to Final Visit in Visual Analog Scale of Anxiety (VAS-A)
Visual Analog Scale of anxiety self assessment: metric measurement (in 2 mm interval) from the visual analog scale; 0 mm = no anxiety, 100 mm = extreme anxiety. Change from Baseline to Final Visit: score at final visit minus score at baseline.
Measured: Baseline, Week 16 (Final Visit), Last Observation Carried Forward
Number of Subjects With Categorical Scores on Clinical Global Impression of Severity (CGI-S)
CGI-S scale: physician's global impression of a subject's clinical condition, at baseline in terms of severity. Numerical scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill subjects). Numbers of subjects in each category are presented.
Measured: Baseline
Number of Subjects With Categorical Scores on Clinical Global Impression of Change(CGI-C)
CGI-C scale: physician's global impression of a subject's clinical condition in terms of change from baseline. Improvement = CGI response of very much improved, much improved, or minimally improved. No Change = CGI response of no change. Worsening = CGI response of very much worse, much worse or minimally worse.
Measured: Week 16 (Final Visit)
Medical Outcomes Sleep Scale (MOS-S)
MOS-S: subject reported measure with 12 items that assess key constructs of sleep over the past week. Scoring based on 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes:1, no:0). Six(6) and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = greater intensity of attribute.
Measured: Baseline, Week 16 (Final Visit )
Number of Subjects With Change in Response Categories in Medical Outcomes Sleep Scale (MOS-S): Optimal Sleep Subscale
MOS: subject rated questionnaire to assess sleep quality and quantity. Optimal sleep subscale is derived from Sleep Quantity average hours of sleep each night during the past week. Number of subjects with response: YES (Optimal) if sleep quantity was 7 or 8 hours per night, or response = NO (Non-Optimal) if sleep quantity was less than (<) 7 hours per night. Number of participants with shift in response categories from Baseline to Final Visit.
Measured: Baseline, Week 16 (Final Visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2008 (estimated)
- Study startJul 2008
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for EpilepsyStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 199 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
- NCT00684424
- Sponsor's protocol ID
- A0081213
- Status last verified
- May 2010
- First submitted
- 22 May 2008
- Last updated
- 10 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Interventional Study (NIS) With Lyrica In Patients With Epilepsy As Adjunctive Therapy Of Partial Seizures To Reduce Seizure Frequency
- ClinicalTrials.gov ID
- NCT00684424
- Acronym / sponsor ID
- A0081213
- Conditions
- Epilepsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 26 May 2008 (estimated)
- Results
- Posted 24 Jun 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary efficacy parameter will be the responder rate, defined as the proportion of subjects who had at least a 50% reduction in 28 day seizure rate during the maintenance phase
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Outpatients with epilepsy | – | Other: Non-Interventional Study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- outpatients
Key inclusion criteria (2 listed)
- age over 18 years old, patients with epilepsia with partial seizures
- Enrollment to study is fully on physician decision in compliance with current SPC.
Key exclusion criteria (1 listed)
- Patient who did not meet indication according to SPC Lyrica
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 |
|---|---|---|
| Non-Interventional StudyObservational Only | Other | Outpatients with epilepsy |
Primary outcome
Responders: Number of Subjects With a 50% or Greater Reduction in Seizure Frequency
Time frame: Baseline through Week 16
Responders: number of subjects with a 50 percent (%) or greater reduction in partial seizure frequency from Baseline to Final visit. Seizure frequency in treatment period = total number of partial seizures in maintenance treatment phase * 28 divided by total number of days in the maintenance treatment phase. Missing category includes subjects with missing attack date, insufficient length of treatment period or no seizures in both baseline and treatment periods. Subjects with zero seizures in the baseline period and some seizures in the treatment period were treated as non-responders.
11 secondary outcomes
Antiepileptic Drugs Used in the Past
Time frame: Baseline
Change in 28 Day Partial Seizure Frequency
Time frame: Baseline through Week 16 (Final Visit )
Seizure Freedom: Number of Seizure-free Subjects During the Last 4 Weeks of the Study
Time frame: Week 8 up to Week 16 (Last 4 weeks of the treatment period)
Concomitant Drug Treatments
Time frame: Baseline through Week 16 (Final Visit)
Average Dosage of Pregabalin Taken at Baseline and Final Visit
Time frame: Baseline, Week 16 (Final Visit )
Visual Analog Scale of Anxiety (VAS-A)
Time frame: Baseline, Week 4, Week 16 (Final Visit), Last Observation Carried Forward
Change From Baseline to Final Visit in Visual Analog Scale of Anxiety (VAS-A)
Time frame: Baseline, Week 16 (Final Visit), Last Observation Carried Forward
Number of Subjects With Categorical Scores on Clinical Global Impression of Severity (CGI-S)
Time frame: Baseline
Number of Subjects With Categorical Scores on Clinical Global Impression of Change(CGI-C)
Time frame: Week 16 (Final Visit)
Medical Outcomes Sleep Scale (MOS-S)
Time frame: Baseline, Week 16 (Final Visit )
Number of Subjects With Change in Response Categories in Medical Outcomes Sleep Scale (MOS-S): Optimal Sleep Subscale
Time frame: Baseline, Week 16 (Final Visit)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc..
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 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jun 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Responders: Number of Subjects With a 50% or Greater Reduction in Seizure Frequency (time frame: Baseline through Week 16). 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 10 Feb 2021.